Pharmaceutical News

FDA guilty of malfeasance

Can the Food and Drug Administration be charged with malfeasance in office?

I have a complaint that I have found is not unique. Others have had the same problem with other prescriptions.

A foot injury many years ago has left me subject to attacks of gout. I have been taking a daily maintenance dose of colchicine that is now suddenly not available.

A drug known since ancient times, it was grandfathered in when the FDA established its list of approved drugs.

Recently a pharmaceutical company discovered that it had never had the testing to be listed as “certified.” Apparently there are a number of these drugs that are being claimed by these opportunistic drug companies.

In return for doing the testing on this drug, already in use for centuries, the company was granted a patent by the FDA and no one can market it. The company has given it a new name and put it back on the market.

My problem? The drug that I have been getting for years at $10 for a three months supply will now cost $170 a month.

You can understand my outrage.

Who paid off whom?

My answer for the moment is to hoard the small amount I have on hand, stop taking this drug and hope the gout does not return.

Teva Warns, and Merck and Glaxo Post Losses

One of the world’s largest generic drug makers disclosed Thursday that the Food and Drug Administration had sent it a warning letter over manufacturing problems.

Separately,two major pharmaceutical companies reported fourth-quarter losses Thursday, hurt by one-time charges for product setbacks.

Teva Pharmaceutical Industries, the Israeli generics company that is the largest supplier of prescription drugs in the United States, disclosed in a government filing that the F.D.A. had warned it about manufacturing problems at a plant in Jerusalem.

The F.D.A. warning says Teva failed to adequately investigate impurities in the diabetes medicine glyburide metformin (generic Glucovance), product specification errors in the sleep pill zolpidem tartrate (generic Ambien) and cross-contamination issues.

“Without proper separation, your firm lacks assurance that one drug does not contaminate another drug,” Richard L. Friedman, director of the F.D.A. division of drug manufacturing and product quality, wrote in the letter, released by Teva.

The company said it received the warning letter Jan. 31 after responding last October to an F.D.A. inspection in September. The company said it was working diligently to solve the problems.

Mr. Friedman wrote that Teva could be barred from exporting products from the Jerusalem Oral Solid Dosage facility to the United States if the problems are not corrected. The F.D.A. had no immediate further comment.

Analysts say the facility accounts for less than 3 percent of the products from Teva, which has about $16 billion annual sales. Teva reports fourth quarter earnings next week.

Meanwhile, special charges wiped out fourth-quarter profits for GlaxoSmithKline and Merck.

GlaxoSmithKline, which is based in London, took a $3.5 billion charge to settle litigation over the diabetes pill Avandia. The drug was banned in Europe and severely limited in the United States last year because of heart risks.

Merck took a $1.7 billion charge to write down a suspended clinical trial on an experimental blood thinner, vorapaxar, once considered the best prospect from the company’s $49 billion purchase of Schering-Plough.in 2009.

Merck’s 2011 forecast also fell short of analyst estimates. Its chief executive, Kenneth C. Frazier, said the company would no longer give longer-term forecasts.

Merck stock fell 1 cent to close at $32.89.

Shares in GlaxoSmithKline closed unchanged at $38.01 as investors cheered the resumption of a share buyback program. Pfizer stock also got a big boost earlier this week from adding billions of dollars to share buybacks.

Research pharmaceutical companies are facing a cascade of risks including price pressures in Europe and the United States, disappointments in some core research areas, and the loss of sales to generic competitors like Teva.

Elite Pharmaceuticals Announces FDA Approval for Generic Phentermine HCL Tablets

Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCBB:ELTP) announced today the approval of an Abbreviated New Drug Application (ANDA) for phentermine HCl 37.5 mg tablets by the U.S. Food and Drug Administration (FDA). The phentermine HCl tablets are the generic equivalent of the Adipex-P® 37.5 mg tablets. The product and its equivalents had annual sales of approximately $40 million in 2010 and there are currently six other approved generic manufacturers plus the innovator. On September 16, 2010, Elite had previously announced the acquisition of the ANDA for this generic product from Epic Pharma LLC (“Epic”). The ANDA approval was granted under Epic Pharma’s name and transfer of the ANDA into Elite’s name will begin immediately.

