Dec 20 2015
Turing Pharmaceuticals AG, a privately-held biopharmaceutical company focused on developing and commercializing innovative treatments for serious diseases and conditions, today emphasizes the continued availability of Daraprim and cautions healthcare providers of proposed alternatives to Daraprim.
In light of recent leadership changes at Turing Pharmaceuticals, there may be concerns regarding the continued availability of Daraprim. Turing assures healthcare providers and patients that Daraprim remains available and is unaffected by these events. Additionally, Turing has started to expand its distribution partnerships in the outpatient setting to ensure optimal patient access.
"Our priority continues to be supporting our healthcare providers and their patients to ensure that patients who need Daraprim have ready and affordable access to it," said Nancy Retzlaff, Turing's Chief Commercial Officer. "We pledge that no patient needing Daraprim will be denied access."
Despite Daraprim's availability, certain compounding pharmacies have announced that they have created unapproved fixed-dose combinations of pyrimethamine and leucovorin. These combinations are not approved by the U.S. Food and Drug Administration (FDA) for any use, nor have they been tested in accordance with FDA regulations to ensure safety to patients and equivalency to Daraprim. Daraprim is the only drug approved by the FDA in combination with a sulfonamide for the treatment of toxoplasmosis. Express Scripts and CVS Health Corp are offering these new products as valid alternatives to Daraprim. No data exists to demonstrate that these compounded products are acceptable alternatives to Daraprim.
The FDA ensures that products have demonstrated acceptable safety profiles and have well-defined efficacy based on clinical trials. The FDA also safeguards that manufacturing is performed under controlled processes that ensure the product is manufactured in a consistent manner. Compounded products are not subjected to these rigorous controls which may lead to suboptimal product that could impact patients' health. Since 2012, 90% of the 160 FDA inspections of compounding pharmacies identified "objectionable conditions."
Turing Pharmaceuticals is committed to ensuring patient access and affordability for Daraprim through the Daraprim Direct program. A copay mitigation program, patient assistance program for uninsured patients and donations to charitable organizations for Medicare Part D copay assistance help ensure Daraprim affordability for all patients. Turing is committed to the pledge that no patient needing Daraprim will be denied access.
SOURCE Turing Pharmaceuticals AG