The Burrill Report

A Sanofi research chemist pleaded guilty to stealing information about experimental compounds from the company and putting the compounds up for sale through a Chinese company. Yuan Li, a Chinese national, worked as a research scientist for Sanofi from August 2006 to June 2011, where she worked to develop a number of compounds the company believed were potential building blocks for future drugs. While at Sanofi, Li was also a partner in Abby Pharmatech, a U.S. subsidiary of a Chinese chemical company. Li admitted that between 2008 and 2011, she accessed an internal Sanofi database and downloaded information about a number of compounds which she then proceeded to make available for sale on Abby’s website. Li is expected to face up to 10 years in prison and a $250,000 fine when she is sentenced on April 23, 2012.

Novartis’ multiple sclerosis drug, Gilenya, is under investigation by The European Medicines Agency after 11 patients died while taking the drug. The agency is investigating whether Gilenya, which can cause a slow heart rate when first taken, had any role in the deaths. At least one of the fatalities occurred in the United States, prompting the U.S. Food and Drug Administration to conduct a data analysis. The FDA has yet to reach a definitive conclusion and does not know when the review will be completed. For its part, Novartis has advised doctors to expand monitoring of patients using electrocardiograms and measuring blood pressure and heart rates every hour.

Roche’s melanoma drug Zelboraf speeds the growth of another less deadly form of skin cancer, according to researchers at the Institute of Cancer Research. The researchers examined DNA in 21 tissue samples from Zelboraf patients who developed cutaneous squamous-cell carcinoma and found that nearly 60 percent of the samples had one of two known cancer-causing gene mutations not targeted by Zelboraf. About 15 to 30 percent of melanoma patients treated with Zelboraf end up developing non-melanoma skin cancers, the researchers said in an article published in the New England Journal of Medicine. Zelboraf basically “accelerated the inevitable in patients that are already predisposed to the disease,” said Richard Marais, a professor of molecular oncology at the London-based institute, in an interview with Bloomberg. The researchers also noted that combining Zelboraf, which blocks a mutation known as BRAF, with a second melanoma drug that blocks another mutation known as MEK, helped solve the problem in lab mice.

Months after closing its $14 billion Nycomed buyout, Takeda Pharmaceuticals plans to cut approximately 9 percent of its workforce, or about 2,800 jobs by the end of fiscal year 2015. The company plans to eliminate 2,100 jobs in Europe and 700 jobs in the United States, primarily as a means of saving nearly $2.6 billion in expenses. The job cuts will coincide with the closing of an unspecified number of sites and includes the merging or shrinking of various subsidiaries. Most of the downsizing will occur in Takeda’s R&D operations where the company plans to shift its focus from mature products to new therapeutics in oncology, cardiovascular health, CNS, and metabolic diseases among others.

A lawsuit filed by a whistle-blower and the state of Texas alleged that Johnson & Johnson hid three studies from the U.S. Food and Drug Administration that showed some patients using its antipsychotic drug, Risperdal, developed diabetes. J&J obtained the data from a comparison study with Eli Lilly’s antipsychotic drug, Zyprexa, that showed about half the patients taking Risperdal developed diabetes after a year on the medication, said a witness. Despite the findings, J&J sales representatives told doctors that researchers had concluded that the drug didn’t cause diabetes. The drugmaker also neglected to turn over to the FDA the results of two other later studies that found Risperdal and Zyprexa posed comparable diabetes risks. The lawsuit seeks to order J&J and its subsidiary Janssen to pay at least $579 million in damages caused by Risperdal marketing practices.

AstraZeneca and Bristol-Myers Squibb announced that the U.S. Food and Drug Administration rejected their New Drug Application for dapagliflozin, an experimental treatment for type 2 diabetes in adults. In a response letter, the FDA spelled out the need for more data, which may require new clinical trials, to better assess the risks and benefits of the first-in-class experimental drug. A majority of the agency’s expert panel voted against an approval of dapagliflozin in July 2011 over concerns about cancer risks and liver injury. The agency was originally due to decide on the drug in October 2011 but pushed the decision date back to January 28, 2012. Its potential approval is now pushed back even further, raising questions about the drug’s future. “To us, the product either becomes multi-billion dollar or it never sees the light of day in the market,” Panmure Gordon analyst Savvas Neophytou told Reuters.

Columbia Laboratories saw its shares drop 54 percent, the biggest single-day decline in almost five years, after the U.S. Food and Drug Administration said that the company’s progesterone gel wasn’t effective in reducing the risk of preterm birth. Watson Pharmaceuticals, a partner on the drug, saw its shares fall 6.8 percent the same day, the greatest single-day loss the company had seen in nearly three years. FDA reviewers were quick to criticize Columbia for pooling data from the 10-country study because the gel seemed to be much more effective in foreign countries than it did in the United States. In the U.S., pregnant women who were given the gel experienced preterm birth in 16.8 percent of all the cases tracked compared to 19.2 percent of the women taking a placebo. The FDA deemed the data an improvement, but not a statistically significant figure. “It does not appear that the applicant has identified a population of U.S. women who are likely to benefit from the use of progesterone gel to reduce their risk of preterm birth,” the agency said. For its part, Columbia Labs said that the FDA was basing its conclusions on a narrow group of participants in the study. “It was designed as a global study,” a Columbia Labs spokeswoman said in an interview with Bloomberg. “The FDA agreed.”

Alnylam intends to implement a strategic corporate restructuring that includes axing nearly 33 percent of its workforce, as it aligns its resources behind its leading pipeline candidates. The developer of RNA-interference drugs plans to make its early-stage RNAi therapies its lead candidates and hopes restructuring allows the company to save $20 million in 2012, capital the company plans to use to continue developing the drugs through clinical trials. “As we effect our ongoing transformation from a platform company to a product company, now is the time to focus our near-term efforts and resources on what we believe to be our highest value opportunities,” said John Maraganore, CEO of Alnylam, in a statement.


January 20, 2012
http://www.burrillreport.com/article-sanofi_scientist_pleads_guilty_to_thefts.html