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PathoGenesis Corp. Announces Two-Year Data on TOBI
THE HAGUE, Netherlands, June 14 /PRNewswire/ -- Two-year data on TOBI(R)
(tobramycin solution for inhalation), which is marketed by PathoGenesis Corp.
(Nasdaq: PGNS), were presented at a satellite meeting of the 23rd European
Cystic Fibrosis Conference.
"The two-year adolescent data are particularly exciting, because the
results suggest that TOBI can modify the course of the disease," said
C. Michael Bowman, Ph.D., M.D., of the University of Southern California
Department of Pediatrics, Los Angeles, who presented the data at the European
conference. "The data show that chronic intermittent therapy with TOBI
maintains benefits to patients for at least 96 weeks."
Patients inhaling TOBI in repeated cycles of 28 days on drug, 28 days off
drug were treated for up to two years. At the end of the last on-drug period,
these patients had on average a 4.8 percent relative improvement in lung
function above the baseline. Although this treatment experience was open
label, other studies and statistics generally have shown an annual relative
lung function decline of 2 percent to 7 percent in comparable cystic fibrosis
patients receiving standard therapies, or about 4 percent to 14 percent over
two years. While TOBI therapy resulted in treatment benefits for all age
groups, patients who were 13 to 17 years old demonstrated a larger treatment
effect of 14.3 percent in relative lung function improvement above the
baseline after two years.
"The two-year data confirms what we've been hearing from cystic fibrosis
patients," said Wilbur H. Gantz, chairman and chief executive officer of
PathoGenesis. "TOBI works and it works well."
Additional data from the two-year study of TOBI will be presented at the
North American Cystic Fibrosis Conference, Oct. 7-10 in Seattle.
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 DeVilbiss Pulmo-Aide(R) air compressor. It
is inhaled twice daily and requires about 15 minutes per treatment. The TOBI
treatment regimen consists of repeated cycles of 28 days on drug, followed by
28 days off drug.
Seattle-based PathoGenesis Corp. is a pharmaceutical company that develops
drugs to treat chronic infectious diseases -- lung infections, in particular
-- where there is a significant need for improved therapy. The company
markets TOBI, an inhaled antibiotic, in the U.S., Canada, and Argentina for
management of P. aeruginosa infections in patients with cystic fibrosis.
Applications for regulatory approval of TOBI have been filed in Europe and
other markets. In addition, PathoGenesis is further developing TOBI and other
drug candidates to treat serious chronic lung infections, including those
common in cystic fibrosis, bronchiectasis and tuberculosis patients.
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 only began commercial operations in 1998, its dependence on
TOBI, the degree of penetration of its markets and frequency of TOBI's use by
patients, third party reimbursement and product pricing, seasonal impacts on
hospitalizations or exacerbations experienced by cystic fibrosis patients,
variability in wholesaler ordering patterns, drug development and clinical
trials, competition and alternative therapies, and other factors described in
PathoGenesis' filings with the Securities and Exchange Commission, including
the company's Form 10-K for 1998 and Exhibit 99.1 to that Form 10-K.
SOURCE PathoGenesis Corporation
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