Biotech company news

Pozen shares sink on latest Trexima delay

Thu, 02 Aug 2007 06:59:58 -0400

Pozen stock took a painful dive this morning after GlaxoSmithKline announced that their two-in-one migraine drug Trexima would be delayed yet again--this time to satisfy FDA demands for more information on evidence of genotoxicity seen in a preclinical study. That genotoxicity was seen in Trexima, but was not apparent when the two compounds used in Trexima were studied alone. That was bitter news for investors, who were hoping that the second approvable letter from the FDA--the first arrived more than a year ago--would be the charm. They drove down Pozen's value by close to half. Researchers say they'll shoot for an early meeting with the FDA to better determine how to proceed.

- check out the release
- here's the AP report on Pozen

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Nuvelo hands out pink slips--again

Thu, 02 Aug 2007 06:59:57 -0400

Hammered by the failure of its experimental blood clot drug in a recent clinical trial and Bayer's subsequent pullout from a development partnership, Nuvelo is reaching for the axe again. This time it plans to cut 30 percent of its workforce, leaving 80 workers in place. Through the course of the year, San Carlos, CA-based Nuvelo has sliced away close to half of its payroll. Out the door in this restructuring is CFO Ward Wolff. The biotech says it will continue to concentrate on developing alfimeprase as well as NU 206 and 172. The developer is suspending work on rNAPc2, a cancer therapy.

"We are confident that our current strategy focuses our resources on our highest priority programs and will allow us to build shareholder value," said Dr. Ted W. Love, chairman and CEO of Nuvelo.

- see the release on the layoffs
- here's the AP report on Nuvelo

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Troubled Pfizer blueprints biotech venture effort

Thu, 02 Aug 2007 06:59:56 -0400

Up to now, Pfizer's use of investment funds has followed a few narrow channels: Diagnostics, software and drug technology outfits that promised to help in their drug commercialization efforts. But now Pfizer plans to take the wraps off the moribund strategy as it moves money into a wider array of startups. Barbara J. Dalton, who has headed GlaxoSmithKline's ambitious investment efforts, is being brought in to run the new venture investment arm of Pfizer with plans for six to eight new investment deals per year. The new venture strategy is being prompted by some big failures in Pfizer's pipeline--with torcetrapib leading that list--and the woeful initial results from sales of Exubera. Pfizer launched a biotech incubator in May as part of a new focus on early-stage companies.

- read the AP report on Pfizer

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Anadys dumps hep B compound in restructuring

Thu, 02 Aug 2007 06:59:55 -0400

Anadys Pharmaceuticals in San Diego is also restructuring to account for a development failure. Out the door go 29 of 88 employees as it halts work on ANA975 for hepatitis B. Toxicology testing on ANA975, which was partnered with Novartis, delivered some discouraging news. CEO Lawrence Fritz says the remaining workers will concentrate their efforts on ANA598 for hepatitis C and ANA773 for cancer.

"With our cash balance of $69 million, we believe we have the resources to carry these two compounds forward to achieve meaningful clinical milestones," added Fritz.

- see this release from Anadys
- check out the San Diego Union-Tribune report

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J&J makes big cuts at Alza and Scios

Wed, 01 Aug 2007 06:59:58 -0400

Two Bay area biotechs, Alza and Scios, are in line for some big layoffs as Johnson & Johnson slims down its pharma operations. Acquired for $12 billion six years ago, J&J says that it is shutting down Alza's Mountain View facility and laying off 600 workers. J&J is largely ending the R&D efforts at Alza, which had been structured to tweak the pharma giant's therapies. The San Jose Mercury News also reported that Scios--which markets Natrecor--has already seen the pink slips fly and more cuts are expected. Two other J&J companies working in medical devices are also expected to undergo significant restructuring.

- read the report from the Wall Street Journal (sub. req.)

Related Articles:
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FDA committee backs Tysabri for Crohn's

Wed, 01 Aug 2007 06:59:56 -0400

Elan and Biogen Idec have won the backing of an FDA expert committee in its quest to gain regulatory approval for Tysabri as a therapy for Crohn's disease. The backing came for the use of Tysabri for Crohn's patients that either haven't benefited from existing therapies or can't tolerate them. The vote marks another careful step forward for Tysabri, which has been linked to a deadly nervous system disease.

- check out the release on the approval
- here's the AFX report on the vote

Industry exec says FDA approval process too strict

Wed, 01 Aug 2007 06:59:55 -0400

Citing the recent decision by GPC Biotech to withdraw its application for satraplatin, Pharmacyclics CEO Richard Miller says that the FDA is making it too tough to gain approvals for new cancer therapies and other drugs that fight life-threatening illnesses. Writing in The Wall Street Journal, Miller maintains that satraplatin is just the latest in a series of cases where the FDA has been making life too difficult for developers. Only one therapy achieved accelerated approval last year and none have made it through that process so far this year. He calls on the agency to revise its approach to drugs that can save the lives of patients who have exhausted other possible treatments.

- read the commentary from the Wall Street Journal (sub. req.)

Related Article:
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ImmunoGen surges on milestone trial achievement

Wed, 01 Aug 2007 06:59:54 -0400

Shares of ImmunoGen took off yesterday after the biotech announced that Genentech's launch of a mid-stage cancer trial for trastuzumab-DM1 would trigger a $5 million milestone payment. The drug, which is being developed to treat a certain kind of breast cancer, is a combination of ImmunoGen's cell-killing agent and an antibody from Genentech. Analysts called the start of the Phase II trial as a significant validation of ImmunoGen's technology. Genentech has a pact to use ImmunoGen's technology in its drug discovery work.

- see ImmunoGen's announcement
- check out the AP report for more info

Related Article:
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Noven garners $25M payday on sales milestone

Tue, 31 Jul 2007 06:59:55 -0400

Noven will pocket the second of three potential $25 million milestones outlined in its deal with Shire. Shire says that the ADHD drug Daytrana continues to rack up enough market share to trigger the payments, exceeding $50 million in revenue for the 12 months ended on June 30. Noven will get its third big milestone payment if Daytrana breaks the $75 million mark.

- check out the release
- here's the report from Tech Journal South

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New rules limit use of anemia drugs

Tue, 31 Jul 2007 06:59:54 -0400

Shares of Amgen slid on new government rules for reimbursing the biotech's blockbuster anemia drugs. The rules, though, are actually less restrictive than the proposed guidelines that were released for review earlier this year. The rules released today restrict the use of anemia drugs to prevent hemoglobin levels from declining.

- read the AP report on Amgen

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