FDA advisory committee supports efficacy, safety data of Acorda’s MS drug
HAWTHORNE, N.Y. A Food and Drug Administration advisory committee has given favorable review to an investigational drug for multiple sclerosis.
Acorda Therapeutics announced the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 12-to-1 to support the efficacy data and 10-to-2 to support the safety data of the drug fampridine-SR in patients taking 10 mg of the drug twice daily to improve walking ability.
“We are pleased with the outcome of [today’s] advisory committee meeting,” Acorda president and CEO Ron Cohen said in a statement. “People with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life.”
The committee’s vote does not guarantee approval of the drug, but the FDA seeks the advice of advisory committees when making its final decision on whether to grant approval.
The committee’s vote stands in contrast to comments that FDA officials made last week in documents posted on the agency’s Web site, in which they said the drug had “very limited effect” despite promising clinical trial data, causing the company’s stock to fall by 18% on NASDAQ. Trading of Acorda’s stock on NASDAQ has since stopped.
The drug maker’s shares soared by $8.43 (50%) to $25.17 Thursday morning. It was the shares’ biggest gain since they tripled on Sept. 25, 2006, according to reports.
Costco reports drop in Q4, fiscal-year earnings
ISSAQUAH, Wash. A combination of the recession and foreign exchange rates have hit mass merchandiser Costco hard over the past year.
The Issaquah, Wash.-based mass merchandiser reported net sales of $21.89 billion during the 16-week period ended Aug. 30, a 3% decrease from $22.63 billion in net sales that the company had in fourth quarter 2008. Net sales for fiscal year 2009 were $69.89 billion, a 2% decrease from $70.98 billion in fiscal year 2008. Nevertheless, the five-week period ending Oct. 4 saw net sales of $6.85 billion, an increase over the $6.67 billion during the same five-week period last year.
Net income during the fourth quarter was $374 million, compared with $398 million in fourth quarter 2008. Net income for the entire fiscal year was $1.09 billion, compared with $1.28 billion in fiscal year 2008.
“Fiscal 2009 results, including those of the fourth quarter, were negatively impacted by these previously reported factors: ongoing softness in U.S. sales, primarily the result of a weak economic environment; higher employee benefit costs, mainly consisting of higher healthcare eligibility and usage; and lower U.S. dollar amounts of international profits as a result of weaker foreign currencies,” Costco CFO Richard Galanti said in a statement.
‘Fright Aid’ coupons help shoppers save
CAMP HILL, Pa. To help customers get their spook on for less this year, Rite Aid is offering in-store “Fright Aid” coupons worth more than $30 off select merchandise including Halloween and fall seasonal goodies.
Smart shoppers can also use their Halloween receipts dated Oct. 17 or earlier to earn additional savings of $5, $10 and $20 gift certificates through Rite Aid’s Rake in the Savings program. Details are available at www.riteaid.com.
“We know many Americans are a bit spooked this year by all the gloomy economic news,” said Bryan Shirtliff, SVP category management at Rite Aid. “But we also know that Halloween is a fun time for many to bury their worries and dress up as someone – or something – else.”
In the past, Saturday holidays such as this year’s have meant increased interest in attending or hosting Halloween parties, Shirtliff adds. The National Retail Federation predicts the average Halloween shopper will spend $56.31 with total holiday spending reaching $4.75 billion.