PHARMACY

Amylin accuses Lilly of anticompetitive activity in diabetes drug development, commercialization

BY Alaric DeArment

SAN DIEGO — Amylin Pharmaceuticals filed suit against Eli Lilly in federal court Monday concerning an agreement between the latter and German drug maker Boehringer Ingelheim to develop drugs for diabetes.

In a complaint filed in the U.S. District Court for the Southern District of California, Amylin said Lilly engaged in unlawful and anticompetitive activity in its development and commercialization agreement with BI for Tradjenta (linagliptin), an orally administered Type 2 diabetes drug that the Food and Drug Administration recently approved.

Since 2002, Lilly and Amylin have had a global development and commercialization agreement concerning the injectable Type 2 diabetes drug Byetta (exenatide). Amylin said that Tradjenta would directly compete with Byetta and Bydureon, a long-acting form of exenatide currently under FDA review and that Lilly had breached its contractual agreement with Amylin to maximize commercialization of exenatide products.

Amylin is seeking to prevent Lilly from using the same sales staff to sell Tradjenta and Byetta and Bydureon.

“Amylin selected Lilly as a partner to promote development and maximize sales of Amylin’s exenatide products,” a statement by Amylin read. “We are disappointed that we could not resolve this matter amicably and that we were forced to bring legal action to protect our rights our products and our shareholders. Amylin is committed to exenatide, a franchise that we believe provides important treatment options for the millions of patients around the world with Type 2 diabetes. Notwithstanding this litigation, we intend to continue to collaborate with Lilly in the development and commercialization of exenatide products.”

Lilly rejected Amylin’s allegations in a statement released soon after, saying that injectables, such as Byetta, usually compete against other injectables rather than against such orally administered drugs as Tradjenta and also said that the contract between Lilly and Amylin allows Lilly to develop and market “a full range of diabetes treatment options for patients.”

“We emphatically reject the allegation that we did not meet our contractual obligations under the Lilly and Amylin alliance,” Lilly Diabetes president Enrique Conterno said. “Lilly has been and remains fully committed to fulfilling its obligations under its exenatide collaboration agreement with Amylin, as well as to complying with all laws and regulations.”

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NCPA applauds ‘Today Show’ segment on proper storage, disposal of medication

BY Allison Cerra

ALEXANDRIA, Va. — A segment on NBC’s "Today Show" that emphasized the importance of properly storing and disposing medication has received praise from the National Community Pharmacists Association.

The segment, “What to Toss, What to Keep in Your Medicine Cabinet,” featured Dr. Nancy Snyderman, reminded viewers to safely store their medications, as well as suggested that a disposal option is to contact one’s local pharmacist. The NCPA and its members support the voluntary Dispose My Meds program, which offers take back programs for consumers to properly dispose of unused and unwanted drugs.

“Community pharmacists are the healthcare professionals advising patients before medications are used and stand ready to assist patients if their medications go unused or expired,” said Robert Greenwood, NCPA president and Iowa pharmacy owner. “We highly encourage patients to talk with their community pharmacists about the best way to store and dispose of medicine no longer needed.”

Click here to view the segment.

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N.Y. lawmakers seek to help patients with low health literacy

BY Alaric DeArment

NEW YORK — State lawmakers in New York have introduced legislation that would require simplifying and translating medication labels and providing oral interpretation services.

A.7342, introduced in the New York State Assembly by Democrat Richard Gottfried of New York City, and S.5000, introduced in the State Senate by Republican Kemp Hannon of Long Island, also would modify prescription forms to include a section for doctors to note that a patient has limited English-speaking and comprehension ability and indicate what language the patient speaks. Gottfried and Hannon are the respective chairmen of the Assembly Health Committee and the Senate Health Committee.

Nearly half the population of the United States has low health literacy, meaning a lack of the reading and numeracy skills necessary to understand such healthcare information as prescription drug instructions.

“If a patient can’t understand the label on medication or understand the answers to questions about it, the medication won’t be effective, and the patient can be injured or killed,” Gottfried said. “Chain and mail-order pharmacies should be required to provide translation services, just as hospitals do. And standardizing drug labels will help all of us.”

Advocacy group Make the Road New York and nonprofit civil rights legal firm New York Lawyers for the Public Interest praised the bill, saying it would improve access and adherence to prescription drugs in the state.

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