The companies, which are both involved with respiratory care, will jointly promote asthma-drug Zyflo, in its regular and extended-release versions. The extended-release formulation remains under FDA review. They will also co-promote DEY's candidate for Chronic Obstructive Pulmonary Disease [COPD], which is also under review at the FDA. Critical Therapeutics rose 22%, gaining 39 cents to end at $2.19.
Curis (CRIS) has selected its first anti-cancer compound to develop. The company’s development program covalently links two active drug components, called pharmacophores, that target at least one clinically validated target. CUDC-101 inhibits EGFR and another, undisclosed target. In vitro tests showed that CUDG-101 was 20 times more potent in inhibiting EGFR and 10 times as strong against the second target.
Avigen (AVGN) was given a green light by the FDA to begin a Phase II test of AV650 (Tolperisone) for spasticity and muscle spasms. In addition to looking at safety and efficacy, the trial will assess the lack of sedation in spinal cord injury patients who suffer from spasticity. The drug is already on the market in Europe and Japan by Sanochemia Pharmazeutika AG.
The FDA accepted the filing by Adams Respiratory (ARXT) for approval of new combination doses of extended-release guaifenesin, a cough surpressant. The agency gave an action date of October 27, 2007 for the drug.
Advanced Life Sciences Holdings (OTCPK:ADLS) received Orphan Drug Designation for cethromycin as a prophylactic treatment for exposure to anthrax. The drug is currently in a pivotal Phase III trial for community acquired pneumonia. Using in vitro methodology, it has shown activity against 30 anthrax strains.
Memory Pharma (MEMY) began dosing patients in a Phase IIa trial of MEM 3454, its lead nicotinic alpha-7 receptor partial agonist as a therapy for Alzheimer’s disease. The trial will assess the safety, tolerability and cognitive effects of three doses of the drug. Results are expected in the fourth quarter.
Roche (OTCQX:RHHBY) ended a development collaboration with Maxygen (MAXY). The two companies intended to develop MAXY-VII, a second generation Factor VII for acute bleeding. But no animal model could be found that would allow the companies to test the drug before administering it to humans.
Biotech closed with a gain. The Centient Biotech 200™ rose 22 points to end at 3805, an increase of .58%. The S&P 500 traded higher by .67% and Nasdaq was up .90%.