Elite Pharmaceuticals unveils positive top-line data from key bio-equivalence study for undisclosed antibiotic generic drug

Elite Pharmaceuticals Inc (OTCBB:ELTP), a pharmaceutical group that develops abuse-deterrent opioids and niche generic drugs, has unveiled positive top-line results from key bio-equivalence studies conducted for an undisclosed antibiotic generic drug now being co-developed with SunGen Pharma.

The top-line results show that the generic product is bio-equivalent to its branded product in studies where patients either fasted or were fed.

The studies were open-label, randomized, single oral dose, bio-equivalence studies evaluating healthy adult volunteers in both the fed and fasted states.

Read: Elite Pharmaceuticals reports sharp drop in revenue in fiscal 2018 due to sluggish sales of methadone

The filing of an abbreviated new drug application for the undisclosed drug is expected before the close of the year.

“I am pleased we have achieved this milestone and are expected to file this [abbreviated new drug application] by year-end,” said Elite CEO Nasrat Hakim.

“Elite continues to build a strong pipeline by combining its own products with those co-developed with SunGen,” he added.

Read: Elite Pharmaceuticals Inc surges on FDA milestone for SequestOX

Based in Northvale, New Jersey, Elite Pharmaceuticals bills itself as a specialty pharmaceutical company which is developing a pipeline of abuse-deterrent opioid products as well as niche generic drugs. Elite owns generic and OTC (over the counter) products which have been licensed to TAGI Pharma, Epic Pharma, Glenmark Pharmaceuticals and Dr. Reddy’s Laboratories.

Its partner SunGen Pharma, which is headquartered in Princeton, New Jersey, meanwhile, focuses on the development of high-quality generic drugs and has over forty products under development at various stages that either have been or will be filed with the US Food and Drug Administration.

Elite shares were up 1.7% at US$0.10 in afternoon trade.

Contact Ellen Kelleher at [email protected]

Story by ProactiveInvestors