The Burrill Report


Federal prosecutors are seeking about $1 billion to settle their investigation into Johnson & Johnson's marketing of the antipsychotic drug Risperdal, The Wall Street Journal reported. The report was attributed to “people familiar with the matter.” Such a settlement would be among the largest in a string of settlements related to off-label marketing of drugs in recent years. The federal government has been investigating J&J’s marketing of Risperdal for unapproved uses since 2004.

New research suggests chronic users of acetaminophen, a painkiller sold as Tylenol in the United States and paracetamol in Europe, are at slightly increased risk for blood cancers, Reuter Health reported. The report emphasized that the risk is low and how the drug elevates the risk is unclear. Previous research has suggested aspirin use might lower the risk of dying from colon cancer but increase the risk of bleeding ulcers. A research at the Fred Hutchinson Cancer Research Center in Seattle who worked on the study said prior to this work there was little evidence that aspirin reduces a person’s risk of blood cancers. The scientists followed nearly 65,000 older men and women in Washington State. The study found that a person who is age 50 or older has about a 1 percent risk of developing a blood cancer in ten years. If you use acetaminophen at least four times a week for at least four years, the study suggests that risk would increase the risk to about 2 percent.

Napo Pharmaceuticals filed a lawsuit against Salix Pharmaceuticals alleging breaches of contract relating to its experimental treatment for diarrhea, crofelemer, BioSpace reported. Napo agreed to license crofelemer to Salix for all human indications of the drug in North America, Europe, and Japan and for certain indications worldwide at the end of 2008. Under the terms of the agreement, Salix was obligated to develop, manufacture and commercialize crofelemer within areas licensed to it by Napo, but Napo says it has failed to live up to its obligations. Napo is claiming damages exceeding $150 million and seeks a declaratory judgment entitling Napo to terminate the collaboration agreement with Salix. Salix has said the suit is "without merit.”

The U.S. Attorney for the District of Massachusetts has subpoenaed Forest Laboratories seeking documents related to three of its hypertension drugs, Reuters reported. The office wants documents related to Benicar, Benicar HCT, and Azor. The company said it intends to cooperate in responding to the subpoena.

A study from the Centre for Medicines Research finds that success rates of experimental drugs in mid-stage trials as well as approved drugs being tested for major new indications are lower than at any other stage of development today, Nature Reviews Drug Discovery reports. The study examined phase 2 drug failures between 2008 and 2010. It examined the 16 companies representing 60 percent of global R&D spending. It found success rates fell to 18 percent from 2008 to 2009 compared to 28 percent during 2006 to 2007. A Thomson Reuters Life Science Consulting analysis of the 108 reported phase 2 failures from 2008 to 2010 found 87 percent provided reasons why. In 51 percent of those cases, failures were due to insufficient efficacy, in 29 percent they were due to strategic reasons, and in 19 percent they were due to concerns about safety.


May 13, 2011
http://www.burrillreport.com/article-feds_seek_1_billion_from_jj_to_settle_risperdal_case.html