Also previously disclosed on September 16, 2010, this product was part of a license agreement and a manufacturing and supply agreement (together the “Agreements”) with Precision Dose, Inc. (Precision Dose) which has a wholly owned subsidiary, TAGI Pharma, Inc. (“TAGI Pharma”) which will distribute the product. Pursuant to the previously disclosed Agreements, TAGI Pharma will market and sell this product and Elite will manufacture the product. Elite will receive a milestone payment upon shipment of the first product to Precision Dose and Elite will receive a percentage of the gross profit, as defined in the License Agreement, and earned by TAGI Pharma as a result of sales of the products. The license fee is payable monthly for the term of the License Agreement.

“Elite currently manufactures Lodrane 24® and Lodrane 24D® which are marketed by our partner, ECR Pharmaceuticals, for allergy treatment, and in addition to this phentermine product, we expect to launch two additional products this year that will be marketed by TAGI. Collectively, these products will allow the company to fully realize the implementation of the business plan that was put in place to turn the company into a profitable operational company,” commented Jerry Treppel, Chairman and CEO.

About TAGI Pharma, Inc.

TAGI Pharma was launched by Precision Dose in 2010 as a specialty pharmaceutical company focused on the Retail Market Segment. A key component of TAGI Pharma’s strategy is the leveraging of its sales and distribution core competencies with the formation of strategic partnerships with product development and manufacturing companies such as Elite. The phentermine HCL 37.5 mg product represents the first of these initiatives, and we expect an additional five product launches in the next six months. As the company sources products through development, acquisition and licensing opportunities, key areas of focus will be in the tablet, capsule and injectable dosage formats, with an emphasis on controlled substances, where there are additional barriers to entry. TAGI Pharma is located in South Beloit, Illinois, and additional information can be obtained from its website www.tagipharma.com.

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops and manufactures oral, controlled-release products using proprietary technology. Elite’s strategy includes the development of life cycle management products to lengthen the franchise life of drug products facing patent expiration, the development of controlled-release formulations of existing products to improve their clinical profile, and the development of generic versions of controlled-release brand drug products with high barriers to entry. Elite developed and manufactures for its partner, ECR Pharmaceuticals, Lodrane 24® and Lodrane 24D®, a non-sedating antihistamine for the treatment of allergy symptoms. The company recently purchased, and expects to soon launch three approved generic products. In addition, Elite has a pipeline of additional generic and branded drug candidates under active development. Two of the branded products under active development are ELI-216, an abuse resistant oxycodone product, and ELI-154, a once-a-day oxycodone product. Elite conducts research, development and manufacturing in its facility in Northvale, New Jersey.

NRC-IRAP Funds the Latest Innovation from PharmaTrust™ in Pharmacy Medication Management Systems

Tony Clement, Federal Industry Minister, announced today a contribution agreement of up to $300,000 in funding for PharmaTrust™ from the National Research Council of Canada’s Industrial Research Assistance Program (NRC-IRAP). PharmaTrust™ is an Oakville based company developing innovations in remote healthcare technologies and services. The funding will enable the development of MedHome™, a personal medication management system that addresses the critical issue of medication compliance, helping patients safely and effectively manage their own medications.

“We are pleased to be able to support the inventive work of PharmaTrust in remote healthcare technologies”, said Minister Clement. “Partnering with organizations like PharmaTrust to foster the development of innovative technologies creates valuable opportunities for Canadian business, both at home and abroad.”

PharmaTrust™ is the creator and developer of the MedCentre™, which makes use of advanced robotics, scanning and video-conference technology, to connect individuals in real-time to a pharmacist in another location. In 2009, NRC-IRAP announced a $1.5 million contribution to support the development of telepharmacy, primary care platform and advanced manufacturing techniques and technologies by PharmaTrust™. The MedHome™ will lever the telepharmacy platform previously developed by PharmaTrust™ to manage and monitor patient drug therapy compliance and adherence.

“When patients receive multiple medications, they face an increased risk of complications which arise due to non-compliance and adherence to their medication orders,” said Don Waugh, CEO of PharmaTrust™. “Many individuals have trouble properly following their medication schedule as directed by their physician.” Studies indicate that medication non-adherence among older adults is a prevalent and costly problem; approximately one half have problems following their prescribed medication regimen, and more than 10% of hospital admissions are the result of medication non-adherence.”1

The $300,000 contribution from NRC-IRAP will support the software and engineering development activities required to deliver a working prototype of MedHome™.

Federal funding for at-home drug dispenser

The Oakville manufacturer of remote healthcare technologies has received funding from Ottawa for the development of a new product, which the company president said should reach the commercial trial stage this summer.

