PHARMACY

Endo to commercialize Fortesta in the U.S.

BY Alaric DeArment

CHADDS FORD, Pa. A U.S. drug maker has signed an agreement with a company in the United Kingdom to commercialize a testosterone gel in the United States.

Endo Pharmaceuticals announced Wednesday the agreement, with U.K.-based ProStrakan Group, regarding Fortesta (testosterone gel 2%).

Fortesta is a transdermal gel for testosterone replacement therapy in men with male hypogonadism, using a metered-dose delivery system designed to allow dose adjustment. The Food and Drug Administration is currently reviewing ProStrakan’s approval application for the drug.

Under the terms of the agreement, Endo will make an upfront payment of $10 million to ProStrakan and up to $40 million more in milestone payments by the end of 2010, additionally paying $160 million after reaching various sales targets. ProStrakan will supply Fortesta exclusively to Endo for sale in the U.S. market.

“We are committed to advancing men’s health with effective new medicines,” Endo CEO David Holveck said in a statement. “Being in a position to potentially offer ths treatment, alongside our new long-acting injectable testosterone product, will help fill an important gap in testosterone replacement.”

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PHARMACY

NACDS utilizes Rapid Response program to dispute inaccurate assertions on drug importation

BY Allison Cerra

ALEXANDRIA, Va. The National Association of Chain Drug Stores implemented its Rapid Response Program, following a recent editorial on drug importation.

NACDS president and CEO Steve Anderson penned a response to the editor to the Delaware County Daily Times (Delaware County, Pa.) after an editorial ran on Aug. 19, which cited NACDS and asserted that chain drug stores should not be concerned about where prescription medications come from so long as they are less expensive for consumers to purchase.

“Pharmacies are convenient, accessible healthcare providers. Your neighborhood pharmacist counsels patients in obtaining the most cost effective and appropriate medications and therapies to improve their health outcomes,” Anderson wrote to the paper. “However, we do not believe that consumer safety should be compromised to achieve lower costs. Safety cannot be ensured in any system that allows for the personal importation of prescription medications.  In addition, individuals who obtain prescription medications through a personal importation scheme do not have a licensed pharmacist available to consult with them about using the medications safely and effectively.”

The NACDS Rapid Response Program was created to address inaccurate or inappropriate portrayals of pharmacy, or call attention to an issue that impacts the pharmacy industry.

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Tobacco Products Scientific Advisory Committee set in motion

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has started exercising its newfound power to regulate tobacco.

The agency announced Tuesday the establishment of the Tobacco Products Scientific Advisory Committee as part of the implementation of the Family Smoking Prevention and Tobacco Control Act, which President Obama signed into law in June.

The committee will provide advice, information and recommendations to FDA commissioner Margaret Hamburg on health and other issues related to tobacco products. It will comprise 12 members, including nine medical, science and manufacturing technology experts and government officials who will each have a vote, and three industry representatives who will not.

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