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Turing responds to claims made at the hearing of the US Senate Special Committee on Aging

Turing regrets that the company was not allowed, at the Committee hearing on March 17, 2016, to fully respond to many claims and criticisms of the company. Turing was unable to persuade the Committee to call as witnesses Turing executives with detailed knowledge of the company’s Commercial and Research & Development operations.

Below are a number of claims made at the hearing, together with responses intended to help the Committee and others acquire a more accurate and complete knowledge of Turing Pharmaceuticals.

Claim: ‘Companies like Turing operate more like hedge funds than pharmaceutical companies.’
Claim: ‘Turing conducted no R&D before Mr. Howard Dorfman’s departure.’

FROM ITS LAUNCH IN FEBRUARY 2015, TURING HAS OPERATED AS A RESEARCH-BASED BIOPHARMACEUTICAL COMPANY.

Turing’s leadership team has decades of experience in this highly regulated industry. Their responsibility is to manage Research & Development, Commercial and other activities that clearly identify Turing as a research-based pharmaceutical company.

Turing has institutional and private investors. These investors have entrusted Turing’s leadership team to manage the company.

Turing’s R&D investments began in October 2014, when the first R&D employee joined the company. There were 10 R&D employees in June 2015, when Turing appointed its President of R&D. Mr. Dorfman left the company in September 2015.

Between June and December 2015 Turing’s pipeline included six pre-clinical and three clinical-stage programs in severe and neglected diseases. Turing’s R&D department performed during that period a large number of investigations including six toxicology studies in animals, as well as pharmacokinetic assessments in animals and humans, Good Laboratory Practices-regulated genetic toxicology studies and two high throughput screening campaigns. After the acquisition of Daraprim in August 2015 a computational drug design effort was launched in an effort to determine the Structure-Activity Relationship and binding affinities of pyrimethamine and to discern whether more selective and potent molecules could be designed. Hundreds of compounds were designed with promising in silico characteristics and 24 were synthesized and evaluated in functional enzyme assays. Turing also invested in building an in vivo infectious disease model of toxoplasmosis with the intention to test its proprietary newly synthetized compounds in this model in the coming months. Two human studies were also initiated: a Single Ascending Dose and a Multiple Ascending Dose safety and pharmacokinetic study in healthy volunteers, both with TUR-004, a treatment for a severe epileptic encephalopathy. Also during the second half of 2015 Turing met twice with FDA to discuss its clinical programs, submitted two Investigational New Drug Applications, and obtained approval for a Clinical Trial Application from Health Canada. The financial records made available to the committee show R&D investments on a month-by-month basis. In 2015, the company invested 60 per cent of its net revenues into R&D.

Just one year after its launch, Turing has a pipeline of experimental drug candidates, focused on toxoplasmosis and a serious form of epilepsy.

In 50 years, there has been no new treatment for toxoplasmosis, and Turing is unaware of any other company that has conducted significant research targeted against the disease, classified as a neglected parasitic infection by the Centers for Disease Control.

Claim: ‘Members of the Turing management committee repeatedly raised business objections to Daraprim’s commercialization plans.’

FROM DAY ONE, TURING’S LEADERS HAVE SUPPORTED A PLAN THAT FUNDED RESEARCH & DEVELOPMENT AND ENSURED EVERY PATIENT HAS ACCESS TO MEDICINES, REGARDLESS OF ABILITY TO PAY.

Although there was discussion about the timing and extent of the price rise, and whether it should be delayed until all customers understood Turing’s commitments to R&D, comprehensive access programs, and national disease education programs, there has always been complete agreement among Turing’s leadership team that raising the price of Daraprim was necessary and appropriate in light of Turing’s commitment to research and to patient access.

Turing’s Daraprim sales began in August 2015. Access programs were launched in the same month, and the price rise was announced. Modifications have been made to the access programs to ensure that every patient is able to access Daraprim.

R&D investments had started more than 10 months earlier, in October 2014. In 2015, the company invested 60 per cent of net revenues into R&D. A national disease education team began work in September 2015.

Claim: ‘Turing’s management team lacks pharmaceutical industry experience.’

TURING’S MANAGEMENT TEAM HAS DECADES OF RELEVANT EXPERIENCE IN THE PHARMACEUTICAL INDUSTRY.

President of R&D Eliseo Salinas, MD, MSc has a 25-year career in the pharmaceutical industry and has conducted numerous pre-clinical and clinical programs targeting multiple disease areas. Under Dr. Salinas' direction, 15 drug programs have led to approvals by the Food and Drug Administration and international regulatory bodies of new drugs for Central Nervous System, Gastrointestinal and Renal disorders. A native of Argentina, Dr. Salinas received his medical degree from the University of Buenos Aires, performed his residency in psychiatry at the Clinique des Maladies Mentales et de l´Encéphale, and received his master's degree in pharmacology at the Pierre and Marie Curie University, both in Paris. Dr. Salinas served on the faculty of Rene Descartes University in Paris and has published scientific papers in the area of psychopharmacology and methodology of research.

