Wyeth

Alzheimer's drug results boost Elan, Wyeth

Maureen Martino — Tue, 17 Jun 2008 13:02:51 -0400

Wyeth and Elan's shares were up today as the companies announced potentially promising results from a phase II trial of bapineuzumab, an Alzheimer's treatment. The study did not attain statistical significance on the efficacy endpoints in the overall study population, but the vaccine helped patients without a gene known as ApoE4. About 70 percent of Alzheimer's sufferers don't have the ApoE4 gene. A spokesperson for the company said the results support the decision to move bapineuzumab into Phase III trials.

- see this release for more

Elan wins $55M judgment in patent scrap

John Carroll — Mon, 16 Jun 2008 07:38:16 -0400

Ireland's Elan won a $55.2 million judgment against Abraxis BioScience on Friday, prevailing in its case that Abraxis' breast cancer drug Abraxane uses a technology protected by an Elan patent. Abraxane was approved by the FDA three years ago. This fight is far from finished, as Abraxis says it plans to appeal the ruling.

- read the report from RTT News

ALSO: Investors are anxiously awaiting a Phase II update from Elan and Wyeth on bapineuzumab, a potential blockbuster drug targeted at the root causes of Alzheimer's. Significant success in the clinic would pave the way for a new drug to compete against therapies that offer little long-term benefit. Report

Wyeth gets approvable letter for bazedoxifene

Fri, 23 May 2008 06:59:58 -0400

The FDA handed Wyeth a third approvable letter for bazedoxifene, a treatment for postmenopausal osteoporosis. In the letter, the FDA said it needed more information concerning the incidence of stroke and venous thrombotic events. Wyeth said the delay was expected. "In our conference with the Agency earlier this year, they stated their desire to convene an advisory committee to review the pending new drug applications for both treatment and prevention of postmenopausal osteoporosis," said Gary L. Stiles, M.D., Wyeth's CMO. The company expects to file a response by the end of 2008. A recent IMS report predicted that bazedoxifene could become a much-needed blockbuster for Wyeth if approved.

- see this release
- here's the IMS report

Related Articles:
Wyeth's reports strong Phase III bazedoxifene data
Wyeth to slash another 1,200 jobs

Progenics, Wyeth drug fails late-stage trial

Thu, 22 May 2008 06:59:55 -0400

There's more bad news for Wyeth and Progenics Pharmaceuticals for their late-stage drug Relistor. Researchers say the drug failed to hit a primary endpoint in restoring gastrointestinal function following surgery. Just as in another late-stage trial, preliminary data revealed no significant reduction in recovery time to a first bowel movement after surgery. Relistor won approval from the FDA for treating opioid-induced constipation. The companies say they'll study the data before deciding how to proceed with their research plans.

In a separate Phase II trial involving 122 patients with chronic, non-malignant pain who were receiving opioids for pain management, "the once daily oral formulation of Relistor showed statistically significant activity as assessed by the occurrence of spontaneous bowel movements and other efficacy measures."

Earlier this week Adolor and GSK won approval for Entereg for post-operative ileus, making it the only such drug on the market.

- read the press release
- here's the AP story

Pharmacopeia shares rise on blood pressure data

Fri, 16 May 2008 06:59:54 -0400

Pharmacopeia's shares were up today on trial results for PS433540, a hypertension drug. Data showed 'significant' blood pressure reductions in a Phase IIa study in patients with mild to moderate hypertension. The company is also testing PS433540 as a kidney disease treatment.

"We are very pleased with the results of this important Phase IIa trial and look forward to future studies which will further assess the potential of PS433540, perhaps even beyond blood pressure lowering...We believe PS433540's dual mechanism of action may have a positive effect on diabetic kidney disease," said Joseph A. Mollica, Ph.D., Chairman of the Board and Interim President and Chief Executive Officer of Pharmacopeia.

