Does anyone have any idea what's going on with ELTP? PPS jumped up to nearly .20 a few months back, but now is back down to .07 and has been in that range for a while.
Last edited by FavStocks; 07-12-2009 at 03:56 PM.
Reason: added chart
PATENTS and have pending applications for 5 and seven foreign patents
be can penny stock?" The simple answer, "I HAVE NO IDEA, BUT TIME TO
BUY IT NOW AND HOLD LONG SO I
CAN BE REWARDED IN THE NEAR TERM."
Well the near term is starting NOW, with the Annual Meeting of
Stockholders of Elite Pharmaceuticals, Inc.being held at the Company’s
headquarters at 165 Ludlow Avenue, Northvale,
New Jersey 07647, on October 23, 2009 at 10:00 a.m. be ready for news
on PENDING PATENTS & THEIR TOP LINE RESULT FOR PHASE III of Oxycodone
CR (Currently there is no
abuse deterrent oxycodone product available commercially. Elite
estimate that the U.S. market for controlled-release, twice-daily
oxycodone was about $2.8 billion in 2008.!!!)
****HISTORY OF OXYCODONE****
In May 2005, the FDA accepted Elite’s IND for ELI-216, Elite’s once-a-
day, abuse resistant oxycodone painkiller. After the acceptance of the
IND, Elite completed two pharmacokinetic
studies and a euphoria study in recreational drug users to assess the
abuse deterrent properties of ELI-216. Elite met with the FDA in
October 2006 and received guidance for the ELI-
216 development program and in November 2007, Elite reached agreement
with the FDA on a Special Protocol Assessment for the Phase III
protocol for ELI-216. Elite is currently scaling
up the product and it will begin its Phase III studies for this
product upon the completion of a joint development and distribution
agreement. Currently there is no abuse deterrent
oxycodone product available commercially. Elite estimate that the U.S.
market for controlled-release, twice-daily oxycodone was about $2.8
billion in 2008.
With potential release of news of PHASE III (LONG TIME IN THE MAKING &
$2.8BILLION MARKET and PATENTS, I am LONG on ELTP) ELTP WILL RETEST 52-
week high of $.34,
currently sitting at .13!!!! 300%+ gainer coming these next few days.
Authorized 210Mil shares as of June 30, 2009, actually Float is much
less. This will be a mover, I dont think anyone is selling!!
***GLIMPSE INTO THEIR PIPELINE***
Programs Under Development
Branded Products (a)
TOP LINE PRODUCT:
-Oxycodone CR
Once a day
NA
Pain
NDA
Phase III pending
-Abuse Resistance Product for use with Oxycodone or other opioids N/A
Pain
NDA
Phase II
-Diltiazem
Once a day
Cardizem CDŽ
Cardiovascular
ANDA
Pilot BE study complete
-Lodrane
Once a Day
N/A
Allergy
NDA
Launched
Partnered up with ECR Pharmaceuticals
Lodrane 24D
Once a day
N/A
Allergy
NDA
Launched
Partnered up with ECR Pharmaceuticals
Undisclosed
Twice a Day
Undisclosed
Infection
ANDA
Pilot BE study complete
Preclinical testing refers to studies done before initiation of any
human studies. Pilot Phase I studies for the NDA products are
generally preliminary studies done in healthy human
subjects to assess the tolerance/safety and pharmacokinetics (PK) of
the product. Additional larger studies in humans will be required
prior to submission of this product to the FDA for
review. Pilot bioequivalence (BE) studies are initial studies done in
humans for generic products and are used to assess the likelihood of
achieving bioequivalence for generic products.
Larger pivotal bioquivalence studies will be required prior to
submission of the product for FDA for review.
***PATENTS***
ELTP have secured five United States patents and have pending
applications for five United States patents and seven foreign
patents. Two of the United States issued patents have
been assigned for a fee to Celgene Corporation for the pulsed released
delivery of methylphenidate.
The pending patent applications relate to four different control
release pharmaceutical products on which we are working. Included
among these patent applications are applications for
the U.S. patents relating to formulations for delayed and sustained
release of drugs. In addition, an application for a U.S. patent for a
narcotic antagonist product that we are developing
to be used with Oxycodone and other narcotics to minimize the abuse
potential for the narcotics was filed.
