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Elite Pharmaceuticals, Inc. (ELTP) develops oral sustained and controlled release products. The company`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.
Overview of pipeline ELTP has seven commercial products currently being sold, twelve additional approved products pending manufacturing site transfer and two additional products under review pending approval by the FDA, according to a Jun. 30 press release.
ELTP`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. ELTP 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, 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.
ELTP reports 35 percent revenue increase in most recent fiscal year Last month, ELTP announced that consolidated revenues were $4.6M for the most recently reported fiscal year, an increase of $1.2M or approximately 35 percent over consolidated revenues for the prior year.
In addition, ELTP`s “balance sheet was also its strongest on record, reporting a working capital surplus of [$3.8M], the first working capital surplus in 5 years,” a Jun. 30 press release stated. “Based on the strength of its balance sheet, combined with the growth in commercial operations and access to significant financing, management determined that Elite is sufficiently capitalized to operate as a going concern.
Elite`s independent auditors agreed with this determination, and have issued an unqualified opinion without a going concern paragraph. This is the first audit opinion without a going concern paragraph since 2002.” “Fiscal 2014 will be known as the year of Elite`s turnaround,” said ELTP`s CEO Nasrat Hakim in the Jun. 30 press release. “We successfully completed a bioequivalence study for ELI-200, initiated other human trials, and are well positioned to file the first of our abuse resistant opioid products by the end of this year. We have emerged as one of the leaders in the development of abuse deterrent opioids. In addition, we launched three new generic products and acquired twelve additional generic products, which we expect to provide a stable and growing foundation of revenues to sustain us on an ongoing basis. I want to thank and congratulate the entire Elite team for the spectacular accomplishments during Fiscal 2014, on which we continue to build and move forward.” ELTP initiates pivotal bioequivalence study for ELI-201 Most recently ELTP announced the first dosing of a pivotal bioequivalence study in healthy volunteers for ELI-201, the company`s twice daily abuse deterrent oxycodone/naltrexone product, utilizing Elite`s proprietary pharmacological abuse deterrent technology.
The study is an open-label, single-dose, partially-randomized crossover study in healthy adult subjects, a Jul. 15 press release stated. The primary objective of this study is to compare the bioavailability and establish bioequivalence of ELI-201 controlled-release capsules, 40 mg to OxyContin(R) controlled-release tablet, 40 mg. The secondary objectives include determining the bioavailability of oxycodone from ELI-201 under fasted and fed conditions and evaluating the safety and tolerability of ELI-201.
“We are pleased to have initiated our third key bioequivalence trial this year for Elite`s abuse-deterrent opioid products,” Hakim said in the Jun. 15 press release.
“Elite has a range of abuse deterrent products that use Elite`s proprietary pharmacological abuse deterrent technology and this is one of several abuse deterrent products currently under development by Elite. Our plans for the second half of 2014 include completing In Vitro Lab Abuse studies and In Vivo Human Abuse Liability studies and filing an NDA for ELI-200. Elite is excited to be developing these new approaches to help address the prevalent issue of prescription drug abuse.” To learn more about ELTP, visit: http://www.elitepharma.com .
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The information contained on our website or in any of our newsletters is for informational purposes only, and is not intended to be advice, nor a recommendation and/or guidance for investment decisions. In preparing this publication, we have relied upon information supplied by public information, and press releases which we believe to be reliable; however, such reliability cannot be guaranteed, nor is it verified by us. We are engaged in the business of profiling companies for monetary compensation. All direct and third party compensation received has been disclosed on our newsletter and/or our website in accordance with Se ction 1 7 (b) of the Sec uri ties A c t of 1 9 3 3.
Compensation: We have not been compensated for this publication. We do not own any shares of Elite Pharmaceuticals, Inc.
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