history

History

February 24, 2015 – Launch of New Company

Turing Pharmaceuticals began commercial operations as a privately-held, research-based pharmaceutical company.

The term "research-based" means the company makes substantial investments in Research & Development - to invent new medicines, to find new uses for existing medicines, and to further develop current therapies.

The new company announced its focus on developing and commercializing innovative treatments for serious diseases and conditions for which there are currently limited or no treatment options.

At the time of launch, Turing acquired its first marketed product - Vecamyl®.

The company leased offices at 1177 Avenue of the Americas, New York, NY and continued building its R&D, Commercial, Sales, Administrative and Support Teams.

June 2015 – Research & Development Head Appointed

Eliseo Salinas, MD, MSc, joined Turing as president of Research & Development.

August, 2015 – DARAPRIM Acquired

Turing purchased the sole rights to manufacture and sell Daraprim® in the United States and Puerto Rico.

The company's Research & Development program included:

  • Several basic research programs in toxoplasmosis – designated a Neglected Parasitic Infection (NPI) and a priority for public health action by the Centers for Disease Control and Prevention.
  • Nonclinical activities to support regulatory submissions for the initiation of clinical programs for two drug candidates: TUR-002 (suicidality) and TUR-004 (epileptic encephalopathy).
  • Multiple discovery stage research programs in rare neurological diseases, including Canavan, Lafora, and Smith-Lemli Opitz Syndrome.

October 2015 – Access Assured

Turing provided details of its various programs1 that aim to ensure that every patient who needs DARAPRIM has ready and affordable access. These include:

  • 'Penny pricing' for Medicaid and 340B patients. These programs pay Turing $1 per 100-tablet bottle, net after discount.
  • Assistance for qualified patients with commercial insurance. Out-of-pocket expenses limited to $10 per prescription.
  • No out-of-pocket expense for uninsured patients, who meet financial need criteria.

1Financial assistance programs are subject to terms and conditions and patient eligibility requirements. Restrictions, including where prohibited by law, may apply. Offers are subject to change or discontinuance without notice. Financial assistance programs are not insurance nor are they intended to be a substitute for insurance.

October 2015 – First Investigational New Drug (IND) application

The United States Food and Drug Administration (FDA) granted Fast Track designation to Turing's first Investigational New Drug (IND) application. The decision authorized a clinical trial of TUR-004, intended for use against a severe form of epilepsy.

November 2015 – DARAPRIM® Discount

Turing offered to discount DARAPRIM's price for hospitals by up to 50 percent. The company also announced distribution of a 30-tablet bottle that allows hospitals to stock this medicine more easily.

December 2015 – Leadership Change

February 2016 – FDA accepts Turing's Investigational New Drug application

The Food and Drug Administration (FDA) accepted the new Investigational New Drug application for TUR-002 for suicidality in post traumatic stress disorder (PTSD).

February 2016 – Testimony Highlights Access, Affordability and R&D Investments

Nancy Retzlaff, Turing's Chief Commercial Officer provided testimony to the US House Committee on Oversight and Government Reform. Highlights included:

  • In 2015, Turing invested 60 percent of net revenue (income minus business expenses) into Research & Development
  • Turing aims to ensure that all patients (insured and uninsured) can afford access to its medicines. It supports patient assistance programs, co-pay support and a 'bridge program' if insurance coverage is delayed1.
  • Around two thirds of DARAPRIM patients receive the medicine through government programs that pay Turing a discounted price of 1 cent per tablet.

1Financial assistance programs are subject to terms and conditions and patient eligibility requirements. Restrictions, including where prohibited by law, may apply. Offers are subject to change or discontinuance without notice. Financial assistance programs are not insurance nor are they intended to be a substitute for insurance.

May 2016 – FDA Accepts Turing's Third Investigational New Drug application

The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for TUR-002 for the treatment of suicidality in patients with major depressive disorder (MDD) (Press Release).

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