Elite Pharmaceuticals Inc (OTCMKTS:ELTP) commenced shipment of generic Isradipine capsules in second-half of January. The capsules, which are available in 2.5 mg and 5.0 mg strength, can be defined as a medication for hypertension. Elite acquired Isradipine from Mikah Pharma and then licensed it to Epic Pharma in 2014. Under the Manufacturing and License agreement, Epic will look after distribution and Elite will take care of the manufacturing process. The first shipment results in a major milestone to Elite.
The annual U.S. sales for Isradipine 2.5 mg and 5.0 mg capsules was around $5.5 million for the year ended June 30, 2014. As of now, there is a single generic form marketed in the United States for immediate release Isradipine capsules.
The management view
Nasrat Hakim, the CEO of Elite, said that Elite Pharmaceuticals Inc (OTCMKTS:ELTP) is delighted to reach the important milestone of introducing Isradipine. The primary objective of the company is the development and approval of its abuse-deterrent products. The management remains committed to increasing shareholder value through means of portfolio expansion of generic products. Elite will develop a wide range of opioid abuse-deterrent products. It will use its proprietary technology in developing unique products and will create a niche in the industry of generic drugs.
The other details
Elite Pharmaceuticals declined more than 3% on Tuesday. Elite Pharmaceuticals Inc (OTCMKTS:ELTP) posted consolidated revenues of $1.4 million in 3Q2015, up 8.5% from 2Q2015. The increase in revenues sequentially is primarily due to the expansion and growth of Elite’s generic product lines.
Investment in clinical trials
The development of abuse-deterrent opioid technology will remain a priority of Elite Pharmaceuticals Inc (OTCMKTS:ELTP) in 2015. In 3Q, Elite invested $2.3 million in clinical trials and product development activities including ELI-200. The total investment in clinical trials for the three-quarters in 2015 amounts to $9.9 million.