Pharmaceutical News: Pharmaceutical company recalls high blood pressure drugs over dangerous labelling mix-up

Pharmaceutical company recalls high blood pressure drugs over dangerous labelling mix-up

A pharmaceutical company has launched a voluntary recall of a drug which may have been mislabelled — with possible “life-threatening” consequences for patients with high blood pressure, says Health Canada.

Following a complaint by a pharmacist regarding a prescription product containing the wrong medication, Mylan Pharmaceuticals is recalling one lot of Mylan-Minocycline 50 mg capsules and Mylan-Amlodipine 5 mg tablets, both sold in bottles of 100.

The risk, says Health Canada, is that patients sensitive to tetracyclines or minocycline may be taking minocycline in error, due to mislabelled bottles.

“In addition, a patient who requires MYLAN-AMLODIPINE for their high blood pressure or angina will not get the medication needed to help them treat these conditions,” said a Health Canada statement.

Mylan-Amlodipine is used to treat high blood pressure and chest pains. Mylan-Minocycline is used to treat certain types of skin infections, urinary tract infections, gallbladder infections, and respiratory tract infections such as bronchitis, pneumonia, and sinusitis.

According to Mylan Pharmaceuticals, the company was contacted in mid-March by a pharmacist who reported that she had ordered four 100-count bottles of Mylan-Minocycline and received one bottle labelled as Mylan-Amlodipine which actually contained Mylan-Minocycline tablets.

The company says its quality investigation, which is ongoing, revealed a labelling error in which the labels for the Mylan-Amlodipine 5 mg tablets were mixed in with labels for the Mylan-Minocycline 50 mg capsules.

The company is advising pharmacists and wholesalers to return all quantities of lot number 1037180 to Mylan Pharmaceuticals.

Health Canada urges consumers to contact their doctors of pharmacists with any questions, and to contact Health Canada to report any adverse reactions possibly linked to the drugs.

Cortex Pharmaceuticals (CORX.OB) Shares Surge on Q4, FY2010 Results, Recent Business Highlights

Cortex Pharmaceuticals Inc., a neuroscience company focused on novel drug therapies for treating psychiatric disorders, neurological diseases and sleep apnea, surged more than 21% to close at $0.15 today after the company announced its fourth-quarter and year-end results for 2010.

The company reported a net loss applicable to common stock of $(984,000), or $(0.01) per share for the quarter ended December 31, 2010, compared with a net loss of $(1.59 million), or $(0.02) per share for the corresponding prior year period. For the fiscal year ended December 31, 2010, Cortex reported net income applicable to common stock of $(1.62 million), or $(0.02) per share, compared to a net loss of $(10.78 million), or $(0.19) per share, for the corresponding prior year period.

For the year ended December 31, 2010, operating results reflect revenues from the Company’s earlier transaction with Biovail Laboratories International SRL in March 2010 when Cortex sold its rights to CX717 and certain other AMPAKINE® compounds to Biovail as a potential treatment for respiratory depression and vaso-occlusive crises associated with sickle cell disease, an orphan drug indication. Cortex received $10 million from Biovail during 2010.

For the year ended December 31, 2009, the net loss applicable to common stock includes non-cash charges of approximately $(2.34 million), or $(0.04) per share, related to the beneficial conversion feature of preferred stock issued by the company in April 2009 and July 2009.

The company also noted recent business highlights, including top-line results from an exploratory clinical study with AMPAKINE CX1739 in subjects with sleep apnea.

Cortex also announced it received word from Servier, France’s largest privately held pharmaceutical company, of its intent to move forward into phase I clinical studies with the jointly-discovered High Impact AMPAKINE S47445 (CX1632).

The company also noted that it regained worldwide rights to develop and commercialize AMPAKINE compounds for the treatment of schizophrenia and depression; obtained exclusive worldwide rights from the University of California for the combination of AMPAKINE and mGluR5 compounds for the treatment of various conditions; and received a grant from The Michael J. Fox Foundation for Parkinson’s Research to test selected compounds from the AMPAKINE platform for their ability to restore brain function in animal models of Parkinson’s disease.

New CEO of pharmaceutical giant Omnicare promising turnaround

The new CEO of Cincinnati-area pharmaceutical supply giant Omnicare Inc. says he’s ready to put the company back on a growth track and reduce its hefty losses, the Cincinnati Enquirer reports.

John Figueroa took control of Covington, Ky.-based Omnicare (NYSE:OCR) three months ago after its former chief abruptly retired in July. By 2013, he said he’s hoping the company is pulling in double-digit earnings growth as it diversifies and shifts away from practices that contributed to a more than $100 million loss in 2010, the paper reported.

Figueroa acknowledged that officials on both sides of the Ohio River are negotiating as the company looks to consolidate its 700 employees in four regional offices. Omnicare is committed, however, to staying in the Cincinnati region, he said.

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Pharmaceutical Industry Today: NHS trusts fight health secretary over ‘value-added’ drug pricing

NHS trusts fight health secretary over ‘value-added’ drug pricing

Plans by the health secretary, Andrew Lansley, to change the way the NHS agrees drug prices with pharmaceutical companies could leave the health service footing a large bill with no real benefit to patients, the government has been warned.

The NHS Confederation, which represents NHS trusts, says the government is right to pursue pricing based on “value”, but says the scheme risks pouring money into new drugs at the expense of preventing disease or providing palliative care.

“The current process is not perfect and pricing based on value is good in principle. But this is a case of a good idea that has turned into poor policy,” said Nigel Edwards, acting chief executive. “We simply don’t see that the process suggested will achieve what the government wants. These proposals could push up costs without increasing effectiveness, damage public confidence in the decision-making process and fail to spark greater innovation.”

Lansley has said he intends to stop the National Institute for Health and Clinical Excellence (Nice), from banning ineffective and expensive new medicines from use in the NHS.

Until now, Nice has based its decisions on cost-effectiveness and has ruled that some drugs offer too little benefit to the patient to justify the high price. This has proved controversial where the treatment is for a terminal disease, such as cancer, and offers a few more weeks of life, albeit for tens of thousands of pounds.

Nice does not set prices but, where companies’ drugs have been turned down, they have increasingly offered to reduce the cost to the NHS through special-access schemes, where the manufacturer may pay after a patient has received a certain number of treatments.

Companies at present set the price of their drugs but the amount of money they can earn in a year from the NHS is capped under the pharmaceutical price regulation scheme. Lansley wants to replace this with value-added pricing, which would see Nice give guidance on cost-effectiveness, but then allow the price to be negotiated between the company and the Department of Health, making allowance for the innovative nature of the drug and the research and development the company has put in, as well as any social benefit, for instance in relieving the burden on carers.

But in its response to the government’s consultation on value-based pricing, the confederation says this process may not be transparent and risks becoming political. It also does not believe that it will act as an incentive to companies to be innovative – designing the drugs that are needed rather than copying the blockbusters of their rivals.

The amount of money the NHS spends on pharmaceuticals, it says, is not “of a sufficient scale to affect the behaviour of a sector populated by multinational organisations with annual turnovers of tens of billions of dollars”. It questions whether innovation should justify paying a higher premium for drugs and suggests that Nice be asked to design a new pricing scheme.

One patient group, Myeloma UK, said it had reservations about the scheme. “It may seem a good idea to pay a higher price for drugs that provide wider societal benefits – for example, getting people back to work – but this will undoubtedly benefit some groups of patients more than others. We have to recognise all the likely consequences of a reward system and be absolutely sure that it reflects what society wants the NHS to pay more for,” said chief executive Eric Low.

The Association of the British Pharmaceutical Industry broadly welcomes the scheme but says much of the detail has yet to be worked out.

Drug pricing: govt hopes for “free dialogue,” says Minister

As the government consultation closes today (March 17) on its plans to introduce a new value-based system of pricing for branded medicines, “we now have three years in which to work through what a value-based pricing (VBP) system will look like,” Health Minister Earl Howe has told Pharma Times.

Ministers will be conducting, over the next three months, what he hopes will be a “free dialogue” with the industry, medical professions and patient groups around such issues as what value looks like, how to assess value and who should do so, and how to ascribe a price. “Once we’ve reached a general understanding, this will lead to detailed negotiations with the pharmaceutical industry,” he said.

A major benefit which will accrue to drugmakers from the move to VBP will be much greater predictability and confidence that drugs representing major therapeutic value will be appropriately rewarded, Earl Howe told Pharma Times.

Health Secretary Andrew Lansley “has absolutely no difficulty with the NHS paying a high price for genuine breakthroughs, but now price is often unrelated to therapeutic value,” he said, and one problem is that value assessments currently do not take account of “things which we think they should,” such as wider societal values. Doing so would be “a major step forward,” he added.

The National Institute for Health and Clinical Excellence (NICE) has done “a really fine job over the last few years,” but it has “struggled with this concept, and we need to wrestle some more with this in redefining value,” said Earl Howe.

The price initially set for a drug under the proposed new system would not be fixed – it could be reviewed at a later date to reflect experience gained over time, and could then go up as well as down. However, problems could arise where there are different indications for the same drug, said the Minister. And, he added, while “we shouldn’t close our eyes” to the use of patient access schemes in the early stages of a drug’s life when evidence is lacking, the government would want to minimise the use of such initiatives where it can.

Late last year, the government identified healthcare and life sciences as one of the first sectors for consideration under its Growth Review programme, and policy announcements are expected alongside the Budget on March 23. Earl Howe, who was speaking to Pharma Times at the NHS Innovation Expo held in London last week, added that the life sciences industry “can expect the spotlight to continue to fall on it for as long as this government in office.”

While a great deal has already been done to make the UK an attractive location for the pharmaceutical industry globally, “that is no reason to say that we shouldn’t punch above our weigh at attracting R&D here,” said the Minister. The UK has everything going for it – skills base, infrastructure, talent, fiscal incentives – and the NHS, which he described as “a unique test bed for new inventions.”

In his address to the conference, Earl Howe emphasised that the UK has to innovate to way out of the current economic situation – it cannot afford not to, but also warned against “confusing the cost of something with its value.”

The NHS is the world’s largest integrated health care system, he said, and called for its services to be opened up to overseas customers. “So long as UK patients are protected, why should the NHS not market itself to overseas patients?” he asked. “Why shouldn’t our hospitals be competing with the Harvard Medicals and the Sloane Ketterings?”

