Eli Lilly (LLY) said that its global phase 3 trial evaluating Alimta (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck failed to meet its primary endpoint for overall survival. Data were presented for the first time at the 35th Annual Meeting of the European Society for Medical Oncology. The phase 3 study, the largest trial conducted in squamous cell cancer of the head and neck to date, evaluated Alimta in combination with cisplatin compared with placebo plus cisplatin given every three weeks in a total of 795 patients. The primary objective of the study was to determine overall survival. The Alimta/cisplatin regimen showed a median overall survival of 7.3 months compared with 6.3 months with cisplatin alone, a result not considered a statistically significant improvement. As a result, Lilly said it will not be submitting marketing authorization applications for Alimta in squamous cell cancer of the head and neck with either the U.S. Food and Drug Administration or the European Medicines Agency.
The U.S. Food and Drug Administration notified Alexza Pharmaceuticals (ALXA) that it would not approve AZ-004, which is being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. Valeant Pharmaceutical's (VRX) subsidiary, Biovail Laboratories International (BVF), entered into a collaboration and license agreement with Alexza in February 2010 for the U.S. and Canadian rights to commercialize AZ-004. The agency said that its primary clinical safety concern was related to data from three phase 1 pulmonary safety studies with AZ-004. Alexza intends to meet with the FDA in the near future to discuss steps necessary to address this FDA concern. The agency also raised issues relating to the suitability of the stability studies undertaken by Alexza and certain other items relating to the FDA's recently completed pre-approval manufacturing inspection. Because AZ-004 incorporates a novel delivery system, the FDA also included input from its Center for Devices and Radiological Health. CDRH requested a human factors study and related analysis to validate that the product can be used effectively in the proposed clinical setting. CDRH also requested further bench testing of the product under an additional “worst-case” manufacturing scenario.
The U.S. Food and Drug Administration notified Jazz Pharmaceuticals that it would not approve the company’s application for JZP-6 (sodium oxybate) for the treatment of fibromyalgia without additional clinical studies. The agency also expressed concerns about the appropriate patient population, methods for ensuring safe use, and the proposed Risk Evaluation and Mitigation Strategy, concentration and trade name for the product. The company said it has requested a meeting with the agency to review its concerns.
Novartis Pharmaceuticals (JAZZ) said its drug kidney cancer drug Afinitor in combination with Sandostatin LAR Depot failed to meet it primary endpoint in a late stage trial in patients with advanced neuroendocrine tumors. The company, however, said that the study showed clinically meaningful extention in the median time without tumor growth to 16.4 months from 11.3 months. Novartis presented the data at the European Society for Medical Oncology. It plans to file a supplemental application with the FDA to expand use of the drug.
Two small European studies are raising questions about the benefits of key drug in fighting colon cancer, Reuters reported. A Nordic study found 566 patients given Erbitux plus a three-drug chemotherapy regimen as a first-line treatment didn’t live longer or have any significant benefit than those on chemotherapy alone. A separate Greek study of 222 patients found patients given Avastin plus chemotherapy did slightly worse then patients give chemotherapy alone, although the difference was not statistically significant. Merck KGaA (OTC:MKGAY), which markets Erbitux in Europe, and Roche (OTC:RHHBY), which markets Avastin, both said results ran counter to a body of other clinical data from much larger studies.
Halozyme Therapeutics (HALO) said it will eliminate 25 percent of its staff as part of an effort to focus its resources on advancing its core proprietary programs and commercializing products and supporting strategic alliances with Roche and Baxter. The cuts involve 40 employees in the company’s discovery and pre-clinical research areas. Halozyme will continue full development of its phase 2 Ultrafast Insulin, phase 1 PEGPH20, and preclinical HTI-501 programs, but will decrease research relating to the discovery and preclinical assessment of new compounds, resulting in a reduction in the workforce of 40 employees. The company expects to incur a one-time charge in the fourth quarter related to the workforce reduction that will be mostly offset by reduced payroll expenses during the quarter. The implementation of this strategy is not expected to impact the company’s previous net cash burn guidance. The company also reiterates its guidance of $40 million to $45 million of net cash burn for 2010.