The FDA has approved Polaris Group's special protocol assessment (SPA) for a Phase III trial of the company's lead candidate, pegylated arginine deiminase (ADI-PEG 20), in patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer.
Repeating earlier claims that Cephalon Inc.'s board of directors had not engaged in timely discussions about his company's $5.7 billion, $73-a-share bid for Cephalon, Valeant Pharmaceuticals International Inc. Chairman and CEO J. Michael Pearson said that Valeant would appeal directly to Cephalon shareholders by commencing a consent solicitation process next week to replace Cephalon's board with Valeant's nominees.
Not bad, but not Quad. That appeared to be the general reaction of analysts to news from Gilead Sciences Inc. that elvitegravir, its oral integrase inhibitor for HIV-1 infection in treatment-experienced patients, met its primary objective in a Phase III trial.
Auxilium Pharmaceuticals Inc. has added another piece to the expanding global market for Xiaflex (collagenase Clostridium histolyticum) with an agreement that gives Asahi Kasei Pharma Corp., of Tokyo, exclusive rights to commercialize Xiaflex for the treatment of Dupuytren's contracture and Peyronie's disease in Japan.
Privately held Synageva BioPharma Corp. closed a $25 million private equity financing that it said would support an early stage clinical program for lead candidate SBC-102, an enzyme replacement therapy for lysosomal acid lipase (LAL) deficiency, and four preclinical compounds for rare disorders. The Lexington, Mass.-based biotech has raised a total of $70 million since early 2009.
Affymax Inc. is reviving efforts to get FDA approval of peginesatide – previously known as Hematide – for treatment of anemia in chronic renal failure patients.
Maxygen, Inc.'s shares and bank balance both grew rapidly on news that Tokyo-based partner Astellas Pharma Inc. exercised its option to buy out Maxygen's 83.3 percent equity interest in the companies' joint venture, Perseid Therapeutics LLC, for $76 million.
A year after agreeing to a $10 million up-front, $15 million milestones deal with Biovail SRL to develop Ampakine compounds for respiratory depression treatments, Cortex Pharmaceuticals Inc. is getting back all of the Ampakine assets and intellectual property it sold. (See BioWorld Today, March 29, 2010.)
