Novartis Halts Development of Two Drugs: Biotech's Latest Tribulations

by: The Burrill Report

Novartis (NYSE:NVS) said that it is discontinuing the development of two investigational compounds and will take charges of $590 million in the third quarter of 2010 as a result. The decision, it said, reflects an enhanced focus on portfolio prioritization and productivity. Novartis and its partner, Human Genome Sciences (HGSI), are stopping development of albinterferon alfa-2b, an investigational compound for the treatment of adults with chronic hepatitis C. Novartis also said it will discontinue development of Mycograb, an antifungal agent being assessed for the treatment of invasive candidiasis in adult patients. The company said the charge will be partially offset by a gain on divestment of Enablex of approximately $390 million to be recognized in fourth quarter 2010.

The U.S. Food and Drug Administration has notified Johnson & Johnson (NYSE:JNJ) that it would not approve the company’s application for the analgesic tapentadol without additional data. The medicine is an oral extended release tabletfor the management of moderate to severe chronic pain in adults. The FDA has not requested any new clinical studies evaluating the efficacy or safety of tapentadol extended release, but is requesting data regarding the conversion of the extended release formulation used in the clinical efficacy and safety trials to a different extended release formulation that is designed to increase mechanical resistance to breaking or crushing.

Rosetta Genomics (NASDAQ:ROSG), a developer of microRNA-based molecular diagnostics, said it is restructuring in an effort to cut the company’s monthly burn rate by 32 percent or $4 million a year. The Israel-based company said it will eliminate 14 positions or nearly 20 percent of its global workforce, primarily in research and development and general and administrative positions, as part of the restructuring. In addition, all company employees will move to a four-day work week with an attendant 20 percent reduction in salary. Rosetta said as a result of the changes it believes it has sufficient cash and cash equivalents to fund operations through March 2011.

The U.S. Food and Drug Administration issued a warning letter to Actelion Pharmaceuticals U.S. (OTCPK:ALIOF) for failing to conform with requirements for post-marketing drug reporting requirements of adverse events. In the warning letter dated September 14, the agency said the company failed to report approximately 3,500 patient deaths reported to Actelion in connection with its drugs Tracleer and Ventavis, without an adequate basis for not reporting them. The agency acknowledged that the drugs, used to treat pulmonary hypertension, are used to treat serious conditions that often result in death. “In issuing this letter we are not concluding or implying that the patient deaths that were not properly reported to FDA in connection with these drugs would ultimately be determined to have been caused by their use.” In calling upon the company to take corrective actions to meet reporting requirements, the agency said because death is a frequent result of the conditions treated by Tracleer and Ventavis “we believe it is in your interest and FDA’s interest to have procedures that could yield information indicating that the underlying condition was the cause of death.”

Federal investigators are investigating allegations that major pharmaceutical companies paid bribes in countries including Brazil, China, Germany, Italy, Poland, Russia and Saudi Arabia, the Wall Street Journal reported. The bribes were intended to increase sales and accelerate the approval of drugs, according to the report. The probe, being conducted by the U.S. Securities and Exchange Commission and the U.S. Department of Justice, is looking at several companies for violations that prohibit companies traded in U.S. public markets from bribing foreign officials to get business.

Targacept (TRGT) said top-line results from a mid-stage clinical trial of its experimental drug AZD1446 conducted by AstraZeneca (NYSE:AZN) in adults with attention deficit/hyperactivity disorder failed to meet the study’s endpoint. The study was one of several designed by AstraZeneca to obtain, in addition to safety and tolerability information, a signal of efficacy to guide dosing in potential later-stage development of AZD1446 in either or both of Alzheimer’s disease and ADHD. AZD1446 was licensed by Targacept to AstraZeneca pursuant to a 2005 collaboration agreement. In the trial, AZD1446 failed to improve core symptoms of ADHD, as compared to placebo. Based on this finding, Targacept does not expect AstraZeneca to progress AZD1446 as a treatment for ADHD. A decision by AstraZeneca as to potential future development of AZD1446 in Alzheimer’s disease is expected in the coming months.

Pfizer (NYSE:PFE) said it recalled 191,000 bottles of the cholesterol fighter Lipitor following concerns about a musty odor coming from some bottles made by a third-party supplier, Reuters reported. The recall, which took place in mid-August, involved seven lots of 40 milligram Lipitor, as well as three other lots of the medicine supplied to a Canadian generic drugmaker. The recalled lots of Lipitor were in the United States and Canada. The U.S. Food and Drug Administration is aware of the recall and monitoring the situation, Pfizer said. Pfizer said there were no supply shortages of 40 mg Lipitor that would affect patients.

Onyx Pharmaceuticals (NASDAQ:ONXX) announced that it will delay its New Drug Application filing for carfilzomib based on a recent meeting with the Chemistry, Manufacturing and Controls review division of the U.S. Food and Drug Administration. The FDA has requested additional information related to commercial-scale manufacturing of carfilzomib. Onyx had previously anticipated filing an NDA by the end of 2010 for accelerated approval of carfilzomib and now expects that its NDA filing for accelerated approval could occur as early as mid-year 2011. The delay is not expected to impact any of the carfilzomib trials currently underway or other development plans.

Boehringer Ingelheim announced the decision to discontinue the development of its investigational compound flibanserin for the treatment of Hypoactive Sexual Desire Disorder. The decision was made following an expert panel review in June that voted unanimously against approval of the drug because it did not have an acceptable risk/benefit profile. The U.S. Food and Drug Administration followed the panel’s recommendation and issued a Complete Response Letter at the end of August. The company said it continues to believe in the value that flibanserin would have had for women suffering with low libido, a significant and recognized medical condition that impacts the lives of many women around the world.

Disclosure: Burrill & Company, publisher of The Burrill Report, is an investor in Targacept..