Pharmaceutical News

Increased excise duty, MAT on SEZs to hurt pharma industry

Leading drug makers on Tuesday said that higher excise duty proposed in the Budget 2011-12 would make medicines costlier and hurt the common man.

Further, pharmaceutical industry players also feared that imposition of Minimum Alternate Tax (MAT) on Special Economic Zones would adversely impact their profits, since most export units of drug firms are located in various SEZs.

“Healthcare has not received the priority it deserves. The one per cent increase in excise duty will increase the cost of medicines to the consumer by about 1.5 per cent,” Pfizer MD Mr Kewal Handa told PTI.

The excise duty on medicines and medical equipment has been increased from four to five per cent.

Mr Handa noted that the government could have done away with customs and excise duties on medicines, which could have helped in taming high inflation.

“It could have benefited the common man, who has to spend for healthcare from his or her pocket,” he added.

Dr Reddy’s Laboratories termed levy of MAT on special economic zone as “negative” for the industry.

”…the levy of MAT on SEZ units is negative for the industry at large. There have been no major provisions for the pharma sector and the budget in general is a neutral one for us,” Dr Reddy’s Laboratories CFO Umang Vohra said.

Lupin President, Finance and Planning S Ramesh said the Budget has little for the pharma industry and the MAT introduction on SEZs and the phasing out of EOUs would hurt the competitiveness of the sector in global markets.

He added: “The Budget, simply put, is long on intent but short on content — while the strategic focus of the Budget on various matters such as fiscal consolidation is explicit, the process by which it will translate into a tangible outcome is still to be made unequivocal.”

Commenting on the Budget, Glenmark Pharmaceuticals CEO & MD Glenn Saldanha today said that the Union Budget had nothing for the pharma industry.

Sturdy Future Awaits Global Pharma Industry

The global pharma industry is expected to grow at a stupendous CAGR of 6.5% during 2011-2013, on the back of rising health concerns and increasing healthcare expenditure in emerging markets.
Our latest research offering “Global Pharmaceutical Market Forecast to 2012”, depicts an upward trend in the global pharma industry as the effects of the recent economic downturn have been fended off leading to worldwide recovery. However, growth in the developed markets of the US and other leading Western European countries will be slow due to high levels of saturation. Hence, the global pharma market will continue its growth in tune with the emerging markets, including the Asia-Pacific, Latin America, and Central & Eastern European markets. Increasing healthcare expenditures and industry-friendly reforms will help the global pharma market to grow at a CAGR of around 6.5% during 2011-2013.

Despite economic and political issues being faced by the developing nations, the pharmaceutical market in these countries is growing due to rise in the demand of drugs. This untapped potential of countries, such as India, China, Brazil, Russia, Indonesia, and others is due to the rising prevalence of diseases. Besides, the governments of these countries are introducing new policies and laws to burgeon the trade and distribution channels of the industry, and controlling the drug counterfeiting and IPR issues. Thus, the major pharma companies are formulating expansion plans in these regions.

To gain in on the opportunities held by the potential of the emerging markets, the companies are considering all possible forms of penetration, even inorganic growth. Additionally, the companies are willing to collaborate with the local companies for a better understanding of the market and its demands. Our report categorically studies the major pharma markets of the world and also the most promising markets by region.

The report also includes a brief overview of the leading therapy classes, drugs, and competitive analysis of the key players in the industry. Moreover, the report has identified North America, Latin America, Europe, Asia-Pacific, and Africa as the most important regions to be looked out for in the pharma market. For a comprehensive outlook of each country, the report contains statistical and analytical information on these markets, covering their current market size, demand, and healthcare statistics. It also features analysis of future directions, supplemented with facts and figures.

Nader Groups Demand Feds Regulate Drug Industry Use of Social Media

With the growth of social media, companies and consumers now use sites such as Facebook and Twitter to share information and provide support and service. Now the use of these tools by one category of companies, the pharmaceutical industry, is under attack by a number of groups under the leadership of Ralph Nader.

The Center for Digital Democracy, Consumer Watchdog.org, US PIRG, and the World Privacy Forum have filed a lengthy and contentious complaint to the Federal Trade Commission (FTC) accusing pharmaceutical companies of inappropriately using social media and digital marketing to promote their products.

“Consumers now confront a sophisticated and largely stealth interactive medical marketing apparatus that has unleashed an arsenal of techniques designed to promote the use of specific brand drugs and influence consumers about treatments for health conditions,” the complaint maintains.

All of the organizations filing the claim, with the exception of the World Privacy Forum, were either started by consumer advocate Ralph Nader or executives who worked for him.

‘No Threat to Public Health’

There is nothing wrong with pharmaceutical companies using social media and digital marketing to reach consumers, says John R. Graham, director of health care studies at the Pacific Research Institute. He maintains the most important thing is that the right medicine gets to the right patient at the right time, which requires free and open communication.

“As long as people engage in social media and digital marketing campaigns voluntarily, there is no threat to consumer privacy or public health,” says Graham. “There is no law compelling any citizen to use any social media. There’s no law compelling anyone to use old media, either. People should be free to decide how they engage social media.”

Graham says social media’s speed of information distribution can improve the public health, as information travels freely without central control.

“If the FTC or Congress limits all digital marketing by pharmaceutical companies, everyone’s rights will be violated. It is absurd to expect research-based pharmaceutical firms to use the most up-to-date technology to invent new drugs and then forbid or limit them from using the most up-to-date technology to communicate the those drugs’ benefits,” Graham said.

“If someone thinks it is wrong for a drug maker to use social media to communicate, that person is under no obligation to communicate with a drug company via social media,” he added.

Regulators Assume the Worst?

According to Joseph Coletti, director of health and fiscal policy studies at the John Locke Foundation, regulators are uneasy about the use of social media as an information resource in part because most social media interaction limits the number of warnings that can easily be communicated.

“Social media is unregulated, and regulators naturally tend to think this is a bad thing. For instance, if you are a patient or a doctor and you talk to a drug company, [the regulators] think that you demand their product from that single contact without having any other knowledge,” Coletti said. “If you put 140 characters on a Twitter message, you can’t possibly have enough warnings about the consequences or side-effects of using their product.”

Coletti maintains Nader and his partner groups don’t see marketing on social media as educational.

“But what is this if not educational?” Coletti asks. “How are you supposed to know what drugs are out there or what can help you? Or if you’re in a Facebook group because of your condition, why shouldn’t a drug manufacturer be able to reach you?”

Europe’s Paternalistic Approach

Devon Herrick, a senior fellow at the National Center for Policy Analysis, says limiting risk and patient preference motivates many of the regulators.

“Europe has a much more top-down, paternalistic society, where doctors act as social advocates. They think they should tell you what to do, what medicines to take, and the patient has little say in the matter,” said Herrick. “Personal media short-circuit this relationship.”

Herrick notes Facebook and other social networks give patients the ability to interact with other patients, doctors, and pharmaceutical companies to learn more about available treatments.

“What better medium than Facebook, where communities can form up around a medicine or treatment, where the company is running the page and moderating it and answering your questions and you’re talking to other patients with similar illnesses? Where else are you are going to bring all the stakeholders together in a transparent manner? If the consumer advocates have their way, all this will be lost,” explains Herrick.

Suppressing Dissenting Information
Regardless of the outcome of the Nader-backed complaint, Graham maintains free and open access to information about new therapies is a key to limiting government control over available treatments—something he says will be all the more important once agencies such as the Independent Payment Advisory Board, created by President Obama’s health care legislation, inevitably seek to limit people’s therapeutic choices.

“President Obama declared that if there is a red pill and a blue pill and one costs more than the other, but the politicians think that they are the same, he’ll [only] let you have the cheaper one,” Graham explains. “Obviously, the government can only impose such a rule if it controls the communications that the people have about medicines, and allows no dissenting information.”

The pharmaceutical industry is helping state law enforcement officers track sales of a popular over-the-counter decongestant as part of a crackdown on “smurfing,” a way of collecting a key ingredient in the illegal drug methamphetamine.

Authorities hope the industry-funded tracking system will tip the advantage in their favor in a long-running battle with meth cooks.

Pharmaceutical companies have been pushing to expand the tracking system amid growing calls to require prescriptions for pseudoephedrine, the legal decongestant that is also used to make meth.
South Carolina is among 10 states that have passed laws adopting NPLEx, the industry’s system to track pseudoephedrine. Two states have begun requiring prescriptions for the drug, often marketed as cold and allergy medicine.

The decongestant remains available without a prescription in S.C., although retailers must keep it behind the counter.

Pharmacies statewide have been recording who is buying the drug and how much since 2006, but they had no means of sharing the information with each other until recently.

NPLEx, or National Precursor Log Exchange, puts all the purchases in one database, making it easier to track sales at different pharmacies. When a customer tries to buy more than the limit, retailers receive a recommendation to deny the sale, as a message is sent to the State Law Enforcement Division.

Sales of more than 6,000 boxes of pseudoephedrine have been blocked since the system went live in the state on Jan. 1, according to SLED records.

“Every single time a product gets blocked, you could be preventing a meth lab from happening,” said Mandy Hagan, the director of state government relations for the Consumer Healthcare Products Association, the group leading the NPLEx lobbying effort.

Privacy Rights Clearinghouse and the Electronic Privacy Information Center said they aren’t watching NPLEx but that the system raises general concerns about privacy of medical records.

