The Burrill Report


A Los Angeles jury ordered Johnson & Johnson to pay a plaintiff $8.3 million after finding the company’s DePuy unit was negligent in designing a defective metal-on-metal hip implant, Bloomberg reported. The ruling comes in the first of more than 10,000 lawsuits against the company to go to trial over the hip implants. The award was for compensatory damages in the suit brought by a retired prison guard from Montana. The jurors found that the defective implant caused his injuries but that DePuy had properly warned of the risks and didn’t owe punitive damages. J&J recalled 93,000 of the implants in August 2010 after 12 percent failed within five years.

The Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug Administration voted 2-12 against approval Depomed's menopause drug, gabapentin. Data presented at the committee meeting included results from the late-stage program, which enrolled 1,706 patients in three studies. Based on the outcome of committee meeting, the company cancelled a previously scheduled conference call, trading was temporarily halted, and the company said it will cease all spending relating to the program. Depomed shares closed at $5.83, down 64 cents. “Based on today's meeting,” Jim Schoeneck, Depomed president and CEO said, “we believe the hurdles for approval of a non-hormonal treatment for hot flashes remain high.”

The FDA refused to grant Janssen Research & Development’s application to expand the use of its blood thinner Xarelto to prevent heart attacks and strokes in patients with acute coronary syndrome. The application includes results from the 15,526 patient late-stage trial published in November 2011 and data from the 3,491 patient mid-stage trial published in November 2008. The agency has been and continues to be concerned with the increased bleeding seen in patients taking the drug. “While we saw an increase in major bleeding, there was no increase in fatal bleeding,” said Christopher Nessel, vice president at Janssen. “We will continue to work with the FDA to address their questions.” Janssen and Bayer HealthCare are co-developing the drug.

AstraZeneca said the Federal Court of Australia invalidated three of its patents covering Crestor, its blockbuster drug for treating high cholesterol. The patents, which cover formulation and use of the drug, were set to expire in 2020 and 2012. Generic drugmakers Apotex, Watson Pharmaceuticals, Ascent Pharmahealth had challenged the patents. The ruling is limited to Australisa and AstraZeneca said the decision has no impact on the validity of its Crestor patents in other countries or the company’s financial guidance for 2013.

Biovest International, a company developing the first cancer vaccine for lymphoma patients, filed for Chapter 11 bankruptcy in order to eliminate approximately $44 million in senior secured debt and gain access of up to $5.6 million in new funding from the company’s senior secured lenders. During this reorganization process, Biovest plans to continue its operations without interruption, including advancing its regulatory strategy seeking approvals in the European Union and Canada for the therapy for the treatment of follicular non-Hodgkin's lymphoma. Biovest also plans to continue to service its cell culture and instruments clients from its Minneapolis facility without interruption.


March 08, 2013
http://www.burrillreport.com/article-jury_orders_jj_to_pay_plaintiff_8_3_million_for_defective_hip_implant.html