Tamiflu

Roche touts corporate Tamiflu stockpiling

Tracy Staton — Fri, 27 Jun 2008 08:24:45 -0400

In what could prove a savvy marketing move, Roche is looking to big companies for the next round of Tamiflu sales. Corporations are, after all, quite vulnerable to a potential avian flu epidemic; with large numbers of people sick, companies would face major absenteeism and, in turn, lost productivity. They might even lose their ability to operate normally.

So Roche is offering them a special purchasing program. Pay an annual fee to stockpile meds for your workers, the drugmaker says, and we'll not only store them for you, but rotate the stock so it stays fresh. If an epidemic breaks out, then Roche will collect the prevailing wholesale price and ship out the drugs within 48 hours.

Tamiflu sales have been slumping, with government stockpiling programs offering only limited growth because of limited budgets. Roche even cut back production last year. But luckily for the company, the U.S. government is now pushing corporate stockpiling to supplement the national Tamiflu supply, which would only cover a small percentage of the population. In fact, the U.S. Department of Health and Human Services helped Roche publicize its new sales program.

- check out Roche's release
- read the San Francisco Chronicle story
- see the analysis at CIDRAP

GSK nabs EU approval for pandemic shot

Tracy Staton — Mon, 19 May 2008 10:42:52 -0400

Put GlaxoSmithKline at the head of the list of vaccine-makers able to profit from a potential flu pandemic. The company just got EU go-ahead to market its H5N1 vaccine, Prepandrix, becoming the first pharma to get a Euro-license for a pre-pandemic vaccine. Prepandrix gives some protection against several currently circulating strains of avian flu. If a pandemic broke out, it would be administered to health workers and others most at risk as a sort of stop-gap measure, while drugmakers worked to develop another vaccine precisely targeted to the pandemic strain.

Countries such as Switzerland and Finland had already placed orders for the shots, anticipating approval, while others are in talks with GSK. As in the case of Roche's Tamiflu antiviral med--and to a lesser extent GSK's antiflu Relenza--countries are looking to stockpile Prepandrix to prep for the possibility of an H5N1 outbreak. Sanofi-Aventis, Novartis, and Baxter all are developing pandemic vaccines, too, but GSK obviously will have the first-to-market advantage.

- see the story in the Wall Street Journal
- check out the coverage in The Times

ALSO NOTED: Appeals court overturns $32M Vioxx award; One-drug stockpiles 'not enough' for pandemic flu;

Thu, 15 May 2008 06:59:50 -0400

> A Texas appeals court overturned a Vioxx jury verdict, ruling in favor of Merck and negating damages originally set at $32 million. Judges said there was "insufficient evidence" supporting the jury's verdict. Release

> The H5N1 strain of bird flu is growing resistant to Tamiflu, the Roche drug stockpiled by governments all over the world in preparation for a possible pandemic; experts now advise countries to stockpile a competing antiviral, Relenza, as well. Report

> Counterfeit drugs in India are becoming such a problem--with an estimated 5 percent to 20 percent of meds sold being fake--that the government may start paying a premium for drugs made by companies with at least one factory approved by foreign inspectors. Report

> The Australian government is moving toward an industry-funded drug-regulatory committee, to the consternation of pharma and public health experts alike. Report

> Health ministers from around the world will meet next week during the World Health Assembly to debate patent rules that developing countries say keep life-saving medicines out of their hands. Report

> For the first time, more than half of insured Americans are taking prescription drugs for chronic health problems, particularly high blood pressure and cholesterol. Report

> Cambridge Major Laboratories is set to build a new 120,000-square-foot plant in Wisconsin, in a bid to expand into large-scale active pharmaceutical ingredient manufacturing. Report

> Sepracor's CFO David P. Southwell resigned, to be replaced by Executive Vic e President Robert Scumaci. Release

> Salix Pharmaceuticals is suing Novel Laboratories for patent infringement over the bowel-cleansing med MoviPrep. Report

> Palatin Technologies is cutting about a third of its workforce and dumping one of its lead development programs--an effort to find a better tolerated successor to sildenafil. Layoff report

> The analysts devoted to tracking biotech companies in the oncology arena will have their hands full tonight at 9 p.m. EST. That's when ASCO will do an online data dump in advance of its annual meeting, revealing many of the little--and big--details that could spell swift gyrations in the value of a company's shares. ASCO report

> Recruiting the right number of the right patients for any clinical trial can be a tough prospect. Now there are a host of new efforts to match a patient with a clinical trial, including a service offered by the for-profit company EmergingMed. Clinical trial report

> You can file the following under the category of really, really bleak forecasts: The rising cost of healthcare in the developing world matched by an aging population is creating a perfect storm for drug developers that threaten their entire industry. Report

And Finally... An expensive drug used to treat the genetic disorder phenylketonuria may also be effective at treating enlarged hearts. Report

ALSO NOTED: Squeaking hip devices worry patients, docs; Biotech M&A has yet to reach its peak;

