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8-K - ELITE PHARMACEUTICALS INC /NV/ | v207735_8k.htm |
EX-10.1 - ELITE PHARMACEUTICALS INC /NV/ | v207735_ex10-1.htm |
ELITE
PHARMACEUTICALS AND HI-TECH PHARMACAL SIGN A DEVELOPMENT AND
SUPPLY
AGREEMENT FOR A GENERIC INTERMEDIATE OF A PRESCRIPTION PRODUCT
NORTHVALE,
N.J. – January 10, 2011 – Elite Pharmaceuticals, Inc. ("Elite" or the “Company")
(OTCBB: ELTP) and Hi-Tech Pharmacal Co., Inc. (“Hi-Tech)(NASDAQ: HITK) today
announced that they have entered into an agreement for Elite to develop for
Hi-Tech an intermediate for a generic version of a prescription product for
which the branded product had sales in 2010 of over $100 million.
Under the
terms of the agreement, Elite will undertake a developmental program for an
intermediate product that Hi-Tech shall then incorporate into a final
product. Hi-Tech, or its designees, shall be responsible for the
filing of the Abbreviated New Drug Application (“ANDA”) for the finished product
and the ANDA will be filed under the Hi-Tech name. Upon approval of
the ANDA, Elite will manufacture the intermediate product. Hi-Tech will
manufacture the final product and will be responsible for the marketing and
sales of the final product. Hi-Tech will pay Elite milestone payments
for the development work. Upon commercialization, Elite will receive payment for
the manufacturing of the intermediate product and a percentage of the profits
generated from the sale of the product.
About Hi-Tech Pharmacal Co.,
Inc.
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. The Company'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.
About Elite Pharmaceuticals,
Inc.
Elite
Pharmaceuticals, Inc. develops oral sustained and controlled release products.
Elite's strategy includes assisting partner companies in the life cycle
management of products to improve off-patent drug products and developing
generic versions of controlled release drug products with high barriers to
entry. Two of Elite’s products, Lodrane 24® and Lodrane 24D®, are marketed by a
partner, ECR Pharmaceuticals, for allergy treatment. Elite’s lead pipeline
products are novel sustained release oral formulations of oxycodone for the
treatment of chronic pain, which address two of the limitations of existing oral
opioids: the provision of consistent relief of baseline pain levels and
deterrence of potential abuse. Both products, ELI-216, a once-daily
abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are in
late-stage development. Elite, with partners, also has an ANDA filed with the
FDA for a generic equivalent of a pain product and has a generic
gastrointestinal drug product in clinical development. Elite operates a GMP and
DEA registered facility for research, development, and manufacturing located in
Northvale, NJ.
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, 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 Elite's filings with the Securities
and Exchange Commission such as the 10K, 10Q and 8K reports. Elite undertakes no
obligation to update any forward-looking statements.
Contact:
Elite
Pharmaceuticals, Inc.
Dianne
Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com