A federal jury in Boston found that Pfizer (PFE) violated U.S. racketeering law in marketing the epilepsy drug Neurontin and said the drug giant should pay $142.1 million, Bloomberg reported. Kaiser Foundation Health Plan and Kaiser Foundation Hospitals claimed in a brief during the trial that Pfizer illegally promoted Neurontin for unapproved uses. The insurer said it was misled into believing migraines and bipolar disorder were among the conditions that could be treated effectively with Neurontin. An attorney for Kaiser told Bloomberg the decision bodes well for future cases.
Genzyme (GENZ) said that the U.S. Food and Drug Administration notified it that the agency will take enforcement action to ensure that products manufactured at the plant are made in compliance with good manufacturing practice regulations. The FDA enforcement action will likely result in a consent decree, under which a third party would inspect and review the plant’s operation for an extended period and certify compliance with FDA regulations, the company said. Under a consent decree, Genzyme also would be required to make payments to the government and could incur other costs. The company said it doesn’t expect the FDA’s actions to cause any interruption in its ability to supply drugs to patients.
Shares of Cell Therapeutics (CTIC) fell 57 percent on news that an advisory panel for the U.S. Food and Drug Administration said there was insufficient data to approve the company’s experimental drug for lymphoma [see story]. The panel voted unanimously that further study of pixantrone was needed before granting marketing approval. A decision by the FDA is expected in April 23.
Oncothyreon (ONTY) said that Merck Serono and its U.S. affiliate, EMD Serono, have temporarily suspended the worldwide clinical development program for its cancer vaccine Stimuvax after a patient in the trial developed encephalitis. The suspension is the result of a suspected unexpected serious adverse reaction in a patient with multiple myeloma participating in an exploratory clinical trial. The suspension affects the late-stage clinical program for Stimuvax including trials in non-small cell lung cancer and breast cancer. Further recruitment of patients into all trials actively recruiting patients and ongoing treatment with Stimuvax in these trials are suspended.
A U.S. Medicare advisory panel said anemia drugs from Amgen (AMGN) and Johnson & Johnson (JNJ) at large doses are likely to make heart problems worse and might reduce changes for survival of kidney patients, Reuters reported. While the panel found data to show that the so-called erythropoiesis-stimulating agents or ESA could improve quality of life for patients and help keep them active, Reuters said most of the members on the advisory panel found enough evidence to conclude these drugs increase heart risks. CMS is trying to decide whether changes are needed to address the use of these drugs.
Genmab (OTC:GNMSF) said that Genentech (DNA) and Biogen Idec (BIIB) filed a declaratory relief complaint at the U.S. District Court, Southern District of California against the Danish company and its partner GlaxoSmithKline (GSK) for patent infringement relating to the production and sale of Arzerra, for the treatment of fludarabine and alemtuzumab refractory chronic lymphocytic leukemia. At issue is Genentech and Biogen Idec’s patent (No. 7,682,612) that contains a claim to a method of treating CLL with anti-CD20 antibodies, wherein the method does not comprise treatment with radiolabeled anti-CD20 antibodies. The company said it is working with GSK to assess and analyze the claims under the initiated legal action and determine the appropriate action in response to the complaint.