Elite Pharmaceuticals Announces First Shipment of Generic Hydromorphone Product
13 March 2012 - 11:30PM
Elite Pharmaceuticals, Inc. ("Elite") (OTCBB:ELTP) announced today
the initial shipment of hydromorphone hydrochloride 8 mg tablets,
the generic equivalent of Dilaudid® 8 mg tablets under the License,
Manufacturing and Supply Agreement with its sales and marketing
partner, triggering a milestone payment. Elite's sales and
marketing partner will distribute the product as part of a
multi-product distribution agreement.
Hydromorphone hydrochloride is a member of the opioid analgesic
and antitussive class. It is a pure opioid agonist used primarily
for pain relief or as a cough suppressant. For the
twelve months ending September 2011, Dilaudid® 8 mg tablets and its
generic equivalents had total U.S. sales of approximately $30
million according to IMS Health Data.
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. Elite
has four ANDA products partnered with the sales and marketing
partner; two ANDA's have launched, one ANDA is in the process of a
manufacturing site transfer and an additional ANDA is currently
under review by the FDA. Elite's lead pipeline products, ELI-216, a
once-daily abuse resistant oxycodone, and ELI-154, a once-daily
oxycodone, are novel sustained release oral formulations of opiods
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. Elite also has partnered with Mikah Pharma to develop a
new product and with Hi-Tech Pharmacal to develop an intermediate
for a generic product. Elite operates a GMP and DEA registered
facility for research, development, and manufacturing located in
Northvale, NJ.
The Elite Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8737
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: For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
www.elitepharma.com
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