Eyebrows were raised when Martin Shkreli, CEO Turing Pharmaceuticals, increased the price of Daraprim® to a staggering $750 per pill. Imprimis CEO and founder Mark Baum gained praises when the announced he'll offer an alternative of the pill at just $1 per tablet. He is in it again after his firm announced to develop and produce a lower cost alternative to the already FDA-approved Thiola by Retrophin, Inc.
The new drug is expected to be available to consumers on April 2016. Retrophin increased the price of the drug by $28.5 a tablet after buying the rights from Mission Pharmacal Co. in 2014. Retrophin, Inc. was co-founded by Martin Shkreli.
"Due to the recent increase in the price of Thiola, many cystinuria patients have been switched to an alternative treatment such as captopril, which is FDA-approved for hypertension and heart failure," said Dr. Christian Mende from the University of California at San Diego.
Thiola, made from tiopronin as its active ingredient, is used to help prevent the formation of cystine (kidney) stones in patients who do not respond to dietary changes and increased fluid intake. This drug is an active reducing agent that undergoes an exchange of thiol-disulfade with cysteine to form tiopronin-cystine disulfide which is water soluble and easily excreted.
According to Mark Baum, thousands of patients contacted Imprimis to produce a generic competition for at least 100 drugs approved by U.S. regulators that were subjected to price hikes in the past year.
"Cystinuria patients in need of Retrophin's Thiola were among the most frequent requests we received because in many cases, they were being switched to non-tiopronin based drugs," Baum added.
Amid the controversy it faces over increasing the price of Thiola, Retrophin, Inc. released a statement that it stands firm on its actions. The company said its drug, Thiola was approved by regulators from FDA, which means it has met rigorous standards of safety and efficacy for patients.
"Imprimis Pharmaceuticals' proposed compounded form of tiopronin, the active ingredient in Thiola, in combination with potassium citrate has no safety or efficacy data supported by clinical trials and should not be considered a valid substitute for Thiola," Retrophin, Inc. said.
The firm added that safety and efficacy standards may not offer the same therapeutic outcome for patients.
Photo: Nick Gaydos | Flickr
