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.
NovaDel Pharma Inc.
Steven B. Ratoff, 908-782-3431 ext. 2650
Chairman
and Interim Chief Executive Officer
sratoff@novadel.com