Elite Pharmaceuticals Granted New Patent for Abuse Deterrent Technology
April 22 2014 - 7:41AM
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP)
announced today the issuance of U.S. Patent No. 8,703,186 titled
"Abuse-Resistant Oral Dosage Forms and Method of Use Thereof". This
patent expands the intellectual property for the Company's opioid
abuse deterrent technology. Elite now has three US patents and one
Canadian patent issued in this area with additional patents pending
in the U.S., Canada and Europe.
"We are pleased with this additional patent coverage," stated
Nasrat Hakim, President and CEO of Elite. "Elite's abuse deterrent
program has made significant progress. In December, a successful
pilot bioequivalence study for ELI-201 was completed and in January
a successful pivotal bioequivalence study for ELI-200 was
completed. These products are the first of our many abuse deterrent
opioid products under development."
About Elite's Abuse Deterrent Technology
Elite's abuse deterrent products utilize the Company's
proprietary pharmacological abuse deterrent technology. Elite's
abuse deterrent technology is a multi-particulate capsule which
contains an opioid agonist in addition to naltrexone, an opioid
antagonist. Naltrexone is an opioid receptor antagonist used
primarily in the management of alcohol dependence and opioid
dependence. When this product is taken as intended, the naltrexone
is designed to pass through the body unreleased while the opioid
agonist releases over time providing therapeutic pain relief for
which it is prescribed. If the multi-particulate beads are crushed,
the opioid antagonist, naltrexone, is designed to release. The
absorption of the naltrexone is intended to block the euphoria by
preferentially binding to same receptors in the brain as the opioid
agonist and thereby reducing the incentive for abuse or misuse by
recreational drug abusers.
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 seven commercial products currently being sold, twelve
additional approved products pending manufacturing site
transfer and two additional products under review pending approval
by the FDA. Elite's lead pipeline products include abuse
resistant opioids utilizing the Company's patented proprietary
technology, and a once-daily opioid. They are sustained
release oral formulations of opioids 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 provides
contract manufacturing for Ascend Laboratories (a subsidiary of
Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the
manufacturing and distribution of eleven approved products pending
manufacturing site, with Hi-Tech Pharmacal to develop an
intermediate for a generic product, and a Hong Kong based company
to develop a branded product for the United States market and its
territories. Elite operates a GMP and DEA registered facility
for research, development, and manufacturing located in Northvale,
NJ.
This news release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Including those related to the effects, if any, on future
results, performance or other expectations that may have some
correlation to the subject matter of this press release, readers
are cautioned that such forward-looking statements involve risks
and uncertainties including, without limitation, its ability to
obtain FDA approval of the transfers of the ANDAs or the timing of
such approval process, delays, uncertainties, inability to obtain
necessary ingredients and other factors not under the control of
Elite, which may cause actual results, performance or achievements
of Elite to be materially different from the results, performance
or other expectations that may be implied by these forward-looking
statements. These risks and other factors, including, without
limitation, the Company's ability to obtain sufficient funding
under the LPC Agreement or from other sources, the timing or
results of pending and future clinical trials, regulatory reviews
and approvals by the Food and Drug Administration and other
regulatory authorities, intellectual property protections and
defenses, and the Company's ability to operate as a going concern,
are discussed in Elite's filings with the Securities and Exchange
Commission, including its reports on forms 10-K, 10-Q and 8-K.
Elite undertakes no obligation to update any forward-looking
statements.
CONTACT: Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
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