Case 1:13-cv-24162-JAL Document 1 Entered on FLSD Docket 11/15/2013 Page 1 of 25 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA Civil Case No. District Judge: Magistrate Judge: LUIS VIZCAY, Individually and on Behalf of all Others Similarly Situated, Plaintiff, CLASS ACTION COMPLAINT v. FOR VIOLATIONS OF FEDERAL SECURITIES LAWS CATALYST PHARMACEUTICAL PARTNERS, INC., PATRICK J. MCENANY, HUBERT E. HUCKEL and STEVEN R. JURY TRIAL DEMANDED MILLER, Defendants. Plaintiff Luis Vizcay (“Plaintiff”), by and through his undersigned attorneys, alleges the following upon information and belief, except as to those allegations concerning Plaintiff, which are alleged upon personal knowledge. Plaintiff’s information and belief is based upon, among other things, his counsel’s investigation, which includes without limitation: (a) review and analysis of regulatory filings made by Catalyst Pharmaceutical Partners, Inc. (“Catalyst” or the “Company”) with the United States Securities and Exchange Commission (“SEC”); (b) review and analysis of press releases and media reports issued by and disseminated by Catalyst; and (c) review of other publicly available information concerning Catalyst. 1 Case 1:13-cv-24162-JAL Document 1 Entered on FLSD Docket 11/15/2013 Page 2 of 25 SUMMARY OF THE ACTION 1. This is a securities class action on behalf of all purchasers of Catalyst securities between October 31, 2012 and October 18, 2013, inclusive (the “Class Period”), seeking to pursue remedies under the Securities Exchange Act of 1934 (the “Exchange Act”). 2. Catalyst is a development-stage specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare neuromuscular and neurological diseases and disorders. The Company’s lead product candidate for U.S. Food and Drug Administration marketing approval is Firdapse, which is currently in Phase III clinical trials for treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”), a rare and sometimes fatal autoimmune disease characterized by muscle weakness. 3. Plaintiff alleges that defendants issued materially false and misleading statements or failed to disclose material adverse facts throughout the Class Period concerning Catalyst’s business, operations and financial prospects. Specifically, defendants failed to disclose that a privately owned competitor company has been providing 3,4-DAP – a drug that is equivalent to Firdapse – free of charge to LEMS patients for approximately the past two decades. 4. On October 18, 2013, the financial website TheStreet published an article titled Catalyst Pharma: Orphan Drug Poseur, Profiteer,” which examines Catalyst’s development of Firdapse and alleges that “Catalyst Pharmaceuticals Partners is considered an orphan drug stock because that's the story management spins.” According to TheStreet , one of the Company’s competitors, the New Jersey-based Jacobus Pharmaceutical Company, has been manufacturing an equivalent drug – 3,4-DAP – and providing it to LEMS patients, free of charge, for the past 20 years. The article further alleges that “[d]ig deeper into Catalyst and you'll discover 2 Case 1:13-cv-24162-JAL Document 1 Entered on FLSD Docket 11/15/2013 Page 3 of 25 allegations of profiteering off a small group of vulnerable, sick patients and a ton of clinical and regulatory risk. " 5. Following this news, the price of Catalyst stock dropped the next trading day by 20%, or $0.38 per share, to a closing price of $1.52 per share on October 21, 2013, thereby damaging investors. JURISDICTION AND VENUE 6. Jurisdiction is conferred by §27 of the Exchange Act. The claims asserted herein arise under §§10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder. This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §1331 and §27 of the Exchange Act. 7. Venue is proper in this District pursuant to §27 of the Exchange Act and 28 U.S.C. §1391(b) as the Company conducts business in this district. 8. In connection with the acts alleged in this complaint, defendants, directly or indirectly, used the means and instrumentalities of interstate commerce, including, but not limited to, the mails, interstate telephone communications and the facilities of the national securities markets. PARTIES 9. Plaintiff Luis Vizcay, as set forth in the accompanying certification, incorporated by reference herein, purchased Catalyst securities during the Class Period, and suffered damages as a result of the federal securities law violations and false and/or misleading statements and/or material omissions alleged herein. 