PR Newswire, Monday, March 23, 1998 at 08:31
SEATTLE, March 23 /PRNewswire/ -- PathoGenesis Corp. (NASDAQ:PGNS) today announced that it has filed a new drug submission in Canada for TOBI(TM)
(tobramycin solution for inhalation) for the management of cystic fibrosis patients with Pseudomonas aeruginosa. The Health Protection Branch of Canada
has granted TOBI a priority review.
"Canada represents our first drug's first market outside the U.S.," said Wilbur H. Gantz, chairman and chief executive officer of PathoGenesis. "We intend to file for regulatory approval in Europe later this year. We are moving as quickly as possible to bring TOBI to the major markets where people
with cystic fibrosis live. Many of their physicians have heard about TOBI at international cystic fibrosis meetings and have already expressed interest in our drug."
TOBI is a stable, sterile, premixed, proprietary formulation of the
antibiotic tobramycin for delivery by inhalation using a Pari LC Plus(TM) nebulizer and Pulmo-Aide(R) compressor. In two double-blind, placebo-controlled, six-month Phase III clinical trials in 520 patients in U.S. cystic fibrosis centers, TOBI enabled patients to improve and maintain lung function. Patients also required fewer days in the hospital and fewer days of other anti-pseudomonal antibiotic therapy.
Cystic fibrosis affects about 3,000 people in Canada. It is a Caucasian genetic disease that is characterized by the production of thick, sticky mucus that obstructs the lung airways and contributes to P. aeruginosa lung infections, gradual destruction of lung tissue, and eventual respiratory failure. Periodic flare-ups of lung infections can cause life-threatening episodes and hospitalization for treatment with intravenous antibiotics. TOBI is designed for patients to take at home in repeated cycles of 28 days on drug, 28 days off drug.
PathoGenesis Corp. develops drugs for treating serious infectious
diseases where there is a significant need for improved therapy. The company is currently developing drug candidates to treat chronic lung infections in cystic fibrosis and bronchiectasis patients, as well as tuberculosis infections. PathoGenesis is headquartered in Seattle and has additional facilities in Skokie, Ill.; Annandale, N.J.; and Brentford, Middlesex, U.K.
Its 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 involve known and unknown risks, uncertainties or
other factors which may cause actual results, performance or achievements of the company to be materially different from any future results, performance or achievements 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 company's dependence on TOBI, government regulation, the development of drug candidates, competition and pharmaceutical
pricing. Further information regarding these and other factors is available in PathoGenesis' Annual Report on Form 10-K for 1996 and other documents filed with the Securities and Exchange Commission.
SOURCE PathoGenesis Corp. -0- 03/23/98
/CONTACT: Alan Meyer, 206-467-8100, or Maryellen Thielen, 847-583-5424, both of PathoGenesis Corp.; or Barbara Lindheim of Noonan-Russo, 212-696-4455,
X237/ /Web site: pathogenesis.com |
