To: Mel Spivak who wrote (215 ) 1/10/2000 6:24:00 PM From: Ram Seetharaman Respond to of 228
January 10, 5:36 pm Eastern Time Company Press Release SOURCE: PathoGenesis Corporation Pathogenesis Corp. Previews Record Fourth Quarter 1999 Sales, Year 2000 Growth Plans at Hambrecht & Quist Conference Sales Exceed Street Consensus Estimate SAN FRANCISCO, Jan. 10 /PRNewswire/ -- PathoGenesis Corp. (Nasdaq: PGNS - news) expects to report record fourth quarter 1999 sales of $19.5 million to $19.7 million for its drug TOBI® (tobramycin solution for inhalation), said Chairman and Chief Executive Officer Wilbur H. Gantz today at the Hambrecht & Quist Life Sciences Conference. These results were at the upper end of the range of analyst expectations. Finalized financial results are scheduled to be announced on Monday, Jan. 24. ''We believe the strength of TOBI's sales is a direct result of the education and outreach programs we implemented last year to help disseminate the positive results of our TOBI studies,'' said Gantz. ''Most of our 1999 sales were in the U.S. We expect to see increased TOBI sales from international markets this year and next, as TOBI receives approvals in additional European countries under the European Union's mutual recognition process. ''TOBI has made PathoGenesis the worldwide leader in inhaled antibiotics,'' added Gantz. ''Our goal is to build on this leadership position with more and better inhaled antibiotics for tough-to-treat lung infections. It's an exciting time to be a pharmaceutical company with expertise in developing aerosolized antibiotics. New technology is creating opportunities for us to help physicians and their patients.'' At the conference, Gantz also announced that: PathoGenesis intends to conduct or co-sponsor in 2000 a number of Phase IV clinical trials of TOBI in a variety of groups, including cystic fibrosis, bronchiectasis, ventilator-associated pneumonia and lung transplant patients. For example, the company plans a clinical trial in cystic fibrosis patients age six through 15 with mild pulmonary symptoms, to investigate whether chronic intermittent use of TOBI will improve pulmonary function versus the decline seen with standard care. In preparation for TOBI's launch in the U.K., where the drug was approved in December 1999, PathoGenesis completed a clinical trial of TOBI in 22 of the country's 44 cystic fibrosis centers. Study results are scheduled to be announced at the 24th European Cystic Fibrosis Conference in June 2000. PathoGenesis intends to develop a more convenient version of TOBI. The company's goal is to reduce TOBI's delivery time from 15-20 minutes to five minutes or less by using a hand-held, portable drug delivery device. Drug delivery companies are developing new generations of nebulizers and dry powder delivery devices that were not available when TOBI was formulated in 1994. A next-generation TOBI could be commercialized as early as 2001, Gantz said. PathoGenesis currently plans to begin Phase I clinical trials of PA- 1806 for inhalation later in 2000. PA-1806, a novel, patented drug candidate, was licensed from Bristol-Myers Squibb and is being developed as an inhaled antibiotic. As a monobactam, PA-1806 has a different mechanism of action than TOBI and potentially could be used in combination with TOBI or in alternating cycles. In preclinical studies, PA-1806 was shown to be active against Pseudomonas aeruginosa, including otherwise resistant strains, as well as other difficult-to-treat lung pathogens, such as Burkholderia cepacia and Stenotrophomonas maltophilia. PathoGenesis intends to select and initiate development of a third antibiotic for inhalation to address broader respiratory infection markets, as a result of its own research programs and collaborations with others. PathoGenesis also announced today a research collaboration with Chiron Corp. (Nasdaq: CHIR - news), with the goal of identifying new classes of antibiotics for oral, intravenous and inhaled administration that could address the increasingly critical issue of drug resistance. The collaboration seeks to combine Chiron's strong combinatorial chemistry library and expertise in high-throughput screening with PathoGenesis' strengths in identifying novel antibiotic targets, assays and drug development. 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 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 patients, variability in wholesaler ordering patterns, drug development and clinical trials, uncertain outcome of the domestic and international 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. SOURCE: PathoGenesis Corporation