×

Opiant Pharmaceuticals, Inc. Announces FDA Orange Book Listing for Narcan® Nasal Spray Patent

SANTA MONICA, Calif., Oct. 27, 2016 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (OTCQB:OPNT), a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders, announced today that its patent for NARCAN® Nasal Spray (“NARCAN”) is now listed in the U.S. Food and Drug Administration (FDA) publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, patent number 9468747.

The patent for naloxone hydrochloride metered 4 milligram nasal spray, N208411, offers product exclusivity for NARCAN until 2035.

“The issuance of this patent and subsequent Orange Book listing significantly strengthens our intellectual property,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “An Orange Book listing requires an Abbreviated New Drug Application (ANDA) applicant seeking FDA approval of a generic version of NARCAN® Nasal Spray to notify us and our partner Adapt Pharma before it can obtain FDA approval. This would be subject to a 30-month stay of marketing approval and potentially longer if notification occurs and a patent infringement suit is successful.”

Opiant successfully developed NARCAN, marketed by its partner and licensee, Adapt Pharma Limited (“Adapt”). In November 2015, NARCAN was approved by the FDA for emergency reversal of opioid overdose.

“There are now two Orange Book listed patents that cover NARCAN® Nasal Spray. This recent one also has broader applicability across Opiant’s portfolio,” said Dr. Crystal. “We expect to continue generating more intellectual property relevant for both NARCAN® Nasal Spray and our development pipeline.”

In December 2014, Opiant announced a licensing deal with respect to NARCAN with Adapt. Pursuant to the terms of the agreement, Opiant could receive total potential milestone payments of more than $55 million, plus up to double-digit percentage royalties on net sales.

About Opiant Pharmaceuticals, Inc.

Opiant Pharmaceuticals, Inc., is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders. Over 45 million people in the U.S. have one of these disorders. The National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH), describes these 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. Its first product, NARCAN® Nasal Spray, is marketed in the U.S. by the company’s partner, Adapt Pharma Limited. Currently, Opiant is developing opioid antagonists for the treatment of substance use, addictive and eating disorders, with a near term focus on eating disorders and cocaine use disorder. For more information please 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. 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. 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.


CONTACT INFORMATION: Corporate Contact: Investor.relations@opiant.com Media Relations and Investor Relations: Scott Stachowiak scott.stachowiak@russopartnersllc.com (646) 942-5630

Source:Opiant Pharmaceuticals, Inc.