Court vacates Amylin restraining order against Eli Lilly
INDIANAPOLIS — A federal court has ruled in favor of drug maker Eli Lilly in a dispute with Amylin Pharmaceuticals over Lilly’s partnership with German drug maker Boehringer Ingelheim.
The U.S. District Court for the Southern District of California vacated a temporary restraining order Wednesday that it granted to Amylin last month. Amylin had sought to prevent Lilly from using the same staff to market Tradjenta (linagliptin), an oral treatment for Type 2 diabetes that it developed with Boehringer Ingelheim, that it used to market Byetta (exenatide), an injected Type 2 diabetes drug that it markets under a partnership with Amylin. The restraining order would also have affected Bydureon, a long-acting form of Byetta currently under review by the Food and Drug Administration.
“We are pleased with the court’s decision to vacate the temporary restraining order and deny Amylin’s request for a preliminary injunction,” Lilly SVP and general counsel Robert Armitage stated. “We have complied with our contractual obligations under our agreements with Amylin and done so in a manner fully consistent with all applicable laws.”
Amylin filed suit against Lilly on May 16, alleging that Tradjenta would compete directly against Byetta and Bydureon, and that Lilly thus had violated its contractual agreement with Amylin. While both drugs treat Type 2 diabetes, Lilly responded at the time by pointing out that the two drugs did not compete because Tradjenta is an orally administered drug while Byetta and Bydureon are injectables.
MinuteClinic to collaborate with Cleveland Clinic Florida
WOONSOCKET, R.I. — MinuteClinic and Cleveland Clinic Florida, a multispecialty academic medical center that is part of the Cleveland Clinic health system, have entered into a clinical affiliation to enhance the healthcare services they provide and offer patients greater access to care.
Under the agreement, Cleveland Clinic Florida family physicians will serve as medical directors for 12 MinuteClinic walk-in medical clinics inside select CVS/pharmacy stores from Palm Beach to Broward counties in Florida. In addition, MinuteClinic and Cleveland Clinic Florida will collaborate on patient education and disease management initiatives. Signage at MinuteClinic locations will inform patients that each site is collaborating with Cleveland Clinic Florida.
"We look forward to working with one of the world’s top medical institutions to expand access to high-quality care in South Florida and deliver positive health outcomes to thousands of patients in the region," stated Andrew Sussman, president of MinuteClinic and SVP/associate chief medical officer for CVS Caremark. "Cleveland Clinic family physicians will be a valuable resource for our nurse practitioners, and we hope to collaborate on a number of initiatives spanning from patient wellness to information connectivity among our clinical practice sites."
Added Eduardo Oliveira, chairman of the division of medicine at Cleveland Clinic Florida, "What is exciting about this partnership is that it gives us the opportunity to explore new ways to deliver patient care and manage chronic conditions. We will also be able to cost effectively provide health screenings and wellness programs, which will be a tremendous benefit to the South Florida community."
MinuteClinic patients with more urgent medical needs will be referred to their existing primary care provider or the nearest urgent care center or emergency room. If patients do not have an existing primary care provider, they will be provided choices that include — but are not be limited to — Cleveland Clinic Florida-affiliated options.
With patient permission, Cleveland Clinic Florida and MinuteClinic will work toward integration of information sharing, including medical histories and visit summaries, among their locations in the region. In the meantime, MinuteClinic stated that it will continue its standard practice of sending visit summaries to primary care providers via fax or mail, typically within 24 hours with patient consent.
FDA recommends limiting use of simvastatin in 80-mg strength
SILVER SPRING, Md. — The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.
The FDA said it would recommend curtailing use of drugs containing 80 mg of simvastatin — the highest dosage approved by the FDA. The drug now is available as a generic, though Merck originally sold it under the brand name Zocor, and it’s one of the active ingredients of Merck’s Vytorin (simvastatin, ezetimibe and niacin). An estimated 2.1 million people were prescribed the 80-mg dose of the drug last year, according to the agency.
The agency said that only patients who have taken the drug for 12 months or longer without ill effect should take the 80-mg dose, and that prescribers should give it to patients only if they have been unable to adequately lower their cholesterol with the 40-mg dose.
“Our overall goal is to get doctors to not start patients on 80 mg of simvastatin,” FDA Division of Metabolism and Endocrinology Products deputy director Eric Colman said.
The FDA also said that all statins carry the risk of myopathy, characterized by unexplained weakness and pain in the muscles, but that 80-mg simvastatin carries especially high risk and that the muscle damage often results from interactions with other medications, while some patients are genetically predisposed to it. Other statins on the market include Pfizer’s Lipitor (atorvastatin) and AstraZeneca’s Crestor (rosuvastatin).