“When personal information is collected into a database, there is always a chance of some secondary use,” said Tena Friery, research director for the San Diego-based clearinghouse.

Federal law makes clear that information gathered by NPLEx is accessible to law enforcement only, Hagan said.

Kentucky, the state that pioneered the system, is blocking the sale of 10,000 grams of pseudoephedrine per month — enough to make 5,000 grams of meth, Hagan said. Meth lab incidents in S.C. fell from 199 to 26 from 2004 to 2007 and then began climbing back up, reaching 77 in 2009, the last year for which data is available, according to the Drug Enforcement Administration.

Each lab costs an average of $2,200 to clean up and is often full of toxic chemicals that can sicken officers or explode, according to an audit by the U.S. Department of Justice’s inspector general.

The state law that brought the tracking system to S.C. also lowered the caps on purchases of pseudoephedrine to 3.6 grams per day and 9 grams every 30 days. Ephedrine and phenylpropanolamine are also subject to the limits.

Customers who buy or possess more than the limit face up to five years in prison and a $5,000 fine for a first offense under the new law. Multiple offenses could result in a 10-year prison sentence or a minimum fine of $10,000.

Dr. Emmanuel Sarmiento of the Allergic Disease and Asthma Center in Greenville said it is rare for patients to need more than 240 milligrams a day.

Patients who do need more can get a letter from a doctor exempting them from state limits, he said. Taking high doses of pseudoephedrine for a sustained period can lead to heart arrhythmia and prostate problems, he said.

Oregon and Mississippi are the only states that require a prescription for pseudoephedrine. State Sen. Mike Fair, R-Greenville, said S.C.’s meth problem left the state with the choice between the tracking system and requiring prescriptions. Only if NPLEx turns out to be an “abject failure” does he expect lawmakers to revisit the prescription idea.

Walgreens, CVS, Rite Aid and Wal-Mart are among the retailers using NPLEx, according to SLED.

Retailers face up to three years in prison and $10,000 in fines for violating the law.

Purchases follow customers over state lines. North Carolina doesn’t use the tracking system, and Georgia lawmakers are considering it, Hagan said.

Pharma Ind expects level playing field in excise duty

According to Indian Drug Manufacturers Association President and Pharmexil Vice-Chairman N R Munjal, the Budget should address the need for research and development (R&D) and the anomalies in the excise duty for the pharma sector.

He said the Union Budget for the last four years did not focus on the push required for R&D in the pharma sector.

“India ranks third in volume and 13th in value in the global pharma market, so there is a tremendous scope for improvement. Since IPR (intellectual property rights) are intangible assets, a measly funding is earmarked for such projects.”

He added, the PPP (public-private partnership) mechanism for the pharma business was quite cumbersome. Most of the pharma companies are flourishing under the PPP model where private universities, government labs and pharma companies collaborate for R&D. We are lagging in this, he rued.

Surya Pharmaceutical Limited Managing Director Rajiv Goyal said, the disparity in the excise duty on finished goods and raw material (the excise duty on raw material is 10.3 per cent and on output is 4 per cent) should be removed. This is the only industry with a differential excise duty on input and output cost.

This has specifically hit the units in tax-free zones as the units located in other parts can obtain 10 per cent modified value added tax to save the tax burden.

Himachal Drug Manufacturers Association Chairman Sanjay Guleria said, the Union Budget should revise the Drug Price Control Order (DPCO). There is a proposal of including 300 drugs under the category of essential drugs, presently there are 72 drugs under this.

Due to the scarce availability of skilled labour, the cost has been rising for drug manufacturers, still Indian drugs are the cheapest in the world.

The government should make provisions for the development of the pharma sector by allocating more funds for R&D and streamlining the tax structure, he finished.

SCOLR Pharma, Inc. Retains Nicholas Hall & Company

SCOLR Pharma, Inc. (OTC Bulletin Board: SCLR) today announced that it has retained Nicholas Hall & Company, a company providing complete support services to the global consumer healthcare industry, to introduce SCOLR to pharmaceutical companies, distributors and retailers that are interested in utilizing the Company’s proprietary technology to develop OTC or prescription pharmaceutical or nutritional products.

With more than 35 years’ experience of strategic planning, market analysis and product placement, Nicholas Hall & Company, possesses detailed knowledge of the consumer healthcare market worldwide.

Stephen J. Turner, SCOLR Pharma’s President and CEO, said, “Nicholas Hall & Company has a long and successful track record of assisting specialty pharma companies with their partnering and marketing strategy. We believe their deep relationship with many of the world’s leading pharmaceutical and over-the-counter (OTC) consumer products companies will be very valuable to SCOLR as we seek to partner and expand the utilization of our technology in OTC and prescription products.”

About SCOLR Pharma:

Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company focused on applying its formulation expertise and patented CDT platforms to develop novel prescription pharmaceutical, over-the-counter, and nutritional products. SCOLR’s CDT drug delivery platforms are based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products.

Forward looking statements:

This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning the anticipated value of services to be provided by Nicholas Hall & Company, and the possibility of transactions involving the use of SCOLR’s proprietary technology. These forward-looking statements involve risks and uncertainties, including activities, events or developments that SCOLR expects, believes or anticipates will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including the willingness of such of third parties to partner with SCOLR on acceptable terms, or at all, competition from larger and better funded pharmaceutical companies, SCOLR’s ability to manage its liquidity and obtain financing necessary to continue its operations and, global economic conditions. Additional assumptions, risks and uncertainties related to SCOLR’s business are described in detail in its registration statements, reports and other filings with the Securities and Exchange Commission, including the “Risk Factors” set forth in its Annual Report on Form 10-K, as supplemented by its quarterly reports on Form 10-Q. You are cautioned that such statements are not guarantees of future performance and that actual result or developments may differ materially from those set forth in the forward-looking statements. SCOLR undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstance.

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.”

Slash your drug costs

Lorene Coates used to pay $200 to $250 for her prescriptions before pharmacies created discount drug plans.

A retiree, Coates became eligible for the Medicare drug card in March and now only spends about $51 each month for her hypertension medicine.

She pays a total of $25 a month for two brand name medications and $26 for a prescription drug card. She also mail orders generic prescriptions and gets them for free under the Medicare plan.

“That’s a great savings for me,” said the former Hattiesburg American employee who retired three years ago. “I was having to pay the full price and (then) I did get all the generics I could.”

Generic is the word to remember when it comes to saving on prescription drugs. Pharmacies across the country are now touting generic prescription plans as money savers with chains like Wal-Mart, Target and Fred’s offering a month’s worth of generic prescription drugs for $4 to $5.

Locally owned and operated Owl Drug Store, a service of Hattiesburg Clinic, offers $5 monthly prescriptions on more than 100 generic drugs, ranging from allergy to diabetic to mental health medications. Many prescriptions also are available in a 60-day supply for $8 and a 90-day supply for $12.

Nancy Rohr, pharmaceutical technician at Southwest Drug Co. on Adeline Street, said the store works with customers to give the lowest price on drugs. She said generic drugs are often the best option. Although they don’t offer a discount plan, Rohr said choosing generic drugs is the key to getting the best bargain.

“If they have a drug plan, we see if it goes through. If it doesn’t, we see if we can find a drug that’s comparable to the one the doctor wrote and is generic,” she said. “If there isn’t we call the doctor to see if there’s something else they can take.”

The Food and Drug Administration’s Web site suggests customers ask their doctor or pharmacist if a less expensive drug will work. The Web site also recommends comparing prices among other pharmacies and using assistance programs.

Sandra Dykes, 67, of Petal gets the bulk of her prescriptions filled through her husband’s military TRICARE insurance plan. When she can, she buys generic drugs for three of her eight prescriptions at Wal-Mart.

Generic drugs have the same active ingredients and effects as brand-name drugs, but they can cost 30 percent to 80 percent less, the FDA’s Web site says.

Older adults with Medicare are eligible for coverage under Medicare Part D drug prescription plan. Rohr said many customers are on this plan and know what medications are covered. She suggests diabetics shop at medical supply stores for test strips and syringes since the purchase will be covered by insurance.

If you can’t afford to buy certain medications, some companies offer free or discounted drugs for people who aren’t eligible for Medicare or insurance.

Launched in 2005, the Partnership for Prescription Assistance is an industry initiative to help patients find assistance programs faster. It provides a single point of access to more than 275 public and private PAPs – including more than 150 programs offered by drug companies. The PPA also will show people how to contact Medicare and other government programs.

Rohr said the pharmacy works with doctors to make sure customers get the medicine they need at an affordable price.

“We try the best we can to give the most reasonable price and service and we also try to thoroughly explain what medicines are for,” she said.

Don’t underestimate the danger of drugs from abroad

Ryan Thomas Haight, a baseball card collector, fantasy sports aficionado, straight-A student and varsity tennis player from La Mesa, died 10 years ago. The facts are simple and tragic: Sometime on Feb. 12, 2001, Haight took a cocktail of painkillers that he had purchased over the Internet without a prescription, had a serious reaction to it and died. Ryan, obviously, wasn’t a hardened criminal, he was simply experimenting with controlled substances – as many teenagers do – and found that widespread, loosely regulated Internet pharmacies made it very easy to get nearly any type of commonly abused prescription drugs. Haight got his drugs after filling out a questionnaire that was “examined” by a doctor who had never met him.

