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): June 13, 2018
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) | |||
Registrant’s telephone number, including area code: (305) 420-3200
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)) |
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 June 13, 2018, the Company issued a press release announcing that Daniel J. Brennan has been appointed to the position of Chief Commercial Officer. In that position, Mr. Brennan will be responsible for leading the Company’s marketing, sales and commercial operations.
A copy of the Company’s 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 | Press release issued by the Company on June 13, 2018 |
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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: June 15, 2018
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Exhibit 99.1
Catalyst Pharmaceuticals Appoints Daniel J. Brennan as Chief Commercial Officer
CORAL GABLES, Fla., June 13, 2018 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced the appointment of Daniel J. Brennan as Chief Commercial Officer. Mr. Brennan will be responsible for leading the Company’s marketing, sales and commercial operations as Catalyst prepares for a potential launch of Firdapse®.
“We are pleased to welcome Dan to the Catalyst team, as he brings extensive experience in leading the commercial efforts at biopharmaceutical companies, particularly those focused on orphan, neurological diseases,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals. “Dan’s expertise in building commercial platforms is ideal as we prepare for a potential approval of Firdapse in the second half of this year.”
“I am very excited to join Catalyst at such a key time for the Company, as we prepare to potentially commercialize an FDA-approved treatment for the symptomatic treatment of Lambert-Eaton myasthenic syndrome,” said Mr. Brennan. “I look forward to joining the senior management team as we work to bring life-changing treatments to patients with rare, debilitating diseases.”
Mr. Brennan most recently served as the Chief Operating Officer at Edge Therapeutics, where he was responsible for pre-commercialization activities of the company’s lead product targeting rare neurological conditions. Previously, Mr. Brennan held several leadership positions at Lundbeck U.S., including Vice President and Group General Manager of Lundbeck’s U.S. Neurology Business Unit and Business Development group. Throughout his time in these positions, Lundbeck’s U.S. Neurology group launched four specialty orphan products and achieved growth in annual sales from $60 million to $820 million. Prior to Lundbeck, Mr. Brennan was at Abbott Laboratories, where he served as Divisional Vice President and General Management of the Acute Care Hospital Business Unit, which was responsible for more than 80 commercial personnel and over $240 million in hospital-based pharmaceutical sales. Mr. Brennan also served in various sales, marketing and new product development roles of increasing responsibility for Eli Lilly and Company from 1997 to 2007. Prior to joining Edge Therapeutics in late 2016, Mr. Brennan served as Chief Operating Officer and Executive Vice President of Insys Therapeutics for approximately 8 months.
Mr. Brennan received a B.A. degree in Psychology from the University of Notre Dame and an MBA degree, with distinction, from the Kellogg Graduate School of Business at Northwestern University.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a 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), congenital myasthenic syndromes (CMS), MuSK
antibody positive myasthenia gravis, spinal muscular atrophy (SMA) type 3, and infantile spasms. Firdapse® (amifampridine phosphate) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LEMS and Orphan Drug Designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.
Catalyst is also developing CPP-115 to treat refractory infantile spasms. CPP-115 has been granted U.S. Orphan Drug Designation for the treatment of infantile spasms by the FDA and has been granted E.U. Orphan Medicinal Product Designation for the treatment of West syndrome by the European Commission. In addition, Catalyst is developing a generic version of Sabril® (vigabatrin).
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Firdapse will ever be approved for commercialization, (ii) whether Catalyst will be the first company to receive an approval for amifampridine (3,4-DAP), giving it 5-year marketing exclusivity for its product, and (iii) those other factors described in Catalyst’s Annual Report on Form 10-K for the fiscal year 2017 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC are available from the SEC, may be found on Catalyst’s 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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