Elite Pharmaceuticals Acquires Trimipramine ANDA
May 22 2017 - 4:11PM
Elite Pharmaceuticals, Inc. ("Elite" or the “Company")
(OTCBB:ELTP), today announced the acquisition of an approved and
currently marketed Abbreviated New Drug Application (“ANDA”) for
Trimipramine Maleate Capsules (“Trimipramine”) 25, 50 and 100 mg,
from Mikah Pharma, LLC (“Mikah”). Dr. Reddy’s Laboratories, Inc.
(“Dr. Reddy”) (BSE:500124), (NSE:DRREDDY), (NYSE:RDY) will
market and sell the Trimipramine products. Epic Pharma will
manufacture the products under current agreements with Mikah.
Eilte will assume these agreements with the acquisition of the
products. This agreement insures the uninterrupted
supply of generic Trimipramine. Trimipramine is a generic
version of Surmontil®, a tricyclic antidepressant. Surmontil®
and generic Trimipramine have total US sales of approximately $2
million in 2016 according to IMS Health Data. The ANDA purchased by
Elite is currently the only marketed generic Trimipramine product.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty
pharmaceutical company which is developing a pipeline of
proprietary pharmacological abuse deterrent opioid products as well
as niche generic products. Elite specializes in oral
sustained and controlled release drug products which have high
barriers to entry. Elite owns generic and OTC products which
have been licensed to TAGI Pharma, Epic Pharma and Valeant
Pharmaceuticals International. Elite currently has eight
commercial products being sold, additional approved products
pending manufacturing site transfer and the NDA for SequestOx™, for
which it received the CRL from the FDA. Elite’s lead pipeline
products include abuse-deterrent opioids which utilize the
Company’s patented proprietary technology and a once-daily
opioid. These products include sustained release oral
formulations of opioids for the treatment of chronic pain. These
formulations are intended to address two major limitations of
existing oral opioids: the provision of consistent relief of
baseline pain levels and deterrence of potential opioid
abuse. Elite also provides contract manufacturing for Ascend
Laboratories (a subsidiary of Alkem Laboratories Ltd.). Elite
operates a GMP and DEA registered facility for research,
development, and manufacturing located in Northvale, NJ. Learn more
at www.elitepharma.com.
About Dr. Reddy’sDr. Reddy’s Laboratories Ltd.
(BSE:500124), (NSE:DRREDDY), (NYSE:RDY) is an integrated
pharmaceutical company, committed to providing affordable and
innovative medicines for healthier lives. Through its three
businesses - Pharmaceutical Services & Active Ingredients,
Global Generics and Proprietary Products – Dr. Reddy’s offers a
portfolio of products and services including APIs, custom
pharmaceutical services, generics, biosimilars and differentiated
formulations. Our major therapeutic areas of focus are
gastrointestinal, cardiovascular, diabetology, oncology, pain
management and dermatology. Dr. Reddy’s operates in markets across
the globe. Our major markets include – USA, India, Russia & CIS
countries, and Europe. For more information, log on to:
www.drreddys.com.
This press 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, Elite’s
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 forward-looking statements may
include statements regarding the expected timing of approval, if at
all, of SequestOx™ by the FDA, the steps Elite may take as a result
of the CRL, and the actions the FDA require of Elite in order to
obtain approval of the NDA. These forward-looking statements are
not guarantees of future action or performance. These risks and
other factors, including, without limitation, Elite’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 and intellectual
property protections and defenses, 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 is under no obligation to update
or alter its forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact:
For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
www.elitepharma.com
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