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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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): December 23, 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 No.) Identification No.)
incorporation)
201 Elliott Avenue West, Seattle, Washington 98119
(Address of principal executive offices)
(206) 467-8100
(Registrant's telephone number, including area code)
Not applicable
(Former name or former address, if changes 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 December 23, 1997 announcing the
marketing clearance received by the Company from the Food and Drug
Administration 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.
Item 7. Exhibits
See Exhibit Index appearing elsewhere herein, which is incorporated herein
by reference.
2
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Dated: December 30, 1997
PATHOGENESIS CORPORATION
By: /s/ Alan R. Meyer
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Alan R. Meyer
Senior Vice President and
Chief Financial Officer
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PATHOGENESIS CORPORATION
EXHIBIT INDEX
Exhibit Number Description
1 Press Release dated December 23, 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
CONTACT: Linda Mura, Porter Novelli
312/856-8882
Maryellen Thielen, PathoGenesis Corporation
847/583-5424
FOR IMMEDIATE RELEASE
FDA GRANTS MARKETING CLEARANCE FOR TOBI/(TM)/
(Tobramycin Solution for Inhalation)
Clinical trial results show improved and maintained lung function
in people with cystic fibrosis
SEATTLE, Dec. 23, 1997 -- PathoGenesis Corp. (Nasdaq: PGNS) today announced
it has received marketing clearance from the Food and Drug Administration (FDA)
for TOBI/(TM)/ (Tobramycin Solution for Inhalation), a new formulation of the
antibiotic tobramycin, specifically designed for inhalation and indicated for
the management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa.
"TOBI is a significant advance in treating people with cystic fibrosis,"
said Robert J. Beall, Ph.D., president and chief executive officer of the Cystic
Fibrosis Foundation (CFF). "By an early age, P. aeruginosa, the bacteria that
causes 80 percent of CF lung infections, becomes the dominant pathogen in the
lungs. These infections make it difficult to breathe and often cause
hospitalization. TOBI is the first FDA-approved antibiotic solution for
inhalation to treat people with CF." CF is the most common life-threatening
inherited disease in the United States, affecting about 30,000 children and
adults.
Two double-blind, randomized, placebo-controlled clinical trials were
conducted for 24 weeks at cystic fibrosis centers across the U.S. A total of 520
cystic fibrosis patients ages 6 to 63 with P. aeruginosa lung infections
participated in the Phase III trials. Patients were divided into two groups --
those receiving standard CF therapy and those receiving TOBI plus standard CF
therapy. TOBI-treated patients received drug in repeated cycles of 28-days on
drug, 28-days off drug.
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page 2
Compared with placebo plus standard CF therapy, six-month clinical trials
of TOBI showed:
. Improved and maintained lung function: TOBI-treated patients demonstrated a
significant improvement in lung function compared to those receiving
standard CF therapy.
. Fewer days in the hospital: On average, TOBI-treated patients were
hospitalized three fewer days than patients receiving standard CF therapy
-- 5.1 days for TOBI patients, compared to 8.1 days for placebo patients.
. Fewer days requiring anti-pseudomonal antibiotics: On average, TOBI-treated
patients required 4.4 fewer days of intravenous anti-pseudomonal therapies
than patients receiving standard CF therapies -- 9.7 days for TOBI
patients, compared to 14.1 days for placebo patients.
"The results from the clinical trials were excellent -- TOBI maintained
improvement in pulmonary function over six months," said Bonnie Ramsey, M.D., CF
Center Director, Children's Hospital and Regional Medical Center, Seattle, and
Principal Investigator of the TOBI clinical trials. "Patients typically lose 2
percent of lung function annually, so this level of improvement is a significant
step forward in managing the disease."
Clinical studies show TOBI was well tolerated by patients. More TOBI-
treated patients experienced hoarseness (13 percent versus 7 percent in placebo
patients) and ringing in the ears (3 percent versus none of the placebo
patients). All episodes of ringing in the ears were temporary and resolved
without stopping the TOBI treatment regimen. Bronchospasm also may occur with
inhalation of TOBI. Caution should be used with patients receiving TOBI who are
known or suspected to have kidney, hearing or neuromuscular problems; are
pregnant or become pregnant; or are receiving intravenous aminoglycoside
treatment. Safety and effectiveness were not studied in patients under the age
of six years, patients with lung function of less than 25 percent or more than
75 percent of predicted normal levels, or patients colonized with Burkholderia
cepacia.
-more-
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Treatment with TOBI did not affect the susceptibility of the majority of P.
aeruginosa isolates during the six-month studies. TOBI therapy resulted in a
significant reduction in P. aeruginosa density in sputum (phlegm) during the on-
drug periods. Sputum bacterial density returned to baseline during the off-drug
periods. Reductions in sputum bacterial density were smaller in each successive
cycle.
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 10-15 minutes per treatment. The TOBI
treatment regimen consists of repeated cycles of 28-days on drug, followed by
28-days off drug.
Cystic fibrosis is characterized by the production of unusually thick,
sticky mucus that typically blocks the airways of the lungs. Consistent
production of mucus prevents clearance of bacteria, allowing them to colonize
and multiply. As a result, chronic infection and inflammation occur, causing
people with cystic fibrosis to experience persistent coughing, sputum
expectoration and wheezing. The continuous inflammation and infection lead to
lung damage and destruction, and ultimately, death. CF can also affect other
areas of the body, including the pancreas and sweat glands.
TOBI was made possible in part by early research into the potential for
aerosolized tobramycin that was supported by a grant from the Cystic Fibrosis
Foundation and conducted by Children's Hospital and Regional Medical Center in
Seattle. Information about the CFF is available on the Internet at
http://www.cff.org.
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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 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 absence of products and 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.
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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 headling "Risk Factors" in the
Company's registration statement on Form S-1, dated March 17, 1997, filed with
the Securities and Exchange Commission pursuant to the requirements of the
Securities Act of 1933, could affect, the Company's 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, even if safe and effective, may not develop into commercially
viable products, or may not be manufactured or marketed economically; and 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 others. 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 TOBI/(TM)/ will be capable of being produced
in commercial quantities at reasonable costs or that any products, if
introduced, will achieve market acceptance.
