GSK to develop, commercialize investigational IBD treatment
LONDON GlaxoSmithKline has obtained an exclusive license to develop and commercialize an investigational treatment for such inflammatory bowel disorders as Crohn’s disease, the British drug maker announced Monday.
GSK said it exercised its option to obtain the license under an agreement with Mountain View, Calif.-based ChemoCentryx, for the drug Traficet-EN (CCX282-B). Under the terms of the agreement, GSK will pay ChemoCentryx $35 million, as well as potential regulatory milestones.
“Progressing the development of CCX282-B takes us closer to a valuable new treatment option for patients who suffer from these chronic, debilitating bowel diseases,” GSK chairman for research and development Moncef Slaoui said in a statement. “CCX282-B may offer advantages over existing therapeutic approaches for Crohn’s disease by potentially offering reduced side effects and convenient oral dosing to patients.”
Walgreens offering free review sessions to Medicare Part D beneficiaries
DEERFIELD, Ill. Walgreens now is offering free review sessions to Medicare Part D beneficiaries at all of its more than 7,100 pharmacies throughout the country.
Following the open enrollment period for Medicare Part D insurance plans, Walgreens is assisting those beneficiaries who’ve made changes to their prescription drug coverage. Review sessions with Walgreens pharmacists are available daily by appointment through Jan. 31, and are designed to help patients maximize their plan benefits.
Review sessions include:
- A review of beneficiary’s current medications, tiers within their selected plan, co-pays and cost-savings opportunities
- Discussion of available health and wellness services including pneumonia and shingles vaccinations and 90-day prescription benefits
- Checks for potential drug interactions
Watson files FDA application for generic LoSeasonique
MORRISTOWN, N.J. Watson Labs, a subsidiary of specialty pharmaceutical company Watson Pharmaceuticals, has filed an abbreviated new drug application to the Food and Drug Administration for an oral contraceptive.
Watson is seeking approval to market its levonorgestrel and ethinyl estradiol (0.10-mg/0.02-mg) oral contraceptive product prior to the expiration of U.S. Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, a subsidiary of Teva. Watson’s levonorgestrel and ethinyl estradiol product is a generic version of Teva’s LoSeasonique, which is indicated for the prevention of pregnancy.
On Nov. 23, 2009, pursuant to the Hatch-Waxman Act, Watson notified Duramed that its ANDA requesting approval from the FDA for a generic version of LoSeasonique contained a paragraph IV certification asserting that the LoSeasonique patent is invalid, unenforceable and/or not infringed. Teva Women’s Health filed suit against Watson on Jan. 6, 2010 in the U.S. District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 7,615,545. Based on available information, Watson believes it may be entitled to 180 days of generic market exclusivity or shared exclusivity should its product receive approval.