EXHIBIT 99.1
ELITE PHARMACEUTICALS REVIEWS BUSINESS DEVELOPMENTS AND PROJECTED CORPORATE
MILESTONES
Tuesday November 15, 10:41 am ET
- - COMPANY TO HOST AN INVESTOR CONFERENCE CALL AT 4:30 EST TODAY
- - COMPANY EXPECTS TO RELEASE PILOT PHASE I DATA FOR ITS ABUSE-RESISTANT
OXY-NAL(TM) BY YEAR-END 2005
NORTHVALE, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Elite Pharmaceuticals, Inc.
(Amex: ELI - NEWS) provided an update on recent achievements and projected
timelines for both its pain management and controlled released drug delivery
programs.
PAIN MANAGEMENT
Elite announced that it expects to release its pilot Phase I data for its
abuse-resistant Oxy-Nal(TM) by year-end 2005.
Oxy-Nal(TM) utilizes Elite's proprietary Abuse Resistant Technology (ART(TM)) to
address the growing opioid abuse problem in this country. Use of opioids for
non-medical purposes has grown over 400% over the past several years, with
abusers primarily crushing/chewing and ingesting, and crushing and inhaling the
drug product. Currently no opioid abuse resistant product is on the market.
Elite anticipates initiating Phase II studies for Oxy-Nal(TM) in 2006. Elite's
goal is to file an NDA in 2008, and expects to have a licensing partner in place
prior to initiation of its Phase III trials.
Oxy-Nal (TM) is based on combining two well-known and well-tolerated compounds
used for years to treat pain and provide relief to alcoholics and drug abusers
during the withdrawal process. Elite's technology incorporates an opioid
antagonist naltrexone hydrochloride with an agonist oxycodone hydrochloride --
in the same formulation, formulated in such a way that naltrexone will only be
released and absorbed if the capsule is crushed or damaged. The naltrexone
interferes with the receptor sites in the brain blocking the effects of
oxycodone, hence preventing the abuser from getting high or achieving the
euphoric effect they are seeking. If the capsule is taken as intended in it's
unaltered form, the naltrexone is not released or absorbed and will not
antagonize the opioid.
In addition to the abuse-resistant product, Elite is continuing to develop other
clinical products in the pain management field. The Company anticipates filing
an IND for its once-daily oxycodone product by the end of the year.
Commenting on Elite's pain management strategy, Mr. Bernard Berk, Chairman and
Chief Executive Officer of Elite Pharmaceuticals, Inc., stated, "We are
encouraged by our early clinical results and believe that we have a compelling
approach to curb opioid abuse. We will continue to develop novel controlled
release drug products to treat and manage pain."
In addition to advances in pain management, Elite has made significant progress
over the past 12 months applying its broad-based controlled-released drug
delivery technology to multiple drugs. Highlights of recent activities include:
-- Launch of Lodrane 24(R), a once-daily antihistamine product for
allergies brought to market in partnership with ECR Pharmaceuticals. The oral
antihistamine market in 2004 was approximately $3 billion.
-- Scale up of Elite's second allergy product with an addressable
market of approximately $500 million.
-- A development and manufacturing license agreement with Pliva, Inc.,
a subsidiary of PLIVA d.d. to develop and manufacture a generic controlled
generic release product of an anti-infective drug with a U.S generic market size
of approximately $90 million in 2004.
-- A development and manufacturing license agreement with Harris
Pharmaceuticals, Inc. and Tish Technologies to develop and manufacture a generic
controlled release product of an anti-infective drug with a U.S brand market
size of approximately $80 million in 2004.
-- A co-development agreement with IntelliPharmaCeutics to develop a
controlled release generic product with a branded market in 2004 of
approximately $4 billion.
Goals over the next 12 months for the controlled-release platform include:
-- Completion of pilot Phase I studies on our abuse resistant program
-- Initiation of Phase II studies on our Oxy-Nal(TM) abuse resistant
program.
-- Launch of Elite's second once-daily allergy product.
-- Filing of two ANDA's for controlled release generic products.
-- Filing of an IND for once-a-day controlled release oxycodone
hydrochloride product.
-- Completion of pilot Phase I studies on once-a-day controlled release
oxycodone product.
Concerning Elite's controlled-release product pipeline, Mr. Berk commented, "We
will continue looking for niche opportunities in the area of controlled release
drug products for difficult-to-formulate drugs which present high barriers to
entry, with particular emphasis on pain management. We have signed three deals
in 2005 and Elite's reputation as a highly specialized company focused on
difficult-to-formulate oral controlled release drugs continues to attract
partners."
Mr. Berk cautioned, however, no representation can be made that the Company will
have sufficient resources, including financial, to complete any of the goals or
as to the period required to accomplish any of these goals or that any material
revenues will result from these undertakings.
CONFERENCE CALL INFORMATION
Elite Pharmaceuticals, Inc. will hold a telephone conference call and live
webcast at 4:30 p.m. ET on Tuesday, November 15, 2005 to review the Company's
accomplishments and outline future goals.
Bernard Berk, Chairman & CEO, will host the call, which will include a
presentation followed by questions and answers. Chris Dick, who is involved in
our business development operations, Dr. Charan Behl, our Scientific Advisor,
and Mark Gittelman, Chief Financial Officer will also participate on the call.
Elite Pharmaceuticals invites interested participants in hearing management's
discussion to join the call by dialing 1-877-407-8033. International callers may
access the call by dialing 201-689-8033. A replay of the conference call will be
available through November 22, 2005 and accessible by dialing 1-877-660-6853 for
domestic participants and 201-612-7415 for international participants. When
prompted participants should enter passcode 286 and conference ID number 177772.
Participant's may access the webcast on the Company website at
www.elitepharma.com and will be available for ninety days.
ABOUT ELITE PHARMACEUTICALS
Elite Pharmaceuticals is a specialty pharmaceutical company principally engaged
in the development and manufacturing of oral controlled-release products. The
Company's strategy includes developing generic versions of controlled release
drug products with high barriers to entry and assisting partner companies in the
life cycle management of products to improve off- patent drug products. Elite's
technology is applicable to develop delayed, sustained or targeted release
capsules or tablets. Elite has one product currently being sold commercially and
a pipeline of seven drug products under development in the therapeutic areas
that include pain management, allergy, cardiovascular and infection. The
addressable market for Elite's current pipeline of products exceeds $6 billion.
Elite also has a GMP and DEA registered facility for research, development, and
manufacturing located in Northvale, NJ.
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 or Pliva, 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 the Elite's filings with the
Securities and Exchange Commission such as the 10K, 10Q and 8K reports. The
companies undertake no obligation to update any forward-looking statements.
Source: Elite Pharmaceuticals, Inc.