TRIALS AND TRIBULATIONS

BMS Backs out of Crowded Hepatitis C Race

The weekly round-up of failed trials, missed targets, and other business mishaps.

The Burrill Report

Bristol-Myers Squibb will officially abandon an experimental hepatitis C compound after one patient died of heart failure and nine others were hospitalized during a mid-stage trial. BMS had earlier suspended the trial due to safety issues among patients and major questions had been raised about the future development of the compound. The company invested $2.5 billion in cash to acquire Inhibitex and its nucleotide polymerase inhibitor earlier this year hoping to be the first to develop an all-oral hepatitis C drug. Critics faulted BMS for paying so much for the early-stage therapy but the company maintains that its rationale was sound since hepatitis C was becoming such an important indication and because it already had another hepatitis C compound in its pipeline. To account for the program’s failure, the company says it will take a pre-tax impairment charge of $1.8 billion in the third quarter of this year.

The U.S. Food and Drug Administration delayed its decision on tofacitinib, Pfizer’s experimental drug for the treatment of rheumatoid arthritis. The regulatory agency has delayed potential approval of tofacitinib until at least November 21 while reviewing new data submitted by Pfizer. The FDA has not, however, asked for any additional studies to be run. Many Wall Street analysts believe tofacitinib has the potential to become a blockbuster as the first in a class of medications known as JAK inhibitors, which have been found to offer similar efficacy to the widely used rheumatoid arthritis injectables on the market today.

Pfizer terminated its three-year old supply deal with Claris Lifesciences, shortly after a ban on Claris’ U.S. sales was lifted. Claris struck a deal with Pfizer in 2009 to gain access to markets in North America, Europe, and Australia. The alliance allowed Pfizer to sell 15 off-patent products made by Claris in the Western markets under its own brand name and add more products to its generics franchise. But, in 2010, the U.S. Food and Drug Administration warned Claris over quality issues and subsequently banned the company from selling its products in the United States. The FDA lifted the ban this week after re-inspecting Claris’ facilities.

Agennix announced a restructuring plan that will eliminate approximately 55 percent of the company’s total workforce. The cuts will affect 37 employees and will take place over two tranches of layoffs. As a result of the restructuring, Agennix’s Houston, Texas facility will be shut down. Torsten Hombeck, CFO of Agennix, said “our immediate objective of conserving cash has sadly necessitated significant reductions in both Germany and the U.S. We are working with our supervisory board to determine the company’s direction and will provide an update in the near future.” The restructuring will leave the company with only 30 employees.

Eli Lilly said that the primary endpoints in two late-stage trials of solanezumab, its experimental drug for the treatment of Alzheimer’s, were not met. However, the company’s pre-specified secondary analysis of pooled data across both of the late-stage trials showed statistically significant slowing of cognitive decline in patients with mild-to-moderate Alzheimer’s disease. “We recognize that the solanezumab studies did not meet their primary endpoints, but we are encouraged by the pooled data that appear to show a slowing of cognitive decline,” says Eli Lilly CEO John Lechleiter. “We intend to discuss these data with regulatory authorities to gain their insights on potential next steps.” In the meantime, an independent analysis of the data from the clinical trials is being performed by the Alzheimer’s Disease Cooperative Study, which will present its findings at the American Neurological Association meeting on October 8, 2012.













August 24, 2012
http://www.burrillreport.com/article-bms_backs_out_of_crowded_hepatitis_c_race.html