Mon, 12 May 2008 06:59:50 -0400

> Replacement hips made with ceramic parts are squeaking in certain patients, some of which have sued Stryker; the company says the noisy side effect happens in less than 1 percent of implants. Surgeons worry that the squeaking signals possible structural problems. Report

> In analyzing the PowerShares Dynamic Biotech & Genome ETF, a fund made up of primarily small- and medium-cap biotech stocks, Seeking Alpha notes that Big Pharma's appetite for biotech acquisitions is far from satisfied. M&A report

> South Korea plans to boost its stockpile of drugs to fight avian flu in humans, securing enough doses to treat 2.5 million; though it didn't specify which antiviral, its health officials have named Roche's Tamiflu as a key treatment. Report

> Takeda Pharmaceuticals has hired the PR firm Fleishman-Hillard to help launch a new drug for Friedreich's Ataxia in Europe. Report

> Responding to HIV-positive critic, one Thai official promised that compulsory licensing is working; second-line treatments are already reaching patients in need. Report

> Novalar got the FDA's blessing on a drug antidote to dental anesthesia, which reverses the oral numbness after dental procedures are finished. Release

> India's Aurobindo Pharma got nine new-product nods in South Africa, bringing to 31 the number of products approved there. Report

> GlaxoSmithKline and Adolor's seemingly never-ending effort to win approval for Entereg has hit yet another delay. Entereg report

> Medical device maker NuVasive is buying Osteocel, Osiris' biologics business, for $35 million up front and an additional $50 million in milestone payments. Report

And Finally... Vaccine experts are pondering just how long vaccines will be able to provide immunity in a world where some diseases are all but eliminated and natural exposure to many common viruses has ended. Report

Under pharma earnings, basic problems

Wed, 23 Apr 2008 06:59:55 -0400

You've heard of see-through buildings. How about see-through pharma earnings? Though drug makers have been reporting increases to their bottom lines, investors are looking past the foreign-currency gains and one-time earnings boosts to the fundamental problems the industry faces.

"Each company generally has had somewhat of the same narrative... limited pipeline visibility, patent expirations, and decelerating growth in their main products," one analyst told the Associated Press. Thus Wyeth lost Protonix revenues; Roche suffered from falling Tamiflu sales; Merck's Singulair, Vytorin, and Fosamax dropped off; Pfizer saw Zyrtec and Norvasc decline; and Lilly's top seller Zyprexa deflated.

Of course Big Pharma also confronts a larger problem, just as most other U.S. companies do: the economy. As Steve Brozak of WBB Securities pointed out, the lackluster quarter is just one more sign of an overall market shift. "This proves to us that we're in a recession," he said.

- read the Associated Press story

Roche warns of Tamiflu psych effects

Wed, 05 Mar 2008 06:59:55 -0500

After some arm-twisting from the FDA, Roche has added stronger warnings to its Tamiflu label. In a Dear Healthcare Professional letter, the company cautioned doctors about the sometimes-fatal psychiatric problems seen in a small number of patients. Some have gone delirious and hurt themselves, even killed themselves, by falling from windows or balconies or running into traffic.

An FDA advisory committee discussed the problems at a November meeting, where the agency revealed nearly 600 reports of psychiatric troubles in Tamiflu patients, three-fourths of them in Japan. But because the flu itself can cause delirium and hallucinations, the new Tamiflu label states that the drug hasn't been definitively linked to the behavior problems.

Now, Australian regulators say they're keeping an eye on Tamiflu. They've updated the labeling for the drug, too.

- read the story in Forbes
- check out the Australian reaction in The Age

Related Articles:
Tamiflu resistant to seasonal strains. Report
FDA does a triple-take on Tamiflu. Report
Tamiflu's Japanese sales to drop by half. Report
Roche's Tamiflu ads spark criticism. Report
EU approves Tamiflu for children. Report

Tamiflu resistant to seasonal strains

Tue, 29 Jan 2008 06:59:54 -0500

Roche's Tamiflu engine is skipping a few beats. Some seasonal flu strains circulating in Europe are "significantly" resistant to the anti-influenza med, stockpiled around the world as insurance against a flu pandemic. According to the European Centres for Disease Control, 13 percent of H1N1 samples contained a mutation associated with high levels of Tamiflu resistance.

This is the first clear sign of resistance to the antiviral. Previous studies have shown only about 0.4 percent of seasonal viruses carrying resistance, while only four patients with H5N1--so-called avian flu--were infected with resistant strains.

It's not good news for Roche, which turned Tamiflu into a blockbuster by selling it to governments in quantity as they prep for a possible pandemic. But it could benefit GlaxoSmithKline, which makes another anti-flu med, Relenza. The European medicines agency has stressed the importance of stockpiling a variety of antivirals, not just Tamiflu. The EMEA says resistance to Relenza is extremely rare.

