Updated from 2:42 p.m. EDTClinical updates peppered biotech news Monday, proving positive and negative for some individual stocks but inflicting little consequence on health indices. Accentia Biopharmaceuticals ( ABPI) said that according to data from an ongoing phase III trial for SinuNase, most if not all cases of chronic sinusitis, or CS, are due to fungal-induced inflammation. SinuNase, Accentia's lead pharmaceutical product, is an intranasal formulation of the antifungal amphotericin B 0.01% suspension. If approved, SinuNase, which has fast-track status from the Food and Drug Administration and is licensed to IMMCO Diagnostics, will be the first therapy available to treat sufferers of CS. Accentia shares gained 27 cents, or 10.8%, to close at $2.76. Pharmasset ( VRUS) said that according to results from a phase I study, its R7128, a candidate for treating chronic hepatitis C, demonstrated potent, dose-dependent antiviral activity across four patient cohorts receiving 750 milligrams or 1500 milligrams once or twice a day for 14 days and was safe and well-tolerated. Based on the positive results, Pharmasset and its partner Roche said that in late September they plan to start enrolling patients chronically infected with HVC genotype 1 for a 28-day study to determine the safety and tolerability of R7128 in combination with the current standard care of Pegasys plus Copegus. Pharmasset shares rose $1.60, or 15.4%, to close at $12.
Metabasis Therapeutics ( MBRX) added 28 cents, or 9.8%, to close at $3.15, after it said the Food and Drug Administration granted its primary-liver-cancer candidate, MB07133, orphan drug designation. The Orphan Drug Act supports the development of drugs for diseases affecting fewer than 200,000 people in the U.S. It entitles a company to seven years of market exclusivity for a product that's approved, as well as other incentives, including tax credits related to clinical trials expenses and an exemption from the FDA prescription drug user fee. Ariad Pharmaceuticals ( ARIA) rose after announcing it reached an agreement with the FDA on the special protocol assessment, or SPA, for its phase III trial for oral deforolimus in patients with metastatic sarcomas. The company said that based on the SPA, progression-free survival will be the primary endpoint, and overall survival will be the secondary endpoint. It plans to begin patient enrollment later this month. Ariad shares climbed 22 cents, or 4.7%, to close at $4.95. Investors were less enthusiastic about other news, including a patent settlement and a stifled FDA submission. On the falling end, Repligen ( RGEN) lost 89 cents, or 17.8%, to close at $4.12, after ImClone ( IMCL) announced that it had
settled patent-litigation with the company and the Massachusetts Institute of Technology for a lump sum of $64 million.
Repligen stands to gain about $40 million in net proceeds from the settlement. In addition to wrapping up the patent-infringement matter that involved ImClone's cancer drug Erbitux, Repligen granted ImClone a sublicense for future use of other patented technology. ImClone, meanwhile, rose $1.19, or 3.2%, to $37.93. Also on the decline Monday, Aspreva Pharmaceuticals ( ASPV) and partner Roche announced they
won't proceed with a regulatory submission for CellCept as an induction therapy for Lupus nephritis, the most serious manifestation of autoimmune disease lupus. The decision was based on preliminary results from an induction stage of a phase III trial that indicated it didn't meet its primary objective of demonstrating superiority of CellCept compared with intravenous cyclophosphamide for inducing treatment response. Aspreva shares gave up $1.04, or 5.2%, to $19.04. The stock (in addition to aforementioned Ariad) is a component of the Nasdaq biotechnology index, which was down 3.92, or 0.47%, to 823.67.