PharmaTrust received $300,000 from the National Research Council of Canada’s Industrial Research Assistance Program (NRC-IRAP).

Federal Industry Minister Tony Clement announced the funding at the PharmaTrust facility on Friday, Jan. 21. He was joined by Oakville MP Terence Young.

“Throughout its growth and development PharmaTrust has maintained important ties with the NRC, which was only too happy to work with these creative and results-oriented individuals,” Clement said in a speech.

“It’s your dedication, your entrepreneurship in developing industry leading and internationally recognized products that is exactly what our government looks for when partnering with Canadian businesses.”

PharmaTrust previously received $1.5 million from IRAP for MedCentre – a drug-dispensing machine for pharmacies. It has now developed the MedHome unit — a small medicine-dispensing device that can go out to a patient’s home.

The MedHome unit is able to dispense medical doses personalized to the patient at pre-set times and sends out reminders, which is especially effective for people with dementia.

The technology also includes an Internet connectable monitoring system and together with a monitoring bracelet it can send medical information about the patient to a health care provider such as a physician or pharmacist.

In addition, patients, such as those suffering from mental health issues, can fill out a questionnaire on a touch screen monitor that could help indicate to a health care professional if there is anything wrong with the patient.

Another feature requires the pushing of a button after the medicine is taken. If the button is not pushed, a message is sent to the patient’s caretaker.

PharmaTrust president, chief operating officer and co-founder Peter Suma said the device will be in commercial trials by July 1. Furthermore, the new federal money, along with private investments, will create six high-tech jobs for the company. The company, which was founded five years ago, currently employs about 120 personnel.

Clement told the gathering the funding is part of the Canadian government’s overall commitment to the health and medical sector, which is part of an even broader picture of a science and technology strategy launched by Prime Minister Stephen Harper in 2007.

“This company is dedicated to developing new remote health care technologies and services and is doing a fantastic job with it,” Young said.

He said the federal funding to the company will be returned to Canadian taxpayers many times through its job creation, business taxes and more.

During a tour of the facility, Clement got a personal demonstration of the MedCentre device. However, instead of receiving prescription medication, the demo unit dispensed a box of Smarties.

Speaking to the gathering, company CEO and co-founder Don Waugh, thanked the government for its continued support.

“We are pleased you could all come and see first hand what we’ve been able to accomplish with the government’s initial investment of $1.5 million in October 2009 that supported the development of the PharmaTrust MedCentre,” Waugh said.

“Since then, we have grown significantly and expanded upon our success to develop new applications and explore the possibility of remote health care technologies throughout the patient’s journey.”

The MedHome unit is part of that expansion.

In an interview after the tour, Suma said the MedHome unit will cost less than $200. However, he expects the costs to individual patients to be lower or even completely absorbed by a pharmacy, giving the example of a wireless provider selling a cell phone to a customer with a contract for much less than its cost. In a similar fashion, he said the device could used as part of a pharmacy’s business model to keep customer loyalty.

Suma said about 35 per cent of all long-term care facility admissions are a result of seniors unable to manage their medication consumption. He said this device won’t solve the problem for everyone, but it will be a solution for some.

“Now those 35 per cent of people have a choice. It’s not for all of them, but for some portion of them the choice will be now: ‘I can stay in my home, get management here, anytime I need anything, anytime I don’t feel well I press the button’ and bang instant video conferencing with your pharmacist who has all your data.”

He said the unit also check a person’s blood pressure and be transmitted to a health care professional. The machine could also similarly detect a health problem that a patient may not even be aware of.

PharmaTrust was founded five years ago for the creation of the MedCentre device. It can house more than 2,000 types of drugs and similarly to a automated banking machine, it is operational non-stop.

“The whole advantage to the public is they are open 24 hours, wherever they are,” Suma said.

To get medication, a patient inserts the prescription paper into the machine and is then video conferenced with a live pharmacist. The pharmacist can converse with the patient, and the machine has various fraud prevention mechanisms. The entire dispensing process is controlled remotely by the pharmacist.

Currently, only four of the MedCentre units are in service in Toronto area hospitals. They are served by a team of 10 pharmacists round-the-clock, who work out of the Oakville facility. However, the technology is not limited to being served only by PharmaTrust pharmacists.

Current laws prohibit the distribution of the machines because they can operate under hospital and physician law, but not yet under pharmacy law. However, Suma has big plans for the machines, saying they will be all over Ontario after the pharmacy law is changed. He believes this will occur in a few months.

