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 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 |
Stock Option Grants
On August 28, 2014, the Compensation Committee of the Company’s Board of Directors (the “Committee”) granted seven-year stock options to purchase an aggregate of 1,210,000 shares of the Company’s authorized but unissued common stock to various current officers, directors and employees of the Company. These stock options were granted under the Company’s 2014 Stock Incentive Plan and have an exercise price of $3.12 per share (the closing price of the Company’s common stock on such date on the NASDAQ Capital Market).
Because the Company did not have sufficient shares of common stock available for grant under its 2006 Stock Incentive Plan at the end of 2013, no option grants were made to the current officers, directors and employees of the Company (consistent with the Company’s historic compensation practices) for 2013 services. With the approval by the Company’s stockholders at the 2014 annual stockholders’ meeting of the 2014 Stock Incentive Plan, the Company again has shares of common stock available for grant to Company officers, directors and employees as part of the compensation for their services. The stock option grants made by the Committee on August 28, 2014 are intended to compensate the Company’s current officers, directors and employees for their services during 2013.
Initiation of Phase 1(b) clinical trial of CPP-115
On September 2, 2014, the Company issued a press release announcing the initiation of its second Phase 1 safety and tolerance study for CPP-115, a novel GABA aminotransferase (GABA-AT) inhibitor. The Phase 1(b) trial is designed in two parts to evaluate the safety and tolerability of single and multiple doses of CPP-115, including CNS side effects, and respiratory and cardiovascular safety.
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 September 2, 2014. |
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 Pharmaceutical Partners, Inc. | ||
| By: | /s/ Alicia Grande | |
| Alicia Grande Vice President, Treasurer and CFO | ||
Dated: September 2, 2014
3
Exhibit 99.1
FOR IMMEDIATE RELEASE
Catalyst Pharmaceutical Partners Initiates Phase 1(b) Safety and
Tolerance Study for CPP-115
Brain GABA Levels, a potential surrogate marker of efficacy, will also be followed
Coral Gables, FL, September 2, 2014 (GLOBE NEWSWIRE) — Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced the initiation of its second Phase 1 safety and tolerance study for CPP-115, a novel GABA aminotransferase (GABA-AT) inhibitor.
“We are excited to be advancing CPP-115 in the clinic,” said Steven Miller, Ph.D., Chief Operating Officer/Chief Scientific Officer. “Our preclinical experience with CPP-115 has demonstrated its potential for certain epilepsy indications, infantile spasms and other neurological diseases. We expect to report the results of this study at the end of the first quarter or early in the second quarter of 2015.”
The Phase 1(b) trial is designed in 2 parts to evaluate the safety and tolerability of single and multiple doses of CPP-115, including CNS side effects, and respiratory and cardiovascular safety. In addition:
Part 1 of the trial is an open label, single descending dose study in up to 3 cohorts of 2 normal healthy, male volunteers, intended to verify that the drug crosses the blood-brain barrier at levels sufficient to significantly raise brain GABA levels as measured by Magnetic Resonance Spectroscopy (MRS). Catalyst believes increases in brain GABA, an inhibitory neurotransmitter, to be a biomarker for the potential efficacy of CPP-115 as a treatment for Tourette Syndrome, Post-Traumatic Stress Disorder (PTSD) and infantile spasms. If the first dose shows a significant increase, lower single doses will be evaluated to determine a minimal effective dose to be able to set the doses to be evaluated in the multiple dose part of the trial.
Part 2 of the study is designed as a randomized, double-blind, multiple ascending dose study in 4 cohorts of eight normal healthy, male volunteers. In addition to studying basic human safety and tolerability, the effect of multiple doses of CPP-115 on brain GABA levels will also be followed by MRS.
About CPP-115
CPP-115 works by the inhibition of GABA aminotransferase, which leads to increased brain GABA levels that reduce epileptogenesis. Non-clinical data of CPP-115 indicate that there may be a significant reduction, and possibly elimination, of visual field defects (VFDs) from the use of CPP-115 compared to vigabatrin, Sabril ®, which works by a similar mode of action.
Further, based on animal testing to date, CPP-115 has been shown to be at least 200 times more potent than vigabatrin in both in-vitro and animal model studies. The increased potency could enable the development of dosage forms potentially administrable by other routes of administration compared with the marketed oral, immediate release formulations of vigabatrin. Further, based on non-clinical testing completed to date, CPP-115 appears to have superior specificity to GABA aminotransferase and we believe, will have a better side effect profile (e.g. less visual field defects) compared with Sabril ® .
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating 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). 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.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties which may cause the Company’s actual results in future periods to differ materially from forecasted results. A number of factors, including whether CPP-115 will be safe for use in humans, whether CPP-115 will be effective for the treatment of Tourette Syndrome, Post-Traumatic Stress Disorder, infantile spasms or other neurological indications, whether CPP-115 will ever be approved for commercialization, and those other factors described in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect the Company. Copies of the Company’s filings with the SEC are available from the SEC, may be found on the Company’s website or may be obtained upon request from the Company. The Company does not undertake any obligation to update the information contained herein, which speaks only as of this date.
| Media/Investor Contacts Brian Korb The Trout Group LLC (646) 378-2923 bkorb@troutgroup.com |
Company Contact Patrick J. McEnany Catalyst Pharmaceutical Partners, Inc. Chief Executive Officer (305) 529-2522 pmcenany@catalystpharma.com |
# # #
Page 2