Report Questions Feasibility of Turing’s R&D Plan

Report Questions Feasibility of Turing Pharmaceuticals’ R&D Plan
December 15, 2015
By Alex Keown, BioSpace.com Breaking News Staff

NEW YORK – On his very active Twitter Martin Shkreli, chief executive officer of Turing Pharmaceuticals, told the Doctors Without Borders account that his company was investing in research and development – a claim the CEO has made repeatedly as part of his justification for the 5,000 percent increase of the 65-year-old toxoplasmosis drug, Daraprim.

On multiple occasions, Shkreli has said there should be more than one treatment for the parasite-caused toxoplasmosis that typically impacts individuals with suppressed immune systems, such as pregnant women or AIDS patients. Shkerli’s Turing acquired Daraprim from IMPAX Laboratories, Inc. in August for $55 million. The medication was available for $13.50 per tablet, but Turing increased the price to $750 per tablet, which drastically raises the cost of treatment for patients.

“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,” Shkreli said in an August statement after the company acquired the drug

But, a report in Forbes casts some question as to whether or not Turing is following through on that plan. Forbes reported Turing lists 13 drug programs are listed on its website, but only one program for toxoplasmosis, TRP-oo4, a program that is years away from approval. The majority of the drug programs in its pipeline are in the preclinical stages, according to the website. Turing launched in February with three products in its pipeline that were acquired from Retrophin, including an intranasal formulation of ketamine, a compound used to treat severe depression but which currently requires IV-infusion therapy.

Additionally, Forbes points out that Turing has zero clinical trials registered with the federal government, something it says should be worrisome to investors – a group of individuals Shkreli said are his first priority. Earlier this month, Shkreli told a Forbes panel that he should have raised the price of Daraprim even higher.

“My investors expect me to maximize profits, not to minimize them, or go half or go 70 percent,” he told the panel.

Daraprim is used by about 2,000 people in the United States annually for a period of six to 12 weeks.

While Shkreli has indicated he intends to come up with a better drug than Daraprim, but one he can still charge a high price for, such a drug is still years away, giving other companies time to enter the market with their own treatment. After the price increase for Daraprim, San Diego-based Imprimis Inc. announced it has developed a compound of pyrimethamine and leucovorin as a low-cost alternative to Daraprim. Imprimis said its combination treatment will have a price tag of $99 for 100 tablets, slightly less than $1 per pill. Additionally, researchers at the Indiana University School of Medicine and University of Notre Dame reported a hypertension drug, guanabenz, could be a possible alternative treatment for toxoplasmosis. Guanabenz is showing positive results in early models, according to a report in The Scientist.

With these treatments coming on, Forbes questioned if Shkreli is “doing justice” to Turing’s shareholders.

According to the U.S. Centers for Disease Control, toxoplasmosis is considered to be a leading cause of death attributed to foodborne illness in the United States. More than 60 million men, women, and children in the U.S. carry the parasite, but most do not show symptoms due to a health immune system. Those with compromised immune systems, including cancer patients, HIV patients and pregnant women. If not held in check by a healthy immune system or medication, the parasite can attack the brain and lead to blindness or brain damage.

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