- see GSK's release on stockpiling
- here's the EMEA guidance about stockpiling anti-flu drugs
- check out this Financial Times article
- get more in PharmaTimes
- read more about the mutation

Related Articles:
FDA does a triple-take on Tamiflu. Report
Tamiflu's Japanese sales to drop by half. Report
Roche's Tamiflu ads spark criticism. Report
EU approves Tamiflu for children. Report

Drug name psychology, or the power of Z

Fri, 18 Jan 2008 06:59:56 -0500

You know about those product-naming experts who charge hundreds of thousands for just the right combinations of vowels and consonants. Well, the Associated Press today draws the curtain aside to reveal just which levers these experts are pulling.

For instance, did you know every letter has a personality? There's Z for speed -- think quick relief from cholesterol with Zocor, from depression with Prozac and Zoloft, from allergies with Zyrtec. Then there's L, R, and S to calm and relax; why else would so many mental health drugs lean on them? Hard consonants like P, T, and K connote effectiveness; hence effective clot-busting with Plavix, effective germ-fighting with Tamiflu, effective HIV-busting with Kaletra. Then there's the all-important letter X, the science guy. Naturally, it graces many names with a white-lab-coat feel: Lexapro, Xolair, Celexa, Zyprexa, Fosamax.

From letters, we move to syllables--two or three--and overall symbolism. Last month, Eli Lilly dubbed its new heart drug Effient (think efficient). Overt symbolism like that is better, the experts say, than the type that plucks at the subconscious. No matter what subliminal advertising nuts claim.

- read the article from the Associated Press

Related Articles:
Drug marketing costs double R&D. Report
NHS: docs overprescribe branded drugs. Report

New drug warnings poised for rollout

Thu, 29 Nov 2007 06:59:57 -0500

New warnings and warning recommendations are flying out of the FDA this week like geese flying south for the winter, partly because of an FDA advisory panel is meeting. Here's the latest:

Committee members want a stronger warning against using Cephalon's Provigil drug in children. Used to treat sleep disorders in adults, the drug sometimes is used off-label in for ADHD in kids. Panelists want doctors to know Provigil shouldn't be used in children. Just recently, Provigil's label got a new warning of serious skin reactions and psychological problems.
Novartis added a new warning of birth defects to its organ-rejection treatment Myfortic. The FDA says women who are planning to get pregnant should only use Myfortic if they have no other options.
The FDA's pediatric committee voted for stronger warnings of psychiatric side effects on both Roche's Tamiflu and GlaxoSmithKline's Relenza. Roche already agreed to the warning, though it admits no causal relationship between its drug and the side effects; so far, Glaxo has only blamed the side effects on the flu itself.
Glaxo's Serevent and Advair also got hit with recommendations for more specific warnings on the risk of asthma-related complications in children. Glaxo says it thinks the current black-box warning is sufficient, even though it doesn't specifically mention kids. The FDA also says it plans a new safety review of the drugs.

- read The Motley Fool report on Myfortic
- see the Provigil article from the Associated Press
- read the latest on Tamiflu and Relenza from the Philadelphia Business Journal
- here's more on GSK's asthma drugs

Related Articles:
FDA warns of Provigil risks. Report
FDA staffers question safety of Provigil for ADHD. Report
FDA does a triple-take on Tamiflu. Report
FDA reconsiders Glaxo asthma meds. Report

ALSO NOTED: Merck plots $295 million vaccine plant; Roche agrees to new Tamiflu warning;

Wed, 28 Nov 2007 06:59:50 -0500

> Merck is stepping up its presence on the Emerald Isle. The drug maker plans to invest $295 million in a new vaccine-production plant in Carlow, Ireland, creating 170 jobs in the process. The new facility will include a formulation and filling operation, plus a research team. Construction is set to begin next year. Report

> Roche accepted the FDA's recommendation for a stronger warning label on Tamiflu highlighting the risk of psychiatric problems, but the company emphasized that flu can itself cause delirium and denied any causal relationship between the drug and the hallucinations and other psychiatric disturbances reported in Tamiflu patients. Report

> An activist shareholder group is lobbying to limit the role of Omega Pharma's founder and non-executive director Marc Coucke, who owns 30 percent of Omega's shares. Report

> Glenmark Pharmaceuticals plans a big push into the Nigerian market, with the launch of respiratory, oncology, and metabolic disease meds; currently the company sells dermatology, gynecology, gastroenterology, and anti-infective drugs there. Report

> Denmark's Lifecycle Pharma alerted investors that stronger-than-expected sales are likely to yield a year-end net loss of $28.7 million to $33.6 million, rather than the $50.5 million to $55.4 million loss previously predicted. Report

> Japan's Astellas has forged a deal to buy Santa Monica, CA-based Agensys for $387 million plus up to $150 million more in milestones. Report

And Finally... Curious how the public--and pharma sales folk--reacted to Dr. Drug Rep's confession? The blogosphere is buzzing. Blog | Blog