Neruochem’s Alzhemed fails phase III clinical trial
NEW YORK Neurochem, a biotechnology company, said Monday its Alzheimer’s disease treatment candidate failed in a late-stage clinical trial, the Associated Press reported.
Alzhemed (tramiprosate) was found not to be statistically significant in the Phase III clinical trial. The company claimed site variations as complications for the failed study. It did say the drug candidate showed “numerical differences” in the 18-month study.
Neurochem said it already met with the Food and Drug Administration to discuss next steps and statistical models. Though the company said the agency “recognized the difficult issues surrounding a trial of this magnitude … neither the proposed adjusted models nor any further adjustments could be used for this trial to provide results in support of a claim of clinical efficacy.”
The results could be used in the future to potentially revise the design of an ongoing European study, according to the Associated Press.
Neurochem said it will continue to study the drug’s effectiveness with post-hoc evaluations. It also established a special advisory board to assist the company over the coming months in reviewing and analyzing the data.
Teva receives final FDA approval for generic Famvir, but will delay marketing until patent hearing
JERUSALEM Teva Pharmaceuticals has been granted final approval on its application to market famciclovir, the generic version of Novartis’ Famvir in the 125, 250 and 500mgs.
Now with the approval from the Food and Drug Administration, Teva is also awarded a 180-day period of market exclusivity. But the company will hold off marketing the item until at least Sept. 5, 2007.
On that day, a hearing will be held involving a patent infringement suit brought against Teva regarding the famciclovir. The hearing is scheduled to meet at the U.S. District Court for the District of New Jersey regarding Novartis’ motion for a preliminary injunction. Therefore, both parties have agreed to not launch a generic version of Famvir until after the hearing.
Forest, Daiichi Sankyo sign agreement for Azor
NEW YORK Forest Laboratories and Daiichi Sankyo have signed a co-promotional agreement for Daiichi Sankyo’s new antihypertension drug Azor. Azor is a combination of the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil.
Under the agreement, Forest will pay Daiichi Sankyo an upfront payment of $20 million and will receive a payment based upon product sales. The agreement is for three years, after which, Daiichi Sankyo will make residual payments to Forest.
The drug is still under review by the Food and Drug Administration with a decision expected by late September. Hypertension affects roughly 72 million people in the U.S., with about 65 percent of those diagnosed having trouble keeping it under control.