PHARMACY

Walgreens releases November sales data

BY Jim Frederick

DEERFIELD, Ill. A weak start to the holiday sales season, a rise in lower-price generic drug introductions, pressures on children’s cough-cold products and other factors combined to slow the growth momentum at Walgreen Co. in November, but the company still eked out modest same-store sales gains amid the uncertainty.

Walgreens reported November sales of $4.77 billion, marking a 9.5 percent increase over the same month in 2006. But sales in comparable stores rose just 4.4 percent.

Pharmacy sales rose 10.6 percent, but the replacement of some big-selling brand name drugs with lower-price generics this year held comp-store pharmacy sales to a 5.5 percent gain—modest by Walgreens standards. “Comparable pharmacy sales were negatively impacted by 4.3 percentage points due to generic drug introductions in the last 12 months,” the company reported today.

Total prescriptions filled at stores open more than a year increased 3.1 percent, Walgreens noted, and pharmacy sales accounted for 65.1 percent of total sales for the month.

At the front end, comp-store sales rose a relatively meager 2.6 percent in November. Walgreens attributed the growth slowdown to “weakness in seasonal categories; aggressive pricing on digital photo prints; the withdrawal from the market and cautions on the use of cough and cold products for children 6 and under; and a mild early flu season compared to last year.”

Among the bright spots at the front end: consumables and everyday electronics, the company reported.

“Although the weak economic environment may have impacted early holiday sales, we believe the economy will benefit drug stores late in the Christmas season as customers take advantage of our wide selection of products and our convenient locations,” said Walgreens chairman and chief executive officer Jeff Rein. “That’s typical of our past experience.”

Rein also pointed out that the specials offered in Walgreens’ circular advertising in November “didn’t offer the deep discounts that other retailers promoted.”

Calendar year-to-date sales were $49.95 billion, an increase of 11.7 percent over the same period last year. For the first quarter of fiscal 2008 ended Nov. 30, Walgreens’ same-store sales rose 5.4 percent, with total sales up 10.2 percent from first-quarter 2006, to $14.0 billion.

Walgreens said it opened 95 stores in November, including eight relocations. The company also acquired three stores and closed eight, ending the month with 6,141 drug stores (including 93 home care division locations, 10 specialty pharmacies and three mail service facilities) in 49 states and Puerto Rico, versus 5,580 a year ago. Franchisees of Option Care, a wholly owned subsidiary of Walgreens, are not included in Walgreens’ store count.

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PHARMACY

Mylan’s nebivolol receives approvable letter from FDA, efficacy not at issue

BY Allison Cerra

NEW YORK Mylan’s new anti-hypertension drug has received a nearly green light from the Food and Drug Administration.

While an approvable letter from the FDA did not raise any questions related to safety or efficacy of nebivol, a novel beta blocker, Mylan and its licensing partner, Forest Laboratories, did report that final marketing approval would depend on the duo’s ability to resolve deficiencies in its manufacturing facility in Belgium, issues which the letter addressed.

At this time, the companies and the FDA have agreed upon product labeling text and the proposed brand name is currently Bystolic.

The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a Jan 2008 launch meeting for Bystolic.

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Caraco receives tentative FDA approval for generic Lexapro

BY Allison Cerra

WASHINGTON The FDA has granted tentative approval for Caraco’s abbreviated new drug application for escitalopram oxalate tablets (escitalopram), 5 mg, 10 mg and 20 mg.

Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.

Caraco and Forest Laboratories have been involved in a patent litigation over the generic Lexapro since July. Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.

“We are extremely pleased to receive this tentative approval,” said Caraco’s chief executive officer, Daniel Movens. “The ANDA was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”

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