Moreover, as a stronghold of innovation, the NHS should be selling more of its ideas and innovations in the global health care market, which is now worth $4.5 trillion a year, he added. NICE is a big success here, he said – the Institute is now “the partner of choice for many health economies,” providing advice on replicating its model to governments in Europe and the Middle East worth £200 million a year.

Taskforce set up to check spurious drugs

NEW DELHI: The Union health ministry has formed a taskforce to tackle the problem of spurious drugs.

A 12-member committee headed by the Indian Council of Medical Research ( ICMR) director-general V M Katoch has been constituted to asses the quantity of spurious drugs floating in the market using anti-counterfeit technologies and recommend measures to address the issue.

The drug taskforce will be looking into step needed to promote indigenous production of bulk drugs and preventing the take over of Indian pharma industry by multi-national companies.

The taskforce has representatives from National Pharmaceutical Pricing Authority, Department of Industry Policy and Promotion, Indian Drug Manufacturers Association, Mumbai, Indian Pharmaceutical Alliance, Mumbai, Organisation of Pharmaceutical Producers of India, Mumbai, among others.

“The taskforce will submit its report within a time period of three months. It will recommend measures to tackle the problem of spurious drugs — use of anti counterfeit technologies as well as consider and advice on any other issue incidental to the above,” said a health ministry official. The constitution of the taskforce comes close on the heels of Union health minister Ghulam Nabi Azad recently meeting with the drug manufacturers.

According to health ministry’s estimates, 5.6% of drugs in the country don’t adhere to standard quality.

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Pharmaceutical News: Canada Drugs Online and Online Pharmacy Coupons Team-up for Best Drug Prices

Canada Drugs Online and Online Pharmacy Coupons Team-up for Best Drug Prices

The most influential decision-making factor in purchasing is the cost. Businesses apply various strategies to lower down their material, machine, manpower and methodology costs. In lieu, Six Sigma and Lean Manufacturing have risen from such needs. Simultaneously, marketing strategies especially in the internet have been maximized further – Search Engine Optimization (SEO), Social Media Marketing (SMM), Search Engine Marketing (SEM), etc. to attract more clients and increase sales the same way low retail price does.

Canada Drugs Online together with Online Pharmacy Coupons managed to serve customers better. With this partnership, best, low, competitive, reasonable, marked-down (whatever you call it) prices are in store for you in every drug and pharmaceutical purchase that you make with Canada Drugs Online.

Are you new on using Online Pharmacy Coupons? You don’t know exactly how it works? Canada Drugs Online makes sure you understand its procedure in order to enjoy safe and effective drugs and other pharmaceutical products at its super best price.

Through Phone or Fax
If you prefer to use the telephone which is by far the easiest, fastest and most popular way in using Online Pharmacy Coupons, call Canada Drugs Online’s customer service agent upon ordering and mention the coupon code and name so that they will automatically deduct the amount of the coupon from your total order amount.

But if your preference is to fax an order form, simply write “Coupon Code” together with the name of the coupon on the order form and similar to phone processing, the coupon’s amount will be subtracted from your total payable.

Through Canada Drugs Online Website
An electronic way of using Online Pharmacy Coupons is by ordering using Canada Drugs Online’s shopping cart. Upon completion of your online order, state the coupon code and they will process your order with pleasure.

Through Email
You can also email your order form to Canada Drugs Online and specify the coupon code and name in the form. Or, after placing an online website order (using the shopping cart) you can send a separate email to the customer service personnel stating the coupon code and name, you order number, customer number and name for fast and easy processing. You are assured that the coupon savings are applied unto your order prior it is sorted out.

Reminder
Use savings and/or promo coupons as soon as you find them to avoid expiration. And, always make sure that coupons are properly encoded into your order form, and that our customer service representative has confirmed and approved the authentication and application of your coupon code and name. Coupons are not applicable to your past orders and orders that have been billed and/or invoiced already.

Bottom line is if you are in a tight budget, and needs a number of vitamins, supplements, medicines, beauty products, home health care goods, and the like, Canada Drugs Online is the best choice. Do not wait for tomorrow what you can do for today – sign up and be a member now with Canada Drugs Online!

For more information on “Canada Drugs Online and Online Pharmacy Coupons Team-up for Best Drug Prices”, make sure to follow the link in the resource box below.

Patients cautioned against fake drugs sold online

According to the World Health Organization (WHO), nearly 50 percent of drugs purchased through the Internet are fake, according to a report in Al-Riyadh Arabic daily.

With an alarming increase in fraud involving pharmaceutical products and equipment, several specialists and experts urged authorities to take stringent punitive action against the fraudsters. The Shoura Council is expected to recommend amendments to the Kingdom’s Pharmaceutical Law in the near future, such as imposing a maximum jail term of five years and a fine of SR5 million to people who commit fraud.

Wael Al-Qassim, an official at the Drugs and Medical Equipment Committee at the Riyadh Chamber of Commerce and Industry, warned against the fraud involving electronically marketed drugs.

“Commercial fraud involving drugs and medical equipment has become a global phenomenon. The WHO asserts that about 10 percent of pharmaceutical products marketed worldwide is counterfeit. This percentage is 30 as far as developing countries are concerned. There have been instances of commercial fraud reported in the case of mortal conditions such as cancer and heart disease. Regarding medical equipment and health care products, there are plenty of fake items, including contact lenses, syringes, surgical equipment and wheelchairs,” he said, while urging sick people to buy pharmaceutical products from approved dealers and licensed pharmacies.

“About 50 percent of products marketed through the Internet are fake,” he said while quoting the WHO report. “In such cases, the loss is not that of money but also that of human beings. Proper awareness among customers as well as stringent punitive action against the fraudsters are the major ways to combat this phenomenon.”

Al-Qassim also underscored the need to take preemptive measures such as collecting information about fake medical products, and extending cooperation and coordination among the concerned agencies in combating all types of fraud occurring in the pharmaceutical field.

Khaled Muhammad Taiba, chairman of the board of directors of the Saudi Society for the Hearing Impaired, said there has been a huge demand for medical equipment and instruments with the establishment of a large number of hospitals, health centers and laboratories across the Kingdom. “Some weak-minded and greedy people are striving to exploit this situation through their involvement in various types of commercial fraud in this vital and sensitive sector. They supply fake medical equipment and instruments used by doctors, technicians and nurses. They are also engaged in selling household medical instruments such as those for testing blood pressure and diabetes,” he said.

Taiba noted that Saudi Food and Drug Administration has introduced and strictly implementing a mechanism to monitor and ensure quality and standards of medical equipment and instruments either manufactured in the Kingdom or imported from outside.

“Even though the authority is keen in maintaining all the required standards and quality for the drugs and medical equipment available in the market, there are some fraudsters managed to smuggle in duplicate and low-quality products. Some doctors are also conniving with these companies,” he said.

On his part, Abdul Rahman Al-Husseini, deputy chairman of the Shariah Health Authority in Jeddah, has pointed out that fake doctors are behind the pharmaceutical fraud.

“If they managed to obtain fake certificates and dare to practice illegally, then they have no hesitation to prescribe fake drugs and unlicensed medical equipment for patients,” he said, while noting that such doctors accept commission from dealers of these equipment and instruments.

Former mayor sentenced for online pharmaceutical drug sales

A well-known Miami-Dade lawyer who pleaded guilty to selling tens of millions in pharmaceutical drugs without prescriptions on an Internet site serving buyers across the country was sentenced to 40 months by a federal judge in California on Thursday.

Robert Smoley, a former mayor of North Bay Village who has represented numerous high-profile clients during his career, admitted he and others distributed in excess of $48 million worth of drugs through his company, United Mail Pharmacy Services.

Federal agents say the 59-year-old attorney set up an elaborate distribution network from a warehouse in Florida, where he and others shipped drugs after taking orders over the Internet and call centers in Costa Rica and the Dominican Republic. Smoley admitted to selling more than seven million pills through more 17 online pharmacy sites – with most of the orders between 2001 and 2008.

‘CHOSE PROFITS’

“The Smoley drug trafficking organization fed the habits of drug seekers while its members chose profits over the health and well-being of those customers,” said DEA special agent Anthony Williams after Smoley’s guilty plea.

The onetime mayor took orders from customers who filled out online orders for medications, but no effort was made to ensure the information they provided was accurate, the plea agreement says.

The orders were then reviewed by doctors who were paid between $2 and $5 per order, with some doctors approving up to 500 orders per day.

Smoley admitted to encouraging doctors to review as many orders as possible each day, knowing they did not conduct physical exams – or review medical paperwork – for his customers.

For years, he managed to conceal the millions his organization reaped by shifting the money through various accounts set up at U.S. banks, court records state.

CAUGHT IN 2008

Though he had been under investigation for several years by federal agents in California, he was finally caught in early 2008 when he ordered more than half a million drugs from an undercover DEA agent.

He pleaded guilty before federal Judge Jeffrey White in San Francisco in November to conspiracy to distribute schedule III and IV controlled substances and conspiracy to launder money.

A practicing attorney since 1978, Smoley served as mayor of North Bay Village from 1980 to 1982, but left office after a controversial term in which citizens waged a recall effort against him and two commissioners.

His most high profile case came in 1991 when he represented Jeff and Kathy Willets, the Fort Lauderdale couple who made international news when they set up a $2,000 a week sex business out of their home, servicing the city’s vice mayor and others.

HIGH-PROFILE CLIENTS

Over the course of his 33-year career, he also represented several high-power officials, including Dade Circuit Court Judge Alfonso Sepe during a bitter judicial race in 1982.

Miami lawyer Richard Sharpstein, who represented Smoley during his drug case, said his client opened his business “fully believing that the Internet pharmacy was legal. Unfortunately for him, over the past five years the government has reversed its position and he was caught in the web.”

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Pharmaceutical News: Asia is Key to Driving Innovation in Drug Development, Overcoming Industry Challenges

Govt will protect interests of drug industry: Scindia

NEW DELHI: Amid concerns expressed by the Indian industry, the government today said in Parliament that it will protect the interest of the domestic drug industry while finalising the free trade pact with European Union.

