Turing Pharmaceuticals AG, a privately-held biopharmaceutical company, has acquired the exclusive rights to market Daraprim (pyrimethamine) in the US from Impax Laboratories, Inc.
The acquisition by Turing is part of a strategic effort focused on treatments for toxoplasmosis and other serious infectious diseases. The company also announced plans to invest in the development of new drug candidates for toxoplasmosis.
Daraprim is indicated for the treatment of toxoplasmosis in combination with a sulfonamide. The most common side effects that may occur with Daraprim include allergic reactions, blood disorders, tongue changes, blood in the urine, heart rhythm disorders, anorexia, and vomiting.
According to terms of the deal, Turing will acquire all US marketing rights and assume all regulatory responsibilities, effective upon registration of the transfer of all necessary regulatory authorisations to Turing.
“The acquisition of Daraprim and our toxoplasmosis research programme are significant steps along Turing’s path of bringing novel medications to patients with serious disorders, some of whom often go undiagnosed and untreated,” said Martin Shkreli, Turing’s founder and chief executive officer.
He added, “We intend to invest in the development of new drug candidates that we hope will yield an even better clinical profile, and also plan to launch an educational effort to help raise awareness and improve diagnosis for patients with toxoplasmosis.”
The Centers for Disease Control and Prevention (CDC) has classified toxoplasmosis as one of the five neglected parasitic infections in the US. It is the second leading cause of death from foodborne illness in the country. CDC estimates that more than 60 million people in the US carry the toxoplasma parasite, which is most dangerous for the very young, pregnant women and those with compromised immune systems. More than one million people in the US are infected annually with the toxoplasma parasite, which is associated with high rates of morbidity and mortality.
“Turing’s commitment to improving treatment for patients with toxoplasmosis is commendable. There is an urgent need for improved treatments for this disease,” said Louis M. Weiss, M.D., M.P.H., professor, departments of medicine and pathology, an infectious disease expert at the Albert Einstein College of Medicine in New York City.
According to the Infectious Diseases Society of America, when used in combination with a sulfonamide and leucovorin, Daraprim is the preferred treatment among infectious disease specialists for toxoplasmosis.
Eliseo Salinas, M.D., MSc, president of Turing’s research and development organisation, said “We intend to advance drug candidates with improved ADMET profiles (absorption, distribution, metabolism, excretion and toxicity) into clinical trials. I am very proud of our research team’s work to bring new drug candidates into in vivo testing, and we look forward to discussions with the FDA to plan development of Turing’s drug candidates to improve the treatment of toxoplasmosis.”
Daraprim is also indicated for the treatment of acute malaria only in patients infected in areas where susceptible plasmodia exist and when used conjointly with a sulfonamide (e.g., sulfadoxine) to initiate transmission control and suppression of susceptible strains of plasmodia. It should not be used alone to treat acute malaria. Fast-acting schizonticides such as chloroquine or quinine are indicated and preferable for the treatment of acute malaria, chemoprophylaxis of malaria due to susceptible strains of plasmodia. It is not suitable as a prophylactic agent for travelers to most areas since resistance to pyrimethamine is prevalent worldwide.