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): August 6, 2020
CATALYST PHARMACEUTICALS, INC.
(Exact Name Of Registrant As Specified In Its Charter)
Delaware | 001-33057 | 76-0837053 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) | ||
355 Alhambra Circle Suite 1250 Coral Gables, Florida |
33134 | |||
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (305) 420-3200
Not Applicable
Former Name or Former address, if changed since last report
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
Name of Exchange on Which Registered |
Ticker Symbol | ||
Common Stock, par value $0.001 per share | NASDAQ Capital Market | CPRX |
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 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 August 6, 2020, the Company issued a press release announcing that Canadas national healthcare regulatory agency, Health Canada, has approved the use of Firdapse® (amifampridine) for the treatment of patients in Canada with Lambert-Eaton myasthenic syndrome (LEMS), an ultra-rare, debilitating and potentially life-threatening neurodegenerative condition.
A copy of the Companys press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits |
99.1 |
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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/ Alicia Grande | |
Alicia Grande | ||
Vice President, Treasurer and CFO |
Dated: August 6, 2020
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Exhibit 99.1
Catalyst Pharmaceuticals Firdapse® (amifampridine phosphate) Receives
Marketing Approval in Canada for Patients with LEMS
CORAL GABLES, Fla., August 06, 2020 (GLOBE NEWSWIRE) Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that Canadas national healthcare regulatory agency, Health Canada, has approved the use of Firdapse® (amifampridine) for the treatment of patients in Canada with Lambert-Eaton myasthenic syndrome (LEMS), an ultra-rare, debilitating and potentially life-threatening neurodegenerative condition.
Firdapse® was approved under Priority Review by Health Canada. The marketing application submitted to Health Canada included safety and efficacy data from Catalysts two previously reported multi-national clinical trials evaluating Firdapse® for the treatment of patients with LEMS, and the data from these trials was used to support the new drug submission (NDS) to Health Canada. Firdapse® was previously approved for marketing by the U. S. Food and Drug Administration and the European Commission in 2018 and 2009, respectively, and is currently being used to treat LEMS patients in the United States and in more than 15 additional countries.
At Catalyst, we are dedicated to changing the lives of patients suffering from rare neuromuscular diseases, and we are proud that we have brought forward an approved therapeutic option for patients in Canada suffering with LEMS. We anticipate continuing to interact with Health Canada as we try to expand the Firdapse® label to include other indications, said Gary Ingenito, M.D., Ph.D., Catalysts Chief Medical and Regulatory Officer.
We are currently in discussions with a potential marketing and distribution partner in Canada to provide access for Firdapse®, patient-by-patient, as rapidly as possible, said David Ailinger, Vice President of Business Development at Catalyst.
About Lambert-Eaton Myasthenic Syndrome (LEMS)
Lambert-Eaton myasthenic syndrome, or LEMS, is a rare autoimmune disorder, most often characterized by muscle weakness of the limbs. The disease is caused by an autoimmune reaction where antibodies are formed against voltage gated potassium channels in the connection between nerves and the muscles they communicate with. In approximately 50% of cases, LEMS is associated with an underlying malignancy, most commonly small-cell lung cancer, and in some individuals, LEMS is the first symptom of such malignancy. LEMS generally affects the extremities, especially the legs. As the disease most affects the parts of limbs closest to the trunk, difficulties with climbing stairs or rising from a sitting position are commonly noted. Physical exercise and high temperatures tend to worsen the symptoms. Other symptoms occasionally seen include weakness of the muscles of the mouth, throat, and eyes. Individuals affected with LEMS also may have a disruption of the autonomic nervous system, including dry mouth, constipation, blurred vision, impaired sweating, and/or hypotension.
About Firdapse®
Firdapse® (amifampridine) 10 mg tablets is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization. This action results in the opening of slow voltage-dependent calcium (Ca2+) channels, allowing for a subsequent influx of Ca2+. In turn, it induces the exocytosis of synaptic vesicles containing Acetylcholine (ACh) to release more ACh into the synaptic cleft, enhancing neuromuscular transmission, and providing for improved muscle function.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG), and spinal muscular atrophy (SMA) Type 3. Catalysts new drug application for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in November 2018 by the U.S. Food & Drug Administration (FDA), and Firdapse® is now commercially available in the United States. Prior to its approval, Firdapse® for LEMS had received breakthrough therapy designation and orphan drug designation from the FDA. Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for myasthenia gravis.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalysts actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Catalyst can successfully commercialize its product in Canada on a profitable basis, (ii) whether Catalyst will reach an agreement with a marketing and distribution partner to commercialize its product in Canada, (iii) whether Catalyst will have competition in Canada for its product, (iv) the impact in the United States if an amifampridine product is purchased in Canada for use in the United States, and (v) those factors described in Catalysts Annual Report on Form 10-K for the fiscal year 2019 and Catalysts other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalysts filings with the SEC are available from the SEC, may be found on Catalysts website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
Investor Contact Brian Korb Solebury Trout (646) 378-2923 bkorb@troutgroup.com |
Company Contact Patrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com | |
Media Contact David Schull Russo Partners (212) 845-4271 david.schull@russopartnersllc.com |
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