****MOVING IN THE RIGHT DIRECTION - RECENT NEW APPOINTMENTS OF CEO &
CSO****
NORTHVALE, N.J., Sep 21, 2009 (GlobeNewswire via COMTEX) -- Effective
as of September 15, 2009, Elite Pharmaceuticals, Inc. ("Elite" or the
"Company") /quotes/comstock/11k!eltp
(ELTP 0.09, +0.00, +1.09%) appointed Jerry I. Treppel as its Chief
Executive Officer, and Ashok G. Nigalaye, Ph.D. as its Chief
Scientific Officer. Jerry Treppel, a Wall Street veteran with
over 20 years' experience as a specialty pharmaceutical analyst, has
served on Elite's Board of Directors since October 2008 and has been
the Company's Chairman since November
2008. Dr. Ashok Nigalaye, a licensed pharmacist with extensive
formulation experience in the pharmaceutical industry, has served on
Elite's Board of Directors since June 2009.
Since 2003, Mr. Treppel has served as the managing member of Wheaten
Capital Management LLC, a capital management company focusing on
investment in the health care sector. In
October 2008, Mr. Treppel was also appointed managing director of
Ledgemont Capital Group LLC, a boutique merchant bank that provides
access to capital and corporate advisory
services to public and private companies. Over the past 20 years, Mr.
Treppel was an equity research analyst focusing on the specialty
pharmaceuticals and generic drug sectors at
several investment banking firms including Banc of America Securities,
Warburg Dillon Read LLC (now UBS), and Kidder, Peabody & Co. He
previously served as a healthcare services
analyst at various firms, including Merrill Lynch & Co. He also held
administrative positions in the healthcare services industry early in
his career. Since 2003, Mr. Treppel has served as a
member of the board of directors of Akorn, Incorporated /quotes/
comstock/15*!akrx/quotes/nls/akrx (AKRX 1.54, -0.02, -1.28%) , a
specialty pharmaceutical company engaged in the
development, manufacturing and marketing of branded and multi-source
pharmaceutical products and vaccines. Mr. Treppel serves as the Chair
of Akorn's Nominating and Corporate
Governance Committee and as a member of its Audit Committee and
Compensation Committee. Mr. Treppel holds a BA in Biology from Rutgers
College in New Brunswick, N.J., an MHA in
Health Administration from Washington University in St. Louis, Mo.,
and an MBA in Finance from New York University. Mr. Treppel has been a
Chartered Financial Analyst (CFA) since
1988.
Since July 2008, Dr. Nigalaye has been the President and Chief
Executive Officer of Epic Pharma LLC, a manufacturer of generic
pharmaceuticals and Elite's strategic partner pursuant
to the Epic Strategic Alliance Agreement. From August 1993 to February
2008, Dr. Nigalaye served as Vice President of Scientific Affairs and
Operations of Actavis Totowa LLC, a
manufacturer of generic pharmaceuticals, where he was responsible for
directing and organizing company activities relating to pharmaceutical
drug manufacturing, regulatory affairs and
research and development. Dr. Nigalaye currently serves as a director
of GTI Inc., a privately held company. Dr. Nigalaye holds a B.S. in
Pharmacy from the University of Bombay, an M.S.
in Industrial Pharmacy from Long Island University, and a Ph.D. in
Industrial Pharmacy from St. John's University. Dr. Nigalaye is a
licensed pharmacist in the State of New York.
What makes me believe news on topline results or patent
"4. The transaction of such other business as may properly come before
the meeting or any adjournment thereof that was not known a reasonable
time before the solicitation. "
Schedule 14A
ELITE PHARMACEUTICALS, INC.
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS
September 8, 2009
NOTICE IS HEREBY GIVEN that the Annual Meeting of
Stockholders of Elite Pharmaceuticals, Inc. (“ Company ”, “ we ”, “
our ” or “ us ”) will be held at the Company’s
headquarters at 165 Ludlow Avenue, Northvale, New Jersey 07647, on
October 23, 2009 at 10:00 a.m., to consider and act upon the
following:
.
4.
The transaction of such other business as may properly come before
the meeting or any adjournment thereof that was not known a reasonable
time before the solicitation.
All stockholders of record at the close of business on August 24, 2009
are entitled to notice of and to vote at this meeting and any
adjournments thereof.
You are requested to sign and date the enclosed proxy card and return
it in the enclosed envelope.
Our Annual Report on Form 10-K for the fiscal year ended March 31,
2009, and our quarterly report on Form 10-Q for the three months ended
June 30, 2009, which are not part of the
proxy soliciting materials, are enclosed.
