SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 5, 2020
OPIANT PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of
(Commission File Number
(IRS Employer Identification No.)
233 Wilshire Blvd. Suite 280
Santa Monica, CA
(Address of Principal Executive Offices)
(310) 598 5410
Registrant’s telephone number, including area code
(Former name or former address if changed since last report,)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange on which registered
Common stock, par value $0.001 per share
Nasdaq Stock Market LLC
Item 8.01 Other Events.
On June 5, 2020, Opiant Pharmaceuticals, Inc. (the “Company”) issued a press release addressing the decision by the U.S. District Court for the District of New Jersey in the patent litigation between Teva Pharmaceuticals Industries Ltd. and the Company’s commercial partner Emergent BioSolutions, Inc. ("EBS") regarding NARCAN® (naloxone hydrochloride) Nasal Spray 4mg/spray product.
The Company, as co-plaintiff with EBS and its Adapt Pharma subsidiaries (collectively, "Adapt"), filed complaints beginning in 2016 against Teva Pharmaceuticals Industries Ltd. ("Teva") for patent infringement, relating to Teva’s abbreviated new drug applications ("ANDAs") seeking to market generic NARCAN® (naloxone hydrochloride) Nasal Spray 4mg/spray. On June 5, 2020, the U.S. District Court for the District of New Jersey issued an unfavorable ruling against the Company and Adapt in the consolidated case. The Company and Adapt intend to appeal the decision to the U.S. Court of Appeals for the Federal Circuit.
The Company and Adapt also filed a complaint related to Teva’s ANDA seeking to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 2mg/spray and that matter is still pending.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. Description
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.
OPIANT PHARMACEUTICALS, INC.
Dated: June 8, 2020 By: /s/ David D. O’Toole
Name: David D. O’Toole
Title: Chief Financial Officer
Opiant Pharmaceuticals Statement on U.S. District Court Decision
SANTA MONICA, Calif., June 5, 2020 – Today, the U.S. District Court for the District of New Jersey entered a decision in the patent litigation regarding NARCAN® (naloxone HCl) Nasal Spray 4mg/spray product. The Court ruled in favor of the Defendants, Teva Pharmaceuticals Industries Ltd. Opiant’s commercial partner Emergent BioSolutions, intends to appeal the decision to the Court of Appeals for the Federal Circuit.
“While we are disappointed by the decision today, we are mindful of the important role NARCAN® Nasal Spray plays across the United States in helping our communities save lives from opioid overdose,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “With our pipeline and strong financial position, we remain committed to develop best-in-class medicines for addiction and overdose.”
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.
Investor Relations Contacts:
VP of Corporate Communications and Investor Relations
LifeSci Advisors, LLC