GENERIC ALBUTEROL INHALERS SHAKE UP ASTHMA MARKET

MARJORIE SHAFFER

Supermarket pharmacists expect lower costs of top-selling asthma medications this year.

The first generic versions of the leading products -- Proventil and Ventolin inhalers -- are beginning to achieve market penetration after the Food and Drug Administration gave approval for generic versions of the drugs in December. Generic drugs are copies of brand-name products that have lost their patents, and typically cost far less than their brand-name counterparts. "It will be interesting to see if physicians consider the generics as equivalents to the brand name products. In any event, the generics will certainly represent some significant cost savings to patients," said Jim Cousineau, director of pharmacy at Brookshire Grocery Co., Tyler, Texas.

Asthma, the chronic inflammatory disease of the lungs, afflicts more than 13 million Americans and is the seventh ranking chronic condition in the United States, according to the American Lung Association. Some one-third of asthma sufferers are under the age of 18. The disease can be brought under control by a variety of medications that comprise $2.3 billion in U.S. retail sales. Despite these medications, the disease still kills nearly 5,000 people a year. Glaxo Wellcome's Ventolin and Schering-Plough's Proventil are brand names for a compound called albuterol, a widely used bronchodilator that relaxes airways, making it easier for asthmatics to breathe.

Albuterol is the leading product sold in the asthma therapy market, according to research firm IMS America, based in Plymouth Meeting, Pa., a division of Dun & Bradstreet, New York. In 1994, the latest year for which full data is available, Proventil and Ventolin accounted for nearly 35% of total prescription drug sales for all medications used for asthma and other respiratory illnesses -- such as chronic obstructive pulmonary disease -- in chain, independent, and supermarket pharmacies as well as hospitals, clinics, health maintenance organizations, and long-term care facilities, according to IMS.

The Food and Drug Administration approved an application by Ivax Corp., a Miami-based generic drug maker, to market a generic version of Ventolin in an aerosol form known as a metered-dose inhaler (MDI). Goldline Co., an arm of Ivax, is selling the product to the retail trade. Ventolin is manufactured by British drug giant Glaxo Wellcome. Proventil is manufactured by Madison, N.J.-based Schering-Plough Corp. The FDA said the generic albuterol MDI "was found to be equivalent to the brand name product, Ventolin MDI. The agency determined that the generic version is bioequivalent to the brand name product based upon a series of laboratory analyses and in vivo tests in humans. The generic version is, therefore, considered as safe and effective as the brand name product." In response to the FDA's action, both Schering-Plough and Glaxo announced plans to market generic versions of their brand name products. Schering-Plough said that it would immediately launch its own generic albuterol inhaler through its Warrick Pharmaceuticals subsidiary based in Niles, Ill.

Glaxo entered into an agreement to provide generic drug company Dey Laboratories, Napa, Calif., with albuterol inhalers. In turn, Dey would sell the product to the trade. The agreement went into effect in December, according to Ramona Jones, a Glaxo spokeswoman. "The albuterol metered-dose inhalers should already be on the market," she stated.

"I am sure that the generics will have a substantial impact on the market," said Mike Lorenzo, a pharmacist at Save Mart Supermarkets, Modesto, Calif.

"Right now the prices of the generics aren't that much less than the branded products, but I think the prices will soon come down," he says.

However, in other regions of the country, prices for the generics have already dropped substantially.

"The generics are just coming onto the market here, but already I am seeing price points that right now look about 33% cheaper than the brand-name products," said Cousineau. While fast-acting bronchodilators like albuterol remain a mainstay of asthma treatment, pharmacists said that there is a growing demand for corticosteroid inhalers like Azmacort and Beclovent, which are used to reduce inflammation and help prevent asthma attacks from starting.

"It is a market that is really overlooked, but more and more specialists are recommending the inhaled steroids to asthma sufferers," confirmed Lon Johnson, director of pharmacy at Jitney Jungle Stores of America, Jackson, Miss. "We are seeing more and more patients who are using the steroids on an everyday basis," agreed Jay Buckley, pharmacy manager at a Giant Eagle supermarket in Mckees Rock, Pa.

But using anti-inflammatories steroids and nonsteroidals can have adverse side effects, and one of the biggest problems is in noncompliance of the drugs' instructions.

Pharmacists usually have to spend time educating new asthma patients about how to use metered-dose inhalers, and recently some supermarket chains have participated in asthma education programs for their pharmacists.

Another growing trend in asthma care is the use of nebulizer machines. Some retailers have contracts with companies that supply the machines, which reduce solutions of Ventolin and other asthma medications to a mist of fine spray.

The machines were once only used in hospitals, but smaller, more portable models have recently become available for home use, says Kathleen Butts, a pharmacist at a Winn-Dixie store in Orange Park, Fla.