PHARMACY

Actavis can launch generic version of Crestor in 2016, under deal with AstraZeneca

BY Alaric DeArment

PARSIPPANY, N.J. — Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

Under a deal to settle a patent-infringement lawsuit, Actavis will be allowed to launch its generic version of Crestor (rosuvastatin calcium) tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths 67 days before July 8, 2016, when the drug’s market exclusivity for use in children expires, at a fee of 39% of net sales to AstraZeneca.

Actavis also can launch rosuvastatin zinc alternate salt starting on May 2, 2016, but the company said it had made no decision regarding a potential launch.

"This agreement ensures that consumers will benefit from an earlier launch of a rosuvastatin calcium product and eliminates ongoing litigation and uncertainty of marketplace acceptance of a non-generically substitutable product if Actavis had proceeded to launch the alternative product," Actavis president and CEO Paul Bisaro said.

Crestor had sales of $4.4 billion in 2011, according to IMS Health. 

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PHARMACY

Drug makers ramp up treatments for chronic conditions in the elderly, PhRMA report finds

BY Alaric DeArment

WASHINGTON — More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

The Pharmaceutical Research and Manufacturers of America listed 465 drugs under various stages of development, adding that the aging of the population made chronic diseases a principal threat to the health and productivity of older Americans, as well as contribution to growing healthcare costs.

"Our ability to prevent, manage and treat chronic diseases has progressed dramatically in recent years, due in large part to the discovery and availability of new innovative medicines," PhRMA president and CEO John Castellani said. "But we can’t rest on our laurels. The more than 400 medicines in the pipeline for diseases prevalent among older Americans have tremendous potential to improve and extend the lives of seniors, and reduce costly emergency room visits, hospitalizations and surgical procedures."

The drugs include 142 for diabetes; 92 for rheumatoid arthritis and osteoarthritis; 82 for Alzheimer’s disease; 48 for heart failure; and 40 for chronic obstructive pulmonary disease. All of these conditions affect millions of elderly people in the United States, and Alzheimer’s could affect nearly 8 million people by 2030 unless a treatment or preventative measure is found.

 

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Lilly, BI apply for diabetes drug approval

BY Alaric DeArment

RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

"We are excited to have submitted an application for a potential new treatment option that may help patients better manage their Type 2 diabetes mellitus," BI VP metabolic-clinical development and medical affairs Christophe Arbet-Engels said. "Type 2 diabetes mellitus is a critical health issue facing the world today, and through Boehringer Ingelheim and Lilly Diabetes Alliance, we are committed to developing new treatments to address patients with this disease."

The submission is part of a partnership between the two companies announced in January 2011.


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