Elite Pharmaceuticals and ECR Pharmaceuticals Launch Lodrane D(R) Allergy Product
September 27 2011 - 8:00AM
Elite Pharmaceutical, Inc.'s ("Elite" or the "Company")
(OTCBB:ELTP) and ECR Pharmaceuticals ("ECR"), a wholly owned
subsidiary of Hi-Tech Pharmacal (Hi-Tech), announced today the
launch of Lodrane D®. Lodrane D® is an immediate release
formulation of brompheniramine maleate and pseudoephedrine HCl, an
effective, low-sedating antihistamine combined with a decongestant.
Lodrane D® will be promoted and distributed in the U.S. by ECR,
Hi-Tech's branded division. The product will be available
over-the-counter but will also have physician
promotion. Lodrane D is one of the only adult brompheniramine
containing products available to the consumer.
Elite will manufacture the product for ECR and will receive
revenues for the manufacturing, packaging, and laboratory stability
study services for this product, as well as royalties on sales. The
current U.S. allergy market exceeds $3.5 billion.
"ECR and Elite have continued to work diligently to provide a
Lodrane product to U.S. consumers. With this launch, we have
accomplished this and look forward, in conjunction with our partner
ECR, to rebuilding this important allergy-relief franchise," said
Jerry Treppel, Chairman and CEO at Elite. "We also look to continue
to build and leverage Elite's technologies through our product
pipeline, partnerships and ventures as we continue to
systematically meet the milestones we have set for ourselves."
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 TAGI Pharma; one ANDA
has launched, two ANDAs are 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 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 has partnered
with Mikah Pharma to develop a new product and with Hi-Tech
Pharmacal to develop an intermediate for a generic
product. Elite also performs contract manufacturing
services. 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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