FDA grants orphan designation for MELAS syndrome drug
WASHINGTON Sirtris Pharmaceuticals has been granted orphan drug designation for resveratrol by the Food and Drug Administration, according to published reports.
Resveratrol is a drug used to treat MELAS syndrome, a progressive fatal aging disease that produces symptoms of muscle weakness, fatigue, recurrent headaches and seizures. The government’s grant is usually offered in cases in which companies are discovering treatments for rare drugs, and the grant would allow the company to speed up their testing period.
Sitris has decided to focus on the SIRT1 gene, which is a gene tied to the aging process. SIRT1 is being studied as a possible source in treating MELAS or type 2 diabetes. According to published reports, the grant has resulted in Sitris being offered seven years of marketing exclusivity for its formulation of resveratrol.
Mylan twarted by court in Topamax case
TITUSVILLE, N.J. The U.S. Court of Appeals for the Federal Circuit has upheld a ruling that prevents Mylan from marketing a generic version of Ortho-McNeil Pharmaceutical’s epilepsy drug Topamax, according to Reuters.
The decision was originally found in a District Court in New Jersey. Now, Mylan has to wait until the patent expires in September before launching a generic.
Topamax had sales in 2007 of over $1.8 billion.
Independents, chains team up to spread the word about e-prescribing
ALEXANDRIA, Va. On April 17, a new campaign will launch in thousands of pharmacies, aimed at informing patients about the benefits of e-prescribing and also encouraging them to tell their doctors about the technology.
Many independent pharmacies are joining the campaign, along with such big chains as CVS, Walgreens, Rite Aid, Kerr and Wal-Mart, to promote the program through in-store signs and educational material. Signage that reads “e-prescriptions filled here” and “give your prescriptions a head start” will be found on pharmacy doors and at counters.
Patients interested in learning more about the program—such as which pharmacies or physicians in their area practice e-prescribing—will be directed to the campaign’s Web site, www.LearnAboutEprescriptions.com.
To prove the worth of e-prescribing, Walgreens and SureScripts, who is providing the network for the e-prescribing pharmacies, have released a survey showing the benefits of implementing e-prescribing in a pharmacy.
According to the findings of the Walgreens/SureScripts study, prescriptions filled at pharmacies increased by 11 percent once physicians began actively using e-prescribing and that the savings for pharmacy labor costs are $1.07 for every new prescription and $0.41 for every refill due to e-prescribing.