- Compounder Imprimis Pharmaceuticals will make a less expensive alternative to Retrophin's kidney stone drug Thiola, which had its price hiked to $30 per tablet from $1.50 by former Retrophin CEO Martin Shkreli.
- Imprimis previously introduced a $1 version of Daraprim, the toxoplasmosis drug which Shkreli increased in price by 5,000% while CEO of Turing Pharmaceuticals.
- For its part, Retrophin noted it had more than doubled access to Thiola since acquiring the drug.
Imprimis is building a business model off of the outrage caused by recent dramatic drug price increases. When the company introduced its $1 compounded version of Turing's Daraprim in October 2015, Imprimis CEO Mark Baum announced a program titled "Imprimis Cares," which would focus on making compounded alternatives to generic drugs manufactured by one supplier.
Shkreli's pricing strategies at both Retrophin and Turing have created a number of potential targets for Imprimis, as well as an opportunity for the compounder to generate positive publicity.
Thiola is typically prescribed for patients with cystinuria, a chronic disease which causes cystine stones in the kidneys, bladder, and urethra. Imprimis's compounded version will combine the drug's active ingredient, tiopronin, with potassium citrate, which Imprimis believes will further help reduce kidney stone formation in patients.
Additionally, the new version will be available in customizable doses. Currently, Retrophin only offers a 100 mg tablet. Patients sometimes need to take more than 10 pills a day so customizable dosing could improve adherence.
However, Imprimis' version is not FDA-approved—a point driven home by Retrophin. "[Imprimis' version] has no safety and efficacy data supported by clinical trials and should not be considered a valid substitute for Thiola," the company said in a statement released in response. Retrophin emphasized it had actually increased the availability of the drug since it acquired it from Mission Pharmacal in 2014.
While drugs like Daraprim and Thiola are off-patent and open to generic competition, it can take the FDA months to approve a new generic version. Until a new generic is approved, the current supplier of the drug enjoys a virtual monopoly on the market.
Imprimis hopes its business model will lead to partnerships with insurers and pharmacy benefit managers interested in securing lower prices. After Imprimis introduced its compounded version of Daraprim, PBM giant Express Scripts partnered with Imprimis to secure the cheaper alternative to the now $750 per pill Daraprim.
The compounded alternative to Thiola will be available to prescribers in April of this year.