“Until the pharmacy law is changed, you can’t service the public in a remote town, outside of the clinic or when the clinic is closed. The real benefit of this technology can’t be explored until this law is changed,” he said.

Suma said PharmaTrust is the largest Angel-funded company in Canada, receiving $30 million from individuals. This does not include funding it received from corporate funding.

Symantec Announces January 2011 MessageLabs Intelligence Report:

Symantec Corp. (NASDAQ: SYMC) today announced the publication of its January 2011 MessageLabs Intelligence Report. Analysis reveals that following a two-week dramatic decline in spam levels, spam now accounts for 78.6 percent of all email traffic, the lowest rate since March 2009, when the global spam rate was 75.7 percent of all email traffic. The volume of spam in circulation in January 2011 was 65.9% lower than for the same period one year ago in January 2010, when the spam rate was 83.9% of all email traffic.

The recent decline, beginning December 25 and continuing through January 1, was the result of both a halt in the spam-sending activities of three botnets — Rustock, Lethic and Xarvester — and also unrest among pharmaceutical spam-sending gangs. During this two week period, spam volumes declined 58 percent from 80.2 billion spam emails per day to 33.5 billion spam emails each day, reminiscent of declines experienced when California-based ISP McColo was taken offline in late 2008 and continuing into early 2009.

“The closure of spam affiliate, Spamit, was partially responsible for the disruption to spam output,” said MessageLabs Intelligence Senior Analyst, Paul Wood, Symantec.cloud. “However, there are likely other factors at work, such as consolidation and restructuring of pharmaceutical spam operations which has led to instability in the market likely to be exploited as a business opportunity by other spam gangs. We expect to see more pharmaceutical spam in 2011 as new pharmaceutical spam brands emerge and botnets compete for their business.”

In May 2010, pharmaceutical spam experienced peak levels when up to 85% of spam was related to pharmaceutical products. However, in January 2011, MessageLabs Intelligence found that pharmaceutical spam accounted for about 59.1% of all spam.

Since the end of 2010, MessageLabs Intelligence has witnessed shifting patterns related to pharmaceutical spam-sending. Previously, the Canadian Pharmacy brand was the most prolific of the pharmaceutical spam brands however, when Spamit shut down in October 2010, the brand disappeared as affiliates switched to sending spam for other brands.

It is no secret the major role that botnets play in spamming and in 2010, spam-sending botnets were responsible for as much as 88 percent of the world’s spam falling to 77 percent by the end of the year. Previously, Rustock had been responsible for 47.5 percent of all spam, approximately 44.1 billion spam emails each day, making it the single, largest spam-sending botnet. Both Lethic and Xarvester accounted for less than 0.5 percent of all spam each.

“At various points during Rustock’s history, the botnet has often exhibited irregular spamming patterns by sending huge volumes of spam before going quiet for several weeks at a time,” Wood said. “But throughout 2010, its spamming pattern was more regular and it had been active non-stop until December 2010. Our investigation revealed no evidence of Rustock being disrupted in any way either by law enforcement or through other action.”

Since January 10, all three botnets have resumed their spam-sending operations but not at their previous levels. Since its return, Rustock, previously the single largest spam-sending botnet, is now responsible for 17.5 percent of all spam in January. The Bagle botnet has now replaced Rustock as the largest spam-sending botnet with output at 20 percent of all spam, but Rustock maintains its position as the largest sender of pharmaceutical spam with 80 percent of its output in January related to pharmaceuticals.
Cheap medications Mexico
During the two weeks that Rustock was dormant, it was being used for click-fraud to generate fake referrals for click-through expenses.

Other report highlights:

Spam: In January 2011, the global ratio of spam in email traffic from new and previously unknown bad sources was 78.6 percent (1 in 1.3 emails), a decrease of 3.1 percentage points since December.

Viruses: The global ratio of email-borne viruses in email traffic from new and previously unknown bad sources was one in 364.8 emails (0.274 percent) in January, a decrease of .03 percentage points since December. In January, 65.1 percent of email-borne malware contained links to malicious websites, a decrease of 2.5 percentage points since December.

Endpoint Threats: Threats against endpoint devices such as laptops, PCs and servers may penetrate an organization in a number of ways, including drive-by attacks from compromised websites, Trojan horses and worms that spread by copying themselves to removable drives. Analysis of the most frequently blocked malware for the last month revealed that the Sality.AE virus was the most prevalent. Sality.AE spreads by infecting executable files and attempts to download potentially malicious files from the Internet.

