Par Pharmaceutical Licenses Nitroglycerin Lingual Spray From
NovaDel Pharma Inc. Agreement Provides Par Access to Potential New Product
SPRING VALLEY, N.Y., Sept. 8 /PRNewswire-FirstCall/ -- Par Pharmaceutical
Companies, Inc. (NYSE:PRX) today announced that it has entered into a licensing
agreement with developer NovaDel Pharma Inc. (AMEX:NVD) to market an aerosol
nitroglycerin lingual spray. In June 2004, NovaDel submitted a New Drug
Application, pursuant to Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act, to the U.S. Food and Drug Administration seeking marketing
approval for the product. Aerosol nitroglycerin lingual spray is intended for
acute relief of an attack or acute prophylaxis of angina pectoris due to
coronary artery disease. The product is delivered via a metered dose dispenser
designed to ensure accurate dose delivery, enabling patients to conveniently
self-administer the product.
Under the terms of the agreement, Par has exclusive rights to market, sell and
distribute aerosol nitroglycerin lingual spray in the U.S. and Canada. NovaDel
is responsible for obtaining regulatory approval for the product and for
supplying the product to Par. NovaDel will receive milestone payments and
royalties on sales of the product.
NovaDel Pharma Inc., located in Flemington, NJ, is a specialty pharmaceutical
company engaged in the development of novel drug delivery systems for
prescription and over-the-counter drugs.
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. DATASOURCE: Par Pharmaceutical Companies, Inc.; NovaDel Pharma Inc.
CONTACT: Stephen J. Mock, Vice President, Corporate Affairs, Par Pharmaceutical Companies, Inc., +1-201-802-4000 Web site: http://www.parpharm.com/
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