While nothing can make up for the loss of Ryan, some good did come of his death. Seven years after he died, partly at his own mother’s urging, Congress approved a law that bears his name: the Ryan Haight Online Consumer Protection Act. It prohibits sales of controlled substances over the Internet without a valid prescription issued during an in-person doctor’s visit. It’s a good start, but if Congress wants to get serious about preventing other tragedies, it must do more.

Although the Haight Act has cut the number of fly-by-night pharmacies based in the United States, in fact, most illegitimate pharmacies exist in other countries. It’s not practical for the United States to actually regulate these entities beyond its borders, but it is in our best interest to coordinate with other countries in efforts to address the growing threat of fake drugs and illegitimate pharmacies.

As we know, a (supply) chain is only as strong as its weakest link. In an economy that is growing more global by the day, the only way to ensure absolute safety of all domestic drugs would be for the American government to somehow enforce American pharmaceutical regulations in other countries – and that’s clearly impossible. What is possible is for stronger and better international cooperation in order to share information on possible counterfeiters, enact effective standards and reviews, and limit the opportunity for counterfeit drugs to get into the pipeline.

Governments and medical professionals alike simply need to do a better job of educating the public about the dangers of unregulated online pharmacies. While drugs sold at physical pharmacy counters in the United Kingdom, Canada and other developed countries can be presumed safe, most online pharmacies that claim to operate in these countries maintain little more than mail drops there and instead import drugs from China, India and other countries that have little quality control over medicines. Some online medicines from “Canada” are sugar pills; others are deadly. Quite simply, Americans need to realize that a web page that shows a maple leaf – or even a mailing address in a familiar sounding, English-speaking city – is not a sign of safe, sound medications.

The United States has the safest drug supply and the best pharmacy system in the world. We must ensure that the legacy of Ryan Haight is not wasted: Ten years after his death, lawmakers should act to ensure that illegal online drug pushers are put out of business. No one should ever have to bet his or her life on the legitimacy of an online pharmacy.

NPS Pharmaceuticals to Present at Upcoming Health Care Conferences

NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) will present at the Citi 2011 Global Health Care Conference in New York on Tuesday, March 1, 2011 at 10:30 a.m. ET and the Cowen and Company 31st Annual Health Care Conference in Boston on Monday, March 7, 2011 at 2:30 PM ET. Presentations will be available as live webcasts with replays available approximately three hours after the presentation has concluded.

About NPS Pharmaceuticals

NPS Pharmaceuticals is an outsourcing-based development company focused on bringing biopharmaceuticals to patients with rare disorders and few, if any, therapeutic options. The company is advancing two Phase 3 registration programs, GATTEX® (teduglutide) in short bowel syndrome (SBS) and NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection) in hypoparathyroidism. NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, Kyowa Hakko Kirin, Nycomed, and Ortho-McNeil Pharmaceutical.

Salix takes center stage in drug-stock trading

BOSTON (MarketWatch) — Shares of Salix Pharmaceuticals Ltd. plunged in afternoon trading Thursday on news that the U.S. Food and Drug Administration does not plan to approve its drug Xifaxan at this time.

Salix (SLXP 31.55, -0.06, -0.19%) shares tumbled 22% to $32.20 at last check. \
The company said that after speaking with FDA officials, it now expects to receive a Complete Response Letter from the agency on or before March 7. The FDA issues a Complete Response Letter when it determines that a drug’s market application is insufficient for approval.

Salix is seeking to have Xifaxan approved to treat certain types of irritable bowel syndrome.

Shares of Protalix BioTherapeutics Inc. (PLX 9.30, -0.06, -0.64%) slipped 2%. The
Israel-based drug maker is expected to hear by late Friday whether the FDA will approve its new treatment for Gaucher’s disease.

If approved, the product, called taliglucerase alfa, would compete against Genzyme Corp.’s (GENZ 75.35, -0.01, -0.01%) flagship drug Cerezyme. Protalix has been
developing the product with Pfizer Inc. (PFE 18.90, +0.14, +0.75%)

Par Pharmaceutical Co. (PRX 34.39, +3.12, +9.98%) shares slid 9%.

Early Thursday, Par said its fourth-quarter profit rose to 48 cents a share from 31 cents a share in the 2009 quarter. Revenue, however, fell to $227 million from $290 million, due in part to increased competition for its drugs metoprolol, meclizine and clonidine.

The drug sector’s two key indexes were mixed. The NYSE Arca Pharmaceutical Index (DRG 301.67, -1.49, -0.49%) eased 0.9% to 300.84, while the NYSE Arca Biotechnology
Index (BTK 1,267, +6.05, +0.48%) rose 0.3% to 1,264.87.

Vertex’s New Cystic Fibrosis Drug Treats the Cause, Not Just the Symptoms

Vertex Pharmaceutical (VRTX) shares soared 15% Wednesday as Wall Street cheered the results of a late-stage study of its new cystic fibrosis drug, an experimental treatment that targets the underlying cause of the disease rather than just its symptoms.

In patients with cystic fibrosis, a defective gene and the protein it creates cause the body to produce unusually thick, sticky mucus that builds up in the lungs and the pancreas, leading to life-threatening lung infections and an impairment of the body’s ability to properly break down and absorb food.

The drug, VX-770, is a pill that targets the defective protein. It showed sustained improvements in lung function of over 10% in patients with a specific gene mutation. The caveat, though, is that the specific mutation being targeted by the drug, G551D, affects just 4% of the CF population. But it’s possible that the results of this trial will provide a basis for the use of VX-770 to treat other mutations. VX-770 is currently being tested in combination with another drug, VX-809, in people with two copies of the more common Delta F508 mutation.

In the trial, patients also showed improvement across all key secondary goals of the study, Vertex said, including decreased pulmonary and respiratory symptoms and weight gain (seven pounds on average). In addition, average sweat chloride (salt) levels, a key clinical indicator of CF, dropped toward normal levels, indicating that the drug is having an effect on the underlying defect.

VX-770 helps “open the gate” at the cell surface — enabling the protein to pass through, as it would in healthy cells. This restores a proper flow of salt and fluids on the surface of the lung, the company explained.

“Treating the underlying cause of cystic fibrosis with VX-770 led to clinical improvements that were far beyond our expectations, providing support for an entirely new approach to the treatment of this disease,” said Peter Mueller, executive VP of global research and development, and chief scientific officer for Vertex.

A Long Time Between Genetic Discovery and New Medicine

“These results are highly encouraging,” said Robert Beall, president and CEO of the Cystic Fibrosis Foundation, which collaborated with Vertex on the drug development, including an approximately $75 million investment. “They provide scientific evidence that support our long-standing belief that targeting the underlying defect of CF may have a profound effect on the disease.”

Cystic fibrosis is an inherited genetic disease that affects about 30,000 people in the U.S. and 70,000 worldwide, according to the Cystic Fibrosis Foundation. In the 1950s, few children with cystic fibrosis lived to attend elementary school. Today, patients can expect to live into their 30s, 40s and beyond. Still, very few treatments are available to CF patients, and those that are generally target the disease’s symptoms.

But while this drug trial is being hailed a victory, it also highlights the problems of targeted therapy, as Mathew Herper of Forbes writes. “Cystic fibrosis is a symbol of how difficult it is to move from genetic discoveries to new medicines. The gene for the disorder, which causes patients’ lungs to fill with thick mucus, was discovered in 1989 by Francis Collins, now the director of the National Institutes of Health. Yet treatments have been slow in coming.”

Vertex said it will file for U.S. approval of the drug in the second half of this year. Analysts estimate VX-770 could, if approved, generate peak annual sales of some $600 million.

Par Pharmaceutical Q4 Profit Rises – Quick Facts

Par Pharmaceutical Companies, Inc. (PRX: News ) Thursday said net income for the fourth quarter was $17.50 million compared to $10.70 million last year. On a per share basis, profit was $0.48 versus $0.31 in the prior year.

Adjusted cash basis from continuing operations was $22.29 million compared to $25.80 million in the previous year. Cash earnings per share from continuing operations was $0.61 versus $0.74 in the previous year.

On average, eight analysts polled by Thomson Reuters expected the company to report earnings of $0.67 per share. Analysts’ estimates typically exclude special items.

Total revenues for the three months were $227.03 million compared to $290.32 million a year ago. Market expectation was for revenues of $210.69 million for the period.

The company attributed the rise in revenues principally to additional competition in metoprolol, meclizine, and clonidine.

Corona new pres. at Masters Pharmaceutical

Masters Pharmaceutical Inc., a Forest Park-based national wholesale distributor of pharmaceutical and medical products, on Tuesday announced the promotion of Wayne A. Corona to president and COO.

Corona, who was formerly senior vice president of purchasing, joined Masters in 2002. Since then the privately held company has grown to more than 15,000 customers nationwide.

“Wayne has contributed greatly to our growth, utilizing his vast experience and skill set. His 35 years in our industry has made him a truly great asset to Masters Pharmaceutical,” said Denny Smith, Masters chairman and CEO.

Global compliance issues influence pharmaceutical traceability

Impending global legislation is set to bring wide-ranging changes to the coding and marking operations of pharmaceutical manufacturers.

More challenges facing the healthcare industry today than at any time in the previous 30 years. Pressure on patents, massive growth in the incidence of counterfeit products, a spotlight on manufacturing efficiency, and the increased complexity of developing and releasing new medicines are all causing major upheaval within the industry.

