PHARMACY

Amicus’ Amigal improves symptoms among Fabry disease patients in trial

BY Alaric DeArment

CRANBURY, N.J. — Amicus Therapeutics received good results from its mid-stage trial of a drug for a rare, genetic disorder, the drug maker said Wednesday.

Amicus announced results of a phase-2 extension study of the investigational drug Amigal (migalastat hydrochloride) designed to improve kidney function in patients with the enzyme disorder Fabry disease. The study — an extension of the original, three- to six-month phase-2 study — used two criteria to measure kidney function, protein in the urine during a 24-hour period and a commonly used measure called estimated glomerular filtration rate, or eGFR. Twenty-six patients participated in the original study, while 23 enrolled in the extension study.

The company said preliminary data indicated that eGFR was stable after three to four years of treatment with Amigal, while protein levels in the urine also were reduced among patients in the extension study.

The company plans to present study results at the Lysosomal Disease Network WORLD Symposium in Las Vegas this week.

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PHARMACY

Sanofi-Aventis obtains Genzyme for $20.1 billion

BY Alaric DeArment

CAMBRIDGE, Mass. — French drug maker Sanofi-Aventis will acquire U.S. biotech giant Genzyme for $20.1 billion, under an agreement the two companies announced Wednesday.

Sanofi has had its eyes on Genzyme since last July, when it offered $18.5 billion, or $69 per share, for the Cambridge, Mass.-based company, but Genzyme initially dismissed Sanofi’s offer as too low. Under the new $74-per-share agreement, Genzyme shareholders will be eligible for additional milestone payments related to the multiple sclerosis treatment Lemtrada (alemtuzumab), or milestone payments related to 2011 production volumes for the Fabry disease drug Fabrazyme (agalsidase beta) and the Gaucher disease drug Cerezyme (imiglucerase).

Sanofi said it plans to make Genzyme its “global center for excellence” in rare diseases. Genzyme has long specialized in treatments for rare, inherited disorders, such as Fabry disease, Gaucher disease and Pompe disease.

Sanofi’s July announcement came not long after Genzyme agreed to pay $175 million to the federal government to address manufacturing problems the Food and Drug Administration found at one of its manufacturing plants in 2009. Those problems led to contamination of supplies of its drugs and nationwide shortages of Fabrazyme and Cerezyme.

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PCMA leader: Generics, mail-order pharmacy help save money

BY Allison Cerra

WASHINGTON — Mark Merritt, the president and CEO of the Pharmaceutical Care Management Association, responded to a provision on the Pentagon’s new budget proposal, which encourages Tricare members to use generic medications and mail-service pharmacies to save money.

Merritt said that "increasing the use of generics and mail-service pharmacies reduces costs and enhances access to prescription drugs for military members and their families," adding that generic drugs have saved the U.S. healthcare system more than $800 billion, and that "mail-service pharmacies lower costs for consumers and payers, make far fewer errors, and increase medication adherence for those suffering from chronic conditions."

PCMA is a group that represents the nation’s pharmacy benefit managers.

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