CBL expands inhaler deal Baltimore company will develop asthma treatment


January 10, 1998|By Mark Guidera | Mark Guidera,SUN STAFF

Chesapeake Biological Laboratories Inc. said yesterday that it has expanded a production agreement with Sheffield Pharmaceuticals Inc. for a new inhaler for people with asthma and other respiratory diseases.

Joseph A. Twist, a spokesman for Baltimore-based CBL, said the deal broadens an alliance formed in May 1996 in which CBL helped St. Louis-based Sheffield develop an inhaler loaded with albuterol sulfate, a medication commonly prescribed for asthma.

CBL contracts with biotechnology and pharmaceutical companies to produce sterile batches of their drugs for clinical trials and marketing.

Under the new agreement, CBL will develop the proper formulation for another asthma medicine, ipratropium bromide, to be used in Sheffield's multidose inhaler.

CBL said it will also provide sterile vials filled with the medicine for clinical trials, and will set up a production process that passes FDA review.

Twist estimated the expanded contract would result in $1 million to $2 million in revenue for the company this year.

"This is a very important contract expansion for us," he said. "We're hopeful we'll develop a long-term relationship with Sheffield."

Carl F. Siekmann, vice president for corporate development at Sheffield, said the company selected CBL to help it develop the proper formulations for the inhalers and other manufacturing needs because CBL has a strong reputation for providing sterile products and strong management.

"They have an inherent quality we knew we could rely on for supplying us for clinical trials and, hopefully, commercialization," said Siekmann.

Earlier this week, Sheffield requested FDA permission to test the albuterol sulfate inhaler in human clinical trials.

Sheffield, which underwent a management overhaul last year, licensed the inhaler technology from Siemans AG.

Sheffield has no approved products on the market yet.

Judy Roescke Bullock, chief financial officer for Sheffield, said the company anticipates that the inhaler, if approved for marketing, would be targeted to children and the elderly with asthma.

Between 10 million and 15 million suffer from the disease in the United States.

An estimated 3 million elderly suffer from chronic obstructed pulmonary disease, another condition the inhalers might be used to treat.

Because of weak lung capacity, many young and old patients must use a breathing mask or other respiratory apparatus to take their medicine. Sheffield believes its inhaler could eliminate the need for those devices.

Twist estimated that if Sheffield lands FDA approval to market its inhalers and CBL is chosen to manufacture products for shipment, the work could result in $2 million to $3 million annually in revenue for CBL.

That would replace the revenue lost last year when Allergan Inc., a California-based medical products company, decided to drop CBL as its contract manufacturer for its surgical eye lubricant, Vitrax.

Allergan decided to shift production to its facility in Ireland.

Production of the lubricant, sold for cataract and eye surgery, accounted for 25 percent to 40 percent of CBL's annual revenue.

Since then, CBL has been seeking to replace the contract with new work and to diversify its customer base to prevent dependence on one client.

The company concluded its 1997 fiscal year in March with a profit of $504,000 on revenue of $8.65 million. For the first six TTC months of the 1998 fiscal year, it has lost $300,000 on $3.4 million in revenue.

Pub Date: 1/10/98

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