Inyx Selected by NovaDel Pharma to Produce Nitroglycerin Lingual
Spray
NEW YORK, Nov. 23 /PRNewswire-FirstCall/ -- Inyx, Inc. (OTC Bulletin Board:
IYXI), a specialty pharmaceutical company with a focus on niche drug delivery
technologies and products, announced today that it has been selected by NovaDel
Pharma Inc. (AMEX:NVD) to produce NovaDel's nitroglycerin lingual spray for the
treatment of acute angina, under an exclusive five-year contract.
In June, NovaDel filed a New Drug Application (NDA) with the U.S. Food and Drug
Administration seeking marketing approval for its aerosol lingual spray version
of nitroglycerin under Section 505(b) (2) application that relies on data
developed by NovaDel and historical data published in the literature. On
September 29, 2004, NovaDel reported that the NDA has been accepted for review
by the FDA. The Prescription Drug User Act (PDUFA) goal date is June 4, 2005.
As a result, the targeted date for Inyx to commence production of the NovaDel
product is mid-2005. Under the contract, Inyx will produce the nitroglycerin
spray for the United States and most international markets for the first five
years on an exclusive manufacturing basis, and then on a non- exclusive basis
for the following five years. Inyx intends to produce the NovaDel
nitroglycerin spray out of Manati, Puerto Rico. On October 7, 2004, Inyx
announced it had agreed to acquire from Sanofi-Aventis Group (NYSE:SNY) the
Aventis Pharmaceuticals Puerto Rico site in Manati, with the acquisition
anticipated to close by March 31, 2005.
Jack Kachkar, M.D., Chairman and CEO of Inyx, said, "We are very gratified to
have been selected by NovaDel to produce this very important product for the
company. We are looking forward to a long-term relationship with NovaDel."
Discussions are already underway regarding agreements for additional products
currently in NovaDel's pipeline.
Gary A. Shangold, M.D., NovaDel's President and CEO, said, "This is the first
of NovaDel's six Tier One priority products to reach the stage of NDA
submission. Inyx was selected because of its manufacturing expertise for
metered dose sprays in particular and inhalation-therapy products in general." If the NDA is approved as submitted, NovaDel's nitroglycerin lingual spray will
be intended for acute relief of an attack or acute prophylaxis of angina
pectoris, which is chest pain or discomfort due to coronary artery disease. The
nitroglycerin treatment is delivered via a metered dose dispenser designed to
ensure accurate dose delivery. This will enable patients to self- administer
the product just as they would a breath freshener.
In the United States alone, nearly seven million people suffer from acute
angina pectoris, according to the American Heart Association, and U.S. retail
sales of nitroglycerin (both capsules and sprays) are in excess of $100 million
annually. Approximately the same number of patients in the five largest
markets of Europe (Germany, United Kingdom, France, Italy and Spain) have acute
angina, according to the British Heart Foundation. It is prescribed that
anyone with chronic stable angina keep nitroglycerin tablets or spray with them
at all times.
On September 8, 2004, NovaDel announced that it entered into a licensing
agreement with Par Pharmaceutical Companies, Inc. (NYSE:PRX) to market its
nitroglycerin lingual spray in the U.S. and Canada. In July, NovaDel was
awarded European Union patent No. 0927032 covering the product.
About Inyx Inyx, Inc. is a specialty pharmaceutical company with aerosol drug delivery
technologies and products for the treatment of respiratory, allergy,
dermatological, topical and cardiovascular conditions. Inyx focuses its
expertise on both prescription and over-the-counter pharmaceutical products,
and provides specialty pharmaceutical development and production consulting
services to the international healthcare market. In addition, Inyx is
developing its own proprietary products to be marketed by selected clients and
strategic partners, which include some of the largest pharmaceutical companies. The company's operations are conducted through its wholly owned subsidiary,
INyX Pharma Limited, with R&D and production facilities located near
Manchester, England, which serves global markets including: North America,
Europe, Latin & South America and the Middle East. Another wholly owned
subsidiary, Inyx Canada, Inc. based in Toronto, provides business development
and support services. Inyx, Inc.'s corporate offices are in New York City.
For more information: http://www.inyxinc.com/.
About NovaDel 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. For more information: http://www.novadel.com/.
About Par Pharmaceutical 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. For more
information: http://www.parpharm.com/.
Safe Harbor Statements about Inyx's future expectations, including future revenues and
earnings, and all other statements in this press release other than historical
facts, are "forward-looking statements" within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934,
and as that term is defined in the Private Securities Litigation Reform Act of
1995. The Company intends that such forward-looking statements be subject to
the safe harbors created thereby. Since these statements involve risks and
uncertainties and are subject to change at any time, the Company's actual
results could differ materially from expected results.
For more information, please contact:
Jay M. Green, Executive VP
Inyx, Inc. 416-250-1999
Barry C. Cohen, VP Business & New Product Development
NovaDel Pharma Inc. 908-782-3431, ext. 2160
DATASOURCE: Inyx, Inc.
CONTACT: Jay M. Green, Executive VP of Inyx, Inc., +1-416-250-1999, ; or Barry C. Cohen, VP Business & New Product Development of NovaDel Pharma Inc., +1-908-782-3431, ext. 2160 Web site: http://www.inyxinc.com/ http://www.novadel.com/ http://www.parpharm.com/
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