It's been a rough ride for drug developers over the past week: Lawsuits, clinical-trial failures and warnings, and an investigation into possible insider trading hammered biotech stocks over the last week. We tally the damage.
It’s been a rough ride for drug developers over the past week: Lawsuits, clinical-trial failures and warnings, and an investigation into possible insider trading hammered biotech stocks over the last week. We tally some of the damage.
AstraZeneca PLC (NYSE: AZN) settled a class-action suit for $103 million over wholesale drug pricing, the Wall Street Journal reported Monday. The suit claimed the drug giant inflated the average wholesale price of drugs such as Zoladex. AstraZeneca denied that it broke any rules, saying a settlement was the best way to resolve the matter and focus on its core business. Its shares were down about 1 percent to $45.06 in midday trading.
Curis Inc. (NASDAQ: CRIS) said Wednesday its GDC-0449 drug didn't prolong disease progression or death in colon or rectal cancer patients sufficiently to meet its primary endpoint in a Phase II study. GDC-0449 is being developed in collaboration with Roche Holding AG and Genentech. Curis shares plunged almost 50 percent on the news. In midday trading, its shares were down another 1.65 percent at $1.79.
Onyx Pharmaceuticals Inc. (NASDAQ: ONXX) and the Germany’s Bayer AG said early last week their cancer drug Nexavar failed to prolong the survival of lung-cancer patients in a late-stage clinical trial. It was the second time the drug failed in a Phase 3 lung cancer study. Nexavar is approved for the treatment of kidney cancer and liver cancer. Investors found reason to be upbeat, however, after the companies said the drug reached its secondary progression-free survival goal in patients with nonsquamous, nonsmall-cell lung cancer. Onyx shares were up 0.60 percent to $23.50 in midday trading.
Human Genome Sciences Inc. (NASDAQ: HGSI) said early in the week that the U.S. Food and Drug Administration is unlikely to approve Zalbin, its hepatitis C drug. The FDA sent the company a "Discipline Review" letter, citing concerns about the risk-benefit profile of Zalbin, an interferon designed for patients undergoing hepatitis C treatment. Novartis Ag, Human Genome's marketing partner, had already withdrawn an approval application for Zalbin in Europe. Human Genome shares were down 1.17 percent to $27.12.
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) disclosed the U.S. District Court of New Jersey granted Sanofi-Aventis S.A. and Albany Molecular Research Inc.’s motion for a preliminary injunction to stop it from selling a generic version the Allegra allergy medication. Dr. Reddy’s intends to appeal the decision. Its shares were up 2.80 percent to $31.55.
The U.S. Securities and Exchange Commission is investigating whether generic-drug company Mylan Inc. (NYSE: MYL) disclosed market-moving information to a meeting of analysts and investors without revealing it publicly, according to a report in the Wall Street Journal. Its shares were down 2.52 percent to $18.16.
And GenVec Inc. (NASDAQ: GNVC) announced that it has asked Wells Fargo & Co. to review of “strategic alternatives,” including a possible sale or merger. The company ended a late-stage trial of its pancreatic cancer drug in March after early data revealed it would provide convincing evidence of efficacy. Shares were flat at 50 cents.