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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 30, 1997
PATHOGENESIS CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 0-27150 91-1542150
(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
201 Elliott Avenue West, Seattle, Washington 98119
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (206) 467-8100
Not Applicable
(Former name or former address, if changed since last report)
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Item 5. Other Events.
Annexed hereto as Exhibit 1 is a copy of a press release issued by
PathoGenesis Corporation (the "Company") on January 30, 1997 announcing the
results of its Phase III clinical trials for TOBI(TM) for treatment of chronic
Pseudomonas aeruginosa lung infections in people with cystic fibrosis.
In connection with the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, the Company is hereby filing as
Exhibit 2 cautionary statements identifying important factors that could cause
the Company's actual results to differ materially from those projected in
forward looking statements of the Company made by or on behalf of the Company in
the press release annexed hereto as Exhibit 1.
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Item 7. Exhibits
1. Press Release dated January 30, 1997.
2. Cautionary Statements for Purposes of the "Safe Harbor"
Provisions of the Private Securities Litigation Reform Act of
1995.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this Report to be signed by the undersigned
hereunto duly authorized.
PATHOGENESIS CORPORATION
(Registrant)
By: /s/ Alan R. Meyer
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Alan R. Meyer
Senior Vice President and
Chief Financial Officer
Date: January 31, 1997
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EXHIBIT INDEX
Exhibit Page Number
1. Press Release dated January 30,
1997.
2. Cautionary Statements for Purposes
of the "Safe Harbor" Provisions of
the Private Securities Litigation
Reform Act of 1995.
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EXHIBIT 1
SEATTLE, Jan. 30 /PRNewswire/ -- PathoGenesis Corp. (Nasdaq: PGNS) today
announced the results of its Phase III clinical trials of TOBI(TM) (tobramycin
for inhalation) for treatment of chronic Pseudomonas aeruginosa lung infections
in people with cystic fibrosis.
PathoGenesis conducted two double-blind, placebo-controlled Phase III
clinical trials of its TOBI drug. A total of 468 patients in 69 cystic fibrosis
care centers in the U.S. completed the trials. Treatment with the drug or a
placebo was intermittent for six months, with patients on 300 mg. of aerosolized
treatment twice daily for four weeks, then off therapy for four weeks. During
the trials, patients continued to be treated with standard therapies as symptoms
warranted. The primary end point studied was lung function, as measured by
forced expiratory volume at one second (FEV1). A secondary end point measured
was hospitalization days.
Compared with placebo, TOBI improved lung function in the two pivotal
trials, resulting in an improvement of more than 11 percent by the end of the
six-month study period. The mean number of hospitalization days across both
studies declined 36 percent to 5.2 days for the TOBI group versus 8.2 days for
the placebo group. Observed bacterial counts in the sputum (phlegm) of patients
taking TOBI declined, while observed bacterial counts increased in the placebo
group. Over the six-month study period, the difference in observed bacterial
density between the two groups was 10-fold. The foregoing data were
statistically significant when analyzed on an "intent to treat" basis.
Reported adverse events were comparable between the groups taking TOBI
and the placebo. In TOBI patients, the presence of pseudomonal bacteria
potentially resistant to levels of tobramycin in the lungs achieved by aerosol
administration was low: 4 percent at the beginning and 5.4 percent at the end of
the trial.
All patients who completed the Phase III clinical trials were eligible
for a follow-on program, allowing them to receive TOBI treatment for another
12-month period. More than 85 percent of the patients chose to participate. This
program allows PathoGenesis to gather longer-term safety and efficacy data.
PathoGenesis intends to file a new drug application for TOBI with the
Food & Drug Administration (FDA) in the second quarter of 1997. The principal
investigator, Dr. Bonnie Ramsey of Children's Hospital, Seattle, expects to make
a scientific presentation of the data at a Cystic Fibrosis Foundation meeting on
March 5-7.
"The success of the study demonstrates what can be accomplished when
dedicated researchers, caregivers and the biotechnology industry work together
with a common goal," said Robert J. Beall, Ph.D., president and chief executive
officer of the Cystic Fibrosis Foundation.
"We are delighted to announce these results -- and to be developing a
product that may significantly improve patients' quality of life," said Wilbur
H. Gantz, chief executive officer of PathoGenesis. "Our company's goal is to
focus on treating serious infectious diseases where there's
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a real need for better treatments. With TOBI as our lead drug, we feel strongly
that we're accomplishing our goal."
