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| 8-K - NOVADEL PHARMA INC | form8k102909.htm |
Exhibit
99.1
NovaDel
Licenses its NitroMist® Lingual Spray to Mist
Flemington,
NJ – October 27, 2009
NovaDel
Pharma Inc., (NYSE AMEX: NVD) has entered into a licensing agreement
with privately-held Mist Acquisition, LLC to manufacture and commercialize the
NitroMist® lingual spray version of nitroglycerine, a widely-prescribed and
leading short-acting nitrate for the treatment of angina pectoris. Under terms
of the agreement, Mist will pay NovaDel a $1,000,000 licensing fee upon
execution of the agreement, milestone payments totaling an additional $1,000,000
over the next twelve months and ongoing performance payments of seventeen
percent (17%) of net sales.
Through a
separate license agreement with Mist, Akrimax Pharmaceuticals, LLC will receive
the exclusive right to manufacture, distribute, market and sell NitroMist® in
North America. NitroMist® provides acute relief of an attack or acute
prophylaxis of angina pectoris due to coronary artery disease. The lingual spray
form of the drug is conveniently administered and is rapidly absorbed into the
bloodstream via the oral mucosa providing patients a fast and tolerable
treatment option for the prevention or relief of pain associated with such
attacks.
“Akrimax’s
focus on metabolic diseases and its leadership’s proven experience launching
successful products and companies makes it an ideal partner to launch this
innovative therapy,” said Steven B. Ratoff, NovaDel’s Chairman and Interim CEO.
“We’re delighted to have Akrimax leveraging its manufacturing expertise and
progressive commercial platform to optimize the value of NitroMist®” he
added.
“NitroMist®
offers an important practical innovation in the delivery of a life support
medicine for cardiovascular patients suffering from angina,” stated Alan L.
Rubino, CEO and President of Akrimax. “We are extremely enthusiastic
to be introducing and commercializing NitroMist® as this new product is an
excellent complement to our developing cardiovascular and metabolic
portfolio.”
About
NovaDel Pharma
NovaDel
Pharma Inc. is a specialty pharmaceutical company developing oral spray
formulations for a broad range of marketed drugs. The Company’s proprietary
technology offers, in comparison to conventional oral dosage forms, the
potential for faster absorption of drugs into the bloodstream leading to quicker
onset of therapeutic effects and possibly reduced first pass liver metabolism,
which may result in lower doses. Oral sprays eliminate the requirement for water
or the need to swallow, potentially improving patient convenience and
adherence.
NovaDel’s
oral spray technology is focused on addressing unmet medical needs for a broad
array of existing and future pharmaceutical products. The Company’s most
advanced oral spray candidates target angina, nausea, insomnia, migraine
headaches and disorders of the central nervous system. NovaDel plans to develop
these and other products independently and through collaborative arrangements
with pharmaceutical and biotechnology companies. To find out more about NovaDel
Pharma Inc. (NYSE AMEX: NVD), visit our website at www.novadel.com.
About
Akrimax Pharmaceuticals, LLC
Akrimax
Pharmaceuticals, LLC is a privately-held, fully-integrated next-generation
specialty pharmaceutical company that acquires, markets and develops products to
address disease states related to metabolic diseases. The company also owns a
world-class manufacturing plant in Rouses Point, NY with a highly skilled
workforce. The plant encompasses 67.6 acres with 38 buildings, offering
approximately 1 million sq. feet of manufacturing and packaging space. Akrimax
was formed in 2007 and purchased the Rouses Point plant from Wyeth in January
2008.
Based in
Cranford, NJ, Akrimax pursues unsurpassed quality in the development,
production, manufacturing, distribution, and commercialization of a full range
of top-quality pharmaceutical products including Inderal®LA and
LoOvral®-28.
www.Akrimax.com
NitroMist® Warnings and
Precautions
Tolerance:
Excessive use may lead to development of tolerance. Only the smallest number of
doses required for effective relief of the acute angina attack should be used
(see Dosage and Administration section of NitroMist® full prescribing
information).
As
tolerance to other forms of nitroglycerin develops, the effect of sublingual
nitroglycerin on exercise tolerance, although still observable, is
reduced.
Hypotension:
Severe hypotension, particularly with upright posture, may occur even with small
doses of nitroglycerin. The drug should therefore be used with caution in
patients who may be volume-depleted or who, for whatever reason, are already
hypotensive. Hypotension induced by nitroglycerin may be accompanied by
paradoxical bradycardia and increased angina pectoris.
The
benefits of NitroMist®
in patients with acute myocardial infarction or congestive heart failure have
not been established. If one elects to use NitroMist® in these conditions, careful
clinical or hemodynamic monitoring must be used because of the possibility of
hypotension and tachycardia.
Hypertrophic
Cardiomyopathy: Nitrate®
therapy may aggravate the angina caused by hypertrophic
cardiomyopathy.
Headache:
Nitroglycerin produces dose-related headaches, which may be severe. Tolerance to
headaches occurs.
Forward-looking
Statements:
Except
for historical information contained herein, this document may contain
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 oral spray products. The filing of an NDA with the FDA is an
important step in the approval process in the United States. Acceptance for
filing by the FDA does not mean that the NDA has been or will be approved, nor
does it represent an evaluation of the adequacy of the data submitted. 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. In
addition, our inability to maintain or enter into, and the risks resulting from
our dependence upon, collaboration or contractual arrangements necessary for the
development, manufacture, commercialization, marketing, sales and distribution
of any of our products could materially impact the Company's actual results.
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 on Form 10-K 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.
For more
detailed information regarding NovaDel’s 2008 financial results and its product
pipeline, please review the Company’s SEC filings on Form 10-Q at the Investor
Relations section of www.novadel.com.
Contact:
Steven B.
Ratoff
(908)
782-3431 ext. 2650
Chairman
and Interim Chief Executive Officer
NovaDel
Pharma Inc.
sratoff@novadel.com