Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study

Rhea-AI Summary

Elite Pharmaceuticals (OTCQB:ELTP) announced positive results from pivotal fasted bioequivalence studies for a generic antimetabolite drug. IQVIA reported annual sales of $42 million for the generic market related to this product as of December 2022. These open-label studies demonstrated that the generic is bioequivalent to its branded counterpart, paving the way for Elite to compile data for an Abbreviated New Drug Application with the FDA.

Elite specializes in niche generic products and operates a registered facility in Northvale, NJ. For more details, visit www.elitepharma.com.

Positive

• Positive bioequivalence results for a generic antimetabolite drug.
• Potential market opportunity with $42 million annual sales reported for this generic product.
• Preparation to file an Abbreviated New Drug Application with the FDA.

Negative

• None.

NORTHVALE, NJ / ACCESSWIRE / February 7, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today reported positive results from pivotal fasted bioequivalence studies for an undisclosed generic drug product in a class of medications called antimetabolites . IQVIA reported annual sales for the twelve months ending December 2022 of $42 million for the generic market for this product.

The studies were open label, single-dose crossover comparative bioavailability studies in volunteers of male and female patients who were already on established drug regimens under fasting conditions. The results indicate that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration.

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops niche generic products. Elite specializes in developing and manufacturing oral, controlled-release drug products. Elite owns multiple generic products which have been licensed to Lannett Company, Prasco, LLC, Epic Pharma, LLC, and TAGI Pharma. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit www.elitepharma.com.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release. Readers are cautioned that such forward-looking statements involve, without limitation, risks, uncertainties, and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of products by the FDA, and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com

SOURCE: Elite Pharmaceuticals, Inc.

View source version on accesswire.com:
https://www.accesswire.com/738300/Elite-Pharmaceuticals-Reports-Positive-Results-from-a-Pivotal-Bioequivalence-Study

FAQ

What are the recent developments for Elite Pharmaceuticals (ELTP) in February 2023?

Elite Pharmaceuticals reported positive results from pivotal bioequivalence studies for a generic antimetabolite drug.

How much is the annual sales figure for the generic drug related to Elite Pharmaceuticals (ELTP)?

IQVIA reported annual sales of $42 million for the generic market for the drug in question.

What steps is Elite Pharmaceuticals (ELTP) taking following the bioequivalence study results?

The company is compiling data to file an Abbreviated New Drug Application with the FDA.

What type of products does Elite Pharmaceuticals (ELTP) specialize in?

Elite specializes in developing niche generic products and oral, controlled-release drug formulations.