lymphoma

Following trial failure, Favrille cuts staff

Thu, 29 May 2008 06:59:54 -0400

San Diego's Favrille is making massive cuts following the trial failure of Specifid announced earlier this week. The company is axing 132 of its 144 employees, including six of its eight executive officers. There was no word on which of the 12 remaining employees would be managing the company. Specifid was treatment for follicular B-cell non-Hodgkin's lymphoma. The drug failed both primary and secondary endpoints in a Phase III trial. The company's stock plunged 90 percent after the announcement on Tuesday and another 30 percent yesterday.

- see the layoff announcement
- read this report for more

Favrille dumps Specifid after trial failure

Tue, 27 May 2008 06:59:57 -0400

San Diego-based Favrille has halted development of Specifid, a treatment for follicular B-cell non-Hodgkin's lymphoma. In a Phase III trial the drug failed to show a statistically significant improvement in the treatment arm, failing both primary and secondary endpoints.

"We are clearly very disappointed with the data from this trial, particularly on behalf of the patients and their families," said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. "Based on these results, we are discontinuing development of Specifid and are currently evaluating steps to conserve cash and recognize value on our assets.

- here's Favrille's release for more

Related Article:
Favrille raises $45M for Phase III work

Rituxan fails (again) in late-stage lupus trial

Tue, 29 Apr 2008 06:59:55 -0400

Genentech and Biogen Idec were taking it on the chin this morning after researchers announced that Rituxan had failed in a later-stage trial as a therapy for lupus. The failure won't harm the blockbuster's penetration of the markets for non-Hodgkin's lymphoma and rheumatoid arthritis. But the companies had high hopes for the drug's ability to treat a condition with few therapeutic options to pick from. Analyst estimated potential sales in that one category at more than a billion dollars.

Rituxan block B cells, which play a role in inflammation, and has already been put into use for lupus on an off-label basis. Rituxan also recently failed a late-stage trial for MS.

- here's the Rituxan release
- read the story in the Wall Street Journal

Genitope suspends cancer work, looks to alternatives

Tue, 11 Mar 2008 07:59:54 -0400

After reviewing a failed late-stage trial of MyVax for Hodgkins lymphoma, Genitope has decided to suspend development work and focus on alternatives like its antibody program. MyVax had already failed to hit a primary endpoint with no significant difference in progression-free survival of patients. But researchers had been enthusiastic about finding a positive response among patients who mounted a positive immune response to the tumor-specific target and those who did not.

"We are disappointed that we will not be able to make MyVax personalized immunotherapy available to patients with follicular non-Hodgkin's lymphoma," said CEO Dan Denney. "We firmly believe that MyVax personalized immunotherapy has the potential to safely induce long-term remissions, possibly including life-long remissions... However, we recognize that the costs and time required for further clinical development of MyVax personalized immunotherapy are prohibitive at this time, and we thus intend to focus our efforts on the development of our monoclonal antibody program."

- check out Genitope's release
- read the report from the East Bay Business Journal

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Amgen inks $520M deal with Kyowa Hakko

Thu, 06 Mar 2008 06:59:58 -0500

Amgen has inked a $520 million deal to acquire Kyowa Hakko's humanized monoclonal antibody (MAb) KW-0761, a treatment for inflammation and oncology settings. Tokyo-based Kyowa Hakko gains $100 billion up front and up to $420 million in development, approval and sales milestones. Amgen has worldwide rights to the drug outside of Japan, Korea, China and Taiwan. KW-0761 is currently undergoing Phase I studies for lymphoma patients; a trial in allergic rhinitis patients has already been completed.

MAbs are currently one of the most attractive segments of the biotech industry. A recent Datamonitor report projected 14 percent annual growth in the market for the antibody drugs, by far the fastest-growing segment of the industry.

- here's Amgen's release

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EUSA, GSK ink $44M pre-clinical antibody deal

Tue, 19 Feb 2008 06:59:54 -0500

EUSA Pharma will keep about half of the $44 million in up front fees and milestones it is scheduled to receive from GlaxoSmithKline for a license covering a pre-clinical antibody targeted at lymphoma and rheumatoid arthritis. The other half goes to its development partner, Vaccines Inc. The antibody--OP-R003--is a protein that targets interleukin-6, a common target for a number of drug developers.

