$heff's $tation of $tocks & $olid DD

[514]

110% up today by end of day.

ELTP DD - Google Docs

Looking at ELTP one can ask, "How can a biotech with a VERY DEEP PIPELINE OF PRODUCTS, 2 OF WHICH ARE PARTNERED UP ALREADY, also having secured 5 UNITED STATES

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!!!! 200%+ 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 CD®
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.


Elite Pharmaceuticals: Home


****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.

http://www.marketwatch.com/story/eli...cer-2009-09-21


****ANNUAL MEETING NEWS Tab #4****

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 PHARMACEUTICALS INC /DE/ (Form: DEF 14A, Received: 09/08/2009 17:24:56)


Digging Deeper in their recent 10Q filing:

Elite has two products, Lodrane 24® and Lodrane 24D®, 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

immediate and controlled-release drug products

ELITE PHARMACEUTICALS INC /DE/ (Form: 10-Q, Received: 08/19/2009 16:57:32)