For the third time, the FDA has put back the action date on the drug, this time until July 27. Originally, Sanofi-Aventis expected to begin marketing the drug in Q2 of 2006. The FDA issued an approvable letter for Acomplia on February 17, 2006, though the agency decided at the same time the drug was not approvable as an aid to quit smoking. Acomplia is the “anti-marijuana” drug, so named because it blocks the central cannabinoid receptors (CB1), which cause the munchies in marijuana smokers (see Acomplia from Sanofi-Aventis Puts Cannabis to Work).
Throughout its year-long negotiations with the FDA, Sanofi-Aventis officials have never shed any light on the issues that cause the FDA to continue investigating Acomplia without granting final approval. It is rumored, however, that the FDA is concerned about the side effect of depression. Acomplia has been on sale in Europe since last summer. Sanofi-Aventis fell 2%, dropping 89 cents to $43.40.
Seattle Genetics (SGEN) won orphan drug designation for two drug candidates: SGN-33 is aimed at acute myeloid leukemia, and SGN-35 is a prospective treatment for Hodgkin’s disease. Seattle Genetics expects to advance SGN-33 into Phase II trials this year, and it also plans to report on a dose escalation Phase I trial of SGN-35 at ASCO in June. Seattle Genetics rose 39 cents (4.5%) to $9.16.
Somaxon Pharma (SOMX) will file for approval of its sedative Silenor in Q3 of 2007. The company has completed four Phase III trials on the drug, and the FDA has agreed that Silenor does not require a complete carcinogenic assessment for approval. Somaxon said the FDA may accept a shorter-term carcinogenicity study for the NDA, with the provision of a two-year study as a Phase IV test. Unlike most sedatives, Silenor does not have a benzodiazepine mechanism. The compound is a low-dose version of a 35-year-old depressions/anxiety drug, doxepin HCl, that is patented for insomnia. Somaxon was up 35 cents at $13.40.
Beckman Coulter (BEC) will exercise an option to continue using the High Mobility Group Box 1 (HMGB1) technology belonging to Critical Therapeutics (CRTX). Beckman Coulter is employing the technology to develop an immunoassay for detection/diagnosis of inflammatory diseases. As a result of the option exercise, Critical Therapeutics will receive a product development fee, whose size was not disclosed. It also stands to receive a milestone payment upon the first sale and royalties. Critical Therapeutics slipped 9 cents lower to $1.54.
Monogram Biosciences (MGRM) and Pfizer (PFE) announced that maraviroc, a first-in-class innovative HIV treatment, won priority review from the FDA and accelerated review in Europe. Pfizer filed for approval of the drug in both locations in December 2006 for use in antiretroviral-experienced patients with a specific strain of HIV (CCR5-tropic HIV-1). Monogram contributes an assay, Trofile, that determines whether a patient is likely to be helped by maraviroc. Monogram moved up 6 cents to $1.89.
Human Genome Sciences (HGSI) and GlaxoSmithKline (GSK) began dosing patients in the first of two pivotal Phase 3 clinical trials of LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus [SLE]. In the Phase II test, LymphoStat-B produced statistically significant reductions in disease activity. Human Genome Sciences added on 4 cents to end at $11.58.
MGI Pharma (MOGN) and Helsinn Healthcare SA of Switzerland received a five-year extension of their patent for Aloxi, a treatment for nausea and vomiting caused by chemotherapy. MGI climbed 28 cents to $21.66.
Biotech ended the day with a small gain. The Centient Biotech 200™ rose 8 points to 4039, an increase of .21%. The S&P 500 was higher by .76% and Nasdaq traded up .39%.