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| |  Multi-Site Outpatient Phase IIb Pulmonary Insulin Trial Initiated PALO ALTO, Calif., Oct. 28, 1996 -- Inhale Therapeutic Systems (NASDAQ:INHL) today announced that Pfizer Inc. has initiated a multi-site outpatient trial to test systemic delivery of insulin through the lungs using Inhale's pulmonary delivery system. The trial is planned to include up to 240 patients. Inhale also announced that Pfizer has made an additional $5 million equity investment in Inhale at a price of $18.35/share. This price represents a 25% premium to the market price of Inhale stock. "This equity investment is an important milestone in our pulmonary insulin program with Pfizer," said Robert Chess, President and CEO of Inhale. "We are pleased that the Phase I and IIa trial results have been encouraging and that we have completed the technology development and scale-up work to begin later-stage clinical trials." The multi-site Phase IIb trial is designed to test the effectiveness of pulmonary-delivered insulin using Inhale's system in controlling blood glucose levels following chronic administration in diabetics over several months of use. The Phase I and IIa trial data indicated that pulmonary insulin was absorbed systemically and lowered glucose levels. Insulin is currently administered by injection. Inhale believes that pulmonary insulin could provide increased user convenience and result in greater patient compliance by reducing or in some cases eliminating injections. Worldwide sales of insulin and syringes for insulin injections were estimated to be $2.7 billion in 1995. In the collaboration between the two companies, Pfizer is leading the clinical development, and Inhale is providing the inhalation devices and packaged powders. Pfizer is providing Inhale with funding for R&D, and will provide milestone payments, and royalties on sales of products in exchange for worldwide commercialization rights. Upon commercialization, Inhale will supply Pfizer with devices and powders. Pfizer made an up-front payment and an equity investment of $5 million in Inhale when the deal between the companies was consummated in February, 1995. Inhale's pulmonary delivery system administers fine, dry aerosol powders to the deep lung. From the deep lung, the aerosolized macromolecules are transported through the lung tissue to the bloodstream for systemic distribution. Like insulin, most peptides, proteins, and other biotechnology-based products currently can only be delivered by injection. Inhale is developing a pulmonary delivery system to enable a wide range of these drugs, including macromolecules, to be delivered by the pulmonary route for systemic and local lung indications. The company currently has four drugs in clinical trials using its delivery system, and has feasibility and development partnerships with several pharmaceutical and biotechnology companies including Baxter, Pfizer, Alza, Immunex, Asahi, Centeon, Genzyme, and others. Inhale is publicly traded on NASDAQ under the symbol INHL.
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