Elite Pharmaceuticals, Inc. specializes in the development of oral controlled release products, such as delayed, sustained, targeted and pulsatile release tablets, pellets, capsules, granules and powders. The Company’s primary focus is in the therapeutic areas of pain management, allergy, cardiovascular and infection.
Elite Pharmaceuticals, Inc., a specialty pharmaceutical company, engages in the development and manufacture of oral, controlled-release products, using proprietary technology and the development and manufacture of generic pharmaceuticals. The company focuses on development of its pain management products; manufacturing of a line of generic pharmaceutical products with approved Abbreviated New Drug Application; development of additional generic pharmaceutical products; development of the other products in its pipeline; commercial exploitation of its products either by license and the collection of royalties, or through the manufacture of its formulations; and development of new products and the expansion of its licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures, and other collaborations. The company has four products, including Phentermine 37.5mg tablets; Methadone 10mg tablets; Lodrane D Immediate Release capsules; and Hydromorphone Hydrochloride 8mg tablets. The company has license agreement with Precision Dose Inc. to market and sell four Elite generic products, consisting of Hydromorphone, Naltrexone, Phentermine 37.5mg tablets (Phentermine 37.5mg) and one additional generic products. The company has a pipeline of additional generic drug candidates under active development, including, without limitation, ELI-154, a once-a-day oxycodone product and ELI-216, an abuse resistant oxycodone product which utilizes its propriety formulation for abuse resistant products utilizing the pharmacological approach (Elite’s Abuse Resistant Technology). Products under Development ELI-154 and ELI-216 For ELI-154, the company has developed a once-daily oxycodone formulation using its proprietary technology. An investigational new drug application (IND) has been filed and Elite has completed two pharmacokinetic studies in healthy subjects that compared blood levels of oxycodone from dosing ELI-154 and the twice-a-day product that is on the market, OxyContin marketed in the U.S. by Purdue Pharma LP. ELI-216 utilizes the company’s patent-pending abuse-deterrent technology that is based on a pharmacological approach. ELI-216 is a combination of a narcotic agonist, oxycodone hydrochloride, in a sustained-release formulation intended for use in patients with moderate to severe chronic pain, and an antagonist, naltrexone hydrochloride, formulated to deter abuse of the drug. The company has developed ELI-154 and ELI-216 and retains the rights to these products. Strategic Alliance Agreement The company and Epic Pharma, LLC and Epic Investments, LLC, a subsidiary of Epic Pharma LLC (collectively, Epic) entered into the Epic Strategic Alliance Agreement. Epic is a pharmaceutical company that operates a business synergistic to that of Elite in the research and development, manufacturing, and sales and marketing of oral immediate release and controlled-release drug products. Research and Development As of March 31, 2012, the company spent $1,735,689 on research and development activities. Commercial Products In 2011, the company commenced shipping phentermine HCl 37.5 mg tablets to TAGI Pharma Inc. Phentermine tablets are a commercial product being distributed by its partner, TAGI Pharma Inc. In 2011, the company made the initial shipment of Lodrane D immediate release capsules to ECR Pharmaceuticals. Lodrane D is an immediate release formulation of brompheniramine maleate and pseudoephedrine HCl. In January 2012, the company commenced shipping Methadone 10mg tablets to ThePharmaNetwork, LLC and its wholly owned subsidiary, Ascend Laboratories, LLC. pursuant to a commercial manufacturing and supply agreement. In March 2012, the company commenced shipping Hydromorphone 8mg to TAGI Pharma Inc. Strategy The company’s strategy includes improving off-patent drug products for life cycle management and developing generic versions of controlled-release drug products with high barriers to entry. Significant Events In April 2011, the company ceased production of the Lodrane Extended Release Products, which are the subject of the agreements with ECR Pharmaceuticals, pursuant to the FDA’s announcement of its intention to remove approximately 500 cough/cold and allergy related products from the U.S. market, including the Lodrane Extended Release Products. History Elite Pharmaceuticals, Inc. was founded in 1984. The company was incorporated in 1997 under the laws of the state of Delaware. In 2012, the company was reincorporated under the laws of the state of Nevada.
NORTHVALE, Apr 11, 2013 (GLOBE NEWSWIRE via COMTEX) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced the initial shipment of phentermine HCl capsules 15 mg and 30 mg under the License, Manufacturing and Supply Agreement with its sales and marketing partner, triggering a milestone payment. Elite's sales and marketing partner will distribute the product as part of a multi-product distribution agreement.
Phentermine is a member of the bariatric class of drugs intended to aid in weight loss. For the twelve months ending December 31, 2012, Adipex-P(R) 15 mg and 30 mg and its generic equivalents had total U.S. sales of approximately $2.5 million and $5 million respectively according to IMS Health Data. U.S. sales of this product are thought to be greater than the IMS data due to its distribution through channels that are not included in IMS data.
"Elite has successfully launched another product line, this one encompassing two dose strengths. Management remains dedicated to enhancing shareholder value by expanding our generic portfolio of products, continuing the development of our abuse-resistant opioid line of products, enhancing our intellectual property, and strengthening the balance sheet," commented Jerry Treppel, Elite's Chairman and CEO.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Elite has five commercial products currently being sold, an additional product approved and soon to be launched, and one additional product pending approval by the FDA. Elite's lead pipeline products include abuse resistant opioids utilizing the Company's patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Actavis and Ascend Laboratories (previously a subsidiary of ThePharmaNetwork and now a subsidiary of Alkem Laboratories Ltd.) and has partnered with Mikah Pharma to develop a new product, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
This news 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, 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 risks and other factors, including, without limitation, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Company's ability to operate as a going concern, 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 undertakes no obligation to update any forward-looking statements.
CONTACT: For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
www.elitepharma.com
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KEYWORD: NORTHVALE
INDUSTRY KEYWORD: Drugs
SUBJECT CODE: Company Announcement
PHARMACEUTICALS
