Impax Labs looks to market generic cancer pain drug
HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.
Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon’s Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can’t be controlled by other drugs.
Impax’s application contained a paragraph IV certification, a legal assertion that one or more patents covering a drug are invalid, unenforceable or won’t be infringed. In response, Cephalon and CIMA Labs filed a patent infringement suit against Impax in the U.S. District Court for the District of Delaware, under the terms of the Hatch-Waxman Act of 1984, the law that created an abbreviated approval pathway for generic pharmaceuticals.
Fentora had sales of about $159 million during the 12-month period ended in September, according to Wolters Kluwer Health.
Mylan granted license to market generic menopause drug
PITTSBURGH — Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.
Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), Mylan said it had received a patent license to begin selling its version of the drug in December 2013.
The Pittsburgh-based generic drug maker was the first to file for regulatory approval of the drug with the Food and Drug Administration, and as such, will be entitled to 180 days of market exclusivity in which to compete directly with the branded version, after which other generic companies will be able to make their own versions.
Vivelle-Dot had sales of $240 million during the 12-month period ended in September, according to IMS Health. The patch is designed to be applied twice a week, and Mylan plans to sell it in the 0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg and 0.1 mg strengths.
NACDS names Kathleen Jaeger SVP pharmacy care, patient advocacy
ALEXANDRIA, Va. — The National Association of Chain Drug Stores has appointed pharmacist and trade association veteran Kathleen Jaeger to fill the newly enhanced position of SVP pharmacy care and patient advocacy. She also will serve in a separate role as president of the NACDS Foundation.
Jaeger will assume her new positions on Nov. 28, and will report to NACDS president and CEO Steve Anderson.
“With 24 years of experience and leadership as a trade association CEO, pharmacist, attorney and advocate, Kathleen Jaeger will serve as a clear and compelling voice for the value of community pharmacy and for the needs of patients in this new and expanded role at NACDS,” Anderson stated.
“NACDS’ absolute commitment to telling the story of community pharmacies as the face of neighborhood health care has brought us to the point that pharmacy no longer is talking only to itself," Anderson continued. "We are raising awareness of the value of pharmacy among consumers and patients, among elected officials and policymakers, among the media and among all healthcare partners and stakeholders. Now, it is time to take this work to the next level of success.”
Previously, Jaeger has served as EVP and CEO of the National Community Pharmacists Association and as president and CEO of the Generic Pharmaceutical Association. She also has been a partner in the food and drug practices of national law firms Kirkpatrick & Lockhart and McKenna & Cuneo. She also has served as a hospital pharmacist at the National Institute of Health.
As NACDS’ SVP pharmacy care and patient advocacy, Jaeger will serve as a spokeswoman for pharmacy patient care before key constituencies and target audiences, including in the media and at public and healthcare events. She also will direct the staff of the newly renamed Pharmacy Care and Patient Advocacy Department, which advances pharmacy information and research, conducts outreach with NACDS members and with external constituencies, including colleges and schools of pharmacy, and provides pharmacy insights and expertise that contribute to NACDS’ public policy advocacy and communications initiatives.
“Every day, countless patient care success stories play out in pharmacies in neighborhoods across America. I look forward to helping to tell this story to advance patient care, and I look forward to doing so with the insights and true passion that flow from being a pharmacist and the daughter of a pharmacist," Jaeger stated. "It is a distinct honor to represent community pharmacy and the value that it delivers to patients and to the broader healthcare system."