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): March 28, 2014
CATALYST PHARMACEUTICAL PARTNERS, 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 1500 Coral Gables, Florida |
33134 | |||
| (Address of principal executive offices) |
(Zip Code) | |||
Registrant’s telephone number, including area code: (305) 529-2522
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)) |
| Item 8.01 | Other Events |
On March 28, 2014, the Company issued a press release announcing that it has appointed Barrett S. McGrath as Chief Commercial Officer, a newly created position. McGrath will lead the formation of the Company’s North America commercial strategy and organization. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
| (c) | Exhibits |
| 99.1 | Press Release issued by the Company on March 28, 2014 | |
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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 Pharmaceutical Partners, Inc. | ||
| By: | /s/ Alicia Grande | |
| Alicia Grande | ||
| Vice President, Treasurer and CFO | ||
Dated: March 28, 2014
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Exhibit 99.1
FOR IMMEDIATE RELEASE
Catalyst Pharmaceutical Partners Expands Executive Leadership Team
to Support the Commercialization of FirdapseTM
Barrett S. McGrath Named as Chief Commercial Officer
CORAL GABLES, Fla., March 28, 2014 — Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a specialty pharmaceutical company focused on developing safe and effective, FDA-approved medicines targeting orphan neuromuscular and neurological diseases, today announced the appointment of Barrett S. McGrath as Chief Commercial Officer, a newly created position. McGrath will lead the formation of Catalyst’s North America commercial strategy and organization. McGrath will report to Patrick McEnany, Chairman, President and Chief Executive Officer of Catalyst.
“With more than 30 years of commercial and business development experience in the orphan and ultra-orphan markets across a range of therapeutic areas, Barrett brings to Catalyst a depth of knowledge and expertise at a pivotal time,” said Patrick McEnany. “He has been a part of the development or execution of more than 20 launch programs. This experience will be invaluable as we begin our plans for an NDA submission of Firdapse™ to the FDA early next year and initiate pre-commercial activities.”
In his most recent industry role, Barrett was the Vice President, Commercial Development at InterMune, Inc. This role began in May 2009 following a 13-month consulting relationship with the company. In both capacities, his primary responsibility was to develop the U.S. commercial strategy and organization in preparation for the launch of Esbriet® (pirfenidone), which is the only approved medicine for idiopathic pulmonary fibrosis (IPF), a large orphan disease, in Europe and Canada.
Mr. McGrath began his career in 1982 at American Hospital Supply Corporation, in the American Critical Care pharmaceutical division. Barrett left American Hospital Supply in 1988 to join Genentech’s growing commercial organization. During a period of 11 years at Genentech, he served in roles of increasing responsibility in sales, sales management and brand management, and had integral roles in the launch of several of Genentech’s successful early brands. Following his departure from Genentech, Barrett served as a commercial consultant to venture-backed start-up Tercica. In 2002, he joined Quintiles, Inc., in Alliance Management for the NovaQuest unit.
Barrett has also served as a Consultant/Advisor to numerous emerging healthcare companies in the areas of commercial strategy, business development and venture-backed company formation. Barrett earned a BS in Business Administration - Marketing from the University of Tennessee – Knoxville.
“I am very excited to be joining Catalyst at this pivotal time for the company,” said McGrath. “I look forward to the opportunity to participate in the development of Catalyst’s mission to assure that all LEMS patients are able to have access to a safe and effective, FDA-approved therapy to address this unmet medical need.”
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), infantile spasms, and Tourette Syndrome. Catalyst’s lead candidate, Firdapse™ for the treatment of LEMS, is currently undergoing testing in a global, multi-center, pivotal Phase 3 trial and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). In 2012, Catalyst licensed Firdapse™ from BioMarin and Catalyst assumed management of the Phase 3 pivotal trial, initiated by BioMarin. Firdapse™ is the first and only European approved drug for symptomatic treatment in adults with LEMS.
Catalyst is also developing a potentially safer and more potent vigabatrin analog (designated CPP-115) to treat infantile spasms, and epilepsy, as well as other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette Syndrome. 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. For more information, please visit www.catalystpharma.com.
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 the timing of completion of Catalyst’s currently ongoing Phase 3 trial of Firdapse™, whether the Phase 3 trial will be successful, whether the receipt of breakthrough therapy designation for Firdapse™ will expedite the development and review of Firdapse™ by the FDA or the likelihood that the product will be found to be safe and effective, whether an NDA for Firdapse™ will ever be accepted for filing by the FDA, the timing of any such NDA filing or acceptance, whether Catalyst will be the first company to receive approval for 3,4-DAP, giving it 7-year marketing exclusivity for its product, whether any of Catalyst’s product candidates will ever be approved for commercialization or successfully commercialized, and those other factors described in Catalyst’s Annual Report on Form 10-K for the fiscal year 2013 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.
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| Media/Investor Contacts | Company Contact | |
| David Connolly or Aurora Krause | Patrick J. McEnany | |
| LaVoie Group | Catalyst Pharmaceutical Partners, Inc. | |
| (617) 374-8800 | Chief Executive Officer | |
| dconnolly@lavoiegroup.com | (305) 529-2522 | |
| akrause@lavoiegroup.com | pmcenany@catalystpharma.com |
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