Fast Track

Melanoma therapy produces positive mid-stage data

Tue, 20 May 2008 06:59:54 -0400

Researchers for GlaxoSmithKline and Synta Pharmaceuticals say a mid-stage study of elesclomol produced "statistically significant" data on progression-free survival of patients with metastatic melanoma.

"These data, combined with earlier clinical and pre-clinical data we have presented for elesclomol, support our belief that oxidative stress induction is a promising new approach to cancer therapy in melanoma and, potentially, other cancer types," said Eric Jacobson, M.D., Synta's CMO.

- here's the press release
- read the AFX report

Talecris' antibody drug gets priority review

Fri, 09 May 2008 06:59:54 -0400

The FDA has granted priority review to Talecris' drug Gamunex, meaning the FDA will review its application in six months rather than the standard 10. Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. It's already approved to treat one autoimmune disease, and bring in about $650 million a year. The company is now pursuing an indication for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare neurological disorder in which patients suffer from weakness and impaired sensory function in the legs and arms. Gamunex previously received fast track and orphan drug status.

- here's the Talecris release
- read this report for more

Related Article:
Talecris backers design a $1 billion IPO

Accentia shares plunge on Phase III failure

Tue, 25 Mar 2008 07:59:58 -0400

Accentia Biopharmaceuticals disappointed its investors with a surprise announcement late Monday that a Phase III trial of SinuNase for chronic sinusitis had failed to hit its primary endpoint. The company's stock plunged 73 percent on the news, dropping to 81 cents a share. Officials for the company had expressed a significant amount of confidence in the therapy. The late-stage trial tested SinuNase in treating fluid buildup in sinuses.

But Accentia isn't abandoning the drug. "The company continues to believe that SinuNase is a viable product candidate for the treatment of chronic sinusitis, and a full data analysis of both the primary and secondary endpoints will be conducted in order to determine the next steps necessary in order to advance the product," Accentia said in a statement.

- see this release
- check out the AP report

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Basilea shares plunge on antibiotic delay

Tue, 18 Mar 2008 07:59:58 -0400

Switzerland's Basilea took its turn on the public markets' whipping post, shedding 27 percent of share value after announcing that its antibiotic ceftobiprole had failed to quickly win over FDA regulators. The agency said that it would need more information on the antibiotic--which is partnered with Johnson & Johnson. In an approvable letter, the FDA outlined its requirements: more information on the drug's impact on diabetic foot infections, more time to assess the data submitted, and a review of the study sites used to test the therapy. Ceftobiprole is intended to treat complicated skin infections, including MRSA.

In a phone call with analysts, Basilea CEO Anthony Man declined to offer a timeline for an approval, but noted that the agency isn't asking for more studies. Researchers are also testing the drug as a possible therapy for pneumonia.

While analysts suggested that a 9 to 12-month delay was likely, at least one was pleased to see that the FDA was willing to go with Basilea's non-inferiority trial, which could have proved to be a sticking point.

- here's the release
- read the article from MarketWatch

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Report: CellCyte stock up after promoter touts shares

Mon, 10 Dec 2007 06:59:56 -0500

After struggling for years to survive on angel investments, the Seattle Times reports that CellCyte Genetics has ridden a wave of hype this fall to push its market value to $440 million. And the biotech's share price rose following a flood of glossy brochures and spam faxes from an outside investor who had been barred from the securities business in British Columbia.

The spike occurred after CellCyte bought an inactive shell company and went public while a Canadian promoter acquired millions of shares. That attracted the attention of regulators, who say they've been guarding against "pump-and-dump" schemes. CellCyte CEO Gary Reys says that the spike in the company's share price simply shows investor confidence in the company's ability to manipulate stem cells.

- check out the article from the Seattle Times

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