Having never before covered Elite Pharmaceuticals Inc (OTCMKTS:ELTP) here on Street Register, we wanted to give a brief rundown of the company as it describes itself.
ELTP 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 Pharmaceuticals Inc (OTCMKTS:ELTP) shares are rebounding after they took a dive after a PR released on Friday. The company reported topline results from a pivotal bioequivalence fed study for SequestOx™. The mean Tmax of SequestOxTM was 4.6 hr with a range of 0.5 hr to 12 hr and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr with a range of 0.5 hr to 12 hr. A key objective for the study was to determine if the reformulated SequestOxTM had a similar Tmax to the comparator when taken with a high fat meal. Elite will pause, not proceed with the rest of the clinical trials, and seek clarity from FDA before deciding on the next steps for immediate release SequestOxTM. Elite will continue to pursue extended release products with its proprietary abuse deterrent technology
Elite’s pipeline objectives for 2017 remain on-target as Elite is planning the submission of one ANDA filing this current quarter and an additional two ANDA filings in the fourth quarter. Elite will update the progress of these targets in the next investor call. Elite’s ANDA filings already submitted to the FDA combined with the three ANDAs targeted for submission later this year have total U.S. sales, for the branded products and their generic equivalents, of $4 billion according to IMS Health Data. Elite’s pipeline will continue to include abuse deterrent products. The next abuse-deterrent product expected to be filed will be a generic version of OxyContin® for which IMS reported approximately $2.5 billion in revenue in 2015.
“We were hoping for better and more decisive results for the reformulated immediate release version of SequestOxTM”, said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “We remain positive with respect to Elite’s abuse-deterrent and generic pipeline. We will see the results of our hard work over the next six to twelve months.”
SequestOx™ is Elite’s investigational immediate-release oxycodone with sequestered naltrexone abuse-deterrent opioid product for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The study was a pivotal, open-label, randomized, single-dose, three-way, crossover study to evaluate the relative bioavailability and bioequivalence of the modified formulation of SequestOx™ to the original formulation of SequestOx™ and to a comparator product under fed conditions. The study also evaluated the Tmax of a reformulated SequestOxTM compared to the original SequestOx™ formulation and a comparator product under fed conditions. (Source: Globe Newswire)
So, while the company and shreholders alike were disappointed by having to place the plans for SequestOX on hold, there was an assurance given as to the direction of the company moving forward, and putting plans on hold does not necessarily mean we’ve heard the end of the SequestOx story, or for that matter, the ELTP story. That’s why we’ll want to keep this stock on watch, and you can do the same along with us. Stay locked to Street Register for updates, and we’ll deliver important developments on ELTP as they unfold. In the meantime, if you’ve yet to sign up for our 100% free newsletter, do so now! Just enter your active email address into the box below and submit!
Disclosure: No one at Street Register has been compensated in any way for the publishing of this article, nor do we hold any position in ELTP stock, short or long.