"The out-licensing of this early-stage antibody is another strategic milestone for EUSA, as we continue to focus our business on marketed and late-stage products in the oncology, pain control and critical care areas," said Bryan Morton, CEO of EUSA, a developer based in the U.S. and the U.K.

- read the release for more info

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Novacea slows down development program for AQ4N

Thu, 03 Jan 2008 06:59:55 -0500

Novacea, which is burning through $17 million to $19 million this year, says it will scale back on the development of AQ4N, shelving a clinical trial in acute lymphoblastic leukemia and delaying a clinical trial in B-cell lymphoma. The news was included in a strategic review of its plans for 2008. An ongoing Phase Ib/IIa clinical trial of AQ4N in patients with glioblastoma multiforme will continue.

"Since we terminated the ASCENT-2 trial in advanced prostate cancer, managing our capital resources, which totaled approximately $110 million in cash and receivables at the end of the third quarter of 2007, is a top priority as we seek to maximize the strategic options available to the company," says Novacea CEO John Walker.

- see Novacea's release
- read the report from Trading Markets

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Santaris grabs $30M in third round venture cash

Tue, 18 Dec 2007 06:59:54 -0500

Denmark's Santaris Pharma has banked $30 million from its latest venture round. Gilde Healthcare Partners put up much of that money with BankInvest, Novo, LD, Forbion Capital Partners, Global Life Science Venture, Sunstone Capital, Seventure, Omega, Innovation Capital and members of the company's board and management joining in.

Santaris has been studying RNA antagonist drug candidates based on its LNA chemistry. In 2008 the company said it expects to advance its SPC2996 compound, an RNA antagonist of Bcl-2, into Phase II clinical trials in chronic lymphocytic leukemia and B-cell lymphoma and initiate phase I volunteer studies of two new RNA antagonists for metabolic disorders.

- check out the release for more info

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BioCryst halts leukemia trial

Fri, 07 Dec 2007 06:59:56 -0500

BioCryst has discontinued a Phase IIb trial of intravenous Forodesine HCl in patients with T-cell acute lymphoblastic leukemia/lymphoma. The decision to discontinue the trial was based on a number of issues. There were delays associated with addressing a previously announced stability problem, a limited number of patients were eligible to be enrolled in the trial and, to cap it all off, there was a lower-than-expected response rate observed in an earlier trial. BioCryst made sure to point out that other clinical trials, which are using the oral capsule formulation of forodesine HCl, are still ongoing.

- see BioCryst's release for more

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Sources: Biogen gets bidders, with Pfizer in lead

Thu, 08 Nov 2007 06:59:56 -0500

The Financial Times is reporting some tantalizing details about the bidding for Biogen Idec, the biotech based in Cambridge, MA, that sent stock analysts into an uproar when it put itself up for sale a few weeks ago. Unnamed sources told the London newspaper that the sequence of events leading to that surprise announcement actually began with Pfizer offering $80 per share for the company. Investor Carl Icahn (photo) then made a counter-offer, and the company retained financial advisors to conduct an orderly sale. Even now, Pfizer remains one of the front-runners for Biogen, the sources said, along with Merck and Johnson & Johnson.

Some other buyers have already dropped out of the race, spooked by the "nosebleed prices" expected. Icahn offered $23 billion, so the winning bid is likely to be higher. Are Biogen's assets worth that much? They include the multiple sclerosis drug Tysabri, in partnership with Elan; the lymphoma and arthritis remedy Rituxan, in collaboration with Genentech; and the MS drug Avonex, which is wholly owns. It also has a pipeline of drugs in development, including two promising MS products.

Meanwhile, headhunters are getting calls from Biogen types expecting a sale to lead to the layoff ax. The non-executive staff is anxious, recruiters said, even though the company continues to hire new workers.

- check out the buyout report from the Financial Times
- read about Biogen staff seeking shelter at Inside Recruiting

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