PHARMACY

Aegerion appoints new CFO

BY Allison Cerra

CAMBRIDGE, Mass. — A biopharmaceutical company has appointed a new CFO.

Aegerion Pharmaceuticals named Mark Fitzpatrick as the company’s new CFO. Fitzpatrick joins the company, which is focused on the development and commercialization of novel therapeutics to treat severe lipid disorders, from Proteon Therapeutics, where he served as VP, CFO and assistant secretary.

In related news, Aegerion said it has been issued a patent by the U.S. Patent and Trademark Office for lomitapide, which specifically is related to the treatment of hyperlipidemia or hypercholesterolemia, including severe hypercholesterolemia. The patent extends until August 2027 and may be eligible for listing in the Food and Drug Administration "Orange Book," the company said.

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DEA kicks off second National Prescription Drug Take-Back Day

BY Allison Cerra

WASHINGTON — The U.S. Drug Enforcement Administration is hosting its second National Prescription Drug Take-Back Day this weekend, the agency said.

The free event, which will be held from 10 a.m. to 2 p.m. on April 30, addresses the proper disposal of unused or expired medications. The DEA is collaborating with government, community, public health and law enforcement partners at more than 5,100 sites nationwide. Collection sites in every local community can be found by going to DEA.gov and clicking on the “Got Drugs?” banner at the top of the homepage, which connects to a database that citizens can search by zip code, city or county.

Last September, Americans turned in more than 242,000 lbs. of prescription drugs at nearly 4,100 sites operated by more than 3,000 of the DEA’s state and local law enforcement partners, the agency said.

“The overwhelming public response to DEA’s first nationwide Take-Back event last fall not only rid homes of potentially harmful prescription drugs, but [also] was an unprecedented opportunity to educate everyone about the growing prescription drug abuse problem," said DEA administrator Michele Leonhart. “Studies have shown that, for many, prescription drugs are the very first drugs they abuse — and all too often they aren’t the last. That is why we are committed to helping Americans keep their homes safe by ridding their medicine cabinets of expired, unused and unwanted drugs.”

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Columbia Labs, Watson submit NDA for Prochieve

BY Allison Cerra

LIVINGSTON and PARSIPPANY, N.J. — A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

Columbia Labs and Watson Pharmaceuticals announced the submission of a new drug application for Prochieve (progesterone gel), which seeks to reduce the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. The NDA submission included data from two phase-3 clinical trials evaluating the use of Prochieve in reducing the risk of preterm birth in women, as well as supportive pharmacokinetic studies.

Columbia Labs said that it has requested priority review from the FDA, which would shorten the review process to six months, versus 10 months for standard review.

"Premature cervical shortening is a powerful predictor of risk for preterm delivery. At present, there are no widely accepted interventions to address this medical need," said Frank Condella, Columbia Labs president and CEO. "The recently published ‘PREGNANT’ study has demonstrated that the use of Prochieve can significantly reduce the incidence of early preterm birth in women with a short cervix at mid-pregnancy, and the study also provided evidence of improvement in infant outcome."

Watson acquired the rights of progesterone products from Columbia Labs last year.

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