Expert Comments:
Andrew Fein, H.C. Wainwright & Co. (10/31/13) "In the end, it is Catalyst Pharmaceutical Partners Inc. and not Jacobus Pharmaceutical Company Inc. that currently holds a breakthrough therapy designation for Firdapse in Lambert–Eaton myasthenic syndrome (LEMS), and is likely to reap the benefits of this new regulatory 'easy-pass'. . .we view the LEMS space through the lens of what makes a durable business that rewards both patients and investors within the framework of existing regulation. In that light, Catalyst stands out as the top LEMS therapeutics contender."
Scott Henry, ROTH Capital Partners (10/22/13) "In our opinion, the fundamentals are unchanged as Catalyst Pharmaceutical Partners Inc. remains the likely winner in the race to bring a Lambert-Eaton myasthenic syndrome treatment to market. We reiterate our Buy rating. . if successful in attaining regulatory approval for Firdapse, the company would have an approved drug with orphan drug exclusivity, which would increase the barriers to successful conversion away from Catalyst Pharmaceuticals to 'black market' supply. . .in the race for approval against Jacobus Pharmaceutical Company Inc., we like Catalyst Pharmaceutical's chances."
Raghuram Selvaraju, Aegis Capital Corp. (10/21/13) "We are raising our expectations on pricing for Catalyst Pharmaceutical Partners Inc.'s lead drug candidate, Firdapse, as we currently believe that this agent is likely to be the sole approved therapy for Lambert-Eaton myasthenic syndrome in the U.S. Recent concerns raised about competitors to Catalyst are unfounded, in our view."
Echo He, Maxim Group (10/18/13) "Catalyst Pharmaceutical Partners Inc.'s stock decline is unfounded; buy on the weakness. . .the company's shares have been under pressure as a result of negative comments published by Adam Feuerstein. . .we believe the Firdapse clinical program, pathway and commercial plan are both sound and viable and that the article misses several key points. . .Catalyst Pharmaceutical's upside is tangible. The fact that Firdapse's active ingredient, amifampridine, is currently approved in Europe and has patient experience in the U.S. (through compounding pharmacies) provides a measure of clinical experience and validation. Previous patient experience and investigators' trials all point to a well-established safety and efficacy profile."
Andrew Fein, H.C. Wainwright & Co. (10/18/13) "In our view, the odds of commercial success remain still remain in Catalyst Pharmeceutical Partners Inc.'s favor (versus generic amifampridine), because: 1.) Ceteris paribus, the Firdapse phase 3 has higher odds of clinical success (pre-approval) and clinical recognition (post-approval), having been designed by an orphan expert company (Biomarin Pharmaceutical Inc.) with FDA input; 2.) The Firdapse study endpoints (QMG, as primary) have been previously employed successfully in evaluating amifampridine, and are well regarded by the niche of neuromuscular specialists; 3.) even assuming positive DAPPER results, Jacobus Pharmaceutical Company Inc. lacks the infrastructure and experience to support a commercial push of amifampridine. . .4.) Firdapse will be aided commercially by clear patient/prescribing information, a pharmacovigilance plan, medicinal access and reimbursement."
