Basilea Pharmaceutica said Johnson & Johnson returned the full rights to its antibiotic Ceftobiprole after the European Committee for Medicinal Products for Human Use rejected its application to begin marketing the drug for treatment of complicated skin and soft tissue infections. The committee said that inspections showed that the phase 3 studies supporting the application had not been conducted in compliance with Good Clinical Practices in some sites. It indicated that, although the study results suggested that the medicine was beneficial to patients, it was concerned about how reliable the results were. Basilea said it is committed to take those steps necessary to allow ceftobiprole to be more widely available to patients in need of new treatment options to fight potentially deadly resistant bacterial infections. Basilea said due to the deficiencies identified by the U.S. Food and Drug Administration in Johnson & Johnson Pharmaceutical Research and Development’s conduct of the clinical investigations and Basilea's claimed breaches of the license agreement with the company, Basilea submitted a request for arbitration under the license agreement for ceftobiprole in February 2009. Basilea's claims under arbitration include that Johnson & Johnson PRD breached the license agreement by, among other things, causing the delay in the approval of ceftobiprole in the United States and European Union. Basilea's said its initial significant damage claims, including milestone payments and additional damages, in the arbitration will increase as a result of this further delay. Basilea anticipates an arbitration decision prior to the end of 2010.

 

People using the cholesterol-lower class of drugs known as statins have a 9 percent increased risk of developing diabetes, according to a report in the journal Lancet. Researchers studied data from 13 controlled statin trials with more than 91,000 subjects and found a 9 percent increase in the risk of diabetes over 4 years. The risk of developing diabetes with statins was highest in older patients, and was not found in patients 60 years old or younger. In an accompanying comment, Chris Cannon, of the Brigham and Women's Hospital and Harvard Medical School says the risks do not appear to outweigh the benefit in the reduction of the number of deaths from heart attack from the use of statins. The study, according to a report in Reuters, suggest that while the findings are unlikely to put a dent in the sales of best selling drugs such as Pfizer’s Lipitor and AstraZeneca’s Crestor, it may cause doctors to rethink the use of statins as a preventative measure in patients at low risk for heart disease.

 

Arkansas Attorney General Dustin McDaniel announced that the State of Arkansas has reached an $18.5 million settlement of its lawsuit filed in 2008 against Eli Lilly over the drug giant’s promotion of the antipsychotic drug Zyprexa. It is the largest pharmaceutical settlement and second largest civil settlement in the State's history. Under federal law, it is a crime for pharmaceutical manufacturers to market their drugs for uses not approved by the U.S. Food and Drug Administration. Zyprexa, during the time addressed in the lawsuit, was approved by the FDA only for treatment of schizophrenia and certain types of bipolar disorder in adults. The Attorney General's complaint alleged that Eli Lilly engaged in illegal and fraudulent off-label marketing of Zyprexa by marketing it for non-FDA approved uses, such as dementia, aggression, hostility, depression and generalized sleep disorders in adults. The state also alleged that Eli Lilly improperly marketed the drug for use in children. In 2009, Eli Lilly settled with multiple entities over its off-label promotion of Zyprexa and agreed to pay $1.42 billion in penalties, including $362 million to 32 states and the District of Columbia, $438 million to the federal government and $615 million to end a criminal probe. Additionally, the company agreed to plead guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act for promoting Zyprexa amongst elderly populations as a dementia treatment. 

Genzyme said profit fell 73 as a result of restricted supplies of its best-selling drugs Cerezyme and Fabrazyme caused by the temporary closing of a manufacturing facility that had become contaminated with a virus, Bloomberg reported. The company forecast 2010 earnings that were lower than analysts had expected. Net income in the fourth quarter fell to $23.2 million, or 9 cents a share compared to $86.7 million, or 31 cents for the same period a year ago. Genzyme adjusted its forecast for 2010 earnings to $2.80 to $3.20 a share. That’s lower than the average $3.37 estimate of 23 analysts surveyed by Bloomberg.

 

Johnson & Johson is cutting the maximum performance bonus for nearly 40 percent of its employees and freezing salaries for certain workers, according to a report in The Wall Street Journal. The Journal, which attributed its report to internal company and other documents, said J&J notified employees that it is taking the steps to standardize compensation across its various businesses and regions, thereby making it easier for its workers to move around within the company. In the United States, the company said the changes will bring bonus targets in line with market levels. A spokeswoman for the company said the savings from the program are minimal and not why the decision was made. Instead, it represents an effort to create a global compensation program “that is consistent and equitable for our employees across the company.”

 

The U.S. Food and Drug Administration announced new warnings on asthma drugs known as long-acting beta agonists saying they should never be used alone in the treatment of the disease for children or adults. These drugs include GlaxoSmithKline’s Advair and Serevent, Novartis’ Foradil, and AstraZeneca’s Symbicort. The agency said manufacturers will be required to include the new warning in product labels as well as taking other steps to reduce the overall use of the medications. The FDA said the new requirements are based on analyses by the agency and clinical trials showing these medicines are associated with increased risk of severe worsening of asthma symptoms, leading to hospitalization and death in some patients.

 

The U.S. Food and Drug Administration notified GlaxoSmithKline and XenoPort that it would not approve the companies’ experimental drug Horizant (gabapentin enacarbil) for treatment of moderate-to-severe primary Restless Legs Syndrome or RLS without additional data. GSK and XenoPort say they are currently evaluating the notification from the FDA, which indicated that a preclinical finding of pancreatic acinar cell tumors in rats was of sufficient concern to preclude approval of Horizant for RLS at this time. FDA acknowledged that similar findings were known for gabapentin at the time of its approval for refractory epilepsy, but concluded that the seriousness and severity of refractory epilepsy justified the potential risks. The companies say they are assessing the appropriate next steps and will be communicating with FDA.

 

ARYx Therapeutics said that it has slashed its staff to less than 20 and retained Cowen and Company to explore strategic options following its inability to reach a licensing agreement for its experimental antiarrythmic drug budiodarone. The company said while discussions continue with pharmaceutical companies regarding the licensing of budiodarone, the companies with whom ARYx was in advanced discussions have recently indicated that they do not intend to proceed to an agreement. ARYx said it will explore the possibility of capturing full near-term value for its three lead programs rather than pursuing licensing deals that provide value over an extended period of time.