October 21, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – U.S. Sen. Bernie Sanders is not done with Ariad Pharmaceuticals .
One week ago today on Twitter he decried the company for systematically increasing the price of its leukemia drug, Iclusig, more than 73 percent since the drug’s launch in 2012. Iclusig is a BCR-ABL kinase inhibitor aimed at the treatment of chronic myeloid leukemia. Sanders said the price increase, which went from a monthly price of $9,580 in 2012 to $16,560 per month—a total price of $198,720 per patient annually. Sanders said Ariad’s price increases amounted to nothing more than greed.
Less than a week later, on Oct. 20, Sanders, along with U.S. Rep. Elijah Cummings, sent a letter to Ariad demanding company justification for the price increase—increases that happened despite problems that actually caused the drug to be temporarily pulled in 2013. The company halted marketing of the drug after the U.S. Food and Drug Administration warned about dangerous side effects. The FDA allowed the drug back on the market by the end of the year, but at that time it included new cardiovascular warnings and its use was restricted to a smaller class of patients as a second-line treatment.
In a statement on his Senate website, Sanders announced he and Cummings, a Maryland Democrat, were questioning not only the price increases, but also investigating whether or not Ariad Pharmaceuticals “took additional steps to boost profits by discontinuing sales of certain dosages and quantities in order to charge patients and insurers more in exchange for less medicine.” The two lawmakers added that Iclusig’s price increases indