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): November 18, 2013
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 November 18, 2013, the Company issued a press release announcing that the journal Epilepsia has accepted for publication an original research paper that demonstrates proof of concept of CPP-115 suppressing infantile spasms (IS) in a pre-clinical study. CPP-115 is the Company’s next-generation GABA aminotransferase inhibitor being developed for the treatment of IS. The Company also announced plans to initiate a Phase I multiple-dose ascending study in the first half of 2014 to evaluate the safety and tolerability of multiple ascending oral doses of CPP-115.
Our investors and others should note that we currently announce material financial and other information to our investors using SEC filings, press releases, and our investor relations website. We use these channels as well as social media channels to announce information about the Company. Consistent with SEC guidance regarding the use of social media channels to announce material and other information to investors, we are notifying investors, the media and others interested in the Company that in the future, we might choose to communicate material information through social media channels, and it is possible that the information we post on social media channels could be deemed to be material information. Accordingly, we encourage investors, the media and others interested in the Company to review the information we post on Twitter at http://www.twitter.com/CatalystPharma.
| Item 9.01 | Financial Statements and Exhibits. |
| (c) | Exhibits | |||
| 99.1 | Press Release issued by the Company on November 18, 2013 | |||
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: November 18, 2013
Exhibit 99.1
NEWS RELEASE
FOR IMMEDIATE RELEASE
Catalyst Pharmaceutical Partners Announces Publication of Preclinical Proof-of-principle
of CPP-115 Efficacy in Suppressing Infantile Spasms in Epilepsia
Phase I Multiple-Ascending Dose Study to be Initiated in 2014
CORAL GABLES, Fla., Nov. 18, 2013 — Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a specialty pharmaceutical company focused on developing safe and effective approved medicines targeting orphan neuromuscular and neurological diseases, today announced that the journal Epilepsia has accepted for publication an original research paper that demonstrates proof of concept of CPP-115 suppressing infantile spasms (IS) in a pre-clinical study. CPP-115 is Catalyst’s next-generation GABA aminotransferase inhibitor being developed for the treatment of IS. Catalyst also announced plans to initiate a Phase I multiple-dose ascending study in the first half of 2014 to evaluate the safety and tolerability of multiple ascending oral doses of CPP-115.
The lead author (Dr. Aristea Galanopoulou) and principal investigator of the preclinical rodent study described in this publication stated, “This publication provides the first proof-of-principle preclinical evidence in support of CPP-115 as a candidate treatment for IS.” Dr. Galanopoulou continued “Because vigabatrin is particularly effective in tuberous sclerosis–related IS, these patients are likely an ideal target for this analogue that seems to be more potent and less toxic.”
Epilepsia, the official journal of the International League Against Epilepsy, has published Dr. Galanopoulou’s paper, “CPP-115, a vigabatrin analogue, decreases spasms in the multiple-hit rat model of infantile spasms” online as an early view of its upcoming publication. The research paper describes the following study conclusions:
| • | CPP-115 suppresses spasms in the multiple-hit model of IS, with onset of effect as early as the day after the first dose. |
| • | The therapeutic doses of CPP-115 were well tolerated in the preclinical model. |
| • | CPP-115 showed efficacy at lower doses which were better tolerated than the previously tested therapeutic vigabatrin doses. |
“There is a significant unmet medical need in this area, as parents of children who have infantile spasms have a very difficult choice when it comes to treatment options, as they must choose between drug-related risks and adequate treatment,” said Patrick J. McEnany, Chairman and CEO of Catalyst. “Thanks to Dr. Galanopoulou and her team at Albert Einstein College of Medicine, we are able to take next steps in the development of CPP-115 shown in this study to be a better and safer treatment option for Infantile Spasms than current options. This study demonstrates that CPP-115 likely has more than a hundred-fold increase in potency and a better safety profile in the expected therapeutic dose range compared to vigabatrin, as well as increased overall efficacy in this model.”
About the Upcoming Phase I Study
The Phase I study for CPP-115 will be a randomized, double-blind, placebo-controlled, safety, tolerability and pharmacokinetic study of multiple ascending oral doses of CPP-115 in healthy volunteers. The primary objective will be to evaluate the safety and tolerability of multiple ascending oral doses of CPP-115. Secondary objectives will be to determine the pharmacokinetic profile of CPP-115 and to determine the effects of CPP-115 on brain GABA levels as measured by Magnetic Resonance Spectroscopy (MRS) following administration of multiple oral daily doses.
Like vigabatrin (SABRIL®), CPP-115 irreversibly inhibits GABA-aminotransferase, raising brain GABA concentrations. Therefore, the anticipated MRS findings of increased brain GABA are a well characterized biomarker, which can be correlated to the potential efficacy of 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.
About the Published Paper
The research paper was authored by Stephen W. Briggs, Wenzhu Mowrey, Charles B. Hall, and Aristea Galanopoulou (corresponding author), of the Saul R. Korey Department of Neurology, Albert Einstein College of Medicine of Yeshiva University, Laboratory of Developmental Epilepsy and Dominick P. Purpura Department of Neuroscience, Albert Einstein College of Medicine of Yeshiva University, Bronx, New York. The abstract can be accessed at http://onlinelibrary.wiley.com/doi/10.1111/epi.12424/abstract.
About Albert Einstein College of Medicine
The Albert Einstein College of Medicine of Yeshiva University is a premier, research-intensive medical school dedicated to innovative biomedical investigation and to the development of ethical and compassionate physicians and scientists. Inspired by the words of its namesake, the school welcomes students, faculty and staff from diverse backgrounds who strive to enhance human health in the community and beyond.
About West Syndrome / Infantile Spasms
West Syndrome is a rare disease having a prevalence in the U.S. of under 200,000 patients. Its estimated prevalence is 2.5 to 6 cases per 10,000 live births or between 2150 and 5160 patients.
An infantile spasm is a type of seizure seen in an epilepsy syndrome of infancy and childhood known as West Syndrome. The onset of infantile spasms is usually in the first year of life, typically between 4-8 months. Spasms often occur in clusters of up to 100 at a time, and infants may have dozens of clusters and several hundred spasms per day. Infantile spasms usually stop by age five, but may be replaced by other seizure types. Many underlying disorders, such as birth injury, metabolic disorders and genetic disorders can give rise to spasms, making it important to identify them (symptomatic IS). In some children, no cause can be found (cryptogenic IS). Mental retardation occurs in 70-90% of persons with infantile spasms, usually involving severe to profound retardation. Early control of seizures is critical for reducing developmental delays and levels of mental retardation, but ~5% of infants with this condition eventually die from complications caused by the seizures.
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 recently 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 EU 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 prove to be an effective treatment for infantile spasms in humans, whether CPP-115 will ultimately prove to have significantly reduced risks of visual field defects compared to vigabatrin, whether CPP-115 will ever be approved for commercialization, and those other factors described in the Company’s filings with the 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.
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| Media/Investor Contacts Donna LaVoie or David Connolly LaVoie Group (617) 374-8800 dlavoie@lavoiegroup.com dconnolly@lavoiegroup.com |
Company Contact: Patrick J. McEnany Catalyst Pharmaceutical Partners Chief Executive Officer (305) 529-2522 pmcenany@catalystpharma.com |