PHARMACY

Roche asks for clearance to bring Mircera to market

BY Drew Buono

BASEL, Switzerland Roche is asking a U.S. judge for clearance to sell an anti-anemia drug by offering a royalty to Amgen and offering the drug at a price that is lower than what Amgen charges for its top anemia drug, according to published reports.

Roche won regulatory approval for Mircera as a treatment for anemia associated with kidney disease in November. But it hasn’t brought the drug to market because it lost a civil trial in October in which a federal jury found Mircera violated patents held by Amgen. Amgen sells drugs Aranesp and Epogen to treat anemia associated with kidney disease and cancer chemotherapy.

Although Roche lost the patent trial to Amgen, it is now seeking permission from Judge William Young to bring Mircera to the market by arguing that it would serve the public interest. Roche also has proposed selling Mircera at an initial “wholesale acquisition cost” that is about 5 percent less than the current “average selling price” of Amgen’s Aranesp. Also, it would pay Amgen a royalty 20 percent of net sales of Mircera while Amgen’s patents are still enforced, assuming the original ruling of infringement stands.

Roche said it would begin taking steps to market Mircera if the judge doesn’t rule on Amgen’s injunction request on Feb. 28, when oral arguments are scheduled in the case. Roche would be doing this even though they would be at risk to pay Amgen penalties if the infringement case isn’t overturned.

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Study shows no link between ADHD medication and drug abuse

BY Diana Alickaj

WASHINGTON A new report published in the March issue of the American Journal for Psychiatry states that children who are given psycho-stimulants for attention deficit-hyperactivity disorder are not more susceptible to begin abusing drugs and alcohol than their peers.

ADHD is a disorder that includes systems of inability to focus, hyperactivity and impulsiveness. According to the Wall Street Journal, 9 percent of children have ADHD in America, but only 32 percent get the medication needed to treat it.

The report was funded by the National Institutes of health and was designed by the Massachusetts General Hospital investigators whose main goal was to make sure to cover all necessary angles in order to receive the correct data for the relationship between drug abuse and ADHD medication.

The researchers interviewed 112 men between the ages of 16 and 27, a decade after they were diagnosed with ADHD and asked about their consumption of tobacco, alcohol, drugs and the type of medication they used. The study concluded that there was no relationship between substance abuse and the prescription ADHD medicines.

“This study is a continuing effort to explicate the factors that mediate risk. It is methodologically sound and suggests that, as always, things are more complicated than we want them to be. The study demonstrates that the use of psycho-stimulants for ADHD children does not increase the risk for substance abuse in adulthood, but it also suggests there is no protective effect,” said Jon Shaw, director of the Division of Child and Adolescent Psychiatry and Behavioral Science at the University of Miami.

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FDA rejects Labopharm’s Tramadol after response to second approvable letter

BY Drew Buono

WASHINGTON Labopharm’s appeal of a second approvable letter from the Food and Drug Administration for a once daily formulation of its pain drug Tramadol has been rejected by the agency.

The director of the Center for Drug Evaluation and Research’s Office of New Drugs, John Jenkins, “has suggested additional statistical analysis of existing data as a means to potentially satisfy the agency’s requirements,” according to Labopharm.

The method Jenkins is proposing is different from the method the FDA requested following its first approvable letter in May 2007, the company said. Jenkins also recommended the company meet with the agency prior to any resubmission.

Labopharm is trying to introduce the once-daily formulation of tramadol, which is its lead product, in various international markets, including Canada, France, Germany, Spain, Italy and the UK.

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