Pharmaceutical Resources (PRX)

[EZ2]

Press Release Source: Par Pharmaceutical, Inc.


Par Pharmaceutical Announces Filing Of Tramadol Hydrochloride Tablets With Acetaminophen
Monday October 21, 6:00 am ET
ANDA Filing with Paragraph IV Certification Is Believed To Be First for Tramadol Hydrochloride Tablets with Acetaminophen


SPRING VALLEY, N.Y., Oct. 21 /PRNewswire-FirstCall/ -- Par Pharmaceutical, Inc., a subsidiary of Pharmaceutical Resources, Inc. (NYSE: PRX - News), today announced that through its alliance partner Kali Laboratories, Inc., an Abbreviated New Drug Application (ANDA) was filed with a paragraph IV certification for tramadol hydrochloride tablets with acetaminophen. Johnson and Johnson currently markets 37.5 mg tramadol HCl/325 mg acetaminophen tablets under the brand name Ultracet®. Introduced in September 2001, Ultracet® is indicated for the short-term (five days or less) management of acute pain. The product achieved U.S. sales of more than $40 million in the second quarter of 2002.
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Kali Laboratories, Inc. submitted the ANDA to the U.S. Food and Drug Administration (FDA) in which Par believes was the first ANDA to be filed with a paragraph IV certification. According to current FDA practice, Par believes it may be entitled to exclusively market a generic tramadol/acetaminophen product for up to 180 days.

"We are very pleased to add another promising drug candidate to our ever expanding new product pipeline," said Scott Tarriff, president and chief executive officer. "Par has over twenty-five drugs awaiting FDA approval and, now with tramadol, as many as six of these may represent first-to-file opportunities. With more than 40 additional drugs currently in development, our Company possesses a new product pipeline that is among the most robust in our industry."

Kali Laboratories, Inc., a research and development-based company located in New Jersey, will manufacture tramadol hydrochloride tablets with acetaminophen and Par will have the exclusive right to market the product. Under terms of its agreement with Kali, Par will retain the majority of the profit generated by the sale of the product following receipt of final marketing clearance.

PRX, a holding company, develops, manufactures, and distributes generic pharmaceuticals through its wholly owned subsidiary, Par Pharmaceutical. Through its FineTech unit, PRX also develops and utilizes synthetic chemical processes to design and develop intermediate ingredients used in the production of finished products for the pharmaceutical industry. PRX currently manufactures and distributes over 139 products representing various dosage strengths of 58 drugs. For press release and other Company information, visit our website at 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, including those concerning management's expectations with respect to future events or future financial performance. Any such statements that refer to PRX's anticipated future results, product performance, release date of future products, or other non-historical facts are forward-looking and reflect PRX's current perspective of existing trends and information. These statements involve risks and uncertainties that cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the uncertainty associated with complex litigation, including the eventual outcome and litigation costs and expenses incurred along the way, the success of PRX's product development activities, and the timeliness with which regulatory authorizations and product introductions may be achieved, market acceptance of PRX's products, the availability of raw materials on commercially reasonable terms, successful compliance with extensive, costly, complex, and evolving governmental regulations and restrictions, exposure to product liability, and other risks and uncertainties detailed in PRX'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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Source: Par Pharmaceutical, Inc.


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