Elite Pharmaceuticals Announces Agreement for the Development of
a Controlled Release Product
NORTHVALE, N.J., June 28 /PRNewswire/ -- Elite Pharmaceuticals, Inc. (AMEX:ELI) announced that it has entered into a product development and license
agreement with Pliva, Inc. (East Hanover, NJ), a subsidiary of PLIVA d.d., a
specialty generics pharmaceutical company, for a generic, controlled release
drug product formulated by Elite. The product is an anti-infective with a U.S
generic market size of approximately $90 million in 2004 and which had an
approximate 10% growth in dose units sold in 2004. A pilot bioequivalence
study has been completed and scale up will begin shortly. Elite will
manufacture the product and Pliva will market and sell the product. The
development costs will be paid by Pliva and Elite and the profits will be
shared equally.
Bernard Berk, Chairman and CEO of Elite, said, "We are very pleased to have
this relationship with Pliva Inc., a well known and highly regarded company in
the generic drug industry. This controlled release product represents another
step in building our pipeline at Elite and is Elite's third product development
agreement 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 $6 billion. Elite also has a
GMP and DEA registered facility for research, development, and manufacturing
located in Northvale, NJ.
About Pliva With over 80 years of experience in the pharmaceuticals arena, PLIVA is now a
global pharmaceutical company focused on the development, production and
distribution of generics and specialty pharmaceutical products with operations
in the US, CEE and Western Europe. Since it's listing on the London Stock
Exchange in 1996, PLIVA has established a fully internationalized business,
with the majority of revenues now realized on Western markets.
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 Pliva, 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 Elite's 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 CONTACT: Dianne Will, Investor Relations for Elite Pharmaceuticals, Inc., +1-518-398-6222, Web site: http://www.elitepharma.com/
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