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.
Behavioral Diabetes Institute addresses emotional, psychological aspects of living with diabetes
SAN DIEGO, Calif. Diabetes patients can ease their worries about living with the disease, as one organization focuses on an often-ignored area of treatment: The emotional and psychological issues surrounding both Type 1 and Type 2 diabetes.
The Behavioral Diabetes Institute is the world’s first organization dedicated to tackling the unmet psychological needs of people with diabetes. The BDI offers an array of evidence-based clinical programs, all designed to help people overcome the emotional and behavioral obstacles to living well with diabetes. Based in San Diego, the BDI is committed to helping people master the unique challenges of diabetes, conducting behavioral research in diabetes and providing healthcare providers with the specialty behavioral training necessary for managing diabetes effectively.
The Behavioral Diabetes Institute was founded five years ago by William Polonsky, a clinical psychologist, certified diabetes educator, associate clinical professor at the University of California – San Diego, and author of “Diabetes Burnout: What To Do When You Can’t Take It Anymore.”
Polonsky and his colleagues provide useful tools through BDI’s Web site, BehavioralDiabetes.org. They also offer small group workshops and programs for adults and adolescents with diabetes throughout the year. These include their core program, “Getting on Track;” the multiweek depression series, “Feeling Good Again: Breaking the Depression/Diabetes Connection,” and — new for 2010 — programs for eating disorders in diabetes.
Pfizer to develop cancer drug with Debiopharm
NEW YORK Two drug makers have entered an agreement to develop a drug designed to treat melanoma.
Pfizer said that it would resume the development of its drug tremelimumab with the help of Swiss drug maker Debiopharm. As part of the agreement, Debiopharm will conduct a phase 3 trial of the drug, while Pfizer will retain responsibility for worldwide commercialization of the compound.
Melanoma, the deadliest form of skin cancer, occurs in about 69,000 patients in the United States each year, and results in about 9,000 deaths. The number of melanoma cases worldwide is increasing faster than any other cancer.
Pfizer’s investigational drug, tremelimumab (CP675,206), currently in phase 2, is a fully human igG2 monoclonal antibody which has been in development for the treatment of advanced melanoma. In April 2008, Pfizer announced that it had discontinued a phase 3 clinical trial for patients with advanced melanoma after the Data Safety Monitoring Board review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy.
“The continuation of the clinical development of tremelimumab with our partner, Debiopharm, is a demonstration of our commitment to personalized medicine for cancer patients,” said Garry Nicholson, president and GM of Pfizer’s Oncology Business Unit. “Debiopharm is a successful company which has achieved impressive results on a global scale. This co-development partnership is an opportunity to leverage the combined expertise of both companies in this innovative endeavor.”
Financial terms of the co-development agreement between Debiopharm and Pfizer have not been disclosed.