NovaDel Signs Exclusive License & Distribution Agreement with Hi-Tech Pharmacal Co., Inc.’s Subsidiary to Commercialize & M...
November 16 2009 - 9:00AM
Business Wire
NovaDel Pharma Inc. (NYSE AMEX: NVD) today announced its entry
into an exclusive license and distribution agreement with ECR
Pharmaceuticals Company, Inc., a wholly owned subsidiary of Hi-Tech
Pharmacal Co., Inc. to commercialize and manufacture ZolpiMist™ in
the United States and Canada. ZolpiMist™ is our oral spray
formulation of zolpidem tartrate approved by the FDA in December of
2008.
Under the terms of the agreement, ECR will pay NovaDel $3
million upon the execution of the agreement. ECR will assume
responsibility for manufacturing and marketing the product in the
United States and Canada. In addition, ECR will pay royalties of up
to 15% on net sales of ZolpiMist™ as well as an additional
milestone payment if sales reach a specified level.
Steven B. Ratoff, Chairman and Interim CEO said, “This is an
important milestone for our company as it recognizes the
opportunity of the use of our NovaMist™ oral spray technology in
what we believe to be an important and sizable clinical
application. We believe that Hi-Tech has the ability to build a
solid position for ZolpiMist™ in the market for prescription sleep
aids.”
Mr. Ratoff continued, “This agreement, in addition to the
recently announced license of NitroMist™, will allow us to initiate
further development of our product pipeline utilizing our patented
NovaMist™ oral spray technology.”
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 Hi-Tech Pharmacal
Hi-Tech is a specialty pharmaceutical company developing,
manufacturing and marketing generic and branded prescription and
OTC products. The Company specializes in difficult to manufacture
liquid and semi-solid dosage forms and produces a range of sterile
ophthalmic, otic and inhalation products. Hi-Tech’s Health Care
Products Division is a leading developer and marketer of branded
prescription and OTC products for the diabetes marketplace.
Hi-Tech’s ECR Pharmaceuticals subsidiary markets branded
prescription products.
www.hitechpharm.com
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 ability of third parties to commercialize
the Company’s products, the successful completion of its pilot
pharmacokinetic feasibility studies, the Company’s ability to
develop product candidates (independently and through collaborative
arrangements), the Company’s ability to obtain additional required
financing to fund its research programs, 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 2009 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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