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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 15, 1999
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 on December 15, 1999 announcing that the U.K.
Department of Health has licensed TOBI(R) for the long-term management of
Pseudomonas aeruginosa lung infections in cystic fibrosis patients aged six
years and older.
Item 7. Exhibits
Exhibit Number Description
1 Press Release dated December 15, 1999
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 15, 1999
PATHOGENESIS CORPORATION
By: /s/ Alan R. Meyer
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Alan R. Meyer
Executive Vice President and
Chief Financial Officer
3
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EXHIBIT 1
[LOGO] NEWS RELEASE
PATHOGENESIS CORPORATION 201 ELLIOTT AVENUE WEST, SEATTLE, WASHINGTON 98119
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(206) 467-8100
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FOR IMMEDIATE RELEASE
Contacts: Alan Meyer Maryellen Thielen Susan Callahan
(206) 270-3328 (847) 583-5424 (206) 794-4706
PATHOGENESIS CORP. GAINS U.K. APPROVAL OF TOBI
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First Step Toward Approval in European Union
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SEATTLE, Dec. 15, 1999 - PathoGenesis Corp. (Nasdaq: PGNS) today announced
that the U.K. Department of Health has licensed TOBI(R) 300 mg/5mL Nebuliser
Solution (tobramycin) for the long-term management of chronic pulmonary
infection due to Pseudomonas aeruginosa in cystic fibrosis patients aged six
years and older.
"We are delighted to bring TOBI to physicians and patients in the U.K.,"
said Wilbur H. Gantz, chairman and chief executive officer of PathoGenesis.
"TOBI has been marketed in the U.S. since 1998. Because the cystic fibrosis
clinical community is close-knit, international awareness of TOBI is already
high."
PathoGenesis Limited, a U.K. company, plans to market TOBI in the U.K.,
where about 6,500 patients with cystic fibrosis are treated at 44 cystic
fibrosis specialist centers. In addition, the U.K. is the lead country for
seeking regulatory approval of TOBI in the European Union. The other E.U.
countries will be asked to approve the inhaled drug through a mutual recognition
process. PathoGenesis intends to market TOBI through its own sales force in the
U.K. and several other E.U. countries, while working through distributors in the
remaining countries. PathoGenesis previously announced distributor agreements in
Germany, the Nordic countries, Greece and Cyprus. An estimated 27,000 people
with cystic fibrosis live in Western Europe.
TOBI is designed for 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 acrosolized and
administered using a PARI LC PLUS(TM) resuable nebulizer and a suitable air
compressor. It is inhaled twice daily and requires about 15 minutes each time.
Seattle-based PathoGenesis Corp. develops and commercializes drugs to treat
chronic infectious diseases -- particularly serious lung infections, including
those common in cystic fibrosis, bronchiectasis and ventilator patients.
PathoGenesis' stock is traded on the Nasdaq
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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, uncertain outcome of
the drug approval process, 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.
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