Phishing: In January, phishing activity was 1 in 409.7 emails (0.244 percent), an increase of 0.004 percentage points since December.

Web security: Analysis of web security activity shows that 44.1 percent of malicious domains blocked were new in January, an increase of 7.9 percentage points since December. Additionally, 21.8 percent of all web-based malware blocked was new in January, a decrease of 3.1 percentage points since last month. MessageLabs Intelligence also identified an average of 2,751 new websites per day harboring malware and other potentially unwanted programs such as spyware and adware, a decrease of 21.5 percent since December.

Geographical Trends:
Oman became the most spammed in October with a spam rate of 88.8 percent.
In the US, 78.8 percent of email was spam and 78.3 percent in Canada. Spam levels in the UK were 78.7 percent.
In The Netherlands, spam accounted for 79.4 percent of email traffic, while spam levels reached 77.8 percent in Germany, 79.8 percent in Denmark and 77.3 percent in Australia.
Spam levels in Hong Kong reached 79.2 percent and 77.2 percent in Singapore. Spam levels in Japan were at 75.2 percent and 84.6 percent in China. In South Africa, spam accounted for 80.0 percent of email traffic.
South Africa remained the most targeted by email-borne malware with 1 in 132.2 emails blocked as malicious in January.
In the UK, 1 in 178.2 emails contained malware. In the US virus levels were 1 in 771.0 and 1 in 212.3 for Canada. In Germany, virus levels reached 1 in 501.1, 1 in 1,215.0 in Denmark, 1 in 858.7 for The Netherlands.
In Australia, 1 in 667.4 emails were malicious and, 1 in 549.9 for Hong Kong, for Japan it was 1 in 1,233.0 compared with 1 in 733.3 for Singapore and 1 in 644.6 for China.

Vertical Trends:
In January, the most spammed industry sector with a spam rate of 82.8 percent continued to be the Automotive sector.
Spam levels for the Education sector were 80.6 percent, 79.1 percent for the Chemical & Pharmaceutical sector, 78.8 percent for IT Services, 77.9 percent for Retail, 77.2 percent for Public Sector and 77.4 percent for Finance.
In January, Government/Public Sector remained the most targeted industry for malware with 1 in 40.9 emails being blocked as malicious.
Virus levels for the Chemical & Pharmaceutical sector were 1 in 439.0, 1 in 497.8 for the IT Services sector, 1 in 714.9 for Retail, 1 in 194.3 for Education and 1 in 676.4 for Finance.

Beck Fearmongers About Gov’t Drug Research Center

Beck: “[I]s Anybody Else Concerned With The Government Being In Charge Of Our Life-Saving Drugs?” On the January 24 edition of his Fox News program, Beck mocked the announcement of a $1 billion government drug development center to help create new medicines, asking his listeners, “[D]o you believe the federal government is the answer to speeding up production of new medicine? Me neither.” He further stated, “Maybe it’s just me, but is anybody else concerned with the government being in charge of our life-saving drugs?” From the broadcast:

BECK: Next headline. The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines. Well, that is fantastic. No, seriously — they’re concerned about the time it takes to get new drugs to the market. Reason: do you believe the federal government is the answer to speeding up production of new medicine? Yeah, me neither. So why is this happening?

Well, I mean, let’s start with this. Why would the drug manufacturers have any problems, you know, making new drugs and getting them to the market. You know, they have to wait for the FDA approval and go through — and this is all fine print. You know, go through the new regulations and the rules of, you know, all this stuff from the FDA. It’s pretty cumbersome, right? I mean, can you imagine? By the way, this isn’t the FDA. These are just the 165 new [Food and Drug Administration] regulations that Cass Sunstein has put in with Obama since 2009. Now it takes an average of 12 years and over $350 million, U.S. dollars, to get a new drug from the lab — laboratory to the pharmacy shelf.

So, they’re serious. What they’re going to do now is add incompetence. Maybe it’s just me, but is anybody else concerned with the government being in charge of our life-saving drugs? Remember, when they want to have a solution to something, they get serious. Remember when there were long lines at the post office? I am not making this up. Do you know what their solution was? Do you know, Erin? She knows. She knows. Take the clocks out of the lobby so nobody could see the clock. That was it. Like you don’t have watches or a cell phone? While we’re at the post office, by the way, the U.S. Postal Service is going to start the process of closing additional 2,000 branches operating in a deficit now, but they have to lobby Congress to allow it to change the law so it can close the most unprofitable post offices. The law currently allows the Postal Service to close post offices but only for maintenance problems, lease expirations, or other reasons that don’t include profitability.