“Public health concerns and interests of domestic drug industry will guide our negotiating position,” Minister of State for Commerce and Industry Jyotiraditya Scindia said in a written reply to Lok Sabha .

The two sides have already completed 12 round of talks since June 2007 for the Bilateral Trade and Investment Agreement (BTIA) for opening up commerce in goods, services and investment, he said.

The talks had hit roadblocks as there was pressure from EU members that social issues like environment, labour standards and TRIPS plus should be covered in the agreement. However, India has been resisting these efforts.

“India has clarified to the EU that it cannot accept provisions in the agreement, which are beyond TRIPS (Trade Related aspects of Intellectual Property Rights) and domestic law,” he said.

The TRIPS agreement was signed as part of the multilateral trade pact of the WTO during the Uruguay Round in 1994. Under this, developing countries including India made several important changes in their domestic IPR regime to make it more stringent.

However, India is strongly opposing going beyond TRIPS in any bilateral free-trade pact, as the move could render a lot of genuine products like generic medicines and software illegal. It can restrict the ability of Indian pharmaceutical firms to produce and export generic or off-patent drugs.

Indian pharma industry and several NGOs have been strongly opposing the proposed bilateral pact on the grounds that it will require India to make TRIPS-plus commitment.

The EU and other developed countries believe a TRIPS-plus pact is a must for tackling the problem of counterfeit drugs.

The EU is India’s largest trading partner. The bilateral trade in 2009-10 aggregated to USD 75 billion. Both the sides are expected to conclude the negotiations by the end of this year.

Real R&D cost much lower than what pharma cos claim

NEW DELHI: Talk to a drug industry executive about high medicine prices and they throw back the $1.3 billion the industry spends on average on research and development (R&D) of a single drug. In a recent analysis bound to deflate this justification for high pricing, two health economists have demonstrated how the real R&D cost for a new drug could be just 5-15% of the touted $1.3 billion.

The analysis concludes that the real R&D cost for a drug borne by a pharmaceutical company is probably about $60 million. This latest analysis has been done by Donald W Light of Stanford University and Rebecca Warburton of the University of Victoria in Canada. The analysis has been published as an article, ‘Demythologizing the high costs of pharmaceutical research’ in the latest issue of Biosocieties, a quarterly social sciences journal of the London School of Economics and Political Science.

How can there be such a huge difference between the earlier estimated R&D cost and the new calculation? For a start, in the $1.3 billion, the tax exemptions the companies avail for investing in R&D have not been accounted for. Tax write-offs could amount to taxpayers paying almost 40% of the R&D cost. The industry also does not count the cost of basic research, which often takes decades and is mostly done in public funded universities or labs. Yet, industry’s R&D cost includes a substantial amount as cost of discovery despite the fact that there are no credible figures on what exactly those costs are.

Further, half the R&D cost of the industry is not real costs but exaggerated estimates of profits that companies could have made if they had invested in the stock market instead of R&D. The R&D cost has been further padded by showing inflated spending on clinical trials. “Clinical trials were shown to last longer, spending per clinical trial subject was inflated and the average number of participants in a trial was almost doubled,” the analysis found.

So how did the industry arrive at the $1.3 billion figure? This figure was worked out through studies done by the Tuft Center for the Study of Drug Development in Boston, Massachusetts, in 2003. Their figure of $802 million to bring a new drug (not a reformulation of existing drugs) to the market became the figure most widely cited by government officials, the industry’s trade associations and the media. By 2006, this figure was updated by 64% to $1.32 billion. What was not mentioned was that the Tuft Center received substantial pharma industry funding.

Light and Warburton write in their article that such a low estimate as $60 million might seems unbelievable until one learns that the audited cost of all clinical trials submitted by pharmaceutical companies in the late 1990s to the Internal Revenue Service averaged only $22.5 million. Moreover, the median cost to company per approved drug in 2000 varied between $14 million and $204 million depending on the kind of drug being considered.

“Pharmaceutical companies have a strong vested interest in maximizing figures for R&D as high R&D costs have been the industry’s excuse for charging high prices. It has also helped generate political capital worth billions in tax concessions and price protection in the form of increasing patent terms and extending data exclusivity,” stated the article.

Asia is Key to Driving Innovation in Drug Development, Overcoming Industry Challenges

Asia is rapidly becoming a new frontier for drug development as Western companies seek to develop and register their products, while emerging Asian companies seek new capabilities to globalize products.

However, to fully capitalize on the opportunities, the industry will have to abandon its current model and move to a new model of drug discovery and development which embraces multiple strategic partnerships.

This is the conclusion of a new white paper, published by Quintiles, the world’s leading biopharmaceutical company, and authored by Dr. Amar Kureishi, M.D., Head of Strategic Drug Development Asia.

“The rapid ascent of Asia, with its access to fresh capital and willingness to discard old assumptions is injecting new life into global drug discovery and development,” writes Dr. Kureishi and he predicts, “Within the changing landscape, we call the New Health, patient empowerment and market access considerations will be the drivers of innovation and a rebalancing of medical need and commercial considerations will occur.”

However, Dr. Kureishi makes the case that for this to take place; the industry has to radically change its business model.

“This new model will transform from a linear structure, in which one firm owns all of the pieces, to one of multiple partnerships, with a focus on collaboration instead of control,” says Dr. Kureishi. “The model can be represented by a ‘wheel and spokes’ with companies such as a full-service CRO or a large biopharma at the center of the wheel, outsourcing many of the tasks it previously performed in house. In this model, the biopharma company and CRO will play a more strategic role in clinical drug development and help foster innovation.”

Service firms, specializing in clinical research, will become more important in clinical drug development, not only from a contract service provider prospective, but also as experts with deep global experience in strategic drug development. With a cross-industry view of trends, these service companies will be ideally positioned to evaluate risks and make informed decisions within partnerships.

This collaborative model has potential to drive drug development forward in an entirely new way. By reimagining roles and relationships within the larger value chain, companies that focus on their strengths while partnering in other areas are very likely to thrive in this new landscape.

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Pharmaceutical News: Pharma pricing must reflect wider values, progressive innovation

Pharma pricing must reflect wider values, progressive innovation: ABPI

Value-based pricing (VBP) for medicines must reflect the burden of the disease being treated, the wider societal benefits which treatments bring and the fact that innovation is often gradual, the Association of the British Pharmaceutical Industry (ABPI) has told the government.

Moreover, a voluntary agreement for the introduction of VBP for all medicines launched after January 1, 2014 must be accompanied by another pricing structure, similar to the Pharmaceutical Price Regulation Scheme (PPRS), for products which are already on the market, the ABPI says, in its response to the government’s consultation on its proposals to introduce VBP for branded medicines, which closes on March 17. These schemes need to be created through “a well-planned process of co-creation between government and the industry,” it adds.

Commerce Ministry to go ahead with bar-coding of medicines

The Ministry of Commerce and Industry will go ahead with the proposal for 2D bar-coding and a unique ‘randomly generated numeric code’ on packets of medicine destined for export, a senior official said.

According to P.V. Appaji, the executive director of the Pharmaceuticals Export Promotion Council (Pharmexcil, the ministry has set March 31 as the date for receiving objections and suggestions from the Pharma industry, which is opposing the move.

“The government will go ahead with implementation of the bar coding. However, the ministry has asked the industry to come out with their problems before March 31. Bar coding is fixed and the government will implement it as per schedule,” Mr. Appaji said.

The Commerce Ministry had recently made it mandatory for all medicines manufactured and exported out of the country to have a barcode from July 1.

Department of Commerce Additional Secretary Rajeev Kher held a meeting on March 10 with the representatives of pharmaceutical companies Torrent, Lupin and Fortis India, along with officials of Pharmexcil, sources said.

The Director General of Foreign Trade (DGFT) has made it mandatory for drug-makers to print a barcode on every product exported out of the country in the wake of overseas allegations that some local firms ship out counterfeit medicines.

Exports of pharmaceuticals from India stood at Rs. 40,000 crore last fiscal and are expected to witness a growth of 20 per cent this year.

The industry is opposing the move, saying it would incur an additional cost on the bar-coding procedure.

Any value edition to the product would affect pricing, said an official of city-based Natco Pharma.

“As it is, we have been facing serious competition from China on all fronts. Barcoding needs additional investment on manpower as well as machinery and thus puts pressure on pricing,” Natco Pharma Company Secretary and General Manager M. Adinarayana said.

Mr. Appaji said as per government estimates, bar-coding would cost 30 paisa per strip. “Putting barcode on primary packing is difficult and expensive, but secondary and outer layer of the export package will be acceptable for the industry,” he said.

The Drug Controller General of India (DCGI) recently indicated that it would make it mandatory for medicines intended for domestic supply to also bear barcodes. However, the government is yet to come out with an order in this regard.

Govt will protect interests of drug industry: Scindia

NEW DELHI: Amid concerns expressed by the Indian industry, the government today said in Parliament that it will protect the interest of the domestic drug industry while finalising the free trade pact with European Union .

“Public health concerns and interests of domestic drug industry will guide our negotiating position,” Minister of State for Commerce and Industry Jyotiraditya Scindia said in a written reply to Lok Sabha .

The two sides have already completed 12 round of talks since June 2007 for the Bilateral Trade and Investment Agreement (BTIA) for opening up commerce in goods, services and investment, he said.

The talks had hit roadblocks as there was pressure from EU members that social issues like environment, labour standards and TRIPS plus should be covered in the agreement. However, India has been resisting these efforts.

“India has clarified to the EU that it cannot accept provisions in the agreement, which are beyond TRIPS (Trade Related aspects of Intellectual Property Rights) and domestic law,” he said.

The TRIPS agreement was signed as part of the multilateral trade pact of the WTO during the Uruguay Round in 1994. Under this, developing countries including India made several important changes in their domestic IPR regime to make it more stringent.

However, India is strongly opposing going beyond TRIPS in any bilateral free-trade pact, as the move could render a lot of genuine products like generic medicines and software illegal. It can restrict the ability of Indian pharmaceutical firms to produce and export generic or off-patent drugs.

Indian pharma industry and several NGOs have been strongly opposing the proposed bilateral pact on the grounds that it will require India to make TRIPS-plus commitment.

