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FDA orders HFA-propelled inhalers, bans CFCs

BY Drew Buono

WASHINGTON —The Food and Drug Administration at the end of May issued a public health advisory to alert patients, caregivers and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers given the coming ban on chlorofluorocarbon-propelled inhalers, which no longer will be available in the United States after Dec. 31, 2008. All inhalers instead will be powered by ozone-friendly HFAs, or hydrofluoroalkanes.

Brought on as the result of the U.S. Clean Air Act and an international treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer, the inhalers are being phased out because they are harmful to the environment and contribute to the depletion of the earth’s ozone layer, which shields the planet from harmful ultraviolet radiation.

While the FDA first began warning patients of the coming change several years ago, the May 30 advisory instructs anyone still using CFC inhalers to ask their doctor about switching now.

“Concern about the environment stimulated the need to phase out CFCs,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers.”

The FDA warns that patients will face a learning curve: HFA inhalers may taste and feel different. The spray may feel softer. Each inhaler must be primed and cleaned in a specific way to prevent clogs. And—at least for now—they tend to cost more because there are no generic versions of them on the market yet.

Sales growth of aerosol beta agonists

Source: IMS Health
Beta agonists, aerosol Year 2007 total $ Year 2007 total $ % market share % growth 2007 over 2006
ProAir HFA $396,368 36.4% 399%
Albuterol 255,026 23.4 16
Proventil HFA 194,306 17.8 250
Xopenex HFA 145,958 13.4 149
Ventolin HFA 46,995 4.3 414
Total others 50,073 4.6 –9

Currently, the FDA has approved three HFA-propelled albuterol inhalers: ProAir HFA inhalation aerosol, Proventil HFA inhalation aerosol and Ventolin HFA inhalation aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA inhalation aerosol.

Meanwhile, as the change has been coming for some time now, last year marked a shift in sales to HFA inhalers. Prior to 2007, CFC inhalers were still the No. 1 selling drugs in the beta agonist-aerosol category. According to IMS Health, in 2006, albuterol or CFC inhalers had sales of more than $220 million, versus the HFA-propelled albuterol inhaler ProAir, which generated sales of $79.4 million, during that period. But in 2007, ProAir sales reached almost $400 million versus CFC-propelled albuterol, which ranked second, with sales of more than $255 million, according to IMS Health.

While there still is significant growth expected in the migration from CFC to HFA inhalers, it appears most of the conversion has occurred already. According to Dr. Badrul Chowdhury, director of the FDA’s division of pulmonary and allergy products, approximately 65 percent of inhaler users already have switched to HFA inhalers.

To ensure that the market for CFC inhalers drops off rapidly, Armstrong Pharmaceuticals, the sole remaining maker of CFC inhalers, is expected to stop production even before the Dec. 31 deadline. A spokesman for Armstrong’s parent company wouldn’t say when production would stop, but sales of remaining inventory will continue through the end of the year.

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CVS Caremark to expand headquarters, add positions

BY Antoinette Alexander

WOONSOCKET, R.I. CVS Caremark has announced expansion plans for its headquarters over the next two years, a move that will help support the company’s continued growth and current hiring expectations of more than 200 new positions on its corporate campus.

The nature of the new jobs was not disclosed. In Rhode Island, the company currently employs 5,800 associates.

The plans are to build two new 150,000-square-foot office facilities in the Highland Corporate Park in Cumberland, R.I. The company has been based in Highland Corporate Park, which is jointly located in Cumberland and Woonsocket, since 1982. The company significantly expanded its customer support center facilities in 1988 and again in 2000.

“Our company was founded in Rhode Island more than 40 years ago and we feel fortunate to be able to continually reinvest in our home state,” stated Tom Ryan, chairman, president and chief executive officer. “As the largest company in Rhode Island we are looking to further expand our base of operations to support our continued growth and, as a result, increase our workforce over the next few years.”

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A&P announces fiscal Q1 improvements

BY Antoinette Alexander

MONTVALE, N.J. A&P, which operates 446 stores under such banners as A&P, Pathmark and Waldbaum’s, announced on Friday improved results for the first quarter as it nears the completion of the Pathmark integration.

“The first quarter of 2008 clearly demonstrates our continuing progression in operating improvement with the achievement of our fourth straight quarter of comparable store sales of over 3 percent,” stated Eric Claus, president and chief executive officer. “Further, Pathmark is already achieving positive results with comparable store sales climbing above 3 percent for the first time in many years. The company is also well underway with the completion of the Pathmark integration, as many of the planned milestones have been achieved. As of the end of the first quarter, our annualized run-rate of synergies is approximately $100 million.”

Sales for the quarter totaled $2.9 billion compared with $1.7 billion in the year-ago period. Same-store sales rose 3.2 percent, which excludes sales for Pathmark stores acquired in December 2007. Same-store sales for Pathmark, measured during the same period, rose 3.1 percent.

Net income from continuing operations was $3.8 million, with a net loss per diluted share of 48 cents after adjusting for non-operating income related to fair value adjustments. This compares with income of $61.4 million, or $1.45 per diluted share, in the year-ago period.

The company did not break out pharmacy sales results.

As previously reported by Drug Store News, the company announced during the quarter an integral step in its transformation—the conversion of the majority of SuperFresh stores in the Philadelphia market to the recently premiered Price Impact format under the Pathmark Sav-A-Center banner and a number of SuperFresh locations retaining the Fresh format with significant upgrades.

Also during the quarter, the supermarket chain completed the remodel of A&P Fresh in Holmdel, N.J., to the updated Fresh format and began remodeling additional stores. The company also premiered its Price Impact format in the Irvington and Edison Pathmark stores.

“The remainder of fiscal 2008 will be focused on progressing the company further toward operating profitability by: moving forward our operating and aggressive merchandising strategies; maintaining cost control and reduction disciplines throughout the business. Integral to our drive to profitability is the continued and ongoing execution of capital improvement projects all geared for maximum return, and particularly weighted to value propositions,” stated Claus.

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