News

Metabolex, J&J ink rich licensing deal

Johnson & Johnson is buying into Metabolex's program for diabetes and other metabolic conditions with a new collaboration pact that provides a $40 million equity stake and up to $508 million in milestones. J&J has capped its equity stake at 19 percent. Metabolex has two diabetes drugs in development: metaglidasen in Phase II/III and MBX-2044. The biotech company also has programs in obesity and blood fat disorders. In the deal, Metabolex retained U.S. co-promotion rights and a …

Pfizer's sells OTC division to J&J for $16.6B

Clearing the way to focus more on its prescription drug business, Pfizer has agreed to sell its OTC division to Johnson & Johnson for $16.6 billion in cash. The OTC therapies include such market stalwarts as Sudafed and Visine and collectively earned $3.9 billion in revenue last year. J&J also won the OTC rights to Zyrtec when it loses patent protection. Pfizer also said it would buy back up to $17 billion in shares. Shares of Pfizer were buoyed slightly be the news.

- here's the AP report on the sale

Pfizer rejects UK for European HQ

Citing an unwieldy bureaucracy, Pfizer has opted against putting its European headquarters in the UK, opting instead to scatter the jobs that will be created throughout other EU countries. The decision was contained in a new report that harshly criticizes the country's bureaucracy for losing hundreds of millions of pounds in new development due to its slow response times.

- here's the report on Pfizer's decision from the Guardian

Buffett fortune to help fund vaccine development

Warren Buffett's decision to add $30 billion to the $30 billion already in the Bill and Melinda Gates Foundation is likely to prove a windfall for a large contingent of medical researchers. The Gate Foundation has been a major contributor to groups researching vaccines for the diseases that afflict Third World countries. Buffett announced his surprise decision over the weekend.

- here's the report on Buffett from the Baltimore Sun

SPOTLIGHT: FDA OKs Prezista

The FDA has approved Tibotec Pharmaceuticals' Prezista for treatment-resistant HIV patients. "One of the greatest challenges in HIV care is finding therapies for treatment-experienced patients," said Michael S. Saag, M.D., director of the AIDS Outpatient Clinic and the University of Alabama at Birmingham Center for AIDS Research. "This is an important new option for the thousands of people with HIV in the United States who are resistant to more than one protease inhibitor." Release

ALSO NOTED: Schering terminates NexMed deal; Rubin resigns from Critical Therapeutics; and much more...

> Schering has terminated its licensing and distribution deal with NexMed for Alprox-TD, an experimental drug for erectile dysfunction. Report

> Chutes & Ladders: Paul D. Rubin has resigned as CEO of Critical Therapeutics. Report

> Chutes …

Pfizer pulls the plug on indiplon pact

Shares of Neurocrine took another drubbing early today as investors digested the news that Pfizer is pulling out of its co-development pact for the sleep drug indiplon due to regulatory delays. Shares of Neurocrine lost more than a third of their value overnight. Neurocrine regains full control of indiplon, and Pfizer has agreed to support the program for another 180 days to ensure a "smooth transition."

Neurocrine stunned the market with its announcement in mid-May that the FDA …

Merck KGaA drops Parkinson's drug after trial failure

Merck KGaA's Parkinson's program was dealt a severe blow when it announced that it would halt development of Sarizotan after a Phase III trial failed to confirm earlier data on the drug's efficacy. The German developer had hoped the drug would treat the spasmodic jerks Parkinson's patients suffer from. But in a short statement the developer said that the drug had not panned out in a late-stage trial and that it would halt any further work on the drug. The news sliced slightly more than …

Endo, Penwest boosted by new Opana approval

Shares of Endo Pharmaceuticals and its development partner Penwest shot up this morning as news circulated of the FDA's approval of two new versions of its powerful new pain killer Opana. The agency approved an extended-release and immediate-release form of the opiate for chronic and acute pain. Endo officials trimmed their financial outlook on earnings, though, saying that it would bear the full cost of the drug's launch. Endo plans to add 220 sales reps to its current marketing force of …

Scientists confirm human-to-human H5N1 case

Scientists have confirmed the first case of human-to-human transfer of bird flu involving a father and son in Indonesia. The researchers concluded that the virus had slightly mutated, allowing for the confirmation in how the virus spread. But researchers emphasized that the virus had not mutated in a way that would make it easier to spark a pandemic.