BY ORDER OF THE BOARD OF DIRECTORS
/s/ Carter Ward
Chief Financial Officer and Secretary
September 8, 2009
Elite has two products, Lodrane 24Ž and Lodrane 24DŽ, currently being
sold commercially, and a pipeline of five additional drug candidates
under active development in the therapeutic
areas that include pain management, gastro-intestinal and infection.
Of the products under development, ELI-216, a once-a-day, abuse
deterrent oxycodone product, and ELI-154, a
once-a-day oxycodone product, are in clinical trials and Elite has
completed pilot studies on two of Elite’s other generic product
candidates. Elite has also submitted an ANDA with Elite’s
co-development partner, The PharmaNetwork, for a pain management
generic product. The addressable market for the pipeline of products
is approximately $6 billion. Elite’s facility in
Northvale, New Jersey is a Good Manufacturing Practice (“ GMP ”) and
DEA registered facility for research, development and manufacturing.
In January 2006, the FDA accepted Elite’s Investigational New Drug
Application (an “ IND ”) for ELI-154, Elite’s once-a-day oxycodone
painkiller. Elite has completed two
pharmacokinetic studies to evaluate ELI-154’s controlled-release
formulation, of which the most recent study was completed in 2006.
Elite is currently scaling up the product and it will
begin its Phase III studies for this product upon the completion of a
joint development and distribution agreement. Currently there is no
once-daily oxycodone available commercially.
In May 2005, the FDA accepted Elite’s IND for ELI-216, Elite’s once-a-
day, abuse resistant oxycodone painkiller. After the acceptance of the
IND, Elite completed two pharmacokinetic
studies and a euphoria study in recreational drug users to assess the
abuse deterrent properties of ELI-216. Elite met with the FDA in
October 2006 and received guidance for the ELI-
216 development program and in November 2007, Elite reached agreement
with the FDA on a Special Protocol Assessment for the Phase III
protocol for ELI-216. Elite is currently scaling
up the product and it will begin its Phase III studies for this
product upon the completion of a joint development and distribution
agreement. Currently there is no abuse deterrent
oxycodone product available commercially. Elite estimate that the U.S.
market for controlled-release, twice-daily oxycodone was about $2.8
billion in 2008.
Strategy
Elite is focusing its efforts on the following areas: (i) development
of Elite’s pain management products, (ii) manufacturing of Lodrane 24
(R) and Lodrane 24D(R) products; (iii) the
development of the other products in Elite’s pipeline; (iv)
development of the eight products with pursuant to the Epic Strategic
Alliance Agreement and (v) commercial exploitation of
Elite’s products either by license and the collection of royalties, or
through the manufacture of Elite’s formulations, and (vi) development
of new products and the expansion of Elite’s
licensing agreements with other pharmaceutical companies, including co-
development projects, joint ventures and other collaborations.
Elite is focusing on the development of various types of drug
products, including branded drug products (which require new drug
applications (“ NDA ”) under Section 505(b)(1) or 505(b)(2)
of the Drug Price Competition and Patent Term Restoration Act of 1984
as well as generic drug products (which require abbreviated new drug
applications (“ ANDA ”)).
Elite believes that its business strategy enables Elite to reduce
Elite’s risk by having a diverse product portfolio that includes both
branded and generic products in various therapeutic
categories and build collaborations and establish licensing agreements
with companies with greater resources thereby allowing Elite to share
costs of development and to improve cash-
flow.
Epic Strategic Alliance Agreement
On March 18, 2009, Elite entered into the Epic Strategic Alliance
Agreement (amended on April 30, 2009, June 1, 2009 and July 28, 2009),
pursuant to which Elite commenced a strategic
relationship with Epic, a pharmaceutical company that operates a
business synergistic to that of Elite in the research and development,
manufacturing, sales and marketing of oral
I am not sure about this stock simply because of yesterday's spike... Is there any explanation for this sudden move? Anticipation of this Friday's meeting? Or something else?
Mostly because of pending patents, and results of the phase III results for their "abuse deterrent Oxycodone" at the shareholders meeting on Friday. The fundamentals are great, IMO this will gap up in the AM. I am going to hold for a while and see where this thing goes!
The only reason that spike and pps drop happened was because many investors thought that the scheduled shareholder meeting was to announce fda approval...that was not the intention of the meeting from the get go. However, once only general biz was conducted at mtg, many ppl dumped....anything below .09 is grand theft...big pops coming...look what happened just on a rumor of what ppl thought was going to happen at a meeting.
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