Shares in Avexa fell 75 percent after the company said it was stopping development of its experimental drug for HIV due to failed efforts to find a global pharmaceutical partner. The Melbourne, Australia-based company said it has begun a strategic review of its remaining programs and intends to consider suitable merger, acquisition, in-licensing opportunities and other corporate initiatives. The Company has taken immediate action to reduce costs. Julian Chick has resigned from the board and will step down as Avexa CEO on May 31.
Teva Pharmaceutical Industries and Baxter Healthcare each said they will appeal a Las Vegas jury’s award totaling $500 million in a lawsuit involving a man who said he had developed Hepatitis C after a vial of Teva’s drug propofol was shared by patients. Baxter Healthcare distributes the drug. Teva, which was ordered to pay $356 million of the award, said it is reviewing the full judgment and continues to believe that the evidence shows the company acted responsibly. Teva said it believes that the evidence clearly showed that if the plaintiff contracted hepatitis as alleged, it was because a properly labeled product was blatantly misused at the clinic in question.
Embattled Genzyme said it is investigating allegations that certain executive officers and directors took advantage of their knowledge of manufacturing and compliance issues with its Allston facility to illegally sell stock they held in the company. The Genzyme board has designated a special committee of three independent directors to oversee the investigation of the allegations made in letters from shareholders, the company disclosed in a filing with the U.S. Securities and Exchange Commission. The committee has retained independent legal counsel and will determine whether any action needs to be taken against any officer or director.
The U.S. Food and Drug Administration said a study among liver-disease patients taking GlaxoSmithKline's Promacta treatment for low blood platelets was halted due to blood-clot safety issues, Reuters reported. The drug is approved in the United States for treatment of chronic immune idiopathic thrombocytopenic purpura or ITP, a condition in which patients have low blood-platelet level for no known reason. ITP puts people at risk for bruising or serious bleeding. The halted trial was testing use of Promacta in patients whose low platelet levels were due to liver damage. The FDA said the trial was halted after a higher incidence of blood clots was seen in patients taking Promacta than those who received placebos. Six of 150 patients receiving Promacta developed blood clots in a key blood vessel that connects to the liver while just 1 patient on placebo developed such a clot.
NicOx said that the Joint Advisory Committees of the U.S. Food and Drug Administration, including the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 16 to 1 with 1 abstention that they did not have sufficient evidence at this time to support the approval of naproxcinod for the relief of the signs and symptoms of osteoarthritis. The FDA is not bound by the recommendations of the Advisory Committee but may take their advice into consideration when evaluating the NDA for naproxcinod. The FDA is expected to make a decision on whether to approve naproxcinod by July 24, 2010.