Spring Valley, New York, October 25, 2004— Par Pharmaceutical Companies, Inc. (NYSE:PRX) today announced that it has entered into a licensing agreement with developer Nastech Pharmaceutical Company Inc. (Nasdaq:NSTK) to market a calcitonin-salmon nasal spray. In February 2004, the U.S. Food and Drug Administration accepted for filing Nastech's Abbreviated New Drug Application for the product. Novartis AG currently markets calcitonin-salmon nasal spray under the brand name Miacalcin®. The product is indicated for the treatment of postmenopausal osteoporosis and has annual U.S. sales of approximately $240 million.
"Nastech's highly innovative approach to nasal drug formulation and delivery distinguishes them as a leader in this therapeutic area," said Scott Tarriff, president and chief executive officer of Par. "We look forward to working closely with our new partner to successfully commercialize this product, and to providing patients with a much desired generic alternative."
"We believe Par represents an excellent partner with significant experience in specialty pharmaceutical marketing and the resources necessary to maximize the commercial potential of this product candidate," said Steven C. Quay, M.D., Ph.D., chairman, president and chief executive officer of Nastech.
Under the terms of the agreement, Par has exclusive rights to market, sell and distribute calcitonin-salmon nasal spray in the U.S. Nastech is responsible for obtaining regulatory approval for the product and for supplying the product to Par. Nastech will receive milestone payments and a share of the profits from the sales of the product.
Nastech Pharmaceutical Company Inc., located in Bothell, Washington, is a leader in drug delivery. The company is developing a platform technology for delivering both small and large molecule drugs by nasal administration. Additional information about Nastech is available at http://www.Nastech.com.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc., and its recently acquired subsidiary, Kali Laboratories, Inc. The company is also developing an additional line of branded pharmaceutical products for specialty markets and expects to introduce the first of these in 2005. Through its FineTech subsidiary, Par also develops and utilizes synthetic chemical processes to design and develop intermediate ingredients used in the production of finished products for the pharmaceutical industry. Par currently manufactures, markets or licenses more than 80 prescription drugs. For press release and other company information, visit http://www.parpharm.com.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission, such as the company's Form 10-K, Form 10-Q, and Form 8-K reports.
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