In addition, an increasing number of fiscal recovery and legislative compliance programs continue to oblige manufacturers to allocate considerable investment and undertake modifications to existing production lines. Any company supplying to the market in question needs to demonstrate compliance, so that in effect, it’s an issue for virtually the entire global pharmaceutical community. Many manufacturers assume that by implementing a track-and-trace system, they will resolve all or many of the current issues, but that’s not necessarily the case.

It is also worth noting that “track” refers to the identification of the product location in real time as it moves forward through the distribution chain, whereas “trace” defines the historical understanding of where a product has been, looking backwards through the distribution chain. It is therefore entirely possible to implement a track or trace system, which are not interdependent.

Any assumption that track-and-trace is the sole solution to all problems brings to mind the debate in the not too distant past over the potential of RFID. You will no doubt recall there being a tremendous amount of excitement generated around RFID and how this “silver bullet” would hold the answer to fulfilling the authentication requirements of the entire supply chain.

Rumors of RFID’s death have been greatly exaggerated. Indeed, RFID is still alive, well, and active in the business of asset tracking, particularly for high-value goods. What is also true is that other coding strategies, namely one- and increasingly two-dimensional codes, have their place and offer their own particular benefits as data carriers.

Those sectors in which RFID has made inroads, have in some cases, actually seen the technology become a driver for change. In particular, and perhaps because of the imperative of legislative compliance, this includes the pharmaceutical sector, which has to a large extent proven a test-bed for RFID technology. That said, its use within this sector is far from universal; an acknowledged lack of robustness makes it unsuitable for 100% verification at unit-of-sale level on packaging lines, for example.

That’s because the lower read rates compared to conventional codes increase the likelihood for error and hence the potential to undermine the entire audit trail. However, RFID is establishing itself as a data carrier at pallet level, where a simple manual re-scan in the event of a read-failure, reduces such an eventuality.

Fundamentally, the much-vaunted potential of RFID as a data carrier has actually prompted both debate and action on the establishment of an infrastructure for mass serialization. Where the original premise of such systems was that RFID would be the data carrier from packaging line to dispensary, experience shows that a mix of technologies is the most practical solution. At unit-of-sale level, therefore, best practice–as recommended by regulators such as the U.S. Food and Drug Administration and industry bodies including EFPIA–is currently a line-of-sight bar code, such as 2D data matrix. The key difference is that where formerly RFID was perceived to be the solution, the focus now is on the management of captured data, with the choice of data carrier being less significant.

Mass serialization, vignettes, and increased use of 2D data-matrix codes

With mass serialization schemes scheduled for implementation in various European markets over the next four to five years, there are a number of reasons for the continued prevalence of machine-readable codes like 2D data matrix within the pharmaceutical industry. The benefits of mass serialization have also given rise to a move away from covert layers with more secure overt layers and, longer term, the increased potential for online digital tax/duty/vignette labels.

Indeed, a number of legislatures are also proposing schemes based on coded vignette labels, to provide physical as well as electronic records of reimbursement. Irrespective of whether codes are marked directly onto the product or onto a vignette, it is likely that the data carrier will be ECC200 2D data matrix.

Data Matrix ECC200 is the most common format due to its small size, is extremely robust as a data carrier and boasts a large information capacity; it can also be read omni-directionally at low contrasts. ECC200 codes incorporate advanced Reed Solomon encoding error checking and correction, which allows bar codes that are up to 60% damaged to still be recognized.

Since 2004, this type of code has also been part of the GS1 (EAN/UCC) family of standards; the ISO-recognized set of data structures that remain the most commonly used.

Global legislation and its ensuing challenges

The development of technologies capable of printing and reading 2D data matrix codes online has allowed the healthcare industry to realize some of the aspirations in patient safety, through authentication, the prevention of reimbursement fraud, and the combat of illicit trade.

That has given rise to various legislative drivers that are further influencing the move towards machine-readable codes like the ECC200 data matrix. A growing area of interest is mass serialization and a number of countries are changing their packaging requirements through increased traceability legislation. As well as the utilization of 2D bar codes, this is set to involve a greater use of serialized numbers and increased levels of human-readable information.

Among this legislation is France’s CIP13, which, requires every pharmaceutical item produced to incorporate a 2D data-matrix bar code comprising product code/batch number/expiry date.

Other countries also have similar proposals in place to adopt the same legislation, which will mean that manufacturing companies will be obliged to add new print and verify capabilities to their existing lines. Indeed, from a general technology point of view, it is estimated that up to 80% of installed coding devices within the pharmaceutical and healthcare sector required to print this information will be redundant at the speed and quality levels required.

Although it may look like a vastly different set of requirements there are two common themes of either vignette labeling or the addition of machine-readable directly on packaging. For the implementation of machine-readable code printing, excellent coding and good handling is a necessity, while vision and data management might be an additional requirement. The need to add RFID could also be possible, although this is unlikely to be implemented below pallet level. Thermal ink-jet printers, thermal-transfer, print-and-apply labeling, drop-on-demand and piezo ink-jet printingwhich can all be suitable depending upon the particular application needs.

Securetrace

Commercial confidentiality frequently precludes those involved in implementing traceability projects to share their experiences. That was one of the reasons that Pera launched its Securetrace Project. Pera, a U.K. not-for-profit technology centre, received funding for a track-and-trace pilot through the U.K. technology strategy board and subsequently formed a consortium of 10 leading technology partners.

The process begins when pharmaceuticals are imprinted with unique and secure 2D bar codes featuring authenticating markers in the ink. A unique natural fingerprint is also generated using laser surface authentication. Pack data is aggregated to cartons and pallets, bar codes and RFID labels are applied to cartons, and all information is stored in a master database. Once the pharmaceuticals leave the packaging facility, field readers provide authentication and verification of the product as it travels through the supply chain to its point of dispensation.

There are a number challenges associated with printing machine-readable codes–namely that the code formats are much larger. Data-matrix codes need better mechanical handling and process control than normal and the printing technologies depend on several variables.

The choice of vision system is also critical (standards/algorithms/connectivity) and the data management and security is of paramount importance. What is fundamental is the need to have a holistic project approach, as any system is only as good as its worst part.

Implementation issues

It should not be forgotten that, even upon successful application of the appropriate data carrier, problems can still arise further down the supply chain. Like France’s CIP13, Turkey’s ITS (Ilac Takip Sistemi) scheme aims to incorporate the compulsory use of the same 2D code in order to allow full tracking of healthcare products. This includes prescription and over-the-counter medicines and dietary supplement products from their importation or production in the country through to the point of dispensing in the pharmacy.

Despite having the label as one of the world’s foremost distribution hubs for counterfeit medicines, the project was initially designed to combat widespread reimbursement fraud in the country, which is estimated to cost the state around $150m a year. Securing the supply chain from counterfeit, substandard, and diverted medicines is an added benefit.

Implementation of the ITS scheme has suffered ongoing problems; having only just gone live after much delay, ITS illustrates the logistical obstacles that impact upon the rollout of such projects. Most of the opposition to the Turkish system has arisen from smaller pharmacies, which are against the cost of purchasing and implementing the scanner system for the scheme, estimated to cost around $150, and any related equipment such as an updated IT system. This has led many to predict that the date for mandatory implementation may slide even further, if such issues cannot be overcome.

In addition to the EFPIA pan-European proposal and defined implementations in Turkey and France, other countries that are proposing increased product identification and authentication within the healthcare sector include Brazil, China, Serbia, South Korea, Spain, and Greece.

However, there is no one solution that will fit all legislative requirements or customer requests. The best approach is to be clear which markets are being supplied by which lines and therefore determine the minimum requirements for product compliance. Many companies then decide which approach they wish to adopt, if any, above the basic requirements of legislative compliance at a corporate, geographic, or site level.

It is therefore essential that manufacturers and packaging companies sit down with key suppliers and leading industry experts to agree the best approach for a phased, long-term, cost-effective, and sustainable program to suit their needs. After all, there is no universal technology and different packages will work best with different circumstances.

In addition, the irksome and protracted instigation of the Turkish scheme demonstrates one of the fundamental aspects of implementing such systems: regardless of whether it’s an RFID label, 2D data-matrix code, or another form of data carrier, it is how the information is handled and what happens to it after it has been applied that is most important. This will be influenced by a number of cost, logistical, technological, and infrastructural issues, to name a few. Also evident is that the chances of success for any traceability scheme depend on buy-in from the entire supply chain community.

Once these issues are successfully addressed, managing the data correctly will uphold the requirement for supply chain visibility from point of manufacture to point of sale and ensure the fundamental objectives of any identification strategy–irrespective of the type of data carrier–are met.

Pharmacists must send coherent message to GP commissioners, industry leaders warn

One of those points should be getting pharmacy more involved in clinical pathways, he said.

“We have to be there so we can get directed MURs,” Mr Stone warned.

Pushing for a greater medicines management role was also key, according to the Senators.

Senior pharmaceutical adviser for Havering PCT Mohamed Kanji told the Senate that it was clear there were problems with medicines management.

“We know that is not being done as 30 per cent to 50 per cent of medicines are not being used as directed, so [ask GPs] how can we work together to ensure that the medicines are being used in that way,” Mr Kanji advised.

NHS commissioning lead for Rowlands Pharmacy Liz Stafford agreed that pharmacists needed to raise medicines management as a potential area that pharmacists could get more involved in.

Senators also discussed the importance of up-skilling staff, measuring quality and outcomes and working with NHS bodies to develop the role of pharmacy in the “new world” NHS.

