The Burrill Report

Threshold Pharmaceuticals fell the most in nearly three years after it revealed results from a mid-stage trial showing that its experimental pancreatic cancer drug failed to meet the study goal of significantly improving patients’ overall chance of survival. Shares of the company fell 19.7 percent on the day of the announcement, their biggest drop since November 2009.
Threshold shares had been up over 600 percent year-to-date before the announcement. In the trial, Threshold’s TH-302 plus chemotherapy had a median survival of 9.2 months compared with 6.9 months for those treated only with chemotherapy. The trial was intended to detect a statistically significant improvement in overall survival.

Merck KGaA withdrew its second attempt to win European approval for use of its second best-selling drug, Erbitux, against lung cancer. “The decision to withdraw the application was based on feedback from European regulatory authorities, indicating that further data would be required,” Merck said in a statement. Both of Merck’s withdrawn applications focused on the non-small cell type of lung cancer, which accounts for about 80 percent of lung cancer cases.

Progenics Pharmaceuticals cut 26 percent of its workforce, replaced its CFO, and terminated several early-stage research projects to focus on its cancer programs after the U.S. Food and Drug Administration did not approve its constipation drug, Relistor, for use in a wider population. The FDA approved Relistor in 2008 to treat opiod-induced constipation in patients with advanced illnesses, but Progenics and its licensing partner, Salix, had been trying to get the drug approved to treat patients with chronic, non-cancer pain. The company also said that the job cuts are expected to reduce about $8 million in annual cash expenditures after accounting for the restructuring costs.

Astex Pharmaceuticals said that it has discontinued clinical development of amuvatinib (MP-470), its experimental, multi-targeted lung cancer drug. Astex had been investigating the drug in a mid-stage trial and said that although no new safety issues were identified in the study, amuvatinib didn’t meet its pre-specified primary endpoint. The company also said that its decision to end further development was “consistent with [its] corporate strategy to move into advanced clinical stages only those agents that meet [its] pre-specified primary endpoints.” Astex will consider the possibility of licensing amuvatinib to any partners interested in its further development.

Vivus’ stock slipped more than 11 percent in early morning trading on September 21 after the company announced that it is anticipating that the European Medicines Agency will likely deny approval for its weight-loss drug Qsiva (marketed as Qsymia in the United States). A formal decision on the drug will not be made until October. Wells Fargo analyst Michael Tong said that the European setback is only an “incremental modest negative” for Vivus but that if the approval pathway for Qsiva in Europe proves too difficult for Vivus, it would lower projected peak sales for the drug. Vivus said that it will work with the European regulator to address any of its concerns.












September 20, 2012
http://www.burrillreport.com/article-threshold_pharmaceuticals%e2%80%99_cancer_drug_misses_target.html