But let’s get them in the prescription drug business, shall we? Because they can make them better and faster. But why? I think personally, I’d rather have my drugs made by the Federal Express guy. [Fox News’ Glenn Beck, 1/24/11]

Federal Government To Develop Its Own Drugs In Effort to Spur Pharmaceutical Industry

Faced with a diminished drug-development pipeline in the private sector, the Obama administration is starting a federal drug development center, aiming to spur the creation of new medicines.
Viagra Australia pharmacy
The new National Center for Advancing Translational Sciences will get $1 billion in funding to conduct drug research with the goal of attracting private investors. Federal scientists may go so far as to start human trials if necessary, the New York Times reports. Federal officials want the center to open as soon as October.

The National Institutes of Health usually focuses on basic research — like describing the structure of proteins, the Times points out. It’s up to pharmaceutical companies to translate those structures into drugs. But under the new translational sciences center, the institutes might take discovery a step further, such as testing a new chemical in animals or even in human trials — steps that have traditionally been taken by industry, the Times explains.

The Food and Drug Administration has approved fewer and fewer new compounds every year since 1995, the Times reports. Meanwhile, big pharma has been scaling back research spending, and drug giants like Merck and Pfizer have laid off thousands of scientists in the past year alone.

One of the biggest hurdles is cost — it’s really, really expensive to produce a new drug, with an average price tag (from discovery to commercialization) of $1.3 billion, according to a Jan. 5 report from Tufts University’s Center for the Study of Drug Development. It’s also difficult to predict whether a new compound will become popular enough to earn that money back, like, say, Viagra or Lipitor.

Given that uncertainty, and the regulatory hurdles inherent in developing a new drug, pharmaceutical companies have been reluctant to move forward with new compounds. Amazingly, this means promising drugs for the treatment of depression and illnesses like Parkinson’s disease are going untested, the Times says.

The pharmaceutical industry spent $45.8 billion on research last year, which easily dwarfs a $1 billion investment from Uncle Sam. What’s more, funding is still unclear, because Republicans in the House of Representatives have pledged to cut spending for discretionary programs like this. But an influx of funding could help spark new research in otherwise unprofitable areas, like drugs for mental illness, doctors say.

Pharma firms urged to refuse US capital punishment drug

Doctors are backing a call by Health Minister Philipp Rösler for German drug firms to refuse to supply a key agent used in lethal injection executions to the United States.
Pharma firm probed for allegedly bribing doctors – National (22 Jan 11)
Pharma experts doubt new drug testing system – Society (16 Jan 11)
A nation of free thinkers – Analysis & Opinion (12 Jan 11)
The barbiturate anaesthetic sodium thiopental is used in – among other things – the cocktail of drugs given to inmates sentenced to death. The US will soon stop manufacturing the agent, meaning it will be forced to buy its sodium thiopental from other countries.

Rösler has called on the pharmaceutical industry not to supply drugs that include sodium thiopental – also known under the trade name Sodium Pentothal – to the US.

On Monday he received the support of the German Medical Association (BÄK).

“The German pharmaceutical industry can demonstrate that they trade ethically, if they join in here,” Frank Ulrich Montgomery, BÄK vice president, told the Passauer Neue Presse.

Daily Süddeutsche Zeitung recently reported that Rösler wrote to the drug industry asking them to ignore requests from the United States for supplies of the barbiturate.

“As far as your firm markets medical products containing sodium thiopental, I would like to ask you urgently not to meet such requests for supply,” Rösler wrote.

Montgomery described Rösler’s initiative as “a great idea.”

Sodium thiopental is included in drug mixture used in 35 US states in lethal injections to execute prisoners.

Sodium thiopental also has more mainstream uses as a general anaesthetic.

The American Medical Association has also decided not to co-operate with death sentence punishments.

Thiopental shortage to linger with Hospira’s exit

The highly anticipated Q1 2011 resumption of sodium thiopental manufacturing is no longer to be. Hospira is exiting the business and thus adding to the woes of surgeons and executioners alike.

The sole U.S. manufacturer of the anesthetic said Friday it will no longer produce the drug. But Pentothal is an older anesthetic, says Reuters, and doctors have moved on to other anesthetics during its shortage.

