Elite Pharmaceuticals and IntelliPharmaCeutics Announce Agreement
for the Development of a Controlled Release Product
NORTHVALE, N.J., June 22 /PRNewswire-FirstCall/ --
Elite Pharmaceuticals, Inc.
(AMEX:ELI) and IntelliPharmaCeutics Corp. (Toronto, Canada), a privately held,
specialty pharmaceutical company, announced today that they have entered into
an agreement for the development of a generic, controlled release drug product
with an addressable market in the U.S. of approximately $4 billion in 2004. A
pilot bioequivalence study has already been completed and scale up will begin
shortly. After scale up and completion of a successful pivotal bioequivalence
study for the product, an ANDA will be filed with the FDA.
Dr. Isa Odidi, Chairman, CEO and Co-Chief Scientific Officer of
IntelliPharmaCeutics, stated, "The fit between the two companies and the timing
provide excellent synergies. We have a significant product that is ready to be
scaled-up for a pivotal bioequivalence study. Elite has a fully capable
analytical laboratory and cGMP manufacturing facility, and our combined
capabilities put all the pieces in place for a smooth and timely product
development and commercialization.
Bernard Berk, Chairman and CEO of Elite, said, "We are pleased to join forces
with Dr. Isa Odidi and Dr. Amina Odidi, IntelliPharmaCeutic's President and
Co-Chief Scientific Officer, recognized leaders in the development of
controlled release dosage forms. Elite will be combining its capabilities with
IntelliPharmaCeutics for the development of an oral controlled release product
with significant technological barriers, which may be awarded a period of
market exclusivity. This development agreement supports Elite's business
strategy of expanding its pipeline through in-licensing of controlled release
products utilizing proprietary drug delivery platforms. This is the second
product agreement completed this year."
About Elite Pharmaceuticals
Elite Pharmaceuticals is a specialty pharmaceutical company principally engaged
in the development of oral, controlled release products. The Company's strategy
includes developing generic versions of controlled release drug products with
high barriers to entry and assisting partner companies in the life cycle
management of products to improve off-patent drug products. Elite's technology
is applicable to develop delayed, sustained or targeted release capsules or
tablets. Elite has one product currently being sold commercially and a pipeline
of six drug products under development in the therapeutic areas that include
pain management, allergy, cardiovascular and infection. The addressable market
for Elite's current pipeline of products exceeds $2 billion. Elite also has a
GMP and DEA registered facility for research, development, and manufacturing
located in Northvale, NJ.
About IntelliPharmaCeutics
IntelliPharmaCeutics is a drug delivery innovator and developer, specializing
in the controlled and targeted once-a-day delivery of oral, solid dose
pharmaceutical products. It operates from a 25,000 sq ft research laboratory
and manufacturing scale-up facility located adjacent to Toronto International
Airport. The Company utilizes proprietary, patented and proven drug delivery
technologies, to formulate both generic and new drug products with enhanced
performance characteristics. In addition to its pre-clinical portfolio,
IntelliPharmaCeutics has an extensive pipeline of development products in
clinical trials, in therapeutic areas that include neurology, cardiovascular,
GIT, pain and infection. For more information about IntelliPharmaCeutics, visit
the Company's web site at http://www.intellipharmaceutics.com/
This news release contains forward-looking statements, including those related
to the preliminary nature of the clinical program results and the potential for
further product development, that involve known and unknown risks, delays,
uncertainties and other factors not under the control of Elite or
IntelliPharmaCeutics, which may cause actual results, performance or
achievements of the Companies to be materially different from the results,
performance or other expectations implied by these forward-looking statements.
In particular, because substantial future testing will be required prior to
approval, the results described above may not be supported by additional data
or by the results of subsequent trials. These risks and other factors,
including the timing or results of pending and future clinical trials,
regulatory reviews and approvals by the Food and Drug Administration and other
regulatory authorities, and intellectual property protections and defenses, are
discussed in the Companies' filings with the Securities and Exchange Commission
such as the 10K, 10Q and 8K reports. The Companies undertake no obligation to
update any forward-looking statements.
DATASOURCE: Elite Pharmaceuticals, Inc.
CONTACT: Dianne Will, Investor Relations, +1-518-398-6222,
, for Elite Pharmaceuticals, Inc.; John N. Allport, V.P. -
Legal Affairs and Licensing of IntelliPharmaCeutics Corp., +1-416-798-3001,
Web site: http://www.elitepharma.com/
http://www.intellipharmaceutics.net/