3 4-DAP, Amifampridine, Catalyst, Cesca Therapeutics, Charles B. O'Keefe, corruption, FDA, Firdapse, fraud, Jacobus Pharmaceuticals, Lambert Eaton myastenic syndrome, LEMS, Muscular Dystrophy association, Patrick McEnany, Philip H. Coelho
The drug was invented in Scotland in the 1970s, and has been given away for free by Jacobus pharmaceuticals for 20 years. One need only look at this case to see why medical price caps are essential. Neither individuals nor insurance companies nor the US taxpayer can afford US medical charges. The Canadian system works only because of caps on charges, and not just drug charges. US doctors are gouging too.
The $375,000 would even take a big chunk out of the Catalyst CEO, Patrick J McEnany,’s $900.000 salary. US Senator Sanders explains: “Recently, Catalyst licensed the rights to the drug and received exclusive rights to market Firdapse for seven years under the FDA’s orphan drug designation. In December 2018, Catalyst announced to investors it would set the list price for Firdapse at $375,000 per year”
Catalyst was sued by investors in 2013 for failure to disclose the fact that Jacobus had been giving away the drug for decades for free. They apparently settled.
US Senator “Sanders Investigates a $375,000 Price Spike on Old Drug
In a letter sent Monday to the CEO of Catalyst Pharmaceuticals, Sen. Bernie Sanders (I-Vt.) demanded the company explain its decision to set the price of Firdapse, a drug used to treat a rare neuromuscular disease called Lambert-Eaton myasthenic syndrome (LEMS), at $375,000 per year.
For two decades, patients have received the same drug – known as 3,4-DAP – for free from Jacobus Pharmaceutical under the Food and Drug Administration’s compassionate use program. Recently, Catalyst licensed the rights to the drug and received exclusive rights to market Firdapse for seven years under the FDA’s orphan drug designation. In December 2018, Catalyst announced to investors it would set the list price for Firdapse at $375,000 per year.
As a result, patients around the country are frightened as to whether or not they will be able to maintain access to a drug they depend upon to survive.
Last week, Sanders spoke via Skype with one of those patients, Rebecca Hovde of Wellman, Iowa, who told him about the incredible anxiety people with LEMS are living with as a result of Catalyst’s decision to increase the price. “I have friends saying that it’s too much. They know they can’t afford it. And they’re just going to go to bed when their 3,4 DAP runs out,” Hovde told Sanders.
In response to the concerns raised by Hovde and other patients, Sanders asked the CEO of Catalyst how many patients will suffer or die due to their decision to set such an outrageous price, calling that decision “not only a blatant fleecing of American taxpayers, but…also an immoral exploitation of patients who need this medication.”
“Amifampridine, also called 3,4-DAP, was discovered in Scotland in the 1970s, and doctors in Sweden first showed its use in LEMS in the 1980s.
In the 1990s, doctors in the US, on behalf of Muscular Dystrophy Association, approached a small family-owned manufacturer of active pharmaceutical ingredients in New Jersey, Jacobus Pharmaceuticals, about manufacturing amifampridine so they could test it in clinical trials. Jacobus did so, and when the treatment turned out to be effective, Jacobus and the doctors were faced with a choice — invest in clinical trials to get FDA approval or give the drug away for free under a compassionate use program. Jacobus elected to give the drug away, and did so for about twenty years.….
In December 2015 Catalyst submitted its new drug application to the FDA, and in February 2016 the FDA refused to accept it, on the basis that it wasn’t complete and in April 2016 the FDA told Catalyst it would have to gather further data.Catalyst cut 30% of its workforce to save money to conduct the trials. In March 2018 the company re-submitted its NDA.The FDA approved amifampridine for the treatment of adults with Lambert-Eaton myasthenic syndrome on November 29, 2018.” https://en.wikipedia.org/wiki/Catalyst_Pharmaceuticals
Did they really submit additional adequate materials or was this part of the Trump Administration’s “Art of the Con”? Maybe Senator Sanders and others will get to the bottom of it.
Catalyst was sued by investors and appears to have settled: http://securities.stanford.edu/filings-documents/1051/CPRX00_01/2015820_r02k_13CV23878.pdf
Investors lost money when the an article came out discussing the fact that Jacobus had been giving away the drug: “Case 1:13-cv-23878-UU Document 1 Entered on FLSD Docket 10/25/2013 Page 8 of 20 “26. In none of the above releases did Catalyst mention Jacobus Pharmaceuticals, a company that has been giving the same drug to those suffering from LEMS, for free, for the last twenty years in the United States.
THE TRUTH MATERIALIZES CAUSING PLAINTIFF’S LOSSES
27. On October 18, 2013, The Street issued an article entitled “Catalyst Pharma: Orphan Drug Poseur, Profiteer”…” Sood v. Catalyst Pharmaceutical Partners Inc. et al http://securities.stanford.edu/filings-documents/1051/CPRX00_01/20131025_r01c_13CV23878.pdf
Bloomberg estimates McEnany compensation at $900,504
As of Fiscal Year 2017
Patrick J McEnany
Dr Steven R Miller
COO/Chief Scientific Officer
Chief Legal & Compliance Ofcr
Patrick J McEnany
Catalyst Pharmaceuticals Inc
Charles B O’Keeffe
Philip H Coelho “Phil”
Cesca Therapeutics Inc
First 3 pages from the lawsuit.
Case 1:13-cv-23878-UU Document 1 Entered on FLSD Docket 10/25/2013 Page 1-3 of 20
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA
Case No. -Civ- Judge: Magistrate Judge:
ATUL KAMAR SOOD, INDIVIDUALLY AND ON CASE No.: BEHALF OF ALL OTHERS SIMILARLY SITUATED, CLASS ACTION COMPLAINT Plaintiff, FOR VIOLATIONS OF THE vs. FEDERAL SECURITIES LAWS
CATALYST PHARMACEUTICAL PARTNERS INC., PATRICK J. MCENANY, HURBERT E. JURY TRIAL DEMANDED HUCKEL,., and STEVEN R. MILLER Defendants. Read the case here: http://securities.stanford.edu/filings-documents/1051/CPRX00_01/20131025_r01c_13CV23878.pdf
Is Patrick J. McEnany kin to Kayleigh McEnany? She appears to be kin to a Michael Patrick McEnany https://en.wikipedia.org/wiki/Kayleigh_McEnany