Seeking Alpha
Profile| Send Message|
( followers)  
GPC Biotech (GPCB) has completed its filing for approval of satraplatin, a drug intended to treat androgen independent (hormone refractory) prostate cancer.

It is seeking to be indicated for patients who have failed a previous therapy. In the Phase III trial, it produced a statistically significant improvement in survival. GPC rose $1.86 to $32.81, a gain of 6%.

Gilead (GILD) received Priority Review for ambrisentan, a once-daily treatment for pulmonary arterial hypertension [PAH]. Priority Reviews mandates a maximum six-month review by the FDA, so the action date for ambrisentan is now June 18, 2007. Gilead was off 13 cents at $72.06.

Onyx
(ONXX) continued its week-long march upward, this time propelled by better than expected revenues for its lead drug, the cancer treatment Nexavar (see story). The drug produced Q4 revenues of $64 million, while analysts expected only $49 million. For the week, Onyx has gained 126%. Friday, the company moved up $3.05 to $27.75, a 12% jump.

The FDA accepted a filing from ZymoGenetics (ZGEN) for approval of recombinant human thrombin [rhThrombin] as a means to stop bleeding during surgery. The FDA must make a decision on the drug by October 18, 2007. To be approved, the FDA must be convinced that the drug is just as effective as the current treatment, a bovine product, but with fewer side effects. ZymoGenetics slipped 3 cents lower to $16.29.

Inspire Pharma (ISPH) in-licensed the U.S. and Canadian rights to AsaSite, a topical anti-infective for the eye that treats conjunctivitis. Inspire paid $13 million to InSite Vision (ISV) for the rights, and it may pay another $19 million in milestones. The royalty will be 20% in the first two years and 25% thereafter. AsaSite has not yet been approved. Inspire climbed 46 cents to $7.83.

Valeant (VRX) acquired the rights to anti-nausea drug nabilone for the UK and Europe. Valeant already owns rights to the drug for Canada and the U.S., where it markets the drug under the name Cesamet. It is a synthetic cannabinoid, and therefore it is indicated only when other, more traditional drugs are not working. Valeant was up 5 cents at $17.75.

OrthoLogic (OLGC) found that its synthetic peptide Chrysalin was effective in osteopenic women who suffered displaced distal radius (wrist) fractures. The subgroup was defined on a post hoc basis. OrthoLogic stopped a Phase III trial in 2006 of Chrysalin when the drug did not provide a benefit for a more general population. OrthoLogic gained 13 cents to end at $1.66.

Biotech closed lower in Friday’s session. The Centient Biotech 200™ fell 22 points to 4054, a loss of .55%. That left the index with a small gain of 4 points for the week. The S&P 500 was down .09% and Nasdaq was off by .03%.


Disclosure: none.

Source: Biotech Stock Review: GPC Biotech Completes New Drug Approval