Mylan inks agreement with Natco for generic Copaxone
CANONSBURG, Pa. Mylan has signed a license and supply agreement with Natco Pharma for a generic version of Teva’s blockbuster multiple sclerosis drug Copaxone.
Under the terms of the agreement, Mylan will have exclusive distribution rights in the U.S., Europe, Australia, New Zealand, Japan and Canada with an option to expand into other areas. Natco already has commercialized its generic Copaxone (glatiramer acetate) product in India and the Ukraine.
Worldwide sales of the brand drug were more than $1.7 billion in 2007, according to Teva.
The drug has patent protection in the U.S. until 2014.
Major drug companies agree to six-month moratorium on DTC ads
WASHINGTON Under pressure from some of the top members of the House of Representatives, top drug companies, including Merck, Johnson & Johnson and Pfizer, are agreeing on a six-month moratorium on advertising new drugs to consumers and will limit how doctors are used in their ads, according to reports.
The changes were unveiled in letters the manufacturers sent the House Energy and Commerce Committee responding to a request from committee chairman John Dingell, D-Mich., and Rep. Bart Stupak, D-Mich., who head the committee’s oversight and investigations panel.
Dingell and Stupak had wanted the companies to impose a two-year voluntary moratorium on advertising of new prescription drugs to consumers – and possibly even longer in the case of drugs for which not all studies have been completed. The lawmakers also asked the drug companies to limit the use of doctors in their advertising and agree to “black box” warnings on ads if the Food and Drug Administration requested them.
In the letters, executives of J&J, Merck, Merck/Schering-Plough and Pfizer agreed to take several steps, while the Pharmaceutical Research and Manufacturers of America agreed to hold further meetings with the committee. The companies will start following the American Medical Association’s guidelines about using actors to portray doctors, and at least one marketer, J&J, said it would not use doctors in ads to discuss the benefits of a drug.
The drug companies said in their letters that the six-month moratorium formalized industry practice, which is to educate doctors before moving to consumer communications. “We drugs [that] requires that our operating companies spend at least six months after approval have adopted internal guiding practices on direct-to-consumer advertising for prescription of a new medicine educating health professionals before commencing a direct-to-consumer advertising campaign,” wrote William Weldon, chairman and chief executive officer of J&J. He added that the company “does not believe a particular fixed period of time for an advertising moratorium is appropriate in all circumstances.”
Dingell and Stupak said they were pleased with the response, but wanted the drug companies to go further, with a two-year limit.
FDA grants Mylan approval for generic Avalide application
PITTSBURGH The Food and Drug Administration has granted tentative approval to Mylan Pharmaceuticals for its application for a generic version of Sanofi Aventis’ Avalide Tablets.
The tablets, generically known as irbesartan and hydrochlorothiazide, are used to treat hypertension. The application is among the 92 that Mylan has submitted to the FDA for approval.
Avalide had U.S. sales of about $288 million for the 12 months ended March 31, according to IMS Health.