GVAX questions depress Dendreon shares

John Carroll — Thu, 28 Aug 2008 11:43:55 -0400

After halting one GVAX study so it could further investigate a disturbing number of deaths, Cell Genesys' hopes for the vaccine are now focused on a separate Phase III trial that has not raised the same safety concerns. And analysts note that a success in that trial--which provides GVAX alone--could still warrant an approval. In the meantime, shares of Dendreon also traded lower as investors considered the possible implications for all the developers advancing cancer vaccines. Report

Reversal of Fragile X symptoms a possibility

John Carroll — Thu, 28 Aug 2008 11:43:23 -0400

Canadian researchers say that it may be possible to compensate for the key brain protein missing in Fragile X patients, opening the way to a possible therapy that can reverse symptoms of the disease. And that insight into the neurotransmitter dopamine is expected to inspire new clinical trials.

"Something that you thought was not curable, and not treatable, you (may be able to) actually change," said Dr. Carlo Paribello, founder of the Fragile X Research Foundation of Canada.

- check out the story from Toronto Star

Cells coaxed to produce insulin in diabetes breakthrough

John Carroll — Thu, 28 Aug 2008 11:41:45 -0400

A team of scientists at the Harvard Stem Cell Institute have reprogrammed normal pancreas cells into insulin-producing cells in mice. The team injected proteins into the cells to activate genes, flipping a switch on their genetic transformation. After 10 days the cells were able to help regulate blood sugar. And the scientists say the same approach could work across a range of diseases.

"We were able to flip the cell from one state into another," Doug Melton said, adding that the approach should be useful in treating disorders in "any case where there's a cell type missing and there are neighboring cells that are still healthy."

- read the report from the Los Angeles Times

ImClone builds case for higher takeover bid

John Carroll — Thu, 28 Aug 2008 11:40:44 -0400

The executives at ImClone have been carefully crunching the numbers for both its pipeline drugs as well as Erbitux as it builds a case that Bristol-Myers Squibb's current offer is far too low to accept. Sources tell the Financial Times that the company could fetch $70 a share and that Erbitux alone may well be worth about $60 a share.

Much of the analysis is centered on ImClone's pipeline: five main cancer therapies in Phase I and II. The company has been particularly bullish about the prospects of IMC-A12 for prostate cancer. ImClone has been considering splitting up its R&D programs from Erbitux as a possible alternative to a takeover.

"I would say we thought [the company] was worth $70 plus or minus," an industry source familiar with ImClone told the Financial Times, adding that he still felt the pipeline and infrastructure was "pretty interesting."

- read the article from the Financial Times

Replidyne looking for buyer after latest job cuts

John Carroll — Thu, 28 Aug 2008 11:39:44 -0400

Another round of job cuts at the struggling Replidyne will leave only a skeleton staff of five on the payroll of a biotech company that once employed 85. Replidyne was dealt a crushing blow last year by the FDA, which refused to approve its experimental antibiotic without further trials. That decision caused Forest Laboratories to bow out of a $190 million collaboration.

In this latest move, the Louisville, CO-based biotech says it is suspending its two remaining programs and CEO Kenneth Collins says he's looking to sell or merge the company or possibly just sell its drug development programs. Replidyne says it will spend slightly more than $3 million in axing the next 19 jobs.

"The process we are conducting involves a number of alternatives including merger or acquisition of the company together with the possible sale of our C. difficile and DNA replication inhibition programs," said Collins. "While the process is ongoing, we are encouraged by our progress to date."

- check out the Replidyne release
- read the report from the Denver Business Journal

Pfizer fails again in late-stage anti-clotting trial

John Carroll — Wed, 27 Aug 2008 12:26:16 -0400

There's more bad news for Pfizer's pipeline. An anti-clotting drug it is developing with Bristol-Myers Squibb--apixaban--failed to perform better than Lovenox in a late-stage trial. And the disappointing results persuaded the developers to postpone any new drug application for approval, which had been expected in the second half of '09. Researchers for the company say they are considering other studies of the drug to prevent VTE, ailments that include deep vein thrombosis.

In the comparative trial, bleeding rates were comparable between the two therapies and researchers noted that Lovenox performed much better than it had in previous studies. That leaves Pfizer with yet another in a string of late-stage trials that failed to measure up to expectations. The Wall Street Journal notes that in the past two years the pharma giant has had five late-stage programs that either missed critical endpoints or were dropped from its pipeline.

- check out the release
- read the report from the Wall Street Journal

C&L: RHEI names new CEO

John Carroll — Wed, 27 Aug 2008 10:36:07 -0400

RHEI Pharmaceuticals has named Dr. Geert Cauwenbergh as CEO.