- here's the article from the New York Times on the case

Merck's Gardasil faces critical new hurdle

The FDA's approval of Gardasil as a vaccine to prevent cervical cancer faces a series of new critical hurdles. Chief among them is gaining the support of the Advisory Committee on Immunization Practice, which will be hugely influential in determining the states' attitude toward the new vaccine. Failure to gain ACIP's endorsement would slice into a market that may reach as high as $3 billion a year.

- here's the report on Gardasil from TheStreet.com

SPOTLIGHT: Array raises $32M

Array BioPharma has inked a $32 million sale-leaseback deal for two facilities in Colorado. BioMed Realty Trust made the purchase. Report

ALSO NOTED: Clinphone shares rise on debut; Allergan gets FDA OK for eye drug; and much more...

> Shares of Clinphone, a UK company that assists researchers in managing clinical trials, saw its shares jump 15 percent on its market debut. Report

> The FDA has approved Allergan's once daily Lumigan as a first-line therapy for elevated intraocular pressure. Report

> Shares of …

Cortex shares plunge on CX717 failure

Shares of Cortex Pharmaceuticals got hammered on Wednesday when the company announced that a Phase II study to determine its lead drug's effect on wakefulness failed to demonstrate a greater effectiveness than a placebo. The study simulated night shift work among subjects taking CX717 and was funded by the Defense Advanced Research Projects Agency. The results differed markedly from an earlier study, and Cortex says a difference in the way the studies were designed may have played a role …

Diabetes epidemic triggers soaring drug market

The New York Times looks at a group of new and upcoming diabetes drugs that are expected to play a big role in treating an epidemic of diabetes in the U.S. More than 20 million Americans have

GTx touts Acapodene data in cancer trial

GTx says that an interim analysis of late-stage data on Acapodene shows that the drug lowered the level of bad cholesterol and raised the level of good cholesterol. Earlier data indicates that the experimental therapy increases bone mineral density. The drug is being studied to see if it reduces fractures among patients with prostate cancer. The trial included 197 subjects who have completed a year of dosing. Researchers believe the drug can help prevent the serious side effects …

Mayne inks $34M deal to buy SuperGen products

Mayne Pharma is buying the North American rights to the leukemia drug Nipent and a medical surface cleaner from SuperGen for $15 million up front and up to $19 million in milestone payments. Mayne also says it is in talks to buy the cancer therapy mitmycin for the U.S. from SuperGen. "The addition of Nipent fits our strategy perfectly, building on our core oncology capability, particularly in the important US market," Mayne chief executive Dr Thierry Soursac said.

- read the …

GMI garners $15.4M in second round

GlycoMimetics has raised $15.4 million in its second round of venture capital. New Enterprise Associates led the round. Gaithersburg, MD-based GMI is developing novel drug therapies based on specific roles played by certain carbohydrates. Its lead drug candidates--an anti-inflammatory and an anti-infective--are in preclinical development.

- here's the release on GMI's round

SPOTLIGHT: Merck strategy threatens generic makers

Here's a good analysis from the AP on the recent Merck deal to cut the price of Zocor to a lower level than an upcoming generic. The concern is that big pharma can undercut generic makers if they simply cut the price of their name brand drug to less than that of a new competitor. Long-term, that could inflict serious damage to the generic business. But there's no denying that patients--and insurers--make out fine in the price war. And it's likely to be less controversial than …

DEALS: Deals Table headline


Schering, Celera ink $365M deal