The EU and other developed countries believe a TRIPS-plus pact is a must for tackling the problem of counterfeit drugs.

The EU is India’s largest trading partner. The bilateral trade in 2009-10 aggregated to USD 75 billion. Both the sides are expected to conclude the negotiations by the end of this year.

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Pharmaceutical News: No proof of drug industry sway on WHO in pandemic

No proof of drug industry sway on WHO in pandemic: report

Independent experts who examined the World Health Organisation’s handling of the H1N1 pandemic said on Thursday they had found no evidence of drug industry influence on the U.N. agency’s decision-making in the crisis.

But in a draft report made public, the panel said WHO had failed to recognize and manage conflicts of interest among some experts on its advisory Emergency Committee who had disclosed their ties to pharmaceutical companies.

The world remains “ill-prepared” to face a severe influenza pandemic or similar public health emergency, the experts added.

The United Nations agency announced in June 2009 that the newly-emerged H1N1 swine flu virus was causing the world’s first influenza pandemic in more than 40 years. It declared the pandemic over in August 2010, saying that the global outbreak had turned out to be much less severe than was feared.

“WHO performed well in many ways during the pandemic and confronted systemic difficulties and demonstrated some shortcomings,” the panel said in a 33-page report. “The Committee found no evidence of malfeasance.”

“As far as the Review Committee can determine, no critic of WHO has produced any direct evidence of commercial influence on decision-making,” it added.

Critics who have suggested ‘invisible commercial influences’ may account for WHO’s actions ignored the agency’s core public health values to prevent disease and save lives, according to the panel headed by American flu expert Dr. Harvey Fineberg.

The Review Committee, composed of 27 experts, holds its last meeting in Geneva on March 28-30 to finalize its report which is to be submitted to WHO’s annual ministerial meeting in May.

The panel criticised the WHO’s lack of a consistent and measurable description for judging a pandemic’s severity which had created confusion. It suggested a scale of three phases rather than the current six-phase scale which is under revision.

WHO bureaucracy had also prevented a timely distribution of donated vaccines in poor countries during the pandemic, it said.

GlaxoSmithKline and Sanofi-Aventis are among major producers of influenza vaccines.

“The world is ill-prepared to respond to a severe influenza pandemic or to any similarly global, sustained and threatening public health emergency,” it said, citing the risk of massive disruption, suffering and loss of life.

Rapper-Backed Law Easing Overseas Drug Sales Approved By Canada Lawmakers

Canadian lawmakers approved a bill aiming to ease the process that lets generic drug manufacturers produce patented medicines for export to poor nations at cheaper prices in a move the pharmaceutical industry says could undermine intellectual property rights.

The legislation amends Canada’s so-called “access-to- medicines” law, which was enacted in 2004 and meant to make it easier for generic drug producers to get licenses to produce patent-protected drugs for export. The bill, introduced by an opposition lawmaker from the New Democratic Party, has passed the House of Commons and still must be approved by the Conservative-controlled Senate before it can become law.

The measure is “a significant step to save lives” from treatable diseases such as tuberculosis, malaria and HIV/AIDS, said New Democrat lawmaker Paul Dewar in a statement after the vote yesterday. “There is no reason for the Senate to delay the passage of this bill.”

A coalition including former Canadian ambassador to the U.N. Stephen Lewis and Canadian rapper K’Naan pushed for the bill’s passage. Canada’s Research-Based Pharmaceutical Companies, the association that represents the industry in Canada and counts Pfizer Inc. (PFE) and Novartis AG (NVS) among its members, says the it risks fueling black-market sales, encouraging production of counterfeit products and removes “safeguards” on intellectual property.

The bill opens “the doors to export of a wider range of medications to developed countries that do not have a humanitarian crisis,” Russell Williams, president of the association, known as Rx&D, said in an e-mailed statement.
Already Working

Williams said the industry is already working with governments and non-government agencies to provide medicines at no cost or a non-profit basis in poor nations.

The legislation was supported primarily by opposition lawmakers, while most legislators from the governing Conservatives opposed it.

“I don’t think this bill is helpful,” Industry Minister Tony Clement told reporters, adding there is a “lot to go” before the legislation would be signed into law.

Clement said he’s concerned the bill will serve the “commercial” interests of generic companies, and not deal with the humanitarian issues. Clement also said he doesn’t think Canadian companies can produce generic drugs cheaply enough for the legislation to be effective.

Apotex Inc., a Canadian generic pharmaceutical company that is the only manufacturer to have sought a license to export drugs to poor countries under the current law, released a March 8 statement backing the proposed changes.

“Apotex is the only company to have attempted to work through this complex legislation and it took four long years to send the first shipment of medicines via this cumbersome process,” the company said in the statement.

What Technology Can Learn from Big Pharma

With rapid change on the Web amid the information revolution sparked by the Internet, it’s easy for the technology industry to think it’s unique because it constantly breaks new ground and does things nobody has done. But other sorts of businesses have already undergone some of the same radical shifts, with no less a stake in the future.

Take health care, for instance. We often think of it as a huge, lumbering beast, but in the past 200 years medicine has undergone a series of revolutions that are at least equal to those we see in technology and information.

Modern chemistry and biology were only just beginning to stir in the 19th century. In 1967, however, Dr, Christiaan Barnard started transplanting hearts.And it wasn’t until the 1950s that James D.Watson and Francis Crick discovered DNA. Less than 50 years later, the first draft of the human genome was produced. If that’s not rapid, world-shattering change, what is?

Big Pharma has faced other challenges that the Web industry is only starting to comprehend. Drugs can take years to design, test, and manufacture. Accordingly, spending to search and develop pharmaceuticals is very high overall: According to the European Union (PDF), five of the world’s top 10 companies in R&D spending are in drugs or biotechnology. (Among traditional technology companies, only Microsoft, Nokia, and Samsung feature in the list.) The expenditure amounts to a far greater proportion of total turnover—Pfizer spends around one seventh of revenues on research, while Apple spends about a dollar on R&D for every 13 it brings in.
Generic Windows?

And where the planet’s electronics giants spend billions to fight piracy and patent infringement, pharmaceutical companies are rapidly adjusting to the fact that they receive only 12 years before patent protection ends and other companies can introduce generic drugs. Imagine a situation in which Windows 98 were already old enough to be forcibly open-sourced today for an idea of how disruptive that might be.

So what does the pharmaceutical industry have to teach us?

First, be careful. Your property and ideas won’t be proprietary for long.

Second, while new discoveries are important, revolutions can be reliably predicted most of the time. From the outside, Barnard’s transplants were a radical shift in surgery. From inside the profession, it was an obvious step after previous organ transplants.

Third, the way money is spent will inevitably change. It’s already happening, an issue addressed in the latest VC Bulletin from Go4Venture, a London-based advisory group for European entrepreneurs and investors.(You can sign up to receive the monthly here.) The latest dispatch outlines the state of dealmaking in Europe (more frequent but less valuable, as reflected in figures we wrote about last month) and points out that Europe’s technology-financing system is undergoing a significant shift:

There is a major structural change in European venture capital financing where corporates will play a more prominent role going forward. Corporates are facing a lasting ex-growth market environment (courtesy of debt-laden Western economies) and realize that internal R&D is rather expensive and just cannot cover the whole front of innovation. For corporates, investing in startups has the additional advantage of encouraging a more entrepreneurial culture inside and creating a stream of acquisition opportunities. Pharma has been there before, in an early move precipitated by proprietary drugs coming off patent, and we are now seeing the pharma model spreading to other IT-driven sectors.

Spending more of the R&D budget on other companies doesn’t just mean acquisition, although the startup world is familiar with a process that’s clearly the most common option. Just yesterday, Google spent $60 million on the slightly odd purchase of British price-comparison website BeatThatQuote.It could also mean a greater measure of early investment in small companies, such as the $100,000 Microsoft is putting into Moscow-based anti-piracy startup Pirate Pay.

What it ultimately means is faster growth in the number of deals, along with opportunities for innovative startups and smart entrepreneurs. Paired with the aggressive, high-valuation investment strategy of a company such as Russia’s Digital Sky Technologies, it seems likely that we’ll see things explode in Europe and elsewhere over the next year or two.

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Pharmaceutical News: Drug shortage putting Houston patients at risk

No proof of drug industry sway on WHO in pandemic: report

(Reuters) – Independent experts who examined the World Health Organisation’s handling of the H1N1 pandemic said on Thursday they had found no evidence of drug industry influence on the U.N. agency’s decision-making in the crisis.

But in a draft report made public, the panel said WHO had failed to recognize and manage conflicts of interest among some experts on its advisory Emergency Committee who had disclosed their ties to pharmaceutical companies.

The world remains “ill-prepared” to face a severe influenza pandemic or similar public health emergency, the experts added.

The United Nations agency announced in June 2009 that the newly-emerged H1N1 swine flu virus was causing the world’s first influenza pandemic in more than 40 years. It declared the pandemic over in August 2010, saying that the global outbreak had turned out to be much less severe than was feared.

“WHO performed well in many ways during the pandemic and confronted systemic difficulties and demonstrated some shortcomings,” the panel said in a 33-page report. “The Committee found no evidence of malfeasance.”

“As far as the Review Committee can determine, no critic of WHO has produced any direct evidence of commercial influence on decision-making,” it added.

Critics who have suggested ‘invisible commercial influences’ may account for WHO’s actions ignored the agency’s core public health values to prevent disease and save lives, according to the panel headed by American flu expert Dr. Harvey Fineberg.

The Review Committee, composed of 27 experts, holds its last meeting in Geneva on March 28-30 to finalize its report which is to be submitted to WHO’s annual ministerial meeting in May.

The panel criticised the WHO’s lack of a consistent and measurable description for judging a pandemic’s severity which had created confusion. It suggested a scale of three phases rather than the current six-phase scale which is under revision.

WHO bureaucracy had also prevented a timely distribution of donated vaccines in poor countries during the pandemic, it said.

GlaxoSmithKline and Sanofi-Aventis are among major producers of influenza vaccines.

“The world is ill-prepared to respond to a severe influenza pandemic or to any similarly global, sustained and threatening public health emergency,” it said, citing the risk of massive disruption, suffering and loss of life.

