PathoGenesis Corp. Announces Filing for Regulatory Approval of TOBI in Europe
04:32 p.m Aug 17, 1998 Eastern

SEATTLE, Aug. 17 /PRNewswire/ -- PathoGenesis Corp. (Nasdaq:PGNS) announced that it plans to file on Tuesday for regulatory approval of TOBI(R) (tobramycin solution for inhalation) in Europe. The TOBI dossier will be filed with the Medicines Control Agency in the United Kingdom. The U.K. is the lead country for seeking regulatory approval of TOBI in the European Union. After TOBI is approved in the U.K., the other European Union countries will be asked to approve the inhaled drug through a mutual recognition process. TOBI is approved in the United States for the management of cystic fibrosis patients with Pseudomonas aeruginosa lung infections.

"We are pleased to reach this important milestone in TOBI's development," said Wilbur H. Gantz, chairman and chief executive officer of PathoGenesis. "We hope to be on the market in the U.K. in the third quarter of next year."

In the U.K., some 7,000 people with cystic fibrosis are treated primarily at 40 cystic fibrosis specialist centers. About another 23,000 cystic fibrosis patients live elsewhere in Europe. TOBI is designed for these patients to take at home in repeated cycles of 28 days on drug, 28 days off drug. Each ready-to-use ampule of TOBI contains 300 milligrams of tobramycin in a 5 milliliter solution. TOBI is aerosolized and administered using a PARI LC PLUS(TM) reusable nebulizer and a suitable air compressor. It is inhaled twice daily and requires about 15 minutes each time.

Seattle-based PathoGenesis Corp. is a pharmaceutical company that develops and markets drugs to treat chronic infectious diseases -- lung infections, in particular -- where there is a significant need for improved therapy. Its European operation, PathoGenesis Limited, is located near London. PathoGenesis' stock is traded on the Nasdaq National Market System under the symbol PGNS. The company's Web site is located at www.pathogenesis.com.

Note: This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to known and unknown risks, uncertainties or other factors that may cause the company's actual results to be materially different from historical results or any results expressed or implied by such forward-looking statements. Factors that might cause such a difference include, but are not limited to, uncertainties related to the fact that PathoGenesis began commercial operations only recently, its dependence on TOBI, third party reimbursement and product pricing, government regulation, drug development and clinical trials, competition and alternative therapies, and other factors described in PathoGenesis' filings with the Securities and Exchange Commission. SOURCE PathoGenesis Corp.

Copyright 1998, PR Newswire 

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