Turing Pharmaceuticals Acquires U.S. Marketing Rights To DARAPRIM (pyrimethamine)

NEW YORK, Aug. 10, 2015 /PRNewswire/ -- Turing Pharmaceuticals AG today announced that it has acquired the exclusive rights to market Daraprim® (pyrimethamine) in the U.S. 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 (see Important Safety Information below).

According to terms of the deal, Turing will acquire all U.S. marketing rights and assume all regulatory responsibilities, effective upon registration of the transfer of all necessary regulatory authorizations to Turing.

"The acquisition of Daraprim and our toxoplasmosis research program 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 U.S. It is the second leading cause of death from foodborne illness in the country. CDC estimates that more than 60 million people in the U.S. 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 U.S. 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," 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. He added that "There is an urgent need for improved treatments for this disease."

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., M. Sc., President of Turing's Research and Development organization, 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."

About Daraprim

DARAPRIM (pyrimethamine) is indicated for the:

• Treatment of toxoplasmosis when used conjointly with a sulfonamide.
• 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.

IMPORTANT SAFETY INFORMATION

• DARAPRIM is contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation and in patients with documented megaloblastic anemia due to folate deficiency.
• Potential for folate deficiency: Dosage required for toxoplasmosis treatment approaches the toxic level. If signs of folate deficiency develop, reduce the dosage or discontinue the drug according to patient response.  Administer folinic acid (leucovorin) at 5-15 mg per day until normal hematopoiesis is restored.
• Carcinogenic potential: Data indicates that pryimethamine may be carcinogenic.
• Adverse reactions:
  • Hypersensitivity reactions, occasionally severe (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and anaphylaxis), and hyperphenylalaninemia, can occur particularly when pyrimethamine is administered concomitantly with a sulfonamide. Consult the full prescribing information for relevant sulfonamide-associated adverse events.
  • Megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, atrophic glossitis, hematuria, cardiac rhythm disorders, anorexia and vomiting may occur with doses used for toxoplasmosis treatment. Hematologic effects may also occur at low doses in certain individuals.
  • Pulmonary eosinophilia has been reported rarely.
• Keep out of the reach of infants and children: Deaths in pediatric patients have been reported after accidental ingestion.
• Drug Interactions: 
  • The concomitant use of pyrimethamine with other antifolic drugs or agents associated with myelosuppression including sulfonamides or trimethoprim-sulfamethoxazole combination, proguani, zidovudine, or cytostatic agents (e.g., methotrexate), may increase the risk of bone marrow suppression. If signs of folate deficiency develop, pyrimethamine should be discontinued and folinic acid should be given until hematopoiesis is restored (see above).
  • Use Daraprim with caution in patients receiving therapy, such as phenytoin, that affect folate levels.
  • Mild hepatotoxicity can occur when lorazepam and pyrimethamine are administered concomitantly.

About Turing

Turing Pharmaceuticals AG is a privately-held biopharmaceutical company with offices in New York City and Zug, Switzerland. Turing focuses on developing and commercializing innovative treatments for serious diseases and conditions across a broad range of therapeutic areas, for which there are currently limited or no treatment options. Products being developed include intranasal ketamine for a variety of mood disorders and Syntocinon® (oxytocin nasal solution) for multiple indications. Vecamyl® (mecamylamine HCl tablets) for hypertension is Turing's first commercial product.

For more, visit www.turingpharma.com.

Safe Harbor

In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the initiation of product development activities, including but not necessarily limited to clinical trials. Forward-looking statements provide Turing Pharmaceuticals' current expectations and forecasts of future events. Turing Pharmaceuticals' performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Turing Pharmaceuticals undertakes no obligation to update publicly any forward-looking statements.

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SOURCE Turing Pharmaceuticals AG