FDA committee recommends approval for InterMune’s Esbriet
BRISBANE, Calif. A Food and Drug Administration committee has recommended approval for an investigational drug for treating a rare and fatal lung disease.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend that the agency approve InterMune’s Esbriet (pirfenidone), InterMune announced Wednesday.
The drug is used to reduce decline in lung function in patients with idiopathic pulmonary fibrosis, a disease that affects around 200,000 people in the United States and Europe. If approved, it would be the first IPF medication for U.S. patients. Because of the disease’s rarity, the FDA granted Esbriet Orphan Drug, Fast Track and Priority Review designations, and the agency is expected to reach a final decision on May 4.
“We are pleased with the outcome of today’s advisory committee meeting,” InterMune president, chairman and CEO Dan Welch said in a statement. “We look forward to working closely with the FDA as a review of the Esbriet NDA continues.”
An FDA advisory committee’s recommendations are taken into consideration when the FDA decides whether or not to approve a drug, though they are not binding.
Duane Reade’s Q4 driven by store renovations, sales growth
NEW YORK Duane Reade announced on Tuesday that fourth-quarter sales rose 5.3% due in part to store renovations and strong pharmacy same-store sales growth.
Net retail store sales, which exclude pharmacy resale activity, increased 5.3% to $451.3 million from $428.6 million in the fourth quarter 2008. Total net sales inclusive of pharmacy resale activity rose 0.1% to $465 million.
Total same-store sales increased 2.6% as pharmacy same-store sales rose 6%. Front-end same-store sales increased 3.5% driven, in part, by strong sales of food and beverage items and OTC products.
Net loss for the fourth quarter was $84.8 million, compared with a loss of $17.4 million in the year-ago period. The retailer attributed the increase to an additional $59.5 million in fair value charges for the preferred stock’s mandatory redemption features.
For the full year, total net sales were $1.84 billion, reflecting an increase of 3.6%. Net retail store sales increased 4% to $1.76 billion.
Total same-store sales for the year increased 1.5%, with a front-end same-store sales decrease of 0.8% and a pharmacy same-store sales increase of 4.6%.
For the full year, net loss was $124.3 million, compared with a loss of $72.8 million in 2008. The increase in net loss, according to the 257-store chain, is attributable to the fourth-quarter fair value charge related to the company’s preferred stock, partially offset by a $12.5 million gain on debt extinguishment and the improvement in full year operating loss.
As previously reported, Walgreens is looking to acquire Duane Reade from affiliates of Oak Hill Capital Partners in a cash deal valued at about $1.08 billion, which includes the assumption of debt.
Kroger’s Southwest division launches ‘Low Prices Plus More’ campaign
HOUSTON One of the largest retail grocery chains in the United States is reaffirming its committment to customers by kicking off a new marketing campaign in its Southwest division.
Kroger, which operates 209 stores and 90 fuel centers in Texas and Louisiana, is kicking off a cost-saving program. On any given day, more than 10,000 yellow tags are lined along the shelves that indicate deeper cost savings for customers, Kroger said. Additionally, the program will be supported by new store signage, television, print and radio spots to promote its value-added services and broad range of national and store-brand items.
“Kroger continues to be a leader in meeting customers’ ever-changing household needs. We recognize that over the past few years, families have changed their lifestyles and purchase styles but still desire quality products at an affordable cost along with friendly customer service,” said Bill Breetz, president of the Kroger Southwest Division. “In 2009, we saved Texas shoppers over $32 million through our various money-saving features like our everyday senior discount, coupon and fuel rewards programs.”