State penal systems are likewise turning to alternative drugs, as well as alternative sources. An Oklahoma execution last month relied on pentobarbital. And Arizona prison officials were able to obtain sodium thiopental from a non-U.S. supplier, while officials in Nebraska have found a source in India.

The Italian government is likely the straw that broke Hospira’s Pentothal back. The company had planned to produce the drug at its plant there. But the government stipulation that the drug be used for medical purposes only–and specifically not for executions–was more than the drugmaker could agree to. “We cannot take the risk that we will be held liable by the Italian authorities if the product is diverted for use in capital punishment,” the statement says. “Exposing our employees or facilities to liability is not a risk we are prepared to take.”

Big Pharma Outlook Still Bearish After Mixed Earnings

pharmaceutical companies are facing some major profit downers in 2011, as the industry deals with regulatory reform from the health care bill passed last spring, and as major pharmaceutical companies face patent expirations that will send multi-billion-dollar drugs to generics this year.

Bristol-Myers Squibb and Novartis both missed with earnings, but Bristol by a much narrower margin, preventing its stock from sliding into the red. It gained 1.6% in trading Thursday to $26.34. Bristol said sales of its Plavix drug, a blood-thinner, increased 6% in the fourth quarter.

Swiss healthcare manufacturer and drug company Novartis reported a 6% decline in net profit, due to one-time gains in 2010 including sales of the H1N1 vaccine, and restructuring costs, of $1.14 per share. Operating income decreased 6%. Analysts expected $1.25. Novaris shares were down 2.7% Thursday at $56.39.

Novartis mentioned 16 major submissions in its pharmaceutical pipeline in 2010, along with its merger with eye-care company Alcon, which is expected to close in the first quarter of 2011. The company said Alcon sales were $1.8 billion for the fourth quarter, offset slightly by currency exchange losses. Revenue from drug sales should grow in 2011, particularly in emerging markets, where sales contributed a 12% sales boost in 2010. Reported sales will be lower than 2010, however, due to healthcare reform and patent expirations.

Eli Lilly reported a net profit of $1.17 billion for its fourth quarter, or $1.05 per share. Excluding special items like restructuring costs, earnings were $1.11 per share, beating the analyst consensus by a penny. Lilly lists its antipsychotic drug Zyprexa among those that will lose their patents this year.

Lilly said healthcare reforms and patent losses may account for $400-$500 in 2011 sales, and to increase operating expenses by as much as $200 million. Shares in Eli Lilly were up 1.4% Thursday at $35.46.

Procter & Gamble also topped Wall Street’s expectations for its fourth quarter earnings with profits of $1.11 per share, up 10% from last year. The company, which sells a mix of healthcare, beauty and household products, says its market share has grown over the last year, thanks in part to product successes in emerging markets.

Volumes grew 6% globally during the fourth quarter. The company also cited higher commodity costs, however, when it set its fiscal year guidance for 2011 to include 3-5% net sales growth and earnings per share between $3.89 and $3.99, in line with analyst expectations.

P&G shares were down 4.3% Thursday, trading at $63.24.

Germany heeds call to block lethal injection drug supply

The German pharmaceutical industry has agreed to a request by the country’s Health Minister to block exports of the anaesthetic drug sodium thiopental to the US, where the drug is used to execute criminals.

Amid reports of impending shortages of sodium thiopental for use in lethal injections, Hospira, the only producer of sodium thiopental in the US, announced on 21 January it would no longer manufacture the product. Shortly after the news, German health minister Philipp Rösler issued an appeal to German firms not to supply sodium thiopental either directly to US prisons or indirectly through other distributors for use in executions. The German Medical Association subsequently issued a strong statement in support of Rösler’s call.
Sodium thiopental can be used in hospitals as an anaesthetic, but when used in executions is usually injected before two other drugs, which halt breathing and stop the heart. But in some US states sodium thiopental is used alone in high dosages for executions.

Susan Knoll, of Germany’s Association of Research-Based Pharmaceutical Companies (VFA), tells Chemistry World that no member of the organisation supplies such drugs to the US for use in executions, nor will they in future. ‘For members of the VFA, this is an ethical duty,’ she says.

Wolfram Koch, executive director of the German Chemical Society (GDCh), says the society fully supports Rösler’s recommendation. ‘The GDCh position is very clear,’ he says. ‘According to our code of conduct, in which the GDCh and its members commit themselves against the misuse of chemistry, using chemicals to end people’s lives, be it criminals or not, is certainly a misuse and unethical.’ He adds: ‘For us, this is not a question of freedom of trade, but of ethical behaviour.’

