Human Genome Sciences (HGSI) said its experimental drug mapatumumab in combination with the chemotherapy agents paclitaxel and carboplatin failed in a mid-stage trial as a first-line therapy in advanced non-small cell lung cancer. The company said the combination including its drug showed no difference in disease response or progression-free survival compared to the control group. The study showed mapatumumab was well tolerated. Mapatumumab is an agonistic human monoclonal antibody that directly induces cancer cell death by specifically binding to and activating the protein known as TRAIL receptor 1.
) said it is withdrawing its application with European regulators to begin marketing Competact, a prolonged-release formulation of its combination treatment for type 2 diabetes. Competact is a fixed-dose combination tablet of pioglitazone hydrochloride with immediate release metformin hydrochloride. The decision to withdraw the application and discontinue development of the drug came after the company had meetings with the European Medicines Agency’s Committee for Medicinal Products for Human Use and found it was unlikely to confirm the long-term efficacy of the drug and approve its use.
A.P. Pharma (APPA) said the U.S. Food and Drug Administration informed the company that it would not approve its experimental drug APF530 for the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting without addressing concerns raised by the agency. The FDA wants certain deficiencies in the manufacturing facilities used by the company addressed. While the agency did not request additional clinical efficacy studies, it does want the company to perform two studies relating to bioavailability and metabolism of the drug in addition to other requests. The company said it is working with the agency to resolve the issues as quickly as possible but that it does not now expect to launch APF530 in 2010. APF530 is a long acting granisetron using the company’s proprietary drug delivery system.
Johnson & Johnson (NYSE:JNJ
) said results from studies of the experimental Alzheimer’s disease drug bapineuzumab may not be available until 2012, two years later than expected, Bloomberg reported. Johnson & Johnson took over development of the drug after it purchased Elan’s (NYSE:ELN
) Alzheimer’s program in 2009. Bloomberg attributed the delay to the fact the company is still enrolling patients in the study. It will take 18 months to complete the study once the final patient is enrolled.
) said a clinical trial showed that the addition of its blood pressure drug aliskiren to standard treatment for patients recovering from a heart attack failed to demonstrate statistically significant benefit. The trial also found that patients receiving aliskiren in addition to standard therapy had a higher rate of hyperkalemia, hypotension and kidney dysfunction when compared to patients receiving standard therapy alone. The company said based on the results of the trial it will not pursue an outcome trial for post heart-attack patients.
The U.S. Food and Drug Administraton issued a warning letter to Ista Pharmaceuticals (ISTA
) saying the Irvine, California company made false or misleading claims about its eye solution to treat pain and inflammation in people who have undergone cataract surgery. The FDA said the company overstated the efficacy of Xibrom, broadened claims for the drug, and omitted important risk information about its risks. The agency told the company it must immediately cease dissemination of any false and misleading promotional materials. Ista has until March 24 to submit a written plan to explain how it will address the violations.
) said the U.S. Food and Drug Administration has requested additional information before it will approve its application to begin marketing its inhaled insulin product Afrezza [see story
]. The Valencia, California-based company is seeking approval for Afrezza for treatment of adults with type 1 and type 2 diabetes mellitus for the control of hyperglycemia. MannKind said a letter from the agency did not require any additional pre-marketing clinical studies and cited no safety concerns. The FDA would like the company to update safety data and change proposed labeling for the cartridges, foil pouches, and cartons.
Oxigene (OXGN) said the audit report from its independent public accounting firm for the year ending December 31, 2009, raised questions about its ability to continue as a going concern. The South San Francisco, California-based biopharmaceutical company said the statement is included in its annual report filed with the U.S. Securities and Exchange Commission. The company in February announced a restructuring that included the termination of 20 employees or about half its staff.
Dynavax Technologies (NASDAQ:DVAX
) said its auditors have raised questions about its ability to continue as a going concern. The company made the statement in its 2009 annual financial report filed with the U.S. Securities and Exchange Commission. Subsequent to the end of the company’s financial year, it said Merck (NYSE:MRK
) would pay it $4 million to cover expenses relating to the wind-down of a terminated agreement.
The Medicines Company (NASDAQ:MDCO
) said that it is voluntarily expanding the recall of injectable blood pressure medication Cleviprex because of the potential presence of visible particulate matter which has been observed in some vials. Four additional lots of Cleviprex are being recalled. The company said it is cooperating with the U.S. Food and Drug Administration on this recall. The visible particulate matter is primarily made up of sub visible inert stainless steel particles of around 2.5 microns in diameter, the company said. The particles could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs, The Medicines Company said.
The U.S. Food and Drug Administration issued a warning letter to Glenmark Generics informing the company that it was marketing nitroglycerin tablets not approved by the agency. The letter from the agency told Glenmark it needed to take prompt action to correct the violations and respond within 15 days to state whether it plans to cease distributing the drug.
Molecular Insight Pharmaceuticals (MIPI
) said it received a letter from The Nasdaq Stock Market notifying the company that it is out of compliance for listing requirements on the exchange. The letter stated that for the 30 consecutive business days preceding the date of the letter, the company's listed securities did not meet the minimum $50 million Market Value of Listed Securities requirement for continued listing on the Nasdaq Global Market. Molecular Insight has a grace period of 180 calendar days to regain compliance. If the company is unable to regain compliance with the listing requirement, it said it plans to apply to transfer its common stock to the Nasdaq Capital Market provided that it satisfies the requirement for continued listing on that market.