Pharmaceutical Supply Chains Are Due for a Radical Overhaul Says PwC

New Report Outlines Six Trends That Will Change the Way Drugs are Manufactured and Distributed

NEW YORK, Feb. 21, 2011 /PRNewswire/ — While recent attention has focused on issues such as the challenges associated with drug discovery and the regulatory review process, pharmaceutical companies have invested comparatively little effort in updating their manufacturing and distribution operations, many of which are inefficient, under-utilized and ill-equipped to cope with new medicines, cost pressures and health reform expectations, according to the latest report in the Pharma 2020 series, Supplying the Future: Which path will you take?, released today by PwC US.

Representing a significant amount of the cost base of most bio-pharmaceutical companies, the supply chain is the link between the laboratory and the marketplace and includes everything from sourcing raw materials to manufacturing and packaging to inventory warehousing, transportation and distribution. As demand grows for more customized products and services — and as the nature of those products and services becomes more complex — the next generation pharmaceutical supply chains will become an increasingly important source of differentiation for makers of medicines, and will be a more prominent part in the strategic thinking of industry leaders, according to PwC.

In the report, PwC outlines six trends that will fundamentally change the way pharmaceutical companies make and distribute their products.
Health reform shifts emphasis from product features to patient outcomes: The government’s emphasis on health outcomes as a basis for payments will require pharmaceutical companies to not only manage the manufacturing and distribution of medicines and companion diagnostics, but also to combine product offerings with data and supplemental services that add value through improved outcomes and efficiencies.
New products types: The growth of biologics, bioengineered vaccines and advancements such as stem cell research and nanotechnology are diversifying pharma’s portfolio with products that have a shorter shelf life and require more complex manufacturing and distribution processes than shelf-stable pills and conventional medicines.
Incremental product launch alters the sales curve: Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have shown interest in limited label approvals, granting “live licenses” contingent on ongoing testing versus the all-or-nothing phase I through IV approach. Current processes support revenue projections for “big bang” product launches, with peak sales upfront. Pharma companies will need more adaptable cost structures that preserve gross margins at each stage of the product lifecycle.
New modes of healthcare delivery: Greater use of electronic health records, e-prescribing, mobile health applications and remote monitoring are moving healthcare delivery, including medication management, beyond hospitals and physicians offices into homes, communities and direct to patients. Pharmaceutical companies will need real-time information to manage wider distribution networks and demand-driven manufacturing and distribution processes.
Growing importance of emerging markets: The growing importance of the emerging markets will require pharmaceutical companies to understand patient needs and preferences in the developing world and modify cost and design of product offerings and services accordingly.
Greater public scrutiny: Globalization, the foreign sourcing and manufacture of regulated products, and an increase in the volume and complexity of imported products have increased the need for supply chain control to identify the risk of contamination and fake medicines. Regulators are raising the bar on supply chain safety, demanding sophisticated technology solutions to track and trace product throughout the supply chain.

“The current pharmaceutical supply chain worked well when the ‘blockbuster’ paradigm prevailed, but pharma’s focus in a post-health reform world is shifting from products to patients, and their supply chain processes need to adopt the speed and agility of other, more consumer-oriented industries such as consumer electronics and mass retailing,” said Wynn Bailey, head of supply chain strategies, PwC. “In a world where outcomes count for everything, health organizations need to acquire a much deeper understanding of patients and their healthcare needs. Information is the new currency, and the data behind the product may soon be as valuable as the product itself.”

PwC predicts that the pharmaceutical supply chain will undergo three key changes over the next decade. It will become fragmented, with different models for different product types and patient segments; It will become a means of market differentiation and source of economic value; and It will become a two-way street, with information flowing upstream to drive the downstream flow of products and services, and the management of information transferred between the pharma company, the patient and healthcare provider will become as important as the movement of product.

“The most successful pharma companies will be those that recognize the underlying value locked in their supply chain and can leverage it as a value and brand differentiator rather than just a cost,” said Steve Arlington, global advisory pharmaceutical and life sciences leader, PwC. “Companies that recognize information is the currency of the future, will be those that go the final mile and stand out by 2020.”

In its report, PwC outlines four potential scenarios that pharmaceutical companies might explore as a way to restructure their supply chains. Depending on their product and channel portfolio, most companies will have to manage to more than one scenario simultaneously.

Companies that concentrate on specialist therapies might exit from manufacturing altogether and, instead, become a virtual manufacturer, outsourcing the entire supply from production of the earliest clinical batches to full-scale manufacturing, packaging and distribution through a network of integrated supply partners. Alternatively, they might position themselves as service innovators, building supply chains that are capable of manufacturing and distributing complex treatments as well as managing multiple suppliers of integrated, valued-added health management services.

Mass-market manufacturers, such as the makers of generic drugs, might position themselves as high-volume, low-cost providers, borrowing lessons in lean manufacturing, strategic pricing and inventory management from the consumer products industry. Another option for mass mass-market manufacturers is to turn their supply chains into profit centers that combine economic manufacturing and distribution of satellite services, such as direct-to-patient delivery, secondary packaging or distribution to hospitals and pharmacies, and then to franchise it as a stand-alone offering for both internal and external customers.

The findings of the report

The findings of the report

* Thirty (30) pharmacies or 57 per cent of the pharmacies charged higher prices for the same brand and same quantity of medication. In some cases overcharge is by 460 per cent despite PIB regulations allowing a maximum mark-up of 35 per cent on prescription drugs with a dispensing fee of 45 cents. 30 tablets of Microlab were sold by Nadi Chemist for $0.80 where as Midway Pharmacy- Ba & Chovhan Pharmacy Ltd-Lautoka sold same tablet in same quantity for $4.65.

* Forty three (43) pharmacies chose to dispense originator brands for one or more items even though generics are widely available. Thus, a $15.00 prescription ended up costing the customer up to $44.00, which is three times more or three months supply of medicines. Twelve pharmacies charged more than $30.00 while Hyperchem Pharmacy, Lautoka; Thakorlal’s Pharmacy, Nadi and Western Medicare Pharmacy, Ba charged more than $40.00 for the prescribed medicine. These are unreasonable profits that are being made at the expense of the patients. While not breaching any law, these pharmacies have shown gross negligence and complete breach of trust placed on them by ordinary consumers by dispensing originator brands without first consulting the patients.

* A comparison made for those pharmacies selling 6 generics and 1 originator brand Minidiab (glipizide) revealed that the highest price for all 7 medicines was charged by Chovhan Pharmacy Lautoka at $31.00, while Guardian Angel Pharmacy, Laucala Beach had the lowest price of $15.35. The percentage price difference between the lowest and highest for this group was 102 per cent which means double the price for the same set of medicine or a consumer in Lautoka paid $15.65 more to buy the same set of medicines as compared to a consumer in Suva.

* Only three (3) pharmacies dispensed all 7 generic medicines listed in the prescription. Amongst the ‘All Generics’ Group’, the Health Care Chemist in Tavua charged a higher price of $30.70 while Nadi Chemist charged $13.45 for all 7 generic medication. A consumer paid $17.25 more for the same medicine. This is a case of generic medication being sold at a price of originator brand drugs to unsuspecting consumers. Interestingly, 36 pharmacies who sold either one or more originator medicine had a lower total pack price than Health Care Chemist in Tavua.

* Thakorlal’s Pharmacy in Lautoka dispensed wrong dosage of medicine. Instead of 10mg (as per the prescription), the pharmacist dispensed 5mg without informing the patient. Similarly, Sugar City Pharmacy, Lautoka issued 15 capsules of Amoxillin instead of 9 or 10 for eight hourly course.

* Three pharmacies sold generic medication labelled as originator brand and also charged originator brand price. Thakorlal Pharmacy in Nadi, Wyse Pharmacy in Nakasi and Northern Drug Store in Labasa dispensed generic Frusemide-Apo but labelled it as laxis which is a originator brand tablet and also charged the price of Laxis ($4.65) which is much more expensive than generic Apo ($1.35).

* Some pharmacies with same ownership sold same medicine (brand, dosage & batch number) at different prices. For example, Superdrug Nabua charged $0.80 more on the same batch of Minidiab glipizide than its Suva branch. Two pharmacies in Ba – Hyperchem and Midway had a 189% price difference for the same medicine Flaminopril enalapril (Flamingo Pharmaceuticals/#106)

* Nineteen (19) pharmacies violated labelling requirements in one way or another.

* None of the 47 pharmacies provided individual medicine names on their receipts. However, 32 pharmacies provided medicine price on their labels. Nineteen (19) pharmacies provided both itemised receipts using codes and prices on their labels. Out of the 32 pharmacies that provided prices on their labels, 15 did not provide itemised receipts.

* Three pharmacies (Sugar City Pharmacy, Lautoka; Chovhan Pharmacy, Lautoka and Patel Pharmacy, Sigatoka issued a receipt with no company name, no TIN number or company address. Madison Pharmacy, Suva gave a “chit” with company name and total price when a receipt was requested. In the Northern Division, Northern Drug Store, Labasa issued receipt from “My Chemist” instead of a receipt specifically for Northern Drug Store. Ownership is same for My Chemist and Northern Drug Store.

* 51% of the pharmacies made inquiries on the prescription and the patient, while 49% of the pharmaciess dispensed the drugs without any further clarification on the prescription.

