NovaDel Licenses Nitroglycerin Lingual Spray to Par
Pharmaceutical
FLEMINGTON, N.J., Sept. 8 /PRNewswire-FirstCall/ -- NovaDel Pharma Inc. (AMEX:NVD) announced that is has entered into a licensing agreement with Par
Pharmaceutical (NYSE:PRX) to market its nitroglycerin lingual spray.
In June, NovaDel filed a New Drug Application with the US FDA seeking marketing
approval for its aerosol lingual spray version of nitroglycerin under Section
505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Under PDUFA guidelines,
the company said a 10-month review period is customary.
If approved as submitted, the product would be indicated 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. This will enable patients to conveniently self-
administer the product.
"Par Pharmaceutical is a very successful marketer of pharmaceutical products
and we are delighted to have them on board as a partner for our first product
submitted for approval," said Gary A. Shangold, MD, NovaDel's president and
chief executive officer.
Under the terms of the agreement, Par has exclusive rights to market, sell and
distribute nitroglycerin lingual spray in the US 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 double-digit
royalties on sales of the product.
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. Par currently
manufactures, markets or licenses more than 80 prescription drugs.
NovaDel Pharma Inc. is a specialty pharmaceutical company engaged in the
development of novel drug delivery systems for prescription and over-the-
counter drugs. The Company's proprietary lingual spray technology delivery
system offers the patient the potential for (i) fast onset of action; (ii)
improved drug safety by reducing the required drug dosage and reducing side
effects; (iii) improved patient convenience and compliance; and (iv) enhanced
dosage reliability. The Company plans to develop such products independently
and through collaborative arrangements with major pharmaceutical and biotech
companies.
Except for historical information contained herein, this document contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements involve known and unknown risks
and uncertainties that may cause the Company's actual results or outcomes to be
materially different from those anticipated and discussed herein including, but
not limited to, the successful completion of its pilot pharmacokinetic
feasibility studies, the ability to develop products (independently and through
collaborative arrangements), the ability to commercialize and obtain FDA and
other regulatory approvals for products under development and the acceptance in
the marketplace for lingual spray products.. Further, the Company operates in
industries where securities may be volatile and may be influenced by regulatory
and other factors beyond the Company's control. Important factors that the
Company believes might cause such differences are discussed in the risk factors
detailed in the Company's most recent Annual Report and Registration
Statements, filed with the Securities and Exchange Commission. In assessing
forward-looking statements contained herein, if any, the reader is urged to
carefully read all cautionary statements contained in such filings.
Contact:
Barry C. Cohen
VP Business & New Product Development
NovaDel Pharma Inc. 908.782-3431 x 2160 Thomas Redington
Redington, Inc. 203.222.7399
212.926.1733
DATASOURCE: NovaDel Pharma Inc.
CONTACT: Barry C. Cohen, VP Business & New Product Development of NovaDel Pharma Inc., +1-908-782-3431 ext., 2160; or Thomas Redington of Redington, Inc., +1-203-222-7399, or +1-212-926-1733,
|