Antisoma discontinued a late-stage trial of its experimental drug for previously untreated non-small cell lung cancer patients saying a continuation of the trial “would be futile, as there is little or no prospect of demonstrating a survival benefit with ASA404 in this setting.” The news sent shares in the company tumbling down 75 percent and was followed by the departure of the company’s COO Ursula Ney. The company said no new or unexpected serious adverse effects of ASA404 have been identified by the trial's Data Monitoring Committee.
The U.S. Food and Drug Administration has told AstraZeneca and Abbott Laboratories that it wants more data before it will approve the two companies' experimental drug Certriad, a combination of AstraZeneca’s cholesterol dug Crestor and Abbott’s TriLipix. The companies said they are evaluating the FDA’s request and will discuss it with the agency to determine how it will move forward. Reuters noted that some analysts have expressed concern over the prospects of such a combination therapy after an National Institutes of Health clinical trial of TriLipix in combination with Merck’s statin Zocor, provided no additional protection from heart attack, stroke, or death from heart disease in patients with type 2 diabetes.
The U.S. Food and Drug Administration notified Cephalon that it would not approve its application to expand the use of its drug Nuvigil to treat patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. The company said that although it reached statistical significance on both primary endpoints in its study of Nuvigil, the agency raised questions regarding the robustness of the data. It said it has already reviewed the issue with the FDA and will be scheduling a meeting with the agency in the near future to discuss the matter.
Shares of GenVec tumbled nearly 75 percent after the company said it was discontinuing its late-stage clinical trial of its experimental drug TNFerade in patients with locally advanced pancreatic cancer based on results of an interim analysis [see story]. The company said it determined, after conferring with its independent Data Safety Monitoring Board, that the trial would not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval in the population chosen for study.
Vivus said that it has terminated the development and commercialization agreement with FemPharm for Luramist, a metered dose transdermal application of testosterone for women. The agreement with the wholly owned subsidiary of Acrux was originally signed in 2004 along with the agreement to develop Evamist, a metered dose transdermal estradiol spray for menopause. The company will return rights to Luramist to FemPharm and focus its efforts on its late-stage investigational product candidates: Qnexa for obesity and avanafil for erectile dysfunction. Vivus said it terminated the agreement because of “the significant long-term safety requirements for the approval of testosterone products in women.”
Cubist Pharmaceuticals said it will end development of it experimental therapy to reduce blood loss in patients undergoing cardiac surgery. The company said it made this decision after reviewing top line efficacy and safety data from the CB-500,929 mid-stage trials.
Cubist also said it will end its development of CB-500,929 and terminate the 2008 agreement with Dyax under which Cubist in-licensed development and commercialization rights to CB-500,929 for surgical indications in the United States and European Union.