SAN FRANCISCO - Hepatitis C treatment is in a strange space right now. The approval earlier this year of the first two direct-acting antiviral drugs, Incivek (telaprevir, Vertex Pharmaceuticals Inc.) and Victrelis (boceprevir, Merck & Co. Inc.) has brought new options to hepatitis C patients.The approval of telaprevir and boceprevir has already prompted the American Association for the Study of Liver Diseases to release new treatment guidelines for hepatitis C. Read More
Transgene SA became the latest contender to jump on board the interferon-free bandwagon in hepatitis C virus (HCV) therapy, as it unveiled interim data from a 153-patient Phase II trial of its therapeutic vaccine TG-4040, which indicated that the vaccine, when administered in combination with the standard therapy of pegylated interferon alpha plus ribavirin (PEG/Riba) was twice as effective in eliciting a complete early virologic response (cEVR) as standard therapy alone.Transgene is now seeking a series of nonexclusive partnerships to enable it to test TG-4040 in a variety of inte Read More
One week after shares of NPS Pharmaceuticals Inc. were drubbed over safety concerns about the GLP-2 analogue Gattex (teduglutide) in short bowel syndrome, the company sought a ray of sunshine with positive top-line results from its pivotal Phase III REPLACE study of Natpara (NPSP558), a bioengineered replica of human parathyroid hormone (rhPTH 1-84), in adult hypoparathyroidism patients. (See BioWorld Today, Nov. 1, 2011.)In an intent-to-treat analysis, NPS reported that 53 percent (48/90) of Natpara-treated patients achieved the primary endpoint vs. Read More
• Acadia Pharmaceuticals Inc., of San Diego, said the FDA cleared schizophrenia drug AM-831 to begin a Phase I trial. AM-831 is a small molecule that combines muscarinic m1 partial agonism with dopamine D2 and serotonin 5-HT2A antagonism. The drug was discovered by Acadia and developed in collaboration with Tokyo-based Meiji Seika Kaisha Ltd., under the companies' 2009 antipsychotic deal for Asian territories. Read More
• Alchemia Ltd., of Brisbane, Australia, raised A$15 million (US$15.5 million) through an institutional placement of approximately 62.5 million new shares in Australia and the U.S. at A$0.24 per share, a 12.7 percent discount to Alchemia's closing price of A$0.28 on Nov. 3. Shares will be issued in two tranches, with the first A$6.9 million expected to settle Nov. 11 and the second A$8.1 million expected to settle Dec. 21. Read More
• Accentia Biopharmaceuticals Inc., of Tampa, Fla., entered an agreement to sell its health care economics consulting firm, Analytica International Inc., to LA-SER Alpha Group Sarl for up to $10 million in fixed and contingent payments. The company also plans to pay off $4 million in debt and extend the remaining debt payments with its lender for a year, as it focuses on advancing cancer vaccine BiovaxID through its Biovest International Inc. Read More
These items were presented at the American College of Allergy, Asthma and Immunology annual meeting (ACAAI):• Baxter International Inc., of Deerfield, Ill., presented Phase III data that showed patients with primary immunodeficiencies had a reduced rate of serious bacterial infections when treated with HyQ, an investigational combination immunoglobulin product. The data also suggested the possibility for a three- or four-week dosing schedule with single-site, self-administered infusions. The prospective, open-label study enrolled 89 patients in Canada and the U.S. Read More
The following data were presented at the American College of Rheumatology (ACR) and the Association of Rheumatology Health Professionals meeting in Chicago.• 4SC AG, of Planegg-Martinsried, Germany, presented final results from its Phase IIb COMPONENT study that demonstrated substantial anti-inflammatory activity of vidofludimus in rheumatoid arthritis. The international, multicenter, randomized study evaluated the efficacy of vidofludimus in combination with methotrexate (MTX) compared with MTX alone. Read More
