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.
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