SEC Form 8-K filed by Catalyst Pharmaceuticals Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported):
(Exact Name Of Registrant As Specified In Its Charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| |
||
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code:
Not Applicable
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 CFR240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class |
Name of Exchange on Which Registered |
Ticker Symbol | ||
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 8, 2025, the Company issued a press release announcing that it and its licensor, SERB S.A. (“SERB”) have entered into a Settlement Agreement with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively “Teva”). This agreement resolves the patent litigation brought by the Company and SERB in response to Teva’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of FIRDAPSE® (amifampridine) 10 mg tablets prior to the expiration of the applicable patents.
Pursuant to the terms of the settlement agreement, Teva has agreed not to market its generic version of FIRDAPSE® in the United States any earlier than February 25, 2035, if approved by the U.S.. Food and Drug Administration, unless certain limited circumstances customarily included in these types of settlements occur. In accordance with the Agreement, Catalyst/SERB and Teva will terminate all ongoing patent litigation between them that is currently pending in the U.S. District Court for the District of New Jersey.
The Company further reported in the press release that the pending FIRDAPSE® patent litigation against the remaining defendants, Hetero (for all of FIRDAPSE®’s Orange Book-listed patents) and Lupin (only for Catalyst’s FIRDAPSE® patent expiring in 2037) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of FIRDAPSE® to be marketed in the U.S. prior to February 25, 2035.
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. |
| (d) | Exhibits | |
| 99.1 | Press release issued by the Company on January 8, 2025. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Catalyst Pharmaceuticals, Inc. | ||
| By: | /s/ Michael W. Kalb | |
| Michael W. Kalb | ||
| Executive Vice President and Chief Financial Officer | ||
Dated: January 8, 2025
3