Opiant Pharmaceuticals Announces Development Collaboration with National Center for Advancing Translational Sciences for the Development of OPNT004 for the Treatment of Acute Cannabinoid Overdose

SANTA MONICA, Calif., Jan. 02, 2020 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") OPNT, a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today announced that it has signed a Letter of Intent with the National Center for Advancing Translational Sciences (NCATS) to collaborate on the development of OPNT004 (drinabant), a novel cannabinoid receptor antagonist, for the treatment of Acute Cannabinoid Overdose (ACO).  NCATS is one of 27 divisions and centers of the National Institutes of Health (NIH). NCATS will provide development resources around certain pre-clinical activities and studies in order to support Opiant's planned filing of an Investigational New Drug application for OPNT004.  This collaboration will be carried out under a Cooperative Research and Development Agreement between Opiant and the NIH.

Opiant licensed exclusive global rights for the development and commercialization of drinabant for the emergency treatment of ACO from Sanofi in December 2018.  The companies subsequently expanded their partnership in July 2019, whereby Sanofi will be responsible for manufacturing OPNT004. 

"There is an urgent need for a product for the rapid reversal of ACO, and the extensive safety data of orally administered drinabant are encouraging regarding the prospects of an injectable version of the drug to better meet this need in the ER," said Roger Crystal, M.D., Chief Executive Officer of Opiant.  "We view this collaboration with NCATS as an important validation of the need for this product."      

"During 2020, we expected to incur approximately $4.5 million in expenses related to our OPNT004 program," said David O'Toole, Chief Financial Officer of Opiant.  "Although the exact amount of in-kind funding from NCATS is yet to be determined, with this collaboration, we now anticipate that our R&D expenses for the development of OPNT004 will decrease significantly in 2020. We are grateful that our programs continue to be validated and funded by government agencies."

ACO is most often linked to the ingestion of edible products containing large quantities of delta⁹-tetrahydrocannabinol (THC), as well as the use of synthetic cannabinoids.  ACO is characterized by panic and anxiety, feelings of paranoia, agitation, visual and auditory hallucinations, and nausea, and these last several hours to days.  There are no U.S. Food and Drug Administration approved medications that treat ACO; treatment is currently symptom-driven, requiring emergency medical attention and in some instances, hospitalization.  ACO is particularly problematic in children, who inadvertently consume edibles, which are often sold as brownies, cookies and candies.  Opiant estimates that cannabinoid consumption will be responsible for more than 1 million emergency department visits in 2019.

About Opiant Pharmaceuticals, Inc.

Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing medicines for addictions and drug overdose. NIDA, a division of the National Institutes of Health, describes addictive disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. Opiant's first drug overdose product, NARCAN® Nasal Spray, is approved for marketing in the U.S. and Canada by its licensee, Adapt Pharmaceuticals, now owned by Emergent BioSolutions Inc.  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 or our industry's 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, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. 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, 2018, filed with the Securities and Exchange Commission on March 21, 2019, 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.

Investor Relations Contact:

Dan Ferry

Managing Director

LifeSci Advisors, LLC

Daniel@lifesciadvisors.com

(617) 430-7576