UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company 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. ☐
Item 8.01 Other Events
On January 30, 2023, Evoke Pharma, Inc. (the “Company”) announced that a joint stipulation of dismissal has been filed in the GIMOTI® (metoclopramide) patent infringement case (Civil Action No. 1:22-cv-02019). The filing of the stipulation arises from Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.’s conversion from a Paragraph IV certification to a Paragraph III certification. A paragraph III Abbreviated New Drug Application (ANDA) is not eligible for approval until the last expiration date of current and potential future orange book listed patents for the reference listed drug in conjunction with appropriate FDA reivew.
In addition, no future ANDA filer will be eligible to receive 180-day generic exclusivity for an ANDA that references GIMOTI®. This regulatory pathway is typically highly sought after by generic firms.
Safe Harbor Statement
Evoke cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: the anticipated scope and term of any patent protection for GIMOTI; and Evoke’s belief in the strength of the GIMOTI patent protection and ability to defend its intellectual property rights. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke’s ability to obtain, maintain and successfully enforce intellectual property protection for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke is entirely dependent on the success of GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
SIGNATURES
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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EVOKE PHARMA, INC. |
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Date: |
January 30, 2023 |
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/s/ Matthew J. D'Onofrio |
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Name: Matthew J. D'Onofrio |