3 Case 1:13-cv-24162-JAL Document 1 Entered on FLSD Docket 11/15/2013 Page 4 of 25 10. Defendant Catalyst is a Delaware corporation with its principal executive offices situated at 355 Alhambra Circle, Suite 1500, Coral Gates, Florida. Catalyst common stock is traded on the NASDAQ under the symbol “CPRX.” 11. Defendant Patrick J. McEnany (“McEnany”) is a co-founder of Catalyst and was at all relevant times the Company’s President and Chief Executive Officer. 12. Defendant Dr. Hubert E. Huckel (“Huckel”) is the Company’s co-founder and was at all relevant times a Director. 13. Defendant Steven R. Miller (“Miller”) is and was at all relevant times the Company’s Chief Operating Officer and Chief Scientific Officer. 14. The defendants referenced above in ¶¶11-13 are sometimes referred to herein as the “Individual Defendants.” The Individual Defendants, because of their positions with the Company, possessed the power and authority to control the contents of Catalyst’s reports to the SEC, press releases and presentations to securities analysts, money and portfolio managers and institutional investors, i.e. , the market. The Individual Defendants were provided with copies of the Company’s reports and press releases alleged herein to be misleading prior to, or shortly after, their issuance and had the ability and opportunity to prevent their issuance or cause them to be corrected. Because of their positions and access to material non-public information available to them, the Individual Defendants knew that the adverse facts specified herein had not been disclosed to, and were being concealed from, the public, and that the positive representations which were being made were then materially false and/or misleading. 4 Case 1:13-cv-24162-JAL Document 1 Entered on FLSD Docket 11/15/2013 Page 5 of 25 SUBSTANTIVE ALLEGATIONS Background 15. Catalyst operates as a development-stage specialty pharmaceutical company, focused on the development and commercialization of novel prescription drugs targeting rare (or “orphan”) neuromuscular and neurological diseases and disorders. The Company’s lead product candidate for U.S. Food and Drug Administration market approval is Firdapse, a treatment for Lambert-Eaton Myasthenic Syndrome (“LEMS”) -- a rare and sometimes fatal autoimmune disease characterized by muscle weakness. 16. Jacobus Pharmaceutical Company is a privately owned pharmaceutical company that has been manufacturing a treatment for LEMS known as “3,4-DAP,” and providing it to LEMS patients through a so-called “compassionate use program” for the past 20 years. Compassionate use programs allow seriously ill patients who meet certain criteria to gain access to investigational drugs that have not yet been approved by the FDA. Defendants’ False And Misleading Statements During The Class Period 17. On October 31, 2012, the Company issued a press release titled “Catalyst Pharmaceutical Partners and BioMarin Pharmaceutical Enter Into Strategic Collaboration for Firdapse(TM) in North America,” announcing a strategic collaboration with BioMarin Pharmaceutical Inc. for the licensing rights to Firdapse in North America. Therein, the Company, in relevant part stated: BioMarin to Make $5 Million Strategic Equity Investment in Catalyst Catalyst Licenses North American Rights to FirdapseTM, a Phase III Orphan Drug for the Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) 5 Case 1:13-cv-24162-JAL Document 1 Entered on FLSD Docket 11/15/2013 Page 6 of 25 Catalyst Expects Top-Line CPP-109 Phase II(b) Data During First Half of November CORAL GABLES, Fla., Oct. 31, 2012 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) and BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that they have entered into a strategic collaboration for the rights to FirdapseTM in North America. FirdapseTM is an orphan product, which has been approved in the European Union (EU) and is undergoing a Phase III clinical trial in the United States, for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS), a rare, debilitating and sometimes fatal autoimmune disease with the primary symptoms of muscle weakness. The key components of the collaboration include Catalyst licensing the exclusive North American rights to FirdapseTM and BioMarin making a $5 million investment in Catalyst to rapidly advance the FirdapseTM program in the United States. Patrick J. McEnany, Catalyst's Chief Executive Officer, stated: “As part of this arrangement, we are gaining access to a late-stage U.S. orphan drug targeting LEMS, a disease of the central nervous system for which there is not currently an effective treatment approved in the United States. Our existing product candidates are focused on addiction and central nervous system orphan indications like Infantile Spasms/West Syndrome and Tourette's Disorder, and adding FirdapseTM is consistent with our product development strategy. The relationship with BioMarin is