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Wednesday's Health Winners & Losers

Elizabeth Trotta

Then GPC Biotech(GPCB) fell $6.58, or 57.5%, to $4.86, and Spectrum Pharmaceuticals(SPPI) fell 37 cents, or 8.9%, to $3.77 after the companies announced that the SPARC trial on prostate cancer drug Orplanta didn't show a survival benefit. GPC, which licenses the drug from Spectrum, withdrew its new drug application for the drug earlier this year after a panel suggested the FDA wait for the survival data to approve it.

Amylin(AMLN) and Eli Lilly (LLY) said in a phase III study Byetta LAR, a once-weekly injection for diabetes patients, improved blood sugar control more than regular the regular twice-a-day Byetta injection. Byetta LAR uses Alkermes(ALKS) technology.

LAR will be filed for approval by the end of the first half of 2009 -- a long wait, because Amylin is still constructing an LAR manufacturing facility, which needs to be complete before a filing.

Amylin shares fell $1.78, or 3.8%, to $45.02, Alkermes gave up 46 cents, or 2.8%, to $16.20 and Eli Lilly was up 55 cents or 1%, to $54.24. Alkermes and Amylin are both components of the Nasdaq Biotechnology Index, which was up 8.67 points, or 0.98%, to 891.86.

On the regulatory side, BioDelivery Sciences (BDSI) submitted an new drug application for BEMA Fentanyl for patients with breakthrough cancer pain. The company expects a final decision from the FDA by August 2008. Shares rose 15 cents, or 4.7%, to $3.35 on Wednesday.

Also, Allergan(AGN) said Wednesday that the Food and Drug Administration approved Combigan, an eyedrop that reduces intraocular pressure (IOP). The company said Combigan, which reduces elevated IOP in patients with glaucoma or ocular hypertension, will be available in the fourth quarter. Allergan also makes Lumigan and Alphagan for glaucoma.

Shares were gaining $1.87, or 2.9%, to $67.52.

Novavax(NVAX) tacked on 68 cents, or 19.3%, to $4.20, after Oppenheimer & Co. analyst Kevin DeGeeter upgraded the stock to buy from neutral. He cited the likelihood that Novavax will report positive data from an early-stage clinical trial for a bird flu vaccine before the end of the year and may announce a new vaccine program in the fourth quarter.

NPS Pharmaceuticals(NPSP) said that Nycomed will proceed with the development of Gattex, for gastrointestinal disorders, outside of the U.S. According to an agreement signed in September, Nycomed will make a $25 million up-front to NPS. Nycomed has the rights to develop and commercialize Gattex outside the U.S., Canada and Mexico for gastrointestinal disorders. NPS shares gained 71 cents, or 18.4%, to $4.56.

Elsewhere in earnings, Barrier Therapuetics(BTRX) reported a loss of $12.5 million, or 41 cents a share, vs. a loss of $12.7 million, or 50 cents a share in the comparable 2006 quarter. Revenue came in at $7.5 million. That beat the expectations of analysts surveyed by Thomson Financial, who were looking for a loss of 42 cents a share on revenue of $7 million. Barrier shares were losing 11 cents, or 2.3%, to $4.73.

Meanwhile, Flamel Technologies(FLML) reported a net loss of $9.1 million, or 38 cents a share, compared to a loss of $10.2 million, or 43 cents a share, in the year-ago quarter. Shares fell $1.93, or 16.9%, to $9.46 on Wednesday.