Helicos BioSciences announced that Bill Efcavitch, Ph.D., has been named Helicos chief technology officer, Marc Levine has joined Helicos as senior vice president of product development and Stan Letovsky, Ph.D. has joined as vice president for scientific informatics.

Prometheus Laboratories has appointed Mark Spring as senior vice president and CFO.

Biovail named Peggy Mulligan its new CFO.

David Price has been named as the new CFO at Cornerstone BioPharma.

Ikaria Holdings named Stephen Ross senior vice president of commercial operations and James Briggs as senior vice president for human relations.

Intrexon has named Sunil Chada, Ph.D as the senior vice president of clinical research and development.

Sucampo Pharmaceuticals has appointed Kathryn Santis as its new vice president of investor relations and corporate communications.

Znomics has appointed Ofir Moreno as its new senior director of chemistry.

WuXi PharmaTech has promoted Rujian Ma to vice president of synthetic chemistry.

Joe Ciaffoni has accepted the position of chief communications officer for Atlanta-based Sciele Pharma.

Targanta Therapeutics has named StA(C)phane Bancel and Rosemary A. Crane to its board of directors.

Monogram Biosciences has named Christine A. White, M.D. to the company's board of directors.

GeoVax Labs has named Peter M. Tsolinas as a member of its board of directors.

Achillion Pharmaceuticals named Nicholas Simon to its board of directors.

PsychoGenics has named John McCall, Ph.D., as a member of its Scientific Advisory Board.

Partners in pain target new drug

John Carroll — Wed, 27 Aug 2008 10:28:35 -0400

Pain Therapeutics and King Pharmaceuticals, which are already partnered in a major pain drug program, say they are developing a new abuse-resistant prescription pain medication called PTI-721. Like REMOXY, PTI-721's formulation is designed to resist common methods of prescription drug abuse or misuse. The active pharmaceutical ingredient in PTI-721 remains undisclosed. Release

FDA holds back approval for J&J schizophrenia med

John Carroll — Wed, 27 Aug 2008 10:11:34 -0400

The FDA has put up at least a temporary roadblock to J&J's schizophrenia drug paliperidone palmitate. A once-monthly injectable with the same active ingredient as Invega, a newly approved antipsychotic, the agency says it will need more information on the therapy before they can give it the stamp of approval. But it might not present a lengthy delay. J&J noted that the FDA is not asking for a new trial and says it will work with the FDA in answering all of its questions. The therapy uses technology from Elan, which stands to gain from an approval.

- check out the Johnson & Johnson release
- read the report from the Wall Street Journal

Sangamo buoyed by positive mid-stage data

John Carroll — Wed, 27 Aug 2008 10:10:30 -0400

Shares of Sangamo BioSciences were buoyed by positive preliminary data from a small mid-stage study of SB-509. The drug is being tested as a therapy for severe diabetic neuropathy. In the study, five of the eight patients being treated with the experimental therapy reported better nerve potential after about six months of treatment. One of four patients in a control arm reported the same improvement. Analysts saw it as a positive indication of what they may see in the fourth quarter, when Sangamo will deliver results for a study of SB-509 involving 110 patients.

"Such early improvement in severely affected population has never been reported and suggests that SB-509 has novel regenerative potential for the reversal of nerve damage in severe (diabetic peripheral neuropathy)," the company said.

- read the AP report

NexMed tanks after Novartis stalls on fungus drug

John Carroll — Wed, 27 Aug 2008 10:09:25 -0400

Shares of NexMed tanked after the company announced late Tuesday that Novartis would not be submitting an NDA for their partnered nail fungus therapy "at this time." According to NexMed, Novartis was persuaded to pull back after considering the results of late-stage studies. NexMed's stock quickly nosedived, losing 96 cents--or a little more than 70 percent of its value.

Novartis took control of the development program for NM100060 back in 2005 after paying $4 million as an upfront fee and agreeing to up to $47 million in milestone payments. But NexMed hasn't given up on the program.

"While this is disappointing," said Vivian Liu, NexMed's president and CEO, "a European comparator study is still ongoing, and those results are expected mid-2009."

- see NexMed's release
- check out the AP story

Point BioMedical folds after investor pulls out

John Carroll — Tue, 26 Aug 2008 11:30:46 -0400

BioSpace takes a look today at the case of Point BioMedical, which is folding its tent after losing the backing of its lead investor. The biotech pulled its NDA for a molecular imaging product as is liquidating its assets. Ex-CEO Tom Feldman says that Vendanta Capital decided not to go ahead with the second tranche of a $50 million financing. The first tranche of $25 million came through in February.

"I can't tell you why they chose not to invest," Feldman told the site.

- read the report from BioSpace