The Burrill Report

 
The former head of Shanghai Pharmaceutical Wu Jianwen was given a suspended death sentence for accepting bribes and embezzling public funds that enabled him to amass more than $8 million (50 million yuan). The Shanghai Intermediate People’s Court handed down a suspended death sentence with a two-year reprieve, a sentence that usually is commuted to life in prison with good behavior. Wu, who was detained in 2009, took bribes 35 times over a decade in return for buying raw materials to be used in Shanghai Pharmaceutical’s products and for granting sales rights to certain agents, the People’s Daily reported.

AstraZenaca and Targacept announced its TC-5214 depression drug failed to meet primary end-points after an eight week treatment. In a conference call on November 8 Targacept said that while TC-5214 was generally well tolerated and showed an adverse event profile in line with mid stage B studies, the drug failed to meet end-point requirements. Despite the results Targacept will continue to push through with further late stage studies and believes that two positive efficacy studies should be sufficient to support regulatory approval in the United States. Targacept’s stock fell more than 60 percent, to 7.56 after the announcement. Burrill & Company, publisher of The Burrill Report, is an investor in Targacept.

Teva Pharmaceuticals denied reports that it is planning to fire 1,000 to 1,500 employees less than a month after it completed its acquisition of Cephalon. Responding to the reports by the Israeli newspaper The Globes and the news service Ynetnews that layoffs were imminent, Teva released a statement saying, “It is still too early to say what the impact is on both Cephalon and Teva employees.” The Globes, citing market sources, had reported earlier in the week that Teva was planning layoffs in Europe and the United States, and that the job cuts would be concentrated in Cephalon’s generics business. Reports from Ynetnews also suggested that Teva will cut sales, marketing, and administrative expenses by $300 million, R&D by $120 million to $150 million, and production costs by $50 million to $80 million.

Amylin Pharmaceuticals and Eli Lilly & Company will terminate their partnership on diabetes drug Byetta. Under the terms of the agreement, Amylin will gain sole ownership for development and commercialization of Byetta in exchange for a one-time payment of $250 million to Lilly, as well as a $1.2 billion revenue sharing payment for Bydureon if it wins FDA approval by June 30, 2014. If Bydureon does not win approval, Amylin will pay an 8 percent share of sales to Lilly. Amylin is placing much of its success on the future of Bydureon, which the FDA said it would not approve without additional data. A decision is expected in early 2012. Amylin’s stock fell 10.9 percent on the announcement of the split up.

Researchers have stopped recruiting patients for a clinical trial testing Amgen’s colorectal cancer treatment Vectibix in other digestive-tract cancers because of inferior outcomes in patients. Vectibix is already approved to treat advanced colorectal cancer in patients who have undergone chemotherapy treatments and Amgen was determining if there were any other potential indications for the drug.

Merck disclosed in a filing with the U.S. Securities and Exchange Commission that that the U.S. Food and Drug Administration declined to approve two products it has been developing. The FDA notified the company it would need additional data before approving the drugs, an oral contraceptive and a glaucoma drug. The company declined to comment on the matter, but suggested that more information would become available after the company has further conversations with the FDA regarding the complete response letters.

Britain’s National Institute for Health and Clinical Excellence in draft guidance said it would not recommend the state health service use AstraZeneca’s breast cancer drug Faslodex because it is not significantly better than existing treatments, and its widespread use would not be a good use of resources. Faslodex generated $345 million in sales in 2010, and had already totaled $397 million in sales through the first nine months of 2011, according to Reuters. The drug is already reimbursed in 40 markets around the world.

The U.S. Department of Justice issued a subpoena to Merck for information regarding marketing and selling activities of its heart drug Integrillin and its antibiotic Avelox, the Wall Street Journal reported. The DOJ has requested information about the two drugs, which Merck acquired through its 2009 purchase of Schering-Plough. The DOJ wants information about potential off-label marketing between January 2003 and June 2009. In addition, a civil investigation into Inspire Pharmaceuticals, a company Merck acquired in May, has been issued. The new rash of probes adds on the subpoena Merck received earlier this year for its brain-tumor treatment Temodar, another drug acquired through its purchase of Schering-Plough. All this comes in the wake of the ongoing probe into Merck’s pain-killer drug, Vioxx. Merck set aside about $950 million to cover the costs of the expected settlement over the marketing practices of Vioxx.

The U.S. Food and Drug Administration is asking Abbott to conduct a new trial of its cholesterol drug Trilipix after review of a study of a similar compound suggested the active ingredient may not lower the risk of a heart attack or stroke. The study tested the efficacy and safety of a combination of fenofibrate and cholesterol lowering statin against the statin alone and the results showed no significant difference in the risk of experiencing a major adverse cardiac event between the two groups. Because fenofibrate is similar to the active ingredient in Abbott’s Trilipix, the FDA is requiring Abbott to conduct a trial to test the cardiovascular effects of Trilipix in patients taking statins and at high risk of heart disease.

The U.S. Food and Drug Administration notified Alimera that it would not approve Iluvien, its experimental drug for diabetic macular edema, without additional data. It was the second time the FDA refused to approve the drug for marketing. The FDA said that insufficient data to support Iluvien’s safety and efficacy was why it was unable to approve the drug. Alimera’s CEO Dan Myers said that though the company was “surprised and disappointed” by the decision, it still plans to pursue approval of Iluvien in Europe while re-evaluating its options in the United States. Alimera’s shares plummeted more than 70 percent in response to the news.


November 11, 2011
http://www.burrillreport.com/article-former_shanghai_pharmaceutical_exec_gets_suspended_death_sentence_.html