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| 8-K - 8-K - ELITE PHARMACEUTICALS INC /NV/ | v210059_8k.htm |
ELITE
PHARMACEUTICALS ANNOUNCES FDA APPROVAL FOR GENERIC
PHENTERMINE
HCL TABLETS
NORTHVALE,
N.J. – February 4, 2011 – Elite Pharmaceuticals, Inc. ("Elite" or the “Company")
(OTCBB: ELTP) announced today the approval of an Abbreviated New Drug
Application (ANDA) for phentermine HCl 37.5 mg tablets by the U.S. Food and Drug
Administration (FDA). The phentermine HCl tablets are the generic
equivalent of the Adipex-P®
37.5 mg tablets. The product and its equivalents had annual
sales of approximately $40 million in 2010 and there are currently six other
approved generic manufacturers plus the innovator. On September 16,
2010, Elite had previously announced the acquisition of the ANDA for this
generic product from Epic Pharma LLC (“Epic”). The ANDA approval was
granted under Epic Pharma’s name and transfer of the ANDA into Elite’s name will
begin immediately.
Also
previously disclosed on September 16, 2010, this product was part of a license
agreement and a manufacturing and supply agreement (together the “Agreements”)
with Precision Dose, Inc. (Precision Dose) which has a wholly owned subsidiary,
TAGI Pharma, Inc. (“TAGI Pharma”) which will distribute the
product. Pursuant to the previously disclosed Agreements, TAGI Pharma
will market and sell this product and Elite will manufacture the
product. Elite will receive a milestone payment upon shipment of the
first product to Precision Dose and Elite will receive a percentage of the gross
profit, as defined in the License Agreement, and earned by TAGI Pharma as a
result of sales of the products. The license fee is payable monthly
for the term of the License Agreement.
“Elite
currently manufactures Lodrane 24® and Lodrane 24D® which are marketed by our
partner, ECR Pharmaceuticals, for allergy treatment, and in addition to this
phentermine product, we expect to launch two additional products this year that
will be marketed by TAGI. Collectively, these products will allow the
company to fully realize the implementation of the business plan that was put in
place to turn the company into a profitable operational company,” commented
Jerry Treppel, Chairman and CEO.
About
TAGI Pharma, Inc.
TAGI
Pharma was launched by Precision Dose in 2010 as a specialty pharmaceutical
company focused on the Retail Market Segment. A key component of TAGI Pharma’s
strategy is the leveraging of its sales and distribution core competencies with
the formation of strategic partnerships with product development and
manufacturing companies such as Elite. The phentermine HCL 37.5 mg product
represents the first of these initiatives, and we expect an additional five
product launches in the next six months. As the company sources
products through development, acquisition and licensing opportunities, key areas
of focus will be in the tablet, capsule and injectable dosage formats, with an
emphasis on controlled substances, where there are additional barriers to entry.
TAGI Pharma is located in South Beloit, Illinois, and additional information can
be obtained from its website www.tagipharma.com.
About
Elite Pharmaceuticals, Inc.
Elite
Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops and
manufactures oral, controlled-release products using proprietary technology.
Elite's strategy includes the development of life cycle management products to
lengthen the franchise life of drug products facing patent expiration, the
development of controlled-release formulations of existing products to improve
their clinical profile, and the development of generic versions of
controlled-release brand drug products with high barriers to entry. Elite
developed and manufactures for its partner, ECR Pharmaceuticals, Lodrane 24® and
Lodrane 24D®, a non-sedating antihistamine for the treatment of allergy
symptoms. The company recently purchased, and expects to soon launch three
approved generic products. In addition, Elite has a pipeline of
additional generic and branded drug candidates under active
development. Two of the branded products under active development
are ELI-216, an abuse resistant oxycodone product, and ELI-154, a once-a-day
oxycodone product. Elite conducts research, development and
manufacturing in its facility in Northvale, New Jersey.
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