* During the survey, none of the pharmacies asked whether the patient wanted generics or originator brand medications. The general rule amongst pharmacists is to dispense generic drugs when presented with a hospital prescription.

* Generally, the prices of medicines in the Western Division are higher than in Central and Northern Division. In the Central division, Superdrug Pharmacy, Suva and Central Pharmacy, Suva sold 7 medicines for $38.80 and $38.50 respectively.

Incentives help pharmaceutical company to relocate to Piscataway

When Innopharma Inc. ran out of space at its South Brunswick office, company officials began the search for a new home for the growing pharmaceutical and research company.

“New Jersey is the pharmaceutical capital of the world, so for our industry it made sense to stay here,” said Reema Puri, director of human relations and operations for the company, now based in Piscataway. “When the building became available, it was the right place at the right time. It’s centrally located. It’s close to the highways, airports and train stations.”

But there also is a financial incentive for the company to remain in the Garden State — the New Jersey Economic Development Association’s Business Employment Incentive Program or BEIP.

“This is the first year we’ll fill in paperwork for the award, which gives us a tax incentive for every new person we hire in New Jersey,” she said.

Since taking office in 2010, Gov. Chris Christie and his administration have implemented various economic strategies to jump-start the state’s economy and make the Garden State more business-friendly.

Through the Partnership for Action, the administration has continued to advance policies that will improve New Jersey’s business climate, including the need to exercise fiscal discipline and spending restraint, Michael Drewniak, the governor’s press secretary, said.

Drewniak said the administration has sunset the corporate business tax surcharge; put a hard, 2 percent cap on property taxes; signed new, robust business attraction legislation and protected businesses from an average $400 per employee, or 52-percent increase, in the unemployment insurance payroll tax.

Those policies, coupled with the governor’s “Creating Jersey Jobs Summit,” Lt. Governor Kim Guadagno’s “100 Businesses” initiative, and a recent Illinois ad campaign promoting New Jersey as a destination for businesses, all demonstrate that New Jersey is well-positioned for business expansion, economic growth and job creation as the economy recovers, Drewniak said.

MX Solar USA, an Italian solar-panel manufacturer, opened its first U.S. plant in Franklin Township (Somerset County) last June.

“New Jersey after California is the number-two market for solar in the country,” said Carlos Santoro, director of business development. “If you’re going to open up a company dedicated to solar, New Jersey seemed like a good choice because it’s not as saturated as California.”
Location, location, location

For an Italian company, it’s also a little easier to travel to New Jersey than the West Coast, he said.

Santoro said Franklin was selected because of its strategic location.

“It’s close to the airports, close to the ports and close to both (a) skilled and blue-collar work force,” Santoro said. “It’s not a low-cost area, but it was a good compromise. The determining factor in everything was that we found the right building we were looking for in terms of office and production space.”

Santoro said as an added bonus, the company, which is expecting to have almost 200 employees on its roster by year’s end, also is taking advantage of the Edison Clean Energy Manufacturing Fund incentive from the state.

“It’s a low or zero-interest loan for clean energy companies and a small portion is a cash grant,” he said. “It definitely helps offset some of your start-up costs.”

United Silicon Carbide recently moved from New Brunswick to Monmouth Junction in South Brunswick in search of extra space.

“We’ve roughly developed the size of the facility and have a staff of 10,” said president and CEO Chris Dries said. “It’s small numbers, but we’re basically doubling every year.”

Dries said there is a lot of support for clean energy in the state.

The company is in the process of securing a $500,000 Edison Innovation Clean Energy Fund Award that will help support its product.

“The only challenge we face is growing a manufacturing company in the state,” Dries said. “It’s difficult in terms of making it affordable for technicians to live here.”

Joseph J. Seneca, a professor of economics at Rutgers University’s Edward J. Bloustein School of Planning and Public Policy, said he believes the governor’s plan is a good start, but warned “there is a lot of hard work ahead and there is no single magic bullet that will repair the state’s economic climate.”

Seneca said the “broad portfolio approach is what is called for and couldn’t be more on target.

“They are working on reducing regulations and are looking at taxes on businesses,” he said. “They are bringing on economic incentives. I see this as highly appropriate, timely and encouraging in the sense that it has brought private sector participation, has independence and reflects a growing bipartisan realization that New Jersey can only prosper if both businesses and individuals make choices to invest and reside here.”

Inspire Pharmaceuticals Announces Q4 Results (ISPH)

Inspire Pharmaceuticals Inc. (NASDAQ: ISPH) announced strong quarterly results for its fiscal fourth quarter of the year. The company stock reacted positively to the news and is currently trading at $4.36, up 3.32 percent from its previous close. However, the company also announced that it would be cutting 65 jobs. Inspire Pharmaceuticals announced its fourth quarter net loss at $4.3 million, or 5 cents in loss per share. The company was expected to report its loss at 12 cents per share. Inspire Pharmaceuticals had incurred $2.6 million in loss during the corresponding quarter of the last year. For its full year, the company reduced its loss to $35.4 million, down from $40 million in loss it had incurred last year. The company’s full year net loss was expected to be at 50 cents per share.

It is engaged in the business of researching and marketing prescription pharmaceutical products. The company specializes in medicines for pulmonary and ophthalmic diseases. Elestat, AzaSite and Restasis are among its best selling products. The company is operational in the United States and Canada. Inspire Pharmaceuticals Inc. was founded in 1993 and it is based out of North Carolina. It has supply and licensing agreement with many companies such as Santen Pharma. The company also has collaboration with InSite Vision for the commercialization of AzaSite.

Inspire Pharmaceuticals stock opened at $4.24 and touched the high of $4.50. The stock’s lowest price in today’s session is $4.16. The company stock’s beta is 0.93. The company stock has traded in the range of $3.43 and $8.74 during the past 52 weeks. The company’s market cap is $360.36 million.

For the quarter ended Sep 30, 2010, Inspire Pharmaceuticals Inc. reported its quarterly adjusted revenue of $26.732 million. The company reported its net income from continuing operations at ($7.558) million. Inspire Pharmaceuticals Inc. had current assets worth $126.321 million at the end of the quarter and its total assets have been valued at $146.282 million. As on the end of the quarter, Inspire Pharmaceuticals Inc. had current liabilities valued at $47.577 million and its total liabilities were $49.492 million.

BioMarin Pharmaceutical loses $12.2M in Q4

BioMarin Pharmaceutical Inc. lost $12.2 million in the December quarter, compared with a $4.7 million profit a year earlier.

The company’s revenue rose to $101.6 million in the quarter, up from $87.1 million a year earlier.

BioMarin (NASDAQ: BMRN), based in Novato, blamed the fourth quarter loss on $13.7 million in debt conversion expenses.

For the year ended December, BioMarin earned $205.8 million on revenue of $376.3 million. In 2009, it lost $488,000 on revenue of $324.7 million.

The company recorded a $223.1 million tax benefit in 2010. In the third quarter, the company “reversed its deferred tax asset valuation allowance” and took the credit.

At the end of 2010, BioMarin had an accumulated deficit — how much money it has lost or written off since it started — of $371.3 million. That’s down from $577.1 million a year earlier.

Restricting FDI in pharma will be retrograde step: OPPI

NEW DELHI: The Organisation of Pharmaceutical Producers of India (OPPI) today said any move to contain FDI in the pharma sector will be a “retrograde step”.

Asserting that acquisition of domestic firms by global counterparts will not result in increased drug prices, the OPPI noted that Indian companies have also been making overseas acquisitions.

“Any move to contain FDI in the pharma industry will be a retrograde step,” OPPI President Ranjit Shahani told PTI.

He, however, welcomed the recent statement by Commerce and Industry Minister Anand Sharma that 100 per cent FDI in new projects would continue to be allowed through the automatic route.

“Business will gravitate to where there is value and the stance of the Indian government for 100 per cent FDI in greenfield projects is a welcome move,” he said.

Allaying fears that acquisition of domestic pharma companies by MNCs will lead to drug price escalation, Shahani said: “We have a very strong price control authority, the NPPA, who closely monitors the prices of every single drug, effectively acting as a deterrent on any runaway pricing.”

Domestic pharma companies, spearheaded by the Indian Drug Manufacturers Association (IDMA) and Indian Pharmaceutical Alliance (IPA), had raised concerns that the takeover of Indian companies by foreign firms could lead to a situation of over-pricing of drugs and marginalisation of homegrown firms. This view was also endorsed by the health ministry.

In 2008, Japan’s Daiichi Sankyo acquired a majority stake in Ranbaxy Laboratories , while Abbott Laboratories acquired Piramal Healthcare’s domestic formulations business last year.

Shahani, however, said it has not been a one-way traffic. “Indian firms, according to an E&Y report, accounted for acquisitions valued at more than USD 68 billion in 2010 alone. Clearly, this is a two-way street.”

On the issue of limiting the cap on FDI in Indian firms that have benefited from state-funding for R&D activities, Shahani said: “One needs to look at this statement in the context of how much do Indian companies spend on research as a percentage of turnover, whether through direct funding or through state funding.”

The Department of Industrial Policy and Promotion (DIPP), a nodal agency responsible for FDI-related matters, had also raised concerns over the growing dominance of multinationals in the sector.

In a discussion paper release last August, the DIPP had said the acquisitions of Indian companies by foreign multinational companies in the recent past has led to articulation of public concern on its impact on the availability of low-cost medicines.

