NORTHVALE, N.J., July 28, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (OTCBB:ELTP), a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced Elite and SunGen Pharma, LLC will co-develop four additional generic products bringing the total number of products developed under the amended agreement to eight.
Under the terms of Amendments to the parties' 2016 Development and License Agreement (the “Agreement”), Elite and SunGen will share the responsibilities and costs of development. Three products will be owned jointly by Elite and SunGen; three shall be owned by SunGen while Elite shall have the marketing rights once the products are approved by the FDA; and two shall be owned by Elite while SunGen shall have the marketing rights once the products are approved by the FDA. Elite will manufacture and package all eight products on a cost plus basis.
The product classes for the additional four products include antidepressants, antibiotics, and antispasmodics. The additional four products and their generic equivalents had total U.S. sales of more than $1.4 billion in 2016 according to IMS Health Data. The original four products and their generic equivalents had total U.S. sales of more than $3 billion in 2016 according to IMS Health Data.
Building on the success of the original agreement, Elite announced earlier this month a second agreement signed on July 6, 2017, in which Elite and SunGen will collaborate, develop and commercialize generic pharmaceutical products based upon a unique drug delivery platform used for extended release products. The parties will commence development of five generic extended release products and thereafter develop additional such products as there are more than a dozen products utilizing this type of technology. For the twelve months ending March 31, 2017, the initial five products and their generic equivalents had total U.S. sales of more than $2.5 billion according to IMS Health Data.
“We are delighted to continue building on our great partnership with SunGen, and are looking forward to more collaboration in the near future,” said Nasrat Hakim, Chairman and CEO of Elite.
About SunGen Pharma LLC
SunGen Pharma, LLC is a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products. SunGen specializes in the development of oral solid extended release and complex injectable products. SunGen has business partnerships with many US-based generic pharmaceutical companies to develop, manufacture, and sell several pharmaceutical products in the US.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma, and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer and the NDA for SequestOx™, for which it just received the CRL from the FDA. Elite’s lead pipeline products include abuse-deterrent opioids which utilize the Company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.). Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. Learn more at www.elitepharma.com.
