Elite Pharmaceuticals Inc (OTCMKTS:ELTP) is on a roll, and the market is beginning to take notice. With its recent approval from the FDA and positive research results that could deliver industry-changing solutions, it seems the company can only go up from here. In this piece, you will find out about the company and what its strategy for the future is.
Below is the stock’s price movement over the past year:
For our readers who may not be familiar with Elite Pharmaceuticals Inc, here is a brief profile of the company
Elite Pharmaceuticals, Inc. was established in October 1997, and its head office is located in Northvale, New Jersey. The firm is focused on the development and manufacture of oral, controlled-release products, using proprietary know-how and technology, as it relates to abuse-resistant products. The company is currently creating a line of branded pharmacological abuse preventive opioid products and a few other generic products. Its strategy includes off-patent drug products for lifecycle management and developing generic versions of controlled-release drug products.
Currently, it has no less than nine products in the market and another four products which are now awaiting approval from the FDA (Food and Drug Administration). Based on its operations, the company operates in two divisions, Abbreviated New Drug Applications for Generic Products and New Drug Applications for Branded Products.
In addition to its regular business, it cultivates controlled-release merchandises by means of an agreement basis for allergy, aches, bariatric, and contamination medications and it is developing an array of abuse restrictive opioid products. The firm has put in place a licensing and manufacturing contract with Epic Pharma LLC; a manufacturing and supply contract with ThePharmaNetwork LLC; and another development and license contract with SunGen Pharma, LLC.
As at January 2018, the firm announced encouraging results from its bioequivalence studies for one of its generic products being co-developed with SunGen Pharma. The topline results indicated that the generic product would be just as useful as the already products already in the market.
Company CEO, Nasrat Hakim made it clear that management was tremendously delighted with the progressive outcomes from these studies. As the product is another of numerous merchandises undergoing improvement in partnership with company partner, SunGen intends to submit an ANDA on the product in 2018 and to release it in 2019.
The firm had a few months earlier gotten the required approval for its abbreviated new drug application (ANDA) from the U.S. (FDA) for Phendimetrazine Tartrate Tablets USP, 35 mg.
According to data published by in March 2017 by QuintilesIMS, the sales for the product was approximately $4.5 million even with the number of competitors. The sales figures used for the survey only include retail figures.
The approval for Phendimetrazine Tartrate was obtained from an Elite ANDA which the firm filed about six years ago. Since that time, ELTP acquired another approved Phendimetrazine Tartrate ANDA from Mikah Pharma. The firm has sold the product for over five years, and it is currently looking at strategic options, such as a divestiture, for the recently approved drug.
The study focused on carrying out a single dose crossover comparative bioavailability check in people in people in good physical shape for fed and fasting states. IMS Health recorded an estimated $1.6 billion in sales in the market for the product during the year.
Nasrat Hakim agreed that an ANDA approval for Phendimetrazine Tartrate by the close of 2017 was good news for the firm. He went ahead to mention that the company is looking towards getting more approvals in 2018 from other filings recently done.
The firm recorded revenues in the second quarter of roughly $1.6 million, a drop from the results of the second quarter of last year mainly stemming from the decline in sales of naltrexone as well as the contract manufacturing of methadone.
ELTP made considerable investments in the development of products in the course of the period, which led to the submission of an ANDA for generic extended release Oxycodone. It also continued its work on SequestOX and a few other products which were being developed in partnership with SunGen Pharma.The firm was able to sustain its high liquidity level, moving it up from 3.6 to 5.5 in the period. This was done while reducing its high debt figures from $20 million to just $8 million in the year.
Elite Pharmaceuticals Inc is making a massive investment in expanding its operations. It is expected that interest in the company will rise as the market becomes more aware of its potential.
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Disclosure: We have no position in ELTP and have not been compensated for this article.