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Press Release

Opiant Pharmaceuticals Announces Contract with Biomedical Advanced Research and Development Authority for Up to $4.6 Million to Accelerate Development of OPNT003, Nasal Nalmefene, for Treatment of Opioid Overdose


Posted on: 20 Sep 18

SANTA MONICA, Calif., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (NASDAQ:OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions and drug overdose, today announced that it has entered into a multi-year contract with potential funding up to a maximum of approximately $4.6 million, with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response, to accelerate Opiant’s development of OPTN003, its lead product candidate. OPTN003, nasal nalmefene, is a potent, long-acting opioid antagonist currently in development for the treatment of opioid overdose.

Opioid overdose is a significant public health crisis worsened by the increasing prevalence of synthetic opioids, such as fentanyl. Fentanyl is 50-fold more potent than heroin, far easier and less expensive to produce and has a significantly longer half-life. Fentanyl and related synthetic opioids were linked to more than 55% of the nearly 49,000 opioid overdose deaths in 2017 in the U.S.

In the early 2000s, fentanyl vapor was used by Russian forces to end a hostage standoff with Chechen rebels, resulting in 117 deaths and hundreds more hospitalized, illustrating the potential for weaponizing synthetic opioids.  The contract with BARDA will allow for accelerated development of OPNT003 as a medical countermeasure in the event of a fentanyl chemical attack. The high affinity of nalmefene at mu opioid receptors, combined with a rapid onset of action and long duration of action, makes it particularly well-suited to treat fentanyl overdose.

“Current treatments sometimes require multiple doses to be effective and in a large-scale terrorist attack involving fentanyl or similar drugs, repeat doses of the treatment may not always be feasible,” said Rick Bright, Ph.D., director of BARDA. “BARDA is committed to developing opioid exposure treatments to protect public health and our nation’s health security.”

“Our approach to drug development is driven by innovative thinking and a commitment to public-private collaboration,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “This $4.6 million BARDA contract, combined with the recently awarded $7.4 million grant we received from the National Institute on Drug Abuse (NIDA), further validates the potential of nasal nalmefene to be a vital life-saving product, both to reverse opioid overdose and to counter bioterrorism attacks. We expect to begin the pivotal pharmacokinetic study required for approval of OPNT003 by the U.S. Food and Drug Administration in 2019.”

The BARDA contract will cover activities not funded by the NIDA grant through a potential New Drug Application submission, and provides approximately $611,000 for the project from now through September 30, 2019, with the balance to be funded over the subsequent two years, subject to satisfactory project progress, funds availability and certain other conditions.

About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing pharmacological treatments for addictions and drug overdose. The NIDA a component of the National Institutes of Health, describes addictive disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. With its innovative opioid antagonist nasal delivery technology, Opiant is positioned to become a leader in these treatment markets. Opiant's first drug overdose product, NARCAN® Nasal Spray, is approved for marketing in the U.S. and Canada by its commercialization partner, Adapt Pharmaceuticals. For more information please visit: www.opiant.com.

About Biomedical Advanced Research and Development Authority
BARDA was established to aid in securing the nation from chemical, biological, radiological, and nuclear threats. BARDA supports the transition of medical countermeasures, such as vaccines, drugs, and diagnostics, from research through advanced development towards consideration for approval by the FDA and inclusion into the Strategic National Stockpile.

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-KT for the transition period August 1 to December 31, 2017 and Form 10-Qs for the periods ended March 31, 2018 and June 30, 2018 filed with the Securities and Exchange Commission on March 7, 2018, May 8, 2018 and August 9, 2018, 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 Inquiries:
Julie Normart, W2O Group
(415) 946-1087
jnormart@w2ogroup.com

For Investor Relations:
Dan Ferry
Managing Director
LifeSci Advisors, LLC
Daniel@lifesciadvisors.com
(617) 535-7746

GlobeNewswire
globenewswire.com

Last updated on: 21/09/2018

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