GSK’s Benlysta: The new face of a ‘blockbuster’ drug (with more to come)

Years before Benlysta’s approval as the first new lupus treatment in more than 50 years, GlaxoSmithKline (NYSE:GSK) signed a development and commercialization agreement with Human Genome Sciences (NASDAQ:HGSI) in which the two companies would share equally in the costs of developing a new drug and any net proceeds that come from a commercialized product.

That 2006 agreement was preceded by a collaboration between the companies dating back to the 1990s. Back then, there was no way of knowing that the biologic compounds that HGS discovered would become the first lupus drug candidate in decades to advance into a phase III clinical trial. Benlysta, which was approved by the Food and Drug Administration on Wednesday, is now touted as the next blockbuster drug with analysts projecting annual sales ranging from $3 billion to $7 billion. GSK will get half of that under the agreement with Rockville, Maryland-based HGS.

Half of a blockbuster drug is still a substantial chunk of change. One thing’s for sure, though, it will be a very different kind of blockbuster for London-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina.

Consider GSK’s blockbuster drugAdvair, approved by the FDA in 2000 to treat asthma and chronic obstructive pulmonary disease (COPD). The market was eager for a new asthma treatment and within five years, Advair’s annual sales grew to $5.6 billion on 21.1 million prescriptions in the United States, according to IMS Health.

The market is also eager for a new lupus treatment. Aspirin was approved to treat lupus in 1948. Plaquenil, an anti-malarial and anti-rheumatic drug, was approved as a lupus treatment in 1955.The Lupus Foundation of America estimates that 1.5 million Americans suffer from some form of lupus. Worldwide, that figure grows to 5 million. The autoimmune disease, in which the body attacks its own tissues causing inflammation and pain throughout, disproportionately affects women. It is also more prevalent among African Americans.

Although African Americans are more more likely to be diagnosed with lupus, they are also less likely to benefit from Benlysta. Clinical trials found that African American patients and patients of African heritage did not appear to respond to the drug. The FDA instructed HGS and GSK to conduct more studies to find out why. But those clinical trial findings so far further limit the pool of patients who could benefit from the new drug.

Advair became a blockbuster because GSK could sell a lot of the product to the millions who have asthma or COPD. It became a blockbuster because it was a drug that could be sold to many.

Benlysta will become a blockbuster as a drug sold to the few. The drug will be sold to the targeted group of patients who will benefit from it. Those patients will pay a premium for it. On a conference call discussing the FDA approval of Benlysta, HGS Chief Commerical Officer Barry Labinger said the annual cost for the drug would be $35,000, which he noted is in line with other biological drugs. For example, some multiple sclerosis patients face annual costs of $40,000 for their drugs, he said.

Keeping Advair in mind, if every patient paid full price for the Benlysta drug, GSK and HGS would be treating just 200,000 patients each year to reach a $7 billion annual revenue stream.

The two companies say they don’t want cost to be a barrier to a drug that could help lupus patients. Labinger said that the company would have programs to help patients least able to afford Benlysta.

“Our goal is to prevent affordability from getting in the way of access to Benylsta as much as possible for appropriate patients,” he said.

HGS and GSK are both quickly ramping up their Benlysta sales teams. The companies still await European approval for Benlysta, which could come later this year. HGS has set up a headquarters in Switzerland, as well as commercialization teams in Germany, France and Spain. In the rest of Europe, the company will rely on GSK’s sales force.

Benlysta is expected to be available in the United States by the end of March. The company’s sales push for Benlysta will be far and wide even if it’s impact will be felt by a relatively narrow piece of the overall lupus population.

So that’s the picture of the new blockbuster drug: expensive products targeting ever more specific segments of the patient population. And as GSK and other pharmaceutical companies continue working on biologics, expect more of this to come.

The Wall Street Journal pointed out the GSK pipeline for Benlysta-style wins is thick thanks to its long-ago HGS partnership. Darapladib, a cardiovascular drug that blocks a protein that contributes to plaque buildup in the arteries, may be able to cut the risk of heart attacks and strokes. Another, albiglutide, is an injectable drug that maintains blood-sugar levels.

“This business development activity which the pharmaceutical industry has been doing now for 20 years, 25 years, is a long-term game,” Ad Rawcliffe, Glaxo’s head of worldwide business development, told The Journal on Thursday. “And you need to have long-term commitment.”

Drug shortage putting Houston patients at risk

Houston hospitals are struggling to cope with an unprecedented national shortage of drugs that industry officials concede is putting public health – and lives – at risk.

Hospital pharmacists and doctors in the Texas Medical Center said this week they are managing the crisis without incident so far, but acknowledged it’s causing delays in procedures, the substitution of alternative medication and prioritizing which patients get the drugs in short supply.

“It’s been quite the challenge,” said Dan Metzen, director of Methodist Hospital’s pharmacy. “It’s kept us busy – up late at night, in constant meetings – trying to figure out what drugs each new patient needs and where we can get it if we don’t have it.”

The shortage has grown progressively worse the last five years, but Houston pharmacists called the last two months the worst period yet and said no end is in sight. The FDA’s official shortage list now includes 57 drugs, as many as were typically amassed in an entire year prior to 2005. The Food and Drug Administration reported a shortage of 178 drugs last year and the 2011 list is on pace for more than that.

In 2010, most respondents to a national survey of health-care providers were “perplexed” why the United States is experiencing drug shortages of “epic proportion that are often associated with Third World countries.”
Many are cancer drugs

Nationally, at least a handful of deaths have been attributed to the shortage, and an official with the American Hospital Association says the real number is likely significantly more, particularly since many of the drugs treat cancer.

One, cytarabine, is considered indispensable to the treatment of leukemia – it cures the disease 40 percent of the time. Without it, patients typically don’t survive.

“It’s a national tragedy, given there are 30,000 leukemia patients around the country who need the drug,” Dr. Hagop Kantarjian, chairman of the University of Texas M.D. Anderson Cancer Center’s department of leukemia, said. “It’s unconscionable that nobody’s been paying attention. I get calls every day from doctors in other cities who don’t have cytarabine to treat a patient.”

Kantarjian said that so far MD Anderson has not suffered a shortage of cytarabine. Smaller hospitals have been the most affected.

Though cancer medicines have been hit the hardest, the shortage cuts across all drug types, said Rosylne Schulman, the AHA’s director for policy development. They range from drugs that fight infections to those used to restart the heart in emergency rooms to anesthetics used in surgery to the popular blood-thinner heparin. She described many of the drugs – older drugs given by injection – as “life-saving.”
Supply and demand

Experts say there is no single cause of the shortage, but ultimately the problem is one of supply and demand. Factors include stepped-up FDA public safety enforcement, manufacturing difficulties, unexpected demand and a consolidation of the generic-drug industry that’s resulted in many of the drugs being made by only one or two companies.

Part of the problem is unpredictability. In a survey of health-care providers by the Institute for Safe Medicine Practices, more than 80 percent of respondents complained that they were given no advance notice of an impending drug shortage and little information thereafter about how long the drug was likely to be scarce.

The frustration has led to legislation in Congress this year that would require pharmaceutical companies to notify the FDA when they decide to limit or discontinue the production of drugs and penalize those that fail to comply.
Importing from Europe

But the law would do little to solve the problem, which the Institute for Safe Medicine Practices’ survey found has caused more than 1,000 adverse events, near misses and errors. The deaths came as a result of the misuse of a substitute for morphine and the resistance of infections to substitute drugs.

Texas Medical Center hospital pharmacists say they’ve managed the crisis by getting rare FDA exemptions to import drugs from Europe; moving medications between flagship and suburban facilities; waiting to treat some patients until stockpiling all the medication needed for the treatment; and determining which patients can be cured with a particular drug and which can be treated with alternative drugs.

“This is no question this is not the way we’d like to practice oncology,” said Dr. Karin Hahn, chief of oncology for the Harris County Hospital District. “But as long as this shortage continues, this is the world we’re living in.”

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Pharmaceutical News: Drug heist could yield $43m

Drug heist could yield $43m

CAREFUL planning by three thieves carrying sledgehammers has enabled them to make off with pharmaceutical drugs that carry a potential street value of $43 million.

The drugs, 50 kilograms of pseudoephedrine and 67 kilograms of codeine, were stolen from an industrial unit in Kingsgrove in the early hours of Sunday.

Pseudoephedrine is used in clandestine labs to manufacture methamphetamine, most commonly known as speed or ice.
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Australian Federal Police estimated a seizure of 12.5 kilograms of pseudoephedrine from Malaysia could be used to manufacture more than 200,000 doses of speed. The weekend’s theft was four times that amount. Police do not know how the balaclava-clad trio made their way into the Jalco Pharmaceuticals complex on Garema Circuit at 1am on Sunday. The brick building is surrounded by a tall fence with barbed wire and security cameras.

Once inside, the thieves cut the phone lines and tampered with the alarm. It allowed them to take almost two hours to smash their way through a concrete wall into the building’s strongroom.

The drugs were stored inside the room in 60-centimetre high cylinders that contained 25 kilograms of the substances in each.

The theft was reported to police at 3pm the same day, 12 hours after security footage shows the robbers leaving the building. Campsie Acting Inspector Michael Stewart said it was not a random robbery and the level of planning showed the thieves knew the drugs were inside.

Dr David Bright, from the National Drug and Alcohol Research Centre’s drug policy modelling program, said it was almost certain the motivation for the theft was to turn pseudoephedrine into methamphetamine.

Myoderm Increases Its Global Expansion In The European Pharmaceutical Market

Myoderm, a leading global supplier of commercial drugs for clinical research and clinical trials, today announced that they have been granted a Wholesale Dealer License from the Medicines and Healthcare products Regulatory Agency (MHRA). In addition, Myoderm has established a new partnership with a leading European Pharmaceutical logistics provider.

The license agreement granted by the MHRA enables Myoderm to buy, sell and distribute pharmaceuticals within the UK. Providing more direct access to drug manufacturers across Europe, the Wholesale Dealer License will facilitate Myoderm’s current supply capabilities and business objectives of commercial expansion and strategic positioning within the European Pharmaceutical Market.

“Acquiring our Wholesale Dealer License and partnering with a leading European, Pharmaceutical logistics provider is critical to our continued effort to enhance our worldwide supply capabilities,” says Mike Cohen, Myoderm’s Managing Director.

