Opiant Pharmaceuticals and Aptar Pharma Expand Long-Term Collaboration for the Manufacture of Unidose Nasal Spray for OPNT003, Nasal Nalmefene

Rhea-AI Summary

Opiant Pharmaceuticals (NASDAQ: OPNT) has entered a long-term agreement with Aptar Pharma to expand production of the nasal Unidose device for OPNT003, an opioid overdose treatment. The agreement includes a €2 million (approx. $2.1 million) investment from Opiant to support increased production capacity. Opiant is in the process of submitting a New Drug Application (NDA) to the FDA, utilizing the 505(b)(2) pathway, with plans to complete it in the second half of 2022. This move aims to ensure rapid supply of OPNT003 to communities if approved.

Positive

• Opiant's €2 million investment reflects commitment to support production of OPNT003.
• Agreement with Aptar aims to meet potential commercial demand for OPNT003.
• Initiated rolling submission of NDA for OPNT003 using the 505(b)(2) pathway.

Negative

• None.

Long-term agreement includes a €2 million (approximately $2.1 million) investment by Opiant to expand Aptar’s production in support of OPNT003

SANTA MONICA, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (Opiant) (NASDAQ: OPNT) today announced a capacity investment agreement with Aptar Pharma (Aptar), a leading provider of drug delivery systems, to expand production of Aptar’s nasal Unidose device, which will be used in the production of commercial supply of OPNT003, nasal nalmefene.

The agreement includes an investment by Opiant of €2 million (approximately $2.1 million) and a commitment by Aptar to install and maintain equipment in support of increased future production of its Unidose device to meet the potential commercial demand for OPNT003, nasal nalmefene. 

“This capacity investment with Aptar demonstrates Opiant’s commitment to ensure adequate supply of OPNT003, nasal nalmefene, to communities and emergency responders as quickly as possible, if approved,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant.

Opiant has initiated rolling submission of a New Drug Application to the U.S Food and Drug Administration (FDA), for OPNT003, nasal nalmefene, for the treatment of opioid overdose, using the 505(b)(2) pathway. It intends to complete its application in the second half of 2022. Opiant was granted Fast Track Designation in November 2021.

About Opiant Pharmaceuticals, Inc. 
Opiant Pharmaceuticals, Inc., the company that developed NARCAN^® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose. For more information visit: www.opiant.com.

Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements, and among other things, completion of the NDA filing in the second half of 2022. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "projects," "potential," or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended December 31, 2021 and our Form 10-Q for the quarter ended March 31,2022, filed with the Securities and Exchange Commission on March 4, 2022 and May 10, 2022, respectively, including under the caption titled "Risk Factors."  These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.

For Media and Investor Inquiries:
Ben Atkins, Opiant
(310) 598-5410
batkins@opiant.com

FAQ

What is the investment amount Opiant is making in the agreement with Aptar Pharma?

Opiant is making a €2 million (approximately $2.1 million) investment in the agreement with Aptar Pharma.

What is the purpose of the agreement between Opiant and Aptar?

The agreement aims to expand production of Aptar's nasal Unidose device for OPNT003, a treatment for opioid overdose.

When does Opiant plan to complete its New Drug Application for OPNT003?

Opiant intends to complete its New Drug Application for OPNT003 in the second half of 2022.

What designation did Opiant receive for OPNT003 in November 2021?

Opiant was granted Fast Track Designation for OPNT003 in November 2021.