If Genentech exercises its worldwide option, Altus could receive up to an additional $110 million. Altus used its protein crystallization technology to develop ALTU-238, which is a once-weekly injection. The compound has completed its Phase II trial, but has not yet begun a Phase III test. Altus made its IPO in early 2006 (see story) at $15. Today, Altus closed with a 7% gain, rising $1.34 to $20.32. Genentech slipped 28 cents lower to $80.50.
VaxGen (OTC:VXGN) has officially forfeited its $887 million contract to provide 75 million doses of anthrax vaccine to the BioDefense Stockpile. The company could not provide a stabilized formulation of its vaccine in time to meet agency deadlines. Earlier, the contract was the centerpiece of the country’s biodefense initiative. Now, the agency will have to rely on its older vaccine while it develops a new strategy. Investors were expecting the news, so VaxGen actually rose on the report. It was up 2 cents at $1.47.
Artes Medical (ARTE) priced its delayed IPO at $6, a significant cut from its projected range of $12-$14. The company, which has some legal problems with the FDA (see story), has a product that provides a longer-lasting treatment against wrinkles than its competition. Even though the father-son team that began the company was forced to resign, they received generous compensation packages as recompense. IPO investors did well at the reduced price, because Artes climbed 28% in open-market trading. It moved up $1.67 to $7.67.
Kosan Biosciences (KOSN) licensed its motilin agonist program to Pfizer (PFE) for $12.5 million upfront and another $250 million in milestones. The deal includes a pre-clinical drug candidate, KOS-2187, and related compounds that aid gastric emptying. Pfizer will be responsible for all development of the drugs. Kosan soared 10%, moving up 52 cents to $5.40.
Orexigen (OREX) filed its initial submission for an IPO. The company is focused on central nervous system disorders with two drug candidates in clinical trials for obesity. Contrave, expected to begin a Phase III trial next year, is a combination of low-dose opioid-blocker naltrexone sustained release and anti-depressive drug bupropion sustained release. Excalia is in Phase I trials. It combines zonisamide and sustained release bupropion. The 11-person company raised $30 million in a C round last month.
Northfield Labs (NFLD) took a major hit when its blood substitute candidate, PolyHeme, failed to meet its Phase III trial endpoints. Data from the trial was marred by discrepancies, which must be corrected before the final results are known, as well as numerous violations of protocol. In the end, PolyHeme failed to meet the confidence level of 7% in proving non-inferiority. PolyHeme is a human hemoglobin based blood substitute, aimed at use in bleeding patients for whom normal blood is not available. Northfield says it will talk to the FDA about the results before deciding on its next step. The news was devastating to Northfield, which fell 58%, dropping $6.57 to end at $4.85.
Panacos Pharma (OTC:PANC) said its HIV antiviral drug bevirimat did not produce the expected plasma concentrations in a Phase IIb trial. Panacos opined that the oral formulation may be at fault. Panacos slid 31% lower. It was off by $1.75, ending at $3.94.
Janssen, a unit of Johnson & Johnson (JNJ), received FDA approval of Invega as a once-daily treatment for schizophrenia. The drug uses an extended-release technology to deliver paliperidone, the active ingredient in risperidone, a Janssen drug that was first approved in 1993.
Gilead (GILD) said aztreonam lysine, its cystic fibrosis treatment, met its Phase III endpoint. The antibiotic drug, which is administered through a nebulizer, treats Pseudomonas aeruginosa with a 28-day treatment regimen. The trial, AIR-CF2, is one of three Phase III studies of the drug. Gilead gained 12 cents to end at $64.76.
Repros Therapeutics (RPRX) reported that Androxal demonstrated noninferiority in an interim analysis of Phase III data from a trial against secondary hypogonadism. The goal was to correct testosterone deficiency, and the effects of Androxal were compared to Androgel, the testosterone creme. Repros moved up 15 cents to $6.96.
CollaGenex Pharma (OTCPK:CGPI) out-licensed European rights for Oracea to MediGene AG of Germany. CollaGenex will take in $5 million upfront and stands to receive up to $7.5 million in milestones. Oracea is a dermatological drug approved by the FDA in 2006 to treat rosacea. CollaGenex was a 56 cent winner, closing at $13.06.
Seattle Genetics (SGEN) began a Phase II trial of SGN-40, a prospective treatment for large B-cell lymphoma, which is the most common form of non-Hodgkin’s lymphoma. The company reported positive Phase I data for SGN-40 at the ASH conference last week. Seattle Genetics slipped 8 cents to $5.51.
Cytokinetics (CYTK) started a Phase II trial of its kinesin spindle protein (KSP) inhibitor, ispinesib, as a second-line treatment for patients with renal cell cancer and a Phase I trial as a monotherapy in pediatric patients with relapsed or refractory solid tumors. The National Cancer Institutes is sponsoring these trials, and GlaxoSmithKline (GSK), a partner on the drug, has ispinesib in numerous clinical trials against various forms of cancer. Cytokinetics inched 10 cents lower to $6.62.
Hana Biosciences (HNAB) requested a Special Protocol Assessment for a trial of Marqibo in patients with acute lymphoblastic leukemia in second relapse and beyond. Hana ended at $6.70, a loss of 12 cents.
Dynavax (DVAX) began a Phase III trial of Heplisav, its hepatitis B virus vaccine. The trial will compare a two-dose regimen of the drug to a three-dose regimen of Engerix-B. Dynavax closed unchanged at $9.05.
Biotech ended the mid-week session with a small loss. The Centient Biotech 200™ fell 6 points to 3946, a loss of .15%. The broad market indexes were also slightly lower.