Along with the MHRA license agreement, Myoderm’s newest partnership will allow them to offer receiving, inspection, warehousing and distribution of pharmaceutical products. These services will allow Myoderm to have complete control over materials procured and distributed throughout Europe.

About Myoderm
With a proven track record of supply and distribution of pharmaceuticals to depots, clinical trial sites, sponsor companies and clinical packagers around the globe, Myoderm has evolved into a leader within the Clinical Trial Drug Supply industry for over 20 years. Myoderm is confident in its capabilities to continue to expand and strengthen its international relationships.

Hanover pharmaceutical packager TestPak merges, changes name

TestPak Inc., a pharmaceutical packaging and repackaging company based in Whippany, has merged with three other companies and changed its name, according to a news release from the company.

The new company, Aphena Pharma Solutions, will be headquartered in Cookeville, Tenn. William Armero, vice president and general manager of the Whippany operation, said about 105 people are employed in Whippany.

Armero said the merger makes Aphena the fourth largest pharmaceutical contract packaging company in the country. He said the Whippany operation is expanding and in the process of hiring packagers and package line operators.

TestPak had been a privately held company until September, when it was sold to PrePak Systems. The name of the company officially was changed Monday.

“We are excited to announce our new parent company, Aphena Pharma Solutions,” said Renard Jackson, president and chief executive officer of Aphena Pharma Solutions. “Now we can offer more products and even better customer service and efficiency.”

TestPak offers contract packaging and repackaging solutions for the pharmaceutical, over the counter, nutraceutical, animal health and consumer product markets. Among the products offered by the company are low and high volume bottle filling, blister packaging, custom pouching, compliance packaging, unit-dosing/unit-of-use packaging, kitting, and secondary packaging for solid dose products.

The other companies aligned under Aphena are Celeste Contact Packaging in Easton, Md., PrePak in Cookeville, Tenn., and Integrated Pharmaceutical Packaging, in Glasgow, Ky.

“Aphena Pharma Solutions will offer clients a complete range of products and services,” Jackson said. “And we will continue to remain focused on our client’s needs as we move forward with this transition.”

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Pharmaceutical News: Ironwood Pharmaceuticals Provides Fourth Quarter 2010 Investor Update

Ironwood Pharmaceuticals Provides Fourth Quarter 2010 Investor Update

Linaclotide
In November, Ironwood and its U.S. partner, Forest Laboratories, Inc., completed the clinical efficacy portion of the linaclotide development program to support upcoming regulatory submissions in both the U.S. and the E.U. Linaclotide met 66 out of 66 U.S. and E.U. primary and secondary endpoints in the four Phase 3 trials assessing its efficacy and safety in patients with irritable bowel syndrome with constipation (IBS-C) or chronic constipation (CC). Diarrhea was the most common adverse event in linaclotide‐treated patients in these trials.

In the 26-week Phase 3 IBS-C trial, improvements in both abdominal pain and complete spontaneous bowel movements were achieved for linaclotide-treated patients in the first week of treatment, and these improvements were sustained throughout the entire period. Of particular note, at the 26th week of treatment, linaclotide-treated patients had a mean reduction in abdominal pain of 50 percent compared to 27 percent for placebo-treated patients (p<0.0001).
Ironwood and Forest are on track to submit a New Drug Application (NDA) for linaclotide with the U.S. Food and Drug Administration for both the IBS-C and CC indications in the third quarter of 2011.
Ironwood’s European partner, Almirall, S.A., is on track to submit a Market Authorization Application (MAA) for linaclotide with the European Medicines Agency for the IBS‐C indication in the second half of 2011.
Ironwood and Forest were recently informed that all six linaclotide-related abstracts submitted for presentation at the 2011 Digestive Disease Week (DDW) annual meeting have been accepted. Four abstracts will be discussed in oral presentations and two will be made available through poster presentations. These presentations will be the first time that Ironwood and Forest discuss the full results of the two Phase 3 IBS-C clinical trials. These presentations will be made May 7–9, 2011 at the DDW annual meeting in Chicago.

Pipeline and Corporate
Ironwood continues to advance its pipeline, which includes product candidates and research efforts focused on gastrointestinal disease, pain and inflammation, respiratory and allergic disease, and cardiovascular disease. To augment its internal discovery capabilities, Ironwood recently initiated a collaboration with Protagonist Therapeutics, Inc. through which Protagonist will use its proprietary disulfide rich peptide technology platform to discover peptides against targets identified by Ironwood. Ironwood has the right to advance such peptides through preclinical and clinical development, and if such development is successful, commercialization.
Ironwood ended fiscal year 2010 with $248 million of cash, cash equivalents, and available-for-sale securities. Based on its current operating plan, Ironwood targets ending fiscal year 2011 with greater than $150 million of cash, cash equivalents, and available-for-sale securities.

Conference Call Information

Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time today to discuss its business activities. Individuals interested in participating in the call should dial (888) 206‐4836 (U.S. and Canada) or (913) 312‐0679 (international) using conference ID number 9353790. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The call will be available for replay via telephone starting today at approximately 11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on March 17, 2011. To listen to the replay, dial (888) 203‐1112 (U.S. and Canada) or (719) 457‐0820 (international) using conference ID number 9353790. The archived webcast will be available on Ironwood’s website for 14 days beginning approximately one hour after the call.

About Linaclotide

Linaclotide, an investigational drug, is an agonist of the guanylate cyclase type-C (GC-C) receptor located on the luminal surface of the intestine. In preclinical models, linaclotide has been shown to reduce visceral pain, increase fluid secretion, and accelerate intestinal transit. The effects on secretion and transit are mediated through cyclic guanosine monophosphate (cGMP), which is also believed to modulate the activity of local nerves to reduce pain. Linaclotide is an orally delivered peptide that acts locally in the gut with no measurable systemic exposure at therapeutic doses and is intended for once-daily administration. Linaclotide is in Phase 3 clinical development for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation. The efficacy portion of linaclotide’s development program has been completed and will support the NDA submission for both indications, as well as the MAA submission for the IBS-C indication. An issued composition of matter patent for linaclotide provides protection to 2025. Ironwood and Forest are co-developing and, if it is approved, will co-promote linaclotide in the United States. Ironwood has out-licensed linaclotide to Almirall for European development and commercialization, and to Astellas Pharma Inc. for development and commercialization in Japan, Indonesia, Korea, the Philippines, Taiwan, and Thailand.

About Irritable Bowel Syndrome with Constipation (IBS-C)

IBS-C is a chronic functional gastrointestinal disorder characterized by abdominal pain, discomfort, and bloating associated with altered bowel habits, and as many as 11 million people in the U.S. suffer from it. There are currently few available therapies to treat this disorder and there is a high rate of dissatisfaction with available therapies. Patients suffering from IBS-C can be affected physically, psychologically, socially, and economically.

About Chronic Constipation (CC)

As many as 34 million Americans suffer from symptoms associated with CC and 8.5 million patients have sought treatment. Patients with CC often experience hard and lumpy stools, straining during defecation, a sensation of incomplete evacuation, and fewer than three bowel movements per week, as well as discomfort and bloating. This condition significantly affects patients’ quality of life by impairing their ability to work and participate in typical daily activities. There is a high rate of dissatisfaction with currently available treatments.

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial pharmaceutical company dedicated to the art and science of great drugmaking. Linaclotide, Ironwood’s GC-C agonist, is in Phase 3 clinical development for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation. The efficacy portion of linaclotide’s development program has been completed and will support the NDA submission for both indications, as well as the MAA submission for the IBS-C indication. Ironwood also has a growing pipeline of additional drug candidates in earlier stages of development. Ironwood is located in Cambridge, Mass. To learn more, visit www.ironwoodpharma.com.

This press release contains forward looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including, but not limited to, the timing of the filing of a New Drug Application or a Marketing Authorization Application for linaclotide, linaclotide’s potential as a treatment for IBS-C or chronic constipation, our potential presentations at DDW, the potential size of linaclotide’s target patient population, and our targeted cash-on-hand for 2011. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that our linaclotide development activities do not progress as expected, serious adverse events arise in patients that are deemed to be definitely or probably related to linaclotide treatment, the incidence or severity of diarrhea in patients treated with linaclotide is higher than expected, we are unable to produce an adequate commercial supply of linaclotide, as well as risks related to the difficulty of predicting regulatory approvals, the acceptance of and demand for new pharmaceutical products, the impact of competitive products and pricing, and whether linaclotide will ever be commercialized successfully. Applicable risks also include those that are listed in our Quarterly Report on Form 10-Q for the three months ended September 30, 2010, in addition to the risk factors that are listed from time to time in Ironwood Pharmaceuticals’ Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. We undertake no obligation to update these forward-looking statements to reflect events or circumstances occurring after this press release. These forward-looking statements speak only as of the date of this press release.

Bitter pill when politicians swallow big pharma’s spin

Politicians always profess great sympathy for people struggling to keep up with the cost of living but often fail to put that sympathy into practice. Economists like to divide the economy into consumers on one side and producers on the other. They believe the economy should be run for the benefit of consumers, not producers. The consumer is supposed to be king.

Ostensibly, pollies think the same. But they’re always doing deals with producers that allow them to charge higher prices at their customers’ expense.

Why would politicians do such a thing? Because the producers are usually better organised. They have more to gain from a higher price – or lose from a lower price – than individual consumers have to lose or gain. Consumers are amateurs; producers are professionals and they put a lot of effort into lobbying governments.

But there’s another factor. Every voter with a job is a producer as well as a consumer. Politicians care about jobs. And when producers offer to create new jobs – or, more likely, threaten to sack workers if they don’t get what they want – the pollies usually play ball. They’re easily conned.

Consider the case of pharmaceuticals. When a drug company – usually a big American or European corporation – discovers and develops a new medicine, it is granted a patent that amounts to a 20-year monopoly on the production of the medicine. If the medicine is highly effective, the monopoly allows the company to charge a very high price.

The standard justification for patents is that, by holding off competitors, they allow the company a period of grace in which to recover its research and development costs and make a big profit, thus encouraging more invention, to the benefit of society.