Chief Commercial Officer Nancy Retzlaff has a 22-year career in the pharmaceutical industry. She was previously VP of Global Marketing / Commercial at Mesoblast Inc. in New York City. Earlier, at Pfizer, she led Commercial operations in Japan, Australia, Canada and Korea. Also with Pfizer, Ms. Retzlaff held a global role in Neurosciences. In addition, Ms. Retzlaff worked at Schering-Plough and Bayer. She received a Bachelor of Commerce; Marketing & General Business at the University of Saskatchewan.

General Counsel and Chief Compliance Officer Eve Costopoulos, Esq., has a 28-year career in the pharmaceutical industry with impressive legal and compliance experience. At Schering Plough and Eisai, she supported various functions including pharmaceutical research. At Schering Plough, Ms. Costopoulos was Vice President Global Compliance and Business Practices and managed 30 compliance professionals. At Eisai she led the Compliance function for the Americas and managed the internal audit program.

Vice President of Regulatory Affairs Nicholas Pelliccione, Ph.D. has a 26-year career in the pharmaceutical industry as a leader in global Regulatory Affairs and Quality Assurance. At Schering Plough, Chugai and Aeterna Zentaris, Dr. Pelliccione was responsible for regulatory development of new drugs in the oncology, endocrine/metabolic, anti-infectives, cytokines, and cardiovascular therapy areas, leading to a number of approvals. He received a BS in Chemistry from Polytechnic Institute of Brooklyn and a Ph.D. in Biochemistry from Mount Sinai School of Medicine (CUNY).

Claim: ‘The closed distribution system benefits only Turing and ‘gives a monopoly’ by preventing generic entry.’

TURING’S DISTRIBUTION PRACTICES DO NOT PREVENT GENERIC COMPETITION

Only about one quarter of Daraprim sales are within a so-called ‘closed channel’, through Walgreens Specialty Pharmacy. The great majority of sales are to hospitals and other organizations. Regardless of the channel through which product is sold, Turing does not control access to Daraprim.

Specialty distribution has significant administrative advantages for Turing and it provides considerable benefit for patients. It ensures a ‘high touch’ between patient and pharmacist to encourage compliance. Pharmacy support is particularly important for a medicine for a rare disease, like Daraprim, that is used in combination with others, and where dosing can vary over time.

It should not be forgotten that Daraprim was off-patent for decades before being acquired by Turing. In that time, no generic company sought approval from the Food and Drug Administration.

Claim: ‘Turing is not committed to patient access.’

TURING HAS PROGRAMS IN PLACE TO ENSURE THAT NO PATIENT IS DENIED ACCESS, REGARDLESS OF ABILITY TO PAY.

We deeply regret the Weston family’s distress and difficulties accessing Daraprim. We were not aware of their dilemma since no one contacted us for help. These events took place soon after our acquisition of Daraprim and while we were putting in place a comprehensive program that ensures no patient is denied access, regardless of their ability to pay. After the hearing, we immediately reached out to the Weston’s doctor, offering help with continuing affordable access.

Daraprim is used by about 3,000 patients per year. Two thirds of this total access their medicine through state and federal health programs that pay Turing 1¢ per pill ($1 per 100-pill bottle). Turing receives no other income from these sales.

In addition, Turing has implemented numerous other programs directed at ensuring patient access, including a patient assistance program through which eligible uninsured patients can receive their medicine free of charge and eligible patients with private insurance will pay no more than $10 per prescription.

We provide a guide to access for patients and prescribers at www.daraprimdirect.com.

Claim: ‘Nobody has reached out from Turing (to the HIV Medical Association).’

TURING IS SURPRISED AND SADDENED BY THIS CLAIM, AND CAN DEMONSTRATE HOW AND WHEN WE RESPONDED.

Starting in September 2015, Turing made several written requests to HIVMA to discuss many of the issues raised by the Senate Committee. We also offered information about our access programs for HIVMA to share with its members and patients. Sadly, other than one meeting in November 2015 where we updated HIVMA about our patient access programs, our subsequent offers were ignored or rejected.

As recently as February 5, 2016 we responded to a HIVMA concern about access, offering information and follow-up. There was no response to our offer.

Claim: ‘IMS Data show sales of Daraprim dropped significantly after its acquisition by Turing.’

TOTAL SALES OF DARAPRIM REMAINED STEADY IN THE PERIOD AUGUST - DECEMBER 2015

The numbers described by Sen. McCaskill represent a fraction of total sales in the period from August through December 2015. What the IMS data show is the gradual decline of old stock from wholesalers supplied by the former owner of Daraprim. IMS does not track sales through all channels of distribution, and it does not track sales through the distribution channels put into place months before Turing acquired the medicine.

About Turing

Turing Pharmaceuticals AG is a privately-held biopharmaceutical company with offices in Zug, Switzerland, and New York, New York. 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. Daraprim (pyrimethamine) for the treatment of Toxoplasmosis in combination with sulfonamide and Vecamyl® (mecamylamine HCl tablets) for hypertension are Turing's first commercial products.

For more information, visit www.turingpharma.com.

Turing Pharmaceuticals AG
info@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.