Koch says he does not expect any negative consequences for the German chemical or pharmaceutical industries.

Hospira had intended to switch production from North Carolina to Italy, but dropped the plans because it could not guarantee that sodium thiopental produced in Italy would not be used in executions. In a statement, the company said it ‘has never condoned’ the use of sodium thiopental in executions, adding: ‘We regret … that our many hospital customers who use the drug for its well-established medical benefits will not be able to obtain the product from Hospira.’

The UK in November put sodium thiopental under export controls, but in recent months there has been extensive media coverage of a small pharmaceutical company in London that has been supplying the US with the product for use in lethal injections.

Tibotec Signs Multiple Agreements With Generic Manufacturers to Provide Access to New HIV Treatment

CORK, Ireland, Jan. 27, 2011 /PRNewswire/ — Tibotec Pharmaceuticals today announced that it has granted multiple non-exclusive licenses to generic manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naive HIV-1 infected adults. The generic pharmaceutical manufacturers in India will have rights to market the product in sub-Saharan Africa (SSA), Least Developed Countries (LDCs) and India. Aspen will have rights to market the product in SSA including South Africa. Under the agreement, the generic manufacturers will be entitled to manufacture once-daily 25 mg TMC278 as a single agent medicine and a fixed-dose combination (FDC) product. Fixed-dose combinations contain multiple medicines formulated into one tablet helping to simplify HIV therapy and are preferred by public health treatment programs. Tibotec has chosen to collaborate with multiple manufacturers in order to ensure the widespread and sustainable access to, and supply of, TMC278 in areas of high HIV burden and to support generic competition.

Tibotec specializes in the research and development of new medicines for infectious diseases including HIV. It plays a key role in the Johnson & Johnson Global Access & Partnerships Program, which is committed to improving and saving lives by addressing unmet medical needs and ensuring the availability of HIV medicines to patients in need. The Program is already working, through existing agreements with generic manufacturers Aspen of South Africa and Emcure Pharmaceuticals Ltd of India to broaden access to the medicines darunavir and etravirine in SSA and LDCs and to darunavir in India.

“We believe that voluntary licensing is an important mechanism by which to expand access to our HIV portfolio, including our newest medicines,” said Will Stephens, Vice President of Global Access & Partnerships for Janssen Global Services, LLC. “Multiple licenses in place for TMC278 with generic manufacturers made before final regulatory approval in the U.S. and Europe underscore the seriousness and speed with which we’re working to ensure that all patients in need, not just those in Western markets, will have timely access to the most current regimens.”

Tibotec will provide the generic manufacturers with the technical information and knowledge to allow them to manufacture the single agent product. The generic manufacturers will pay royalties ranging from two to five percent. The generic manufacturers will be responsible for timely regulatory filing for generic TMC278 and for seeking pre-qualification from the World Health Organization (WHO) and ANDA approvals. To keep medicines affordable, the generic manufacturers are required to limit their gross profit margin on the sale of TMC278. Prior to the signing of these agreements, Tibotec submitted TMC278 for regulatory approval in the U.S., Europe, Canada, Switzerland, Australia, Russia and South Korea. Upon approval, it is expected that TMC278, in combination with other antiretroviral medicinal products, will be indicated for the treatment of HIV-1 infection in treatment-naïve adult patients.

The agreements cover the manufacture of TMC278 as a single agent medicine and a license to develop an FDC product using TMC278 with 300 mg tenofovir disoproxil fumarate and 300 mg lamivudine.

In July 2009, Tibotec announced that it had entered into a license and collaboration agreement with Gilead Sciences, Inc. for the development and commercialization of a new, once-daily, fixed-dose antiretroviral product containing Tibotec’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride) and Gilead’s Truvada® (emtricitabine and tenofovir disoproxil fumarate). Tibotec and Gilead are committed to working together to make the fixed-dose combination of TMC278 and Truvada available in the developing world and are working towards a separate agreement for these countries.

About Tibotec

Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company and one of the companies that compose the Janssen Pharmaceutical Companies of Johnson & Johnson. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need. The Company’s main research and development facilities are in Beerse, Belgium with offices in Titusville, NJ.

Tibotec has developed a Global Access & Partnerships Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access & Partnerships Program for darunavir and etravirine includes access pricing, registration, medical education for appropriate use and voluntary licensing.