Indian generics to get easier access to Japan post trade pact

New Delhi, Feb 16 (PTI)The Indian pharmaceutical industry is set to gain in a big way with Japan, the world”s second largest market, agreeing to open up by removing import duty on generic drugs shipped from here.
As part of the Comprehensive Economic Partnership Agreement signed between India and Japan today, for the first time ever Japan has committed to give the same treatment to the pharma industry here as it gives to the domestic industry.
“The agreement will ensure access to a highly developed Japanese market for the pharmaceutical sector and for the first time ever, Japan has committed to give the same treatment for Indian generics as their domestic industry,” a statement issued by the Commerce and Industry Ministry said.
Import duties on Indian pharmaceutical products imposed by Japan will come down to zero once the agreement comes into force, expected to happen by this April. At present, Japan imposes import duty ranging 4-10 per cent on pharma products.
Moreover, the agreement will simplify procedures for the Indian companies planning to sell drug there. Japan has its own standards, requiring firms to rely on data specific to the country and cannot depend on tests conducted elsewhere.
Welcoming the development, Indian Drug Manufacturers” Association (IDMA) secretary general Daara B Patel told PTI: “It will help Indian companies to register their products there. It will lead to an increase the business with Japan.”
The Japanese pharmaceuticals market is the second largest in the world after the US, but the generics segment in the country is estimated to have an annual sales of up to USD 6 billion dollars, less than 8 per cent of the total market.
Only recently, the country had moved towards accepting generics drugs in order to bring down healthcare costs, post the financial meltdown in 2008-09 to meet growing requirements of an ageing population.
Analysts pointed out that Japan”s decision to open its market to Indian generics could have been influenced to a large extent by the acquisition by Daiichi Sankyo of Ranbaxy Laboratories, which is a major generics drugs maker.

‘Indian pharma bio-tech industry can tackle global pressures’

The National Institute of Pharmaceutical Education and Research (NIPER) celebrated its foundation day at its convention centre here Tuesday. Pankaj R Patel, Chairman and Managing Director, Zydus Cadila, was the chief guest while Prof KK Talwar, Director, PGIMER, Chandigarh, presided over the function and Prof Harkishan Singh, Emeritus Professor, was the guest of honour.

In his welcome address, NIPER officiating Director Prof KK Bhutani read out the annual report highlighting the activities undertaken by NIPER in last 12 months. Delivering the foundation lecture titled ‘Opportunities and challenges for pharmaceutical scientists in the next decade’, Pankaj R Patel discussed about the globalised world in the pharmaceutical industry and role of India in this.

He added the Indian Pharmaceutical Bio-tech industry is highly regulated, competitive and continuous to face number of pressures. He said the innovation and efficiency is going to drive Indian healthcare industry. Personalized medicine is going to break barriers of “one size fits all approach”.

Success rates for experimental drugs falls: study

NEW YORK (Reuters) – The success rate in bringing new medicines to market in recent years is only about half of what it had been previously, but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday.

And while oncology has been one of the hottest and most active therapeutic areas for drug development, drugmakers may want to take note of a finding that new cancer drugs have proven far more difficult to gain approval than medicines for infectious and autoimmune diseases.

Drugmakers have been complaining about the difficulty of bringing new products to market in a regulatory climate that has become increasingly unpredictable and more likely to err on the side of safety in deciding risk/benefit ratios of experimental medicines.

Data from this new study appears to bear that out.

“It ain’t getting any easier to develop new therapies.” said Alan Eisenberg, head of emerging companies and business development for the biotech trade group Biotechnology Industry Organization (BIO), putting the findings succinctly.

“Knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing,” he said.

The study, covering 2004 through 2010, found the overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 10, down from one in five to one in six seen in reports involving earlier years.

The study, conducted by BIO and BioMedTracker, which collects data on drugs in development, reviewed more than 4,000 drugs from companies large and small and both publicly traded and private. It was released in conjunction with the annual BioCEO and Investor conference in New York.

Adding weight to the desire by major pharmaceutical companies to become increasingly involved in biotechnology was a finding that biologics had a 15 percent chance of going from Phase I through to FDA approval, compared with a 7 percent success rate for traditional small molecule chemical drugs.

When broken down by therapeutic categories, the highest overall success rate from Phase 1 through likelihood of approval was infectious diseases, such as hepatitis and HIV drugs, at 12 percent, followed by endocrine system drugs, featuring diabetes treatments, at 10.4 percent, and autoimmune diseases, such as rheumatoid arthritis, at 9.4 percent, the study found.

John Craighead, BIO’s managing director for investor relations, said clinical trial goals and the approval pathways for infectious diseases and diabetes drugs are clear and very well-established.

“The Phase II results are very predictive of the Phase III outcomes and very predictive of approval,” he said.

“The overall success rate in oncology was the lowest of the therapeutic areas that we looked at,” he said, noting that cancer studies vary dramatically in design and extending survival sets a high bar for approval.

The cancer drug success rate was a mere 4.7 percent, with cardiovascular drugs second-worst at 5.7 percent, as regulators are increasingly demanding proof that heart drugs reduce heart attacks and strokes rather than just lower a risk factor, such as cholesterol levels.

The largest dropout rate along the clinical pathway came in advancing drugs from mid-stage Phase II studies to late-stage Phase III testing.

Some 63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III, which requires a commitment to larger and much more expensive clinical trials. Phase III is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision.

Not surprisingly, the numbers increase after that as the drugs had already shown success in the clinic.

Approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval, although only about half were approved on their initial FDA review.

The 80 percent approval rate, while seemingly high, is down from 93 percent seen in studies of earlier years.

ScinoPharm to Contract Manufacture FDA-Approved Antidepressant

Taipei, Feb. 14, 2011 (CENS)–Scino Pharm Taiwan Ltd. (ScinoPharm), a leading active pharmaceutical ingredient (API) and contract research and manufacturing (CRAM) service provider to the global pharmaceutical and biotechnology industry, recently claimed that it will commercially manufacture vilazodone hydrochloride API for Clinical Data, Inc.`s Viibryd, a new drug recently approved by the Food and Drug Administration (FDA) of the U.S.

According to ScinoPharm, Viibryd is a new drug to treat adults with major depressive disorder (MDD). The drug`s dual mechanism of action and side effect profile differentiates itself from other antidepressants. Use of Viibryd does not cause significant weight gain or interference with sexual function as seen with some rival drugs.

“ScinoPharm is proud of the fruitful partnership with Clinical Data by being its sole API supplier of vilazodone hydrochloride during Viibryd`s launch,” said Jo Shen, President and CEO of ScinoPharm. “Beginning from process research through timely development and optimization of long and complicated synthetic processes, we have established a win-win partnership.”

Similar to the partnership with Clinical Data, ScinoPharm said it partners with other leading pharmaceutical companies for custom contract services from clinical materials to commercial. So far, the Taiwanese drug company has handled more than 60 new chemical entity (NCE) projects, with four currently in phase III and three having already been approved for launch.

ScinoPharm said that it is set to expand its CRAM services through its new GMP plant in Changshu, Jiangsu Province of China, which is expected to start production in the third quarter of 2011. The Changshu plant is expected to further expand the company`s overall R&D and production capabilities to capture more business opportunities in the rapidly expanding Asian pharmaceutical market, ScinoPharm said.

FDA zigs to inspect, zags to funds threat

The FDA says it will turn to contractors in an effort to beef up inspections of overseas drug-making plants. It’s an attempt to leverage limited resources, the need for which is heightened by vows of funding scrutiny by members of Congress.

It’s simultaneously an attempt to answer Government Accountability Office criticism from last fall that the agency’s inspection strategy is misdirected. GAO stats find foreign plant inspections under-represented and an emphasis on plants readying to make newly approved drug. Plants already churning out drugs, inside and outside the U.S., are being checked too infrequently.

“Third-party inspection programs need to be a bigger part of the discussion,” says John Taylor, FDA’s acting principal deputy commissioner, as reported by Bloomberg. Taylor took over the number two spot following the departure Joshua Sharfstein to head Maryland’s health department.

One source the FDA might consider for foreign inspectors is India, which recently has shown interest in enhancing its pharma reputation. Officials announced in August plans to hire drug inspectors to visit the plants of raw material suppliers, notably in China. It boasted nearly 900 inspectors by December, on its way to a short-term goal of 1,400; long term, 3,100. And India has tapped the FDA for training of clinical trial inspectors.

Full Service CRO DSP Clinical Research Triples Revenue in 2010

PARSIPPANY, N.J. — DSP Clinical Research announced record-breaking growth in 2010, tripling its revenue and expanding its staff by 45%. DSP is a nationally-recognized, full service CRO that provides customer-focused, results-driven CRO services for small to mid-size pharmaceutical and biotechnology companies conducting Phase 1-4 clinical studies. DSP delivers the highest quality data with innovative, flexible services; a unique fixed-cost billing model; and hands-on customer service.

New and existing customers chose DSP to manage clinical trials in a range of therapeutic areas including its specialties in women’s health, pediatrics, pain and urology.

2010 highlights included DSP’s completion of enrollment three months ahead of schedule for a large Phase 3 study in women’s health. (DSP is managing the entire study process through NDA submission.)

DSP President and Founder Darlene Panzitta said, “In 2011 DSP will continue to redefine the CRO industry and establish our market dominance as the CRO that’s one step ahead in meeting customer expectations.”

