Data on Orexigen’s anti-obesity drug Contrave presented late Friday at the American Diabetes Association’s annual meeting sent the stock up today, reports Dow Jones Newswires. Orexigen shares rose 18% to close at $4.90.

Contrave is one of three next-generation anti-obesity drugs up for consideration by the FDA this year, with its turn before one of the agency’s advisory panels tentatively set for Dec. 7. Vivus’s Qnexa will be discussed at a July 15 panel meeting, while Arena’s lorcaserin’s date with the panel is currently scheduled for Sept. 16.

The Contrave data showed that after 56 weeks, overweight or obese study participants who also suffered from type 2 diabetes lost more weight and better controlled blood glucose levels than patients taking a placebo. Specifically, 44% of patients taking Contrave reached the ADA’s treatment target for A1C, a measure of glucose control. One analyst told DJN those data were “incremental” and consistent with results seen in the other two drugs. But Orexigen’s CEO told DJN that were Contrave approved, diabetes data on its label could attract the attention of endocrinologists who might prescribe the drug for their patients with the disease.

Arena also presented data at the ADA meeting, reporting that pooled data from the company’s phase 3 trials of lorcaserin showed that the drug worked better than placebo across all patient subgroups and that study participants (both on the drug and on placebo) who lost more than 5% of body weight had improvements in markers of cardiovascular risk such as blood sugar and cholesterol levels.

Source: The Wall Street Journal

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Biogen Idec is suing the makers of multiple sclerosis drugs that, like its own Avonex treatment, are forms of beta interferon.

The biotech claims in a suit filed Friday that drugs sold by companies including Pfizer, Bayer AG and Novartis violate a patent on the use of beta interferon granted last fall, Dow Jones Newswires reports. (A Bayer spokeswoman said the company will defend itself against the suit; a Novartis spokesman had no comment, and Pfizer officials couldn’t immediately be reached for comment, DJN says.)

Biogen doesn’t want the other products — sold as Rebif, Betaseron and Extavia — yanked from the market, but is seeking damages including lost profits from earlier sales and a royalty on sales. A Bayer lawsuit filed last Thursday says Biogen is seeking as much as 8.5% of Betaseron sales, Bloomberg News reports.

Betaseron had about $1.4 billion in sales last year, Rebif had $1.9 billion and Extavia, new to the U.S. market in 2009, posted sales of $49 million, DJN says. Avonex leads the category, with $2.3 billion in 2009 sales.

Beta interferon treatments can cost north of $25,000 a year, DJN says, and the side effects include flu-like symptoms. Earlier this year, researchers reported progress on a test that might help pinpoint MS patients who’d benefit from the treatments.

Source: The Wall Street Journal

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Pfizer said it will cut 6,000 jobs over the next five years, part of ongoing cost cuts and consolidation following its $68 billion acquisition of Wyeth, reports Dow Jones Newswires. The reductions, which fall under Pfizer’s previously announced intention to eventually eliminate 19,000 positions, “will align the 33,000-person manufacturing and supply organization from the combined networks of Pfizer and Wyeth,” DJN says.

Here’s what the Health Blog has written about recently on the pharma job cut front:

• Several hundred job cuts by Merck and Pfizer, some of which were previously announced.

• AstraZeneca’s announcement in January that it would cut another 8,000 positions, including some in R&D, over the next couple of years.

• GlaxoSmithKline’s February news that it would shed an unspecified number of jobs.

Are we missing any big pharma job cut news?

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When we talked to Genzyme CEO Henri Termeer last week, he told us he was open to selling off some of the biotech’s noncore businesses. Today in Boston it told analysts and investors what those units will be, Dow Jones Newswires reports.

By year’s end, the company will pursue strategic alternatives, i.e. somehow spin off or get rid of, its genetic testing, diagnostics, and pharmaceutical intermediates divisions. It will also repurchase $2 billion of its own stock — $1 billion in the short term, and another $1 billion over the course of a year.

When we chatted with Termeer last week, he was full of praise from one of the activist investors who’s been pressing for change at the company — Ralph Whitworth, who recently won a seat on the board. He had fewer kind words for Carl Icahn, who wants to add himself and three others to the company’s board. Icahn isn’t so sweet on Termeer, either; he has filed a proxy statement saying he wants to oust the CEO from the board.

