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Toronto, Canada, June 22, 2005 -- IntelliPharmaCeutics and
Elite Pharmaceuticals, Inc. (Amex: ELI), 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 Corp., 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 Corp. 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
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.
FOR FURTHER INFORMATION, CONTACT:
For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
Phone: 518-398-6222 E-Mail:
dwill@willstar.net
Website: www.elitepharma.com
For IntelliPharmaCeutics Corp.
John N. Allport, V.P. - Legal Affairs and Licensing
Tel: 416-798-3001 Ext. 104; E-mail:
jallport@intellipharmaceutics.com
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