Current Report Filing (8-k)
January 06 2017 - 9:55AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): January 3, 2017
OPIANT PHARMACEUTICALS, INC.
(
Exact name
of registrant as specified in its charter)
Nevada
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000-55330
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46-4744124
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(State or other jurisdiction
of
incorporation)
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(Commission File Number
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(IRS Employer Identification No.)
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401 Wilshire Blvd., 12th Floor
Santa Monica, CA
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90401
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(Address
of Principal Executive Offices)
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(Zip Cope)
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Registrant’s
telephone number, including area code
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(Former name or former address if changed since last report,)
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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:
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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On January 3, 2017, Opiant Pharmaceuticals, Inc. (the “Company”)
and ADAPT Pharma, Inc. (“Adapt Inc.”) received notice from Teva Pharmaceuticals Industries Ltd. (“Teva Ltd.”)
and TEVA Pharmaceuticals USA, Inc., a wholly owned subsidiary of Teva Ltd. (“Teva USA” and, together with Teva Ltd.,
“Teva”), pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) (the “Notice Letter”), that Teva USA had filed Abbreviated
New Drug Application (“ANDA”) No. 209522 with the United States Food and Drug Administration (“FDA”) seeking
regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray (“NARCAN®”)
before the expiration of U.S. Patent No. 9,468,747 (the “’747 patent”). The ‘747 patent is listed with
respect to NARCAN® in the FDA’s Approved Drug Products with Therapeutic Equivalents Evaluations publication (commonly
referred to as the “Orange Book”) and expires on March 16, 2035. Teva’s Notice Letter asserts that its generic
product will not infringe the ‘747 patent or that the ‘747 patent is invalid or unenforceable. The Company and Adapt
Inc. are evaluating Teva’s Notice Letter.
On September 21, 2016, the Company filed a Form 8-K announcing
that it and Adapt Inc. received notice from Teva, pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), that Teva USA had filed ANDA No.
209522 with the FDA seeking regulatory approval to market a generic version of NARCAN® before the expiration of U.S. Patent
No. 9,211,253 owned by the Company (the “’253 patent”). On October 21, 2016, Adapt Inc., Adapt Pharma Operations
Limited and the Company (collectively, the “Plaintiffs”) filed a complaint for patent infringement against Teva in
the United States District Court for the District of New Jersey arising from Teva USA’s filing of the ANDA No. 209522 with
the FDA with respect to the ‘253 patent. The Plaintiffs seek, among other relief, an order that the effective date of FDA
approval of ANDA No. 209522 be a date later than the expiration of the ‘253 patent, as well as equitable relief enjoining
Teva from infringing the ‘253 patent and monetary relief as a result of any such infringement.
The Company has full confidence in its intellectual property
portfolio related to NARCAN® and expects that the ‘253 patent and ‘747 patent will continue to be vigorously defended
from any infringement. The Company may receive additional Notice Letters from other companies seeking to market generic versions
of NARCAN® in the future and, after evaluation, the Company may commence patent infringement lawsuits against such companies.
SIGNATURE
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.
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Opiant Pharmaceuticals, Inc.
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Date: January 6, 2017
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By:
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/s/
Dr. Roger Crystal
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Name: Dr. Roger Crystal
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Title: President and Chief Executive Officer
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