ELITE PHARMACEUTICALS ANNOUNCES FIRST SHIPMENT OF GENERIC ISRADIPINE CAPSULES
Northvale, New Jersey, January 15, 2015: Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) today announced the first shipments of generic Isradipine 2.5 mg and 5.0 mg capsules. Isradipine is a calcium channel blocker prescribed for hypertension. Annual U.S. sales for immediate release Isradipine 2.5 mg and 5.0 mg capsules are approximately $5.5 million for the twelve months ending June 30, 2014 according to IMS Health Data. Currently there is a single generic product marketed in the U.S for immediate release Isradipine 2.5 mg and 5.0 mg capsules.
Isradipine is one of the twelve products that Elite acquired from Mikah Pharma and which Elite licensed to Epic Pharma ("Epic”) last year. Epic will distribute the product and Elite will manufacture the product under the Manufacturing and License Agreement between the parties. The first shipment triggers a milestone payment to Elite.
"We are pleased to have reached this important milestone of launching Isradipine,” said Nasrat Hakim, President and CEO of Elite. "While Elite’s primary focus is the development and approval of our abuse deterrent products, management remains dedicated to enhancing shareholder value by expanding our portfolio of generic products. Elite is creating both a diverse range of opioid abuse-deterrent products using our proprietary technology and building a foundation of attractive niche generic drugs.”
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite has eight commercial products currently being sold, eleven additional approved products pending manufacturing site transfer and two additional products under review pending approval by the FDA. Elite’s lead pipeline products include abuse-deterrent 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 Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site transfer, 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, its 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 risks and other factors, including, without limitation, the Company'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, 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:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com