This explains why pharmaceuticals are so expensive in the United States. But the companies are prevented from charging such high prices in Australia by the operation of our pharmaceutical benefits scheme.

Under the scheme most drugs are, in effect, bought by the federal government, then sold to patients at heavily subsidised prices. This makes the government a ”monopsonist” – a single buyer – and so gives it the ability to beat down the prices the drug companies are able to charge.

This explains why patented pharmaceuticals are so much cheaper in places such as Australia and Canada than they are in the US. The Aussie taxpayer benefits, as does the patient required to pay a smaller out-of-pocket contribution towards the cost of the drug.

Great stuff. But here’s where the story gets bad. When a drug’s patent expires, any drug company is allowed to start producing that drug in competition with the former patent holder. They can’t appropriate the drug’s trade name, of course, so they’re known as generics. Generics are tightly regulated to ensure they’re just as effective as the drug being copied.

So when a drug comes off patent and a lot of cheaper generics come onto the market, you’d expect the price of the trade-name drug to fall sharply. That’s what happens in the US and in many other countries, but not in Australia. Why not? Because our pharmaceutical benefits scheme goes easy on the former patent holders. It drops the price by a bit, not a lot.

And it leaves it up to the prescribing doctor – and sometimes the patient talking to the chemist – to say whether a generic may be substituted. Many doctors and patients have an irrational attachment to the brand name, even though it’s a lot dearer.

Last year the Rudd government proudly announced it had cut a new and tougher deal with the drug companies, represented by Medicines Australia, which would save the taxpayer $1.9 billion over five years.

The patents of a lot of expensive drugs will expire in the next few years. The deal involved cutting the prices of these drugs by 16 per cent and cutting the prices of generic drugs by 2 or 5 per cent from the start of this year.

But a health economist at the University of Sydney, associate professor Philip Clarke, and his colleague Edmund Fitzgerald, argue the deal still leaves our off-patent and generic drug prices much higher than they are in most developed countries. They quote the example of statins, the cholesterol-lowering drugs, where the patents of the various types have expired or soon will. Statins account for about 16 per cent of the total cost of the pharmaceutical benefits scheme.

They surveyed the wholesale price of Simvastatin 40mg in 10 developed countries and found our price was the highest: 50 per cent more than the next highest country and more than four times greater than the average price.

The lowest price was in New Zealand, which stages competitive tenders between the drug companies. Its price is just a fraction of our wholesale price of $1 a tablet. And even in the US, chains such as Kmart Pharmacy sell that statin for $15 for 90 tablets.

Clarke and Fitzgerald estimate that, compared with prices in England and Canada, the Rudd government’s deal with the industry lobby will cost taxpayers and consumers $1.7 billion more over its five-year term. And that’s just for the statin group of drugs.

The saving would be even greater, no doubt, if the government were game to take a firmer line on the prescribing habits of doctors.

Why would a government that professes to care so much about our cost of living cut such an expensive deal with the drug producers? Because, in practice, it gives a higher priority to maintaining an industry that makes the actual pills in Australia.

And the largely foreign-owned drug companies have conned it into believing that, unless it forces Australian consumers to paying much higher prices for off-patent drugs than people in other countries pay, the local industry will curl up and die.

Canada lacks oversight on online medical information, study finds

Canada may have a state-run health-care system, but the federal government is noticeably reticent when it comes to providing medical information online.

Wikipedia entries or pharmaceutical company websites are almost always the top hits when Canadians Google the name of a brand or generic drug, while in the United States, Web surfers are directed to a profile of the drug from the government-run National Library of Medicine’s website.

At a time when Internet searches are common for any type of medical problem – and when the medical credentials of Dr. Wikipedia are dubious at best – the lack of federal government oversight on drug searches raises concerns about the accuracy of information Canadians are receiving.

“There’s estimates that thousands of Canadians suffer adverse drug reactions every year, and providing people with accurate information is fundamentally important,” said Michael Law, an assistant professor at the Centre for Health Services and Policy Research at the University of British Columbia. “People are clearly using the Internet, so we should be interested in what type of information they’re finding.”

Prof. Law and his colleagues conducted searches of nearly 300 drugs, and their results, published online this week in the Annals of Pharmacotherapy, showed that Wikipedia turns up as the first search result about 85 per cent of the time when looking up the generic name of a drug. Industry websites crop up nearly 80 per cent of the time when searching the brand name.

Compare this to the U.S., where about three-quarters of the time Google searches yielded a drug synopsis from the NLM, which is a branch of the National Institutes of Health, the country’s medical research agency.

The main reason for this discrepancy is that the U.S. government struck a partnership with Google last year to display its results more prominently when residents are searching prescription drugs online.

In Canada, no such deal exists – and researchers are encouraging federal regulators to step forward.

Tim Vail, spokesman for Federal Health Minister Leona Aglukkaq, said the government is hoping to address the issue within the next year as it looks to strengthen its online presence. He said Ottawa is looking at all options, including working with search engines like Google to make sure accurate information from Health Canada is more prominent for Canadians doing Web searches on prescription drugs, the next pandemic or any other health issue.

“We’re continuing to modify our website and look at ways that will improve searches for Canadians so that we will be more prominent in search engines when Canadians are looking for it,” Mr. Vail said. “We do realize that we are a trusted name and a trusted brand among Canadians.”

Prof. Law described the online world for medical information as the “Wild West” in terms of what Canadians can find. He said Wikipedia often omits certain information on drugs, and pharmaceutical companies could potentially leave out adverse side effects.

One pharmaceutical company defended its online presence. Pfizer, which makes the cholesterol drug Lipitor, said it provides up-to-date scientific information on its website. A company spokeswoman, however, did encourage Web surfers to check the source of their information and to always seek an opinion from health professionals – a message echoed by Prof. Law.

“I would hope that our study would also make patients aware of the fact that the information they read online may be inaccurate or incomplete,” Prof. Law said. “Patients should be sure to talk to their health-care professionals about information they might find online.”

Pharmaceutical Industry Outlook – March 2011

The pharmaceutical industry continues to witness major challenges like sluggish prescription trends, EU pricing pressure, intensifying generic competition, pipeline failures and limited late-stage catalysts. The next five years are expected to reflect a significant imbalance between new product introductions and patent losses.

According to IMS Health, this is the main reason global pharmaceutical market growth will be restricted to the mid-single digits (5-8%) through 2014. Over the next five years, products that currently generate more than $142 billion in sales are expected to face generic competition, including Lipitor, Plavix and Zyprexa.

In fact, 2011 itself will see products worth more than $30 billion losing patent protection. This includes products like Lipitor, Plavix, Zyprexa and Levaquin. These products generated more than $15 billion in sales in 2010. The effect of the genericization of these products will be felt mostly in 2012, which will be a challenging year for several companies.

At the same time, new products are not expected to generate the same level of sales as products losing patent protection. With revenue growth stalling or slowing down, companies have been resorting to cost-cutting and share buybacks to drive bottom-line growth.

M&A Activity

The pharma sector continued to witness major merger and acquisition (M&A) deals in 2010. With most of the big pharma companies already facing or likely to face patent challenges for their blockbuster products, the companies have been looking towards M&As and in-licensing activities to make up for the loss of revenues that will arise with key products losing patent exclusivity.

We saw huge M&A activity over the last few quarters. Major deals include Johnson & Johnson’s (JNJ – Analyst Report) acquisition of medical devices maker Micrus Endovascular Corp. and Merck KGaA’s (MKGAF) acquisition of Millipore Corporation.

Johnson & Johnson is currently looking to buy out the rest of Dutch biopharmaceutical company Crucell NV. This acquisition should not only help strengthen Johnson & Johnson’s portfolio, it should also allow the company to build its presence in the vaccines market, given Crucell’s expertise in the manufacture, discovery and commercialization of vaccines.

Meanwhile, pharma giant Pfizer (PFE – Analyst Report) recently completed its acquisition of King Pharmaceuticals. With this deal, Pfizer is looking to strengthen its presence in the pain management market.

Oncology also remains a much sought-after therapeutic area with companies like Sanofi-Aventis (SNY – Analyst Report) and Celgene (CELG – Analyst Report) strengthening their presence in this market through acquisitions. Meanwhile, generic player Mylan’s (MYL – Analyst Report) purchase of Irish injectable drug maker Bioniche Pharma Holdings Ltd. provides Mylan with a direct entry into the North American injectable drugs market.

Elsewhere, companies have been looking towards biotech firms to build their product portfolios. Prime examples include Johnson & Johnson’s acquisition of Cougar Biotechnology, Roche’s (RHHBY) acquisition of Genentech, Bristol-Myers Squibbs’ (BMY – Analyst Report) acquisition of Medarex, Sanofi-Aventis’ acquisition of Fovea Pharmaceuticals SA, Astellas Pharma’s acquisition of OSI Pharmaceuticals and Abbott Labs’ (ABT – Analyst Report) acquisition of Facet.

Sanofi-Aventis has also been in the news with its agreement to acquire biotech company Genzyme Corp. (GENZ – Analyst Report).

Going forward, we expect this M&A trend to continue. We also expect a significant pickup in in-licensing activities and collaborations for the development of pipeline candidates. Instead of developing a product from scratch, which involves a lot of funds, pharma companies are shopping for mid-to-late stage pipeline candidates that look promising.

Small biotech companies are also game for in-licensing activities and collaborations. Most of these companies find it challenging to raise cash, thereby making it difficult for them to survive and continue with the development of promising pipeline candidates. Therefore, it makes sense for them to seek deals with pharma companies that are sitting on huge piles of cash.

We would recommend investors to put their money in biotech stocks that have attractive pipeline candidates or technology that can be used for the development of novel therapeutics. Therapeutic areas which could see a lot of in-licensing activity include oncology, central nervous system disorders, diabetes and immunology/inflammation.

Emerging Markets

Another recent trend seen in the pharmaceutical sector is a focus on emerging markets. Companies like Mylan, Pfizer, Eli Lilly (LLY – Analyst Report), GlaxoSmithKline (GSK – Analyst Report) and Sanofi-Aventis are all looking to expand their presence in India, China, Brazil and other emerging markets. Until recently, most of the commercialization efforts were focused on the US market — the largest pharmaceutical market — along with Europe and Japan.