Additional 2010 key achievements included:

National Awards – For the third consecutive year DSP was named to the Inc. 500/5000 list of the fastest growing private companies in the U.S. Additionally, Darlene Panzitta was one of only 11 executives nationwide to win the prestigious Ernst & Young LLP’s 2010 Entrepreneurial Winning Women™ award.

Corporate Development – DSP promoted senior executive Brenda Reese, BSN, RN, CCRA, to Vice President of Business Operations. Ms. Reese, who has been in the pharmaceutical industry for 16 years, offers sponsors a valuable blend of clinical and business expertise. DSP increased its staff by 45% and opened 10 job requisitions including a director of business development to continue innovating and improving customer service.

Thought Leadership – DSP was invited to share insights and advice in bylined articles for prestigious publications such ACRP’s The Monitor and Applied Clinical Trials magazines. DSP executives also were invited to speak at industry events on vital topics such as avoiding changes of scope and the steps to becoming a successful CRO monitor.

About DSP Clinical Research

DSP is a full service CRO that manages Phase 1-4 clinical studies for small to mid-sized pharmaceutical, biotech, and device companies from study set up through FDA submission. DSP helps clients get drugs to market faster than their competition with an aggressive management style and use of a fixed-cost billing model. Services include study management, site monitoring, investigator site management, data management, biostatistics, study rescue, site and monitor training/auditing, medical writing, and FDA submissions. Services are flexible and DSP provides an à la carte approach to complement clients’ clinical experience, resources, and staff. DSP is headquartered in Parsippany, NJ.

Industry accepts decision not to raise drug prices

The Health minister’s decision not to award any increase in the single exit price of drugs this year was in line with the agreed methodology and came as no surprise to the industry, pharmaceutical companies said yesterday.

Aaron Motsoaledi, the Minister of Health, told the industry two months ago that there would be a zero percent rise for medicines this year.

Yesterday Anban Pillay, the director for pharmaceutical economic evaluations in the Department of Health, said that after applying the formula that took into account inflation (70 percent) and the exchange rate (30 percent), it was clear firms could not be allowed to hike prices as the strong rand outweighed mild inflation.

“The industry would have had to decrease the prices, but it was proposed that there should instead be a zero percent increase. This was communicated with the industry,” said Pillay.

Drug makers are vulnerable to the exchange rate because they import all the active pharmaceutical ingredients. This includes the firms that manufacture drugs locally.

Paul Anley, the managing director of Pharma Dynamics, said Motsoaledi’s decision was fair if one took into account the fact that the rand strengthened considerably last year.

“We call on the minister to consistently apply this formula as it is in years when he should grant an increase. We managed our cost base well because of the strong rand, but with the rand weakening, the opposite will happen this year,” said Anley.

Last year Motsoaledi approved a 7.4 percent increase. Stavros Nicolaou, a senior executive at Aspen Pharmacare, said the firm welcomed the decision as it was in accordance with the methodology that the industry and the government had agreed on. “It works out to a neutral position for us as we all have a currency exposure,” said Nicolaou.

INTERVIEW: Pharma’s Painful Changes To Trigger More M&A

LONDON (Dow Jones)–The pharmaceutical industry this year faces a stark environment of rising costs and stagnant drug innovation that will ensure more acquisitions are done, as drug makers try to offset painful and growing business pressures, GlaxoSmithKline PLC’s (GSK) chief strategy officer said Thursday.

“The model that the industry was following up until fairly recently was fundamentally flawed and therefore as a pharma company you have to fundamentally change your business model,” said David Redfern. The process will have winners and losers and will ensure there is more consolidation as a result, he added.

Film on ‘female Viagra’ takes on the drug companies

After years of medical testing and counseling, women can finally rejoice: Lack of consistent orgasms during sex is normal, not a disease. That may not be the best news, since 70 percent of ladies can’t reach the finish line from sex alone. But Liz Canner’s first feature documentary, “Orgasm Inc.,” exposes pharmaceutical companies’ treatment of female sexual dysfunction (F.S.D.) and problems in the search for a cure. The movie, which Newsweek called a “desperately needed antidote” to excessive hype from drug companies pursuing a female Viagra, premieres in the United States at Greenwich Village’s Quad Cinema, 34 W. 13th St., from Feb. 11 to 17.

“Orgasm Inc.” follows the research of creams, pills and probes, all aiming to help satisfy the millions of women struggling to climax. Companies have been trying to cash in on a female love drug for years, though many argue that the disease they hope to treat is a myth. Canner fears that this misrepresentation of female sexuality hurts women.

“It really puts women at risk of being misinformed and taken advantage of,” Canner said in a special advance press screening at New York University.

Currently, the film has been shown across Europe, South America, Japan and Canada. But activists protesting drugs purporting to treat F.S.D. have had difficulties raising awareness, just as Canner has had difficulties distributing the film in the United States. Canner believes her troubles finding U.S. distribution stem from the pharmaceutical industry’s outsized influence in television advertising, along with the sexual content of the movie.

“God forbid there’s a film that features female pleasure,” Canner said.

The documentary, which took Canner 11 years to make, begins when a pharmaceutical company testing a vaginal orgasm cream hires her to create female-friendly pornography to use in their clinical testing. In the ultimate reality show, Canner drags along a camera to film her as she learns tidbits such as the female preference for steamy scenes with story lines. Meanwhile, she slowly realizes that drug companies are not actually treating an already-recognized disease, but creating it in the search for a new revenue stream. The California-based company, Vivus, Inc., she comes to see, is actually trying to adapt its drugs — initially used to treat erectile dysfunction — for women. After tests consistently fail, the company abandons the effort, but other corporations continue the search.

The leading contender ends up as Procter & Gamble’s Intrinsa, a testosterone patch said to increase the female libido. However, opponents argue that the dangerous side effects of increased testosterone — including breast cancer — are too great a risk.

“When you talk about sex drugs, you’re talking about millions and millions and millions of people going on these drugs,” said Canner, 42, whose face barely shows her age and whose ideas firmly resonate with the college crowd decades younger. “We’re talking about a tremendous number of women in the population going on them,” she said.

Canner, who grew up in Groton, Mass., and now lives in Vermont, is a veteran filmmaker whose previous work addressed darker topics. In 1993, Canner’s “State of Emergency: Inside the LAPD” focused on police violence just after the Rodney King incident. Two years later, her film “Deadly Embrace: Nicaragua, the World Bank and the International Monetary Fund” critiqued the effects of globalization.

Canner wanted to move on because these films were giving her terrible nightmares. Though “Orgasm Inc.” seems like a major departure from those earlier films, she believes the subject is comparable.

“The reason I feel that this is a human rights issue,” Canner said, “is because when you have something like the pharmaceutical industry, which is so powerful and so well funded, it really starts to undermine our understanding of sexuality.”

The movie contains striking images certainly suggesting human rights abuses. One woman recounts her vaginoplasty — essentially a vaginal facelift — that bled and drained her body of one-third of its blood and nearly killed her. “Orgasm Inc.” also addresses insecurity and shame. Many of the women in the film feel diseased because they don’t know that their lack of steady, instant orgasms is actually quite usual. But pharmaceutical companies, the film argues, hope to profit by recasting the norm into a medical dysfunction.

“Basically, if you can define a disorder in a really broad way, then you are going to have a lot more people fall into that category,” Canner said, referring to newly created names for common problems, like restless leg syndrome or social anxiety disorder for shyness.

A main figure in “Orgasm Inc.” is Leonore Tiefer, a professor of psychiatry at both New York University School of Medicine and Albert Einstein College of Medicine. Tiefer organized the New View Campaign (N.V.C.), which seeks to “expose the deceptions and consequences of industry involvement in sex research, professional sex.” Although Tiefer said skepticism of pharmaceutical companies is high in the United States, she also recognizes the trouble Canner has had in marketing “Orgasm Inc.” to U.S. TV stations, which are reluctant to show the film.

“The question is getting out our message,” said Tiefer in a telephone interview. “A commercial film and an activist campaign have different places in society and different ways of interacting with institutions. In order to get people to see Liz’s film, she has to get it into theaters and that requires the cooperation of distributors.”

And Canner has not had that cooperation. The film has been shown to several American TV stations and she was turned down each time. Canner feels that the amount pharmaceutical companies spend on advertising has hindered her chances, because the U.S. is one of only two countries in the world that permits direct-to-consumer pharmaceutical advertising. (The other country is New Zealand.) After the major U.S. rules change in 1997 that permitted direct-to-consumer broadcast advertising, pharmaceutical spending soared to nearly $5 billion in 2007 from $220 million in 1997, according to reports by the journal of Minnesota Medicine and marketing research firm Research and Markets.

With the release of “Orgasm Inc.,” Canner hopes to start a greater conversation in America about the growing influence of the pharmaceutical industry. The film is opening in New York, Chicago and Coral Gables, Fl., in February, and in Los Angeles in March.

In addition, Canner is traveling on a college tour and speaking against the treatment of female sexual dysfunction with potentially harmful drugs, such as Intrinsa. Although banned by the U.S. Food and Drug Administration, Intrinsa was made available in Europe in 2007 for “post-menopausal women with diagnosed sexual problems,” according to the Daily Mail.

Canner is desperately searching for a vacation from 11 difficult years of production, but it may still be awhile before “Orgasm Inc.” can be seen throughout the country, allowing Canner some fleeting freedom from the film she has invested so much of her efforts in.