"We look forward to a review of our results by the FDA and the
scientific community," said Dr. Bruce Montgomery, senior vice president of
research and development at PathoGenesis. "In addition, I want to take this
opportunity to thank the clinical investigators, especially those from
Children's Hospital in Seattle, for their contributions. Credit is also due to
the Cystic Fibrosis Foundation, which sponsored the initial research on
aerosolized tobramycin and encouraged us to pursue the idea."
TOBI is a stable, premixed, proprietary formulation of the antibiotic
tobramycin for delivery by inhalation using a nebulizer. Tobramycin, a broad-
spectrum antibiotic, has been administered intravenously to cystic fibrosis
patients with lung infections for more than 20 years. However, its use has been
limited to patients hospitalized for acute flare-ups of their chronic lung
infections primarily because severe kidney damage or hearing loss can result
from extended intravenous treatment. Conversely, delivery by inhalation permits
application of much higher concentrations than intravenous administration, since
the drug is deposited directly to the site of infection in the lungs with little
absorption into the bloodstream. TOBI is designed to expand the use of
tobramycin beyond short-term hospitalizations to long-term, home administration
to suppress the life-threatening pseudomonal infections that are common in
cystic fibrosis patients. Cystic fibrosis affects about 30,000 people in the
U.S., according to the Cystic Fibrosis Foundation, and about 25,000 in Europe,
according to European health authorities. PathoGenesis has received a U.S.
formulation patent for TOBI and an orphan drug designation from the FDA for
inhaled tobramycin to treat pulmonary infections in people with cystic fibrosis.
PathoGenesis Corp. develops drugs for treating serious infectious
diseases where there is a significant need for improved therapy. The company is
currently developing TOBI (tobramycin for inhalation) for treating chronic lung
infections in bronchiectasis patients, as well as TOBI, PA-1648 and PA- 824 for
treating tuberculosis infections. The company has offices in Seattle; Skokie,
Ill.; and Annandale, N.J. PathoGenesis' Seattle headquarters can be reached by
dialing 206-467-8100.
The Cystic Fibrosis Foundation is a nonprofit voluntary health
organization. Its mission is to develop the means to a cure and control of
cystic fibrosis while improving the quality of life for those with the disease
today. Early studies into the potential for aerosolized tobramycin were
supported by a grant from the foundation.
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, those
discussed under the heading "Risk Factors" in the company's prospectus dated
April 25, 1996, which was filed with the Securities and Exchange Commission.
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EXHIBIT 2
CAUTIONARY STATEMENTS FOR PURPOSES OF THE "SAFE HARBOR"
PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
The Company wishes to caution readers that the following important
factors, among others, as more fully described under the heading "Risk Factors"
in the Company's prospectus (the "Prospectus"), dated April 25, 1996, filed with
the Securities and Exchange Commission pursuant to the requirements of Rule
424(b) promulgated under the Securities Act of 1933, could affect, PathoGenesis'
product development efforts relating to its lead drug candidate, TOBI(TM)
(tobramycin for inhalation), as well as any other drug candidates that the
Company may seek to develop in the future.
The Company's product development efforts are subject to a variety of
uncertainties inherent in the development of pharmaceutical products. These
uncertainties include the possibilities that the Company's drug candidates will
be found to be ineffective, unsafe, toxic or otherwise fail to meet applicable
regulatory standards or receive necessary regulatory clearances; that any such
drug candidates, if safe and effective, will be difficult to develop into
commercially viable products, to manufacture on a large scale or be uneconomical
to market; or that proprietary rights of third parties will preclude the Company
from marketing any products developed by the Company. There is, therefore,
substantial uncertainty whether the Company's product development efforts will
prove to be successful. Moreover, the Company is seeking to develop new
treatments for conditions that are also the subject of research and development
efforts by other companies and entities. The Company's competitors may succeed
in developing technologies or products that are more effective or cost effective
than those of the Company. Rapid technological changes or developments by others
may result in the Company's drug candidates becoming obsolete or noncompetitive.
There can be no assurance that regulatory approvals will be obtained or
will be as broad as sought, that TOBI(TM) will be capable of being produced in
commercial quantities at reasonable costs or that any products, if introduced,
will achieve market acceptance.
