Eli Lilly said that its lung cancer drug Alimta failed to meet its primary goal of improved overall survival for patients with non-small cell lung cancer. Patients in one arm of the late stage trial received Lilly’s Alimta in combination with Avastin while another group received a combination of paclitaxel with Avastin. “Phase II results with this combination were promising and we were hoping to demonstrate an improvement in survival for non-small cell lung cancer patients, so we are disappointed with the results of this trial,” said Dr. Allen Melemed, senior medical director with Lilly Oncology. Despite the drug missing its primary end-point in the study, however, it did meet one of its secondary goals of improved progression-free survival.
Salix Pharmaceuticals said that the U.S. Food and Drug Administration postponed its decision on its new medicine to treat diarrhea in people with HIV. The FDA said it is still reviewing the company’s application to sell Crofelemer to patients with HIV. “The FDA continues to work collaboratively with Salix on Crofelemer,” said Bill Forbes the company’s chief development officer. “By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continue.” Salix was not, however, asked to perform any additional studies and is now anticipating an FDA decision on its application by the end of the first quarter of 2013.
China Sky One Medical and its top executives have been sued by the U.S. Securities and Exchange Commission over claims that they inflated revenue by about $20 million with fake sales of a weight-loss product. After first trading on U.S. markets in 2006, the pharmaceutical products firm claimed in 2007 that a Malaysian company would become exclusive distributor of its “slim patch,” generating $1 million per month in sales. In the SEC lawsuit, the agency said that the claims were false and that CEO Yan-qing Liu certified the false statements. China Sky recorded $19.8 million in revenue from Malaysian sales in 2007 and 2008, though the distributor only bought $167,542 in slim patches. “Accurate and reliable financial reporting is the bedrock of our capital markets,” John McCoy III, associate director of the SEC’s regional Los Angeles office said in a statement. “CSKI made a mockery of that by blatantly fabricating sales and overstating its financial results.”
Merck KGaA said it is planning to eliminate 1,100 jobs in Germany by 2015 as it deals with an unsuccessful market launch of its multiple screlorisis drug and a failed attempt to widen the use of its Erbitux cancer treatment. The new job cuts amount to approximately 10 percent of its current workforce in Germany and are part of the company’s “global efficiency” program which it announced last February. “We have had constructive discussions with Works Council members for the past several months and are happy to say that we now have a roadmap that will position Merck Germany in such a way that the company is prepared for the challenges it will face,” Kai Beckmann, a Merck executive board member, said in a statement. Along with the job cuts, the company also announced that it will be investing about $315 million in various Germany facilities.
Palatin Technologies announced that its partner, AstraZeneca, has decided to discontinue further development of AZD2820, one of a number of collaboration compounds in various stages of development for the treatment of obesity. The decision by AstraZeneca comes after an early-stage trial of AZD2820 was halted following a serious adverse event. Though not confirmed, it could not be excluded that the adverse event was linked to AXD2820. Despite the setback AstraZeneca will remain committed to this collaboration program and to the advancement of treatments for obesity. The patient who suffered the severe adverse even has since fully recovered.
September 06, 2012
http://www.burrillreport.com/article-eli_lilly_suffers_another_late_stage_drug_failure.html