We’ve been referring to the company as the beleaguered biotech for its well-publicized manufacturing issues, which led to a plant shutdown and resulting drug shortages. It’s negotiating with the FDA over a consent decree for the plant in question.

Source: The Wall Street Journal

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The FDA today released warning letters it has sent to Novartis and GlaxoSmithKline over how the companies promoted two products, Dow Jones Newswires reports.

The agency dinged Glaxo for a professional pullout, or “slim jim” sales aid, promoting Altabax, an ointment that treats the skin condition impetigo. According to the FDA, the pullout makes claims that go over and above its indication — treating only cases of the condition that are caused by certain bacteria. As written, the brochure suggests the ointment can also treat impetigo caused by other bacterial strains — including the infamous MRSA, the FDA says in a letter.

Glaxo said in a statement it responded to the agency, will stop using the brochure and is “carefully reviewing FDA’s comments and issues.”

Novartis was warned about two websites it sponsors, www.gistalliance.com and www.cmlalliance.com, that didn’t mention the name of Gleevec, the drug the sites were promoting. Gleevec is approved to treat GIST, or gastrointestinal stromal tumor, and a form of leukemia. The content of the websites weren’t submitted for the required prior approval period, the agency says in a letter.

The drug maker didn’t immediately respond to Dow Jones’s request for a comment, but both websites say they’re “temporarily unavailable.”

Source: The Wall Street Journal

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The FDA today disclosed several warning letters it had sent to drug makers and weight-loss spas for “false” and-or “misleading” claims for their products. Here’s a rundown:

• Biogen Idec was cited for a promotional Webcast involving the multiple sclerosis drug Tysabri because it minimized the risk of a serious brain infection, the FDA said. The letter also cited the company for failing to submit the Webcast for FDA review 30 days in advance. Tysabri is sold jointly by Biogen and Elan.

• Gilead Sciences was cited for a print ad for involving its HIV drug Truvada, which the FDA said overstated the effectiveness of the products and minimized the risks associated with the drug.

• Half a dozen spas offering “lipodissolve” injections to get rid of small fat deposits received letters because the FDA said the therapy hasn’t been cleared by regulators. “The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,” one letter said.

Update: A Biogen spokeswoman told Dow Jones Newswires that the company believed “the content and means for communicating this safety information was appropriate, timely, factual and non-promotional, and we plan to have further conversation with the agency.” Gilead said in a statement that takes the FDA’s concerns regarding the advertisements seriously “and we will be working to respond to the FDA promptly,” according to DJ Newswires.

Source: The Wall Street Journal

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A few items of interest involving the FDA:

Congress last year added the tobacco industry to the FDA’s regulatory mix and today a panel of health experts making up the agency’s new Tobacco Products Scientific Advisory Committee is kicking off a two-day meeting. First on the agenda: how menthol flavoring in cigarettes affects smokers’ habits.

Small wonder that menthol is getting early attention, says the New York Times, which notes menthol butts account for almost a third of the $70 billion U.S. cigarette market. After more meetings, the advisory panel will send recommendations to the FDA, which could eventually decide to ban menthol products or take steps to curtail their marketing, Dow Jones Newswires says.

At a meeting of a separate FDA advisory panel today, experts will hear testimony about the amount of radiation exposure Americans receive from CT imaging scans and whether the benefits of the technology are worth the cancer risk from overuse.

The issue is well-traveled territory, but the NYT reported earlier this week that FDA bosses had ignored warnings from its scientists about routine use of CT scans for colon cancer. A former FDA scientist told the panel today that he was fired after raising concerns about the risks of radiation exposure from high-grade medical scanning, according to the Associated Press.

The FDA said late last year it wanted more time before deciding whether Cephalon’s sleep-disorder drug Nuvigil could also be used as a treatment for jet lag. Yesterday the drug maker said it received a complete response letter from the FDA, meaning no approval for jet-lag use — at least for now.

Cephalon gave the FDA data on 427 people who flew from the eastern U.S. to France. Those who took Nuvigil for three days showed a statistically significant improvement of jet-lag symptoms over those who took a placebo, the company said. But the FDA questioned the quality of some of the data, according to Cephalon, which said it would work with the FDA on how to proceed.

