Shares of Cambridge, Massachusetts-based Curis (CRIS) fell nearly 50 percent on news that its experimental drug in combination with Avastin and chemotherapy failed in a mid-stage trial in metastatic colorectal cancer. The drug GDC-0449, being developed by Roche (OTCQX:RHHBY) and Genentech (DNA), did not meet its primary endpoint of extending the time from randomization to disease progression or death in study patients who received GDC-0449 in addition to the current standard of care of Avastin and chemotherapy when compared to those patients that received only the current standard of care treatment. Curis CEO Dan Passeri said Genentech and Roche's clinical development of GDC-0449 in other cancers continues to make good progress.
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals (ONXX
) said that the final analysis of a late-stage clinical trial of Nexavar in patients with advanced non-squamous non-small cell lung cancer failed to meet its primary endpoint of improving overall survival in the first-line setting. The trial evaluated Nexavar compared to a placebo in combination with two chemotherapeutic agents, gemcitabine and cisplatin. A positive secondary endpoint of progression-free survival was observed in the trial. The safety and tolerability of the treatment triplet was as expected and did not show any new or unexpected toxicities. Data from this study are expected to be presented at an upcoming scientific meeting. Nexavar is currently marketed worldwide for the treatment of liver and kidney cancer.
Human Genome Sciences (HGSI) said that in written feedback from the U.S. Food and Drug Administration, concerns were expressed about the safety of its experimental therapy Zalbin at 900 mcg dose every two weeks for the treatment of chronic hepatitis C. The company said while the review of its application to begin marketing the Zalbin is ongoing, it believes it is unlikely the agency will approve Zalbin with the current dosing regimen. Zalbin is being developed by HGS and Novartis (NVS
) under an exclusive worldwide co-development and commercialization agreement entered into in 2006. In April 2010, Human Genome Sciences said that Novartis withdrew its Marketing Authorization Application for the therapy from the European Medicines Agency. HGS and Novartis are considering development of ZALBIN dosed every four weeks, and HGS previously reported the positive interim results of a mid-stage study of this Zalbin regimen. Zalbin is a genetic fusion of human albumin and interferon alfa.
The U.S. Food and Drug Administration is evaluating whether Daiichi Sankyo's (OTC:DSKYY
) blood pressure drug Benicar raises the risk of heart-related death. Data from two trials of the drug showed that patients with type 2 diabetes had a higher rate of death from cardiovascular events than patients on placebo. The FDA emphasized that its has not concluded that Benicar increases the risk of death and that it believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks. The agency said its review is ongoing. It said patients using the drug should continue to do so unless told by a healthcare professional to stop.
Dr. Reddy’s Laboratories (RDY
) said that the U.S. District Court of New Jersey granted Sanofi-Aventis (SNY
) and Albany Molecular Research’s (AMRI
) motion for a preliminary injunction to prevent it from selling a generic version of the allergy medication Allegra. The India-based generic drug company filed an application with the U.S. Food and Drug Administration to market its generic version of Allegra D24. The company said it “strongly disagrees” with the court’s decision and intends to appeal.
) said that its co-founder, Lisa N. Drakeman, stepped down from her post ad CEO and a member of the board of directors. The one-time high flying biotech has seen its share price tumble, faced clinical disappointments, and undergone layoffs and restructuring. Jan G.J. van de Winkel, who served as the Danish company’s chief scientific officer, will serve as CEO.
) said that it has engaged Wells Fargo Securities to conduct a comprehensive review of strategic alternatives for the company including a possible sale or merger. The Gaithersburg, Maryland-based company said it does not intend to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has approved a specific transaction. In March, the company discontinued a late-stage trial of its gene therapy in patients with pancreatic cancer because interim data revealed it would provide convincing evidence of efficacy.