However, emerging markets are slowly and steadily gaining more importance and several companies are now shifting their focus to these areas. Emerging markets should see strong sales thanks to higher demand for medicines. Several factors like government initiatives for healthcare, new patient population, and increasing use of generics should help drive demand. Growth in emerging markets could help stabilize the base business during the industry’s 2010-15 patent cliff.

IMS Health estimates that pharmerging markets will grow 14-17% through 2014, while major developed markets will grow only 3-6%. Although the US will retain its position as the single largest market (estimated growth: 3-6% annually in the next five years), China’s pharmaceutical market is expected to continue to grow more than 20% annually, and contribute 21% to overall global growth through 2013.

Growth Forecasts for 2011

According to IMS Health, the global pharmaceutical industry should record growth of 5-7% in 2011 representing sales of approximately $880 billion.

Pharmerging markets, consisting of 17 countries, are slated to grow in the range of 15-17% in 2011, representing sales of $170-$180 billion. China, which is now the third largest market in the world, is expected to grow 25-27% to more than $50 billion in 2011.

As far as developed markets are concerned, Japan is slated to grow 5-7% in 2011. Major European markets like the UK, Germany, France, Italy and Spain are expected to deliver combined growth of 1 3%. A similar growth rate is expected from Canada. The US market, which is expected to retain its position of the single largest pharma market, is slated to grow 3-5% to $320-$330 billion.

Source of Growth Forecast: IMS Health

OPPORTUNITIES

We currently have a neutral outlook on large-cap pharma stocks, supported by the Zacks #3 Rank. While the companies will continue to face challenges like pricing pressure and genericization, growth in emerging markets and product approvals could help reduce the impact.

Most of the companies have provided a disappointing outlook for 2011 with performance expected to be affected by factors like US healthcare reform, EU pricing austerity, and generic competition among others.

We currently have Neutral recommendations on companies like Abbott Labs (ABT – Analyst Report), Allergan Inc. (AGN – Analyst Report) and Pfizer (PFE – Analyst Report). We believe that Allergan’s presence across different segments and geographies will help maintain decent growth going forward. We believe the company will be back on its historical mid-to-high teens earnings growth trajectory from 2011.

In the biotech space, we are positive on Biogen Idec (BIIB – Analyst Report). Biogen delivered a strong fourth quarter with revenues being driven by Tysabri and Avonex. Earnings estimates for Biogen have gone up significantly for 2011 based on continued strong performance of the multiple sclerosis franchise and share repurchase.

WEAKNESSES

We currently have a negative outlook on European pharma companies like Sanofi-Aventis (SNY – Analyst Report) GlaxoSmithKline (GSK – Analyst Report) and Bayer (BAYRY – Analyst Report). All these companies have witnessed downward estimate revisions following the release of fourth quarter and full year results. US healthcare reform, EU pricing austerity and lower sales of pandemic flu products are likely to impact the performance of companies like Sanofi and Glaxo.

Moreover, Sanofi is facing generic competition for several products and this is expected to continue impacting the company’s performance going forward. For 2011, Sanofi expects earnings to decline 5-10% given the absence of A/H1N1 vaccine sales and the impact of generic competition.

Meanwhile, we have a Zacks #4 Rank (short-term Sell rating) on Johnson & Johnson (JNJ – Analyst Report). The company provided a disappointing outlook for 2011. We expect the poor performance of the company’s Consumer segment due to back-to-back OTC product recalls, EU pricing pressure as well as genericization of certain products to weigh on sales.

We recommend avoiding names that offer little growth or opportunity for a take-out. These include companies which are developing drugs that are likely to face regulatory hurdles. The US Food and Drug Administration (FDA) has been exercising more caution before granting approval to new products and several candidates have been facing delays in receiving final approval.

We currently have a Zacks #4 Rank (short-term Sell rating) on MannKind Corporation (MNKD – Analyst Report). The company suffered a major setback earlier this year when it received a second complete response letter from the US Food & Drug Administration (FDA) for its diabetes treatment, Afrezza.

We would also avoid companies like Eli Lilly & Co. (LLY – Analyst Report), which is facing patent expirations on key products and whose new products may not be enough to make up for the loss of revenues that will take place once generics enter the market. 2011 will be a challenging year for Eli Lilly with the company losing patent exclusivity on Zyprexa. Zyprexa sales should erode rapidly with the entry of generics. Moreover, we expect continued erosion of Gemzar sales due to genericization.

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Pharmaceutical News: BioSante Pharmaceuticals to Raise $25.1 Million in Registered Direct Offering

Fixed ARV pricing may hamper Aspen’s growth

Aspen Pharmacare, Africa’s largest pharmaceutical manufacturer has announced a 33% increase in revenue for the six months to December 32 last year but warns that performance may decline due to single exit prices imposed on anti-retroviral (ARVs) by the health minister.

Single exit price refers to legislation instructing medicine manufacturers to sell their products at the same price to their entire customer base, regardless of the size and levels of consumption.

Health Minister Aaron Motsoaledi has said that no consideration would be given to any price increase until the end of 2011.

Aspen said it had experienced significant growth which led to an increase on headline earnings from continuing operations by 35% to R1.147bn, while medicine manufacturing revenue surged by 33% to R5.99bn.

Buoyed by Aspen’s performance, group CEO Stephen Saad said the company had retained its pole position in the market.

“The South African pharmaceutical division’s consistent performance ensured that Aspen retained its position as the leader in the South African pharmaceutical market,” he said.

Saad revealed that smooth business integration had also contributed to the success of the company. In 2009, Aspen entered into a partnership with Glaxo-

SmithKline (GSK) in a deal valued at R3.5bn.

“The successful integration of the GSK business has further contributed and Aspen is now ranked first in the branded product segment. Aspen’s international and sub-Saharan Africa businesses also performed well, delivering increased revenue and operating profit across the group,” he said.

Saad singled out the South African business entity as the single largest performer for the group. Aspen said the local business increased revenue by 29% to R3.3bn and improved operating profit by 23% to R96m.

“The pharmaceutical division led the growth in revenue raising sales by 36% to R2.682bn,” Aspen said

Aspen, however, warned shareholders that the South African consumer business would be affected by the ending in April 2011 of the Pfizer infant milk licence agreement, which generated annual sales of approximately R250m.

“Pfizer has taken the decision to enter the South African market itself following the acquisition of the infant milk franchise as part of its takeover of Wyeth. Aspen has expanded its own infant milk offering with the introduction of the Infacare Gold range in order to replace the Pfizer brands,” the company said.

Despite the single exit pricing on ARVs, the company was excited after winning 41% of the ARV tender.

“In the recently adjudicated ARVs tender, Aspen was awarded 41% by value of the anticipated ARV requirements of the South African government over a two-year period. This validated the cost competitiveness of the group’s production capabilities,” Aspen said.

The health department awarded ARV contracts worth R3.62bn to various companies last year. The government was to announce six more ARV contracts being negotiated.

The competition among manufacturers has led to price decreases of between 20% and 70%, which according to analysts would hit bottom line including that of Aspen.

It is not all gloom for medicine manufacturers like Aspen, according to a recent report called South African Healthcare Market Analysis, released by an international research firm, the industry was poised for 23% growth by 2013.

The report revealed that a number of factors including HIV-Aids, TB and diabetes would spur health care spending in the near future. Demand for primary health care drugs such as generics and antibiotics would help push profits up for pharmaceuticals in the country, said the report.

“The launch of new products from the extensive product pipeline will provide organic growth across all major markets. The expanded business in the Asia Pacific region is expected to provide further momentum,” Aspen said.

Latin America was a core focus as a region with great potential. Aspen would pursue opportunities to add to its portfolio of global brands.

BioSante Pharmaceuticals to Raise $25.1 Million in Registered Direct Offering

LINCOLNSHIRE, Ill.–(BUSINESS WIRE)–BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that it has received commitments from several institutional investors to purchase $25.1 million of securities in a registered direct offering. BioSante expects to receive net proceeds of approximately $23.8 million after deducting placement agent fees and other offering expenses. BioSante has entered into securities purchase agreements with these investors pursuant to which BioSante has agreed to sell an aggregate of approximately 12.2 million shares of its common stock and warrants to purchase up to approximately 4.0 million additional shares of its common stock. Each unit, consisting of one share of common stock and a warrant to purchase 0.33 of a share of common stock, will be sold for a purchase price of $2.0613, a premium to the closing price on the day before pricing.

“We are pleased to have this commitment from these new and existing institutional investors,” said Stephen M. Simes, BioSante’s president and chief executive officer. “This additional funding provides us with added financial power to continue to fund our ongoing LibiGel® Phase III clinical study program. We recently announced completion of enrollment in the first of the two LibiGel Phase III efficacy trials and expect to announce completion of enrollment in the second in the near future. LibiGel remains the lead pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women, and we continue to believe that LibiGel has the potential to be the first product approved by the FDA for this common and unmet medical need.”

The warrants to purchase additional shares will be exercisable at an exercise price of $2.25 per share beginning immediately and will expire three years from their date of issuance. All of the securities were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used for general corporate purposes, including continuing to fund BioSante’s LibiGel Phase III clinical study program. The offering is expected to be consummated by March 8, 2011, subject to customary closing conditions.

Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc., (NASDAQ: RODM), acted as the exclusive placement agent for the transaction. Oppenheimer & Co. Inc., Roth Capital Partners, LLC, JMP Securities LLC and Trout Capital, LLC acted as financial advisors.

Shelf registration statements relating to the shares of common stock and warrants issued in the offering (and the shares of common stock issuable upon exercise of the warrants) have been filed with the Securities and Exchange Commission (the “SEC”) and declared effective. A prospectus supplement relating to the offering will be filed by BioSante with the SEC. Copies of the prospectus supplement and accompanying prospectuses may be obtained directly from BioSante by contacting BioSante Pharmaceuticals, Inc., 111 Barclay Boulevard, Lincolnshire, Illinois 60069.  This announcement is neither an offer to sell nor a solicitation of an offer to buy any shares of common stock or warrants of BioSante. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies.
Forward-Looking Statements

To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante’s actual results to be materially different than those expressed in or implied by BioSante’s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante’s licensees or sublicensees; the success of clinical testing; and BioSante’s need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante’s actual results are described in BioSante’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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