- take a look at Pharmacopeia's release

SPOTLIGHT: Wyeth R&D chief exits with kudos for success

Thu, 01 May 2008 06:59:53 -0400

The blogsters at In Vivo have weighed in on the news that Wyeth R&D chief Bob Ruffolo is retiring. He may have been tough to get along with, but the blog gives Ruffolo credit for some significant achievements in new drug approvals at a time most of the industry has been experiencing a long, dry spell. Ruffolo had early on noted the rising number of mid-stage trials that were failing, noting that the only sensible response was to increase the number of experimental therapies in the pipeline. All eyes now turn to the new R&F chief, Mikael Dolsten. Report

FDA approves Wyeth, Progenics drug

Fri, 25 Apr 2008 06:59:57 -0400

There's a big sigh of relief coming from Wyeth and Progenics today as the FDA approved Relistor, a subcutaneous injection for opioid-induced constipation in patients with advanced illness who are receiving palliative care. Back in January the FDA added an additional three months of review time so that it could study the drug's side effects. Though European regulators gave a thumbs up to the drug on Thursday, some U.S. analysts doubted Relistor would gain FDA approval. The FDA came through though, and Progenics' stock shot up on the news. The approval triggers a $15 million milestone payment from Wyeth.

"The approval of Relistor is a transformative event for Progenics Pharmaceuticals," says Paul J. Maddon, CEO of Progenics. "This is our first U.S. product approval.

- see the release on Relistor
- read TheStreet report

Wyeth, Elan suspend Alzheimer's vaccine study

Fri, 18 Apr 2008 06:59:54 -0400

Wyeth and Elan have suspended dosing patients in a mid-stage study of the experimental Alzheimer's vaccine ACC-001 after seeing one of the patients in the study develop skin lesions. Studies of ACC-001 that have been mounted outside of the U.S. have also been suspended. Researchers, though, quickly sought to reassure investors that another late-stage program for AAB-001 wasn't affected by the unexplained case of lesions. AAB-001, or bapineuzumab, has demonstrated an improvement in cognitive function in Alzheimer's patients in a small study and is being closely followed by the investment community.

- read the story in the Wall Street Journal
- read the story in TheStreet.com

Related Articles:
Wyeth stumbles badly trying to develop new drugs. Wyeth report
Wyeth, Elan advance Phase III Alzheimer's trial. Alzheimer's report

Wyeth, ViroPharma drops Hep C drug

Thu, 17 Apr 2008 06:59:54 -0400

After observing serious safety problems in a Phase II trial, Wyeth and ViroPharma are dropping development of HCV-796. In August the companies halted study of the drug when the data showed elevated liver enzyme levels in some patients after eight weeks or more of therapy with HCV-796. Two study subjects experienced serious adverse events and dropped out of the trial. The decision to abandon HVC-796 wasn't a surprise to Wall Street, and analysts don't anticipate the move will have a big impact on ViroPharma's stock.

"Clearly, this is a disappointing outcome for patients suffering from this difficult disease," commented Vincent Milano, ViroPharma's president and chief executive officer. "Significant activities were undertaken to determine a clear path forward for HCV-796; however, the risk associated with potential hepatotoxicity ultimately posed too high of a hurdle to merit further development."

- check out the release
- read the report for more

Related Articles:
ViroPharma, Wyeth halt HCV study. HVC report
ViroPharma's HCV drug shows promise. ViroPharma report
Wyeth buying ViroPharma shares. Wyeth report

ALSO NOTED: Ardana meets with potential suitors;Feds go back to basics with AIDS vax research; and much more...

Fri, 28 Mar 2008 07:59:50 -0400

> Ardana has provided an update on it's proposed sale or merger. The company says that it's met with a "significant number of interested parties," and that there is interest among it suitors regarding licensing opportunities for Ardana's products. Release

> About 1,200 Wyeth got pink slips on Wednesday, their jobs eliminated in the drugmaker's previously announced restructuring. Report

> Germany's Stada Arzneimittel says it's checking out potential takeover targets, looking to continue its recent series of acquisitions. Report

> After trying and failing repeatedly to develop an AIDS vaccine, federal officials say they're going back to the drawing board to come up with some new ideas. Report

> Looking for hard evidence that the FDA is tightening approval standards? Here it is. The agency today proposed tougher clinical trial guidelines for drug-coated stents. Report

> It was a busy day yesterday for FDA safety reviews, with a trifecta of announcements raising questions about drugs for everything from allergies to HIV. Report

Most popular this week: Big Biotech's Stock Report. Article

And Finally... Dr. Andrew Wakefield and two colleagues began their defense against charges that they violated ethics guidelines in the U.K. while developing a 1998 paper that linked autism to vaccines. That study raised a hue and cry around the world that has yet to completely die down, even after a raft of studies now conclude that there is no link. Report