Cephalon has been eager to expand uses for Nuvigil, which has patent protection through 2023. Cephalon’s predecessor drug for sleep disorders, Provigil, could face generic competition as soon as 2012.

Source: The Wall Street Journal

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Another day, another stock-price jump.

First, the preliminaries: An advisory panel this afternoon recommended the FDA approve a lung drug developed by InterMune, with majorities of the outside experts saying the proposed treatment appeared effective and safe.

The FDA is expected to decide by early May whether to go along with the panel’s recommendation on pirfenidone, which is intended to treat patients with idiopathic pulmonary fibrosis. The FDA usually follows the lead of its advisory committees.

This all comes as good news for investors in InterMune, whose shares streaked nearly 60% higher Friday because the questions posed by the FDA staff for today’s advisory committee meeting weren’t uniformly negative.

The stock price then barely budged yesterday and trading in the shares was halted today in anticipation of the meeting news. But in after-hours trading today, the news sent the shares soaring up 65% to $38.43. That compares with the stock’s price under $15 at the close last Thursday.

The experts voted 7-5 on the question of data for pirfenidone showing “substantial evidence” of effectiveness. The medicine passed the safety vote 9-3. InterMune had told the panel that “pirfenidone provides a clinically meaningful benefit to patients by reducing decline in lung function.”

Panel member Leslie Hendeles of the University of Florida told Dow Jones Newswires that he didn’t think the data met FDA’s substantial-effectiveness test, but he voted in favor of the medicine because he would want a chance to take the drug if he were diagnosed with pulmonary fibrosis.

The FDA is giving the InterMune drug candidate a priority review process that’s reserved for advances over existing treatments. There aren’t any FDA-approved drugs now for IPF. Here’s more on the disease.

Source: The Wall Street Journal

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The FDA staff said it has a bunch of questions about InterMune’s new drug to slow deteriorating lung functioning. But investors figure the concerns weren’t as bad as they could have been, sending the biotech’s shares soaring.

The stock jumped as much as 74% after FDA reviewers said only one of InterMune’s two late-stage trails for the experimental drug pirfenidone had met its main goal and added that “the clinical significance of the treatment effect size is uncertain.” The FDA documents, which were released ahead of an advisory panel meeting to discuss the drug Tuesday, also had a mix of other things to say.

All things considered, an Oppenheimer analyst noted the “tone was less negative than expected,” all things considered and there was room for the drug to still get FDA approval. The shares settled down in later trading, but still finished up nearly 60% for the day.

InterMune often appears on lists of likely biotech takeover candidates. FDA approval of pirfenidone would give it two drugs on the U.S. market.

The new drug would treat idiopathic pulmonary fibrosis, which affects about 200,000 Americans, the majority of whom eventually die of respiratory failure. The FDA noted that there aren’t any approved drugs to treat IPF, although drugs like corticosteroids and drugs that suppress the immune system are used, according to Dow Jones Newswires.

The company also put out material noting that “the slowing of progression in loss of lung volume constitutes a clear benefit to patients,” Reuters said.

Source: The Wall Street Journal

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It seemed like only a question of time, but Bristol-Myers Squibb said this afternoon that Lamberto Andreotti, its president and chief operating officer since last March, would succeed James M. Cornelius as CEO.

Andreotti, a 12-year veteran of the company, is 59 years old and Cornelius is 66. Cornelius was tapped as Bristol-Myers CEO in 2006 (first on an interim basis) and then got the added job as chairman in 2008. Picking a successor was one of his key missions.

Andreotti takes command after Bristol-Myers decided to sit out the wave of multibillion-dollar takeovers that saw big competitors Pfizer, Merck and Lilly get even bigger. Bristol-Myers instead has pursued smaller biotech deals and alliances as well as developing its own pipeline through what it called a “string of pearls” strategy. The company also decided to shrink its non-core units with the split-off of its Mead Johnson baby-formula business.

Looking ahead, Bristol-Myers will have to cope with the loss of patent protection for money spinners like the company’s anticlotting pill Plavix, the world’s second best-selling drug after Pfizer’s Lipitor. The company has cut costs through layoffs, plant closures and wage freezes, Dow Jones Newswires notes.

Cornelius will remain as the drug maker’s chairman when the switch is made May 4. In 2008, his compensation topped $21 million.

Source: The Wall Street Journal

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