PHARMACY

Experimental ALS drug fails in trial

BY Alaric DeArment

WESTON, Mass. — An experimental drug for Lou Gehrig’s disease made by Biogen Idec has failed in a late-stage clinical trial, the drug maker said Thursday.

Biogen announced results of its phase-3 trial of dexpramipexole in patients with the disease, known technically as amyotrophic lateral sclerosis, or ALS. The drug failed to improve functioning and survival in patients and failed to show efficacy in key secondary endpoints as well, the company said.

"We share the disappointment of members of the ALS community, who had hoped that dexpramipexole would offer a meaningful new treatment option," Biogen Idec EVP research and development Douglas Williams said. "Nevertheless, the ‘EMPOWER’ trial represents a significant contribution to ALS research, and Biogen Idec is committed to advancing ALS science. We continue to work with researchers around the world to understand the causes of ALS and find potential treatments for people with ALS."

ALS causes a loss of muscle strength and coordination that deteriorates and makes tasks such as climbing steps, getting out of a chair and swallowing impossible. It is often called Lou Gehrig’s disease, after the baseball player who suffered from it; physicist Stephen Hawking also has the disease, which the National Institutes of Health estimates to affect five-in-100,000 people worldwide.


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PHARMACY

Rite Aid reports 2.2% decrease in comps for December

BY Alaric DeArment

CAMP HILL, Pa. — A shift in the New Year’s holiday calendar and the introduction of new generic drugs contributed to a decrease in same-store sales for the month of December at Rite Aid, the retail pharmacy chain said Thursday.

Rite Aid reported a 2.2% decrease in comps for the four-week period that ended Saturday, including a 1% decrease in front-end comps and a 2.9% decrease in pharmacy comps. The company said the calendar shift had a negative effect of 1.1% on front-end comps, while the decrease in pharmacy comps included a negative effect of 605 bps from new generic drug introductions. Same-store prescription count increased by 4.4%, including a 1.7% contribution from flu-related prescriptions and flu shots.

Guggenheim Partners analyst John Heinbockel said the results were in line with his firm’s expectations and reiterated Guggenheim’s "Buy" rating of Rite Aid’s stock, noting that the decline was driven largely by the generic wave, and the chain had continued to retain many of the scripts it won over during the Express Scripts-Walgreens dispute. Heinbockel also wrote that the decline in pharmacy comps was "modestly better" than the 4% drop he had forecasted. Rite Aid’s stock opened at $1.40 per share Thursday morning, unchanged from Wednesday’s closing price, falling to $1.38 in late Thursday afternoon trading.

Total sales for the four-week period decreased by 2.7%, to $2.054 billion, compared with $2.112 billion in December 2011.

Comps for the 43-week period that ended Saturday increased 0.1%, including a 1.4% increase in front-end comps and a 0.6% decrease in pharmacy comps, while same-store prescription count increased by 3.6%.

Total store sales for the 43-week period decreased by 0.6%, to $20.913 billion, compared with $21.030 billion during the same period in 2011.

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FDA approves 39 new drugs in 2012, a 16-year high

BY Jason Owen

NEW YORK — In 2012, the Food and Drug Administration approved 39 new drugs, 8 alone in December, marking the largest increase in 16 years. The wave of approvals poises pharmaceutical makers to see big gains after billions in losses in recent years to generic drug makers because of patent expirations.

2012’s tally compares to a total of 30 new drug approvals in 2011 and just 21 on 2010. At least 10 of the 39 drugs received fast-track status, which enabled them to be reviewed more quickly. 2012 saw the highest number since 1996, when 53 so-called new molecule entities received approval.

The pharmaceutical sector needs a pick-up in productivity after numerous patents expired over recent years, hitting a high-point in 2012, allowing generic manufacturers to take some of the market share with low cost substitutions. The rating agency Standard & Poor estimates major U.S. drug companies have lost about $21 billion in revenue, and European businesses lost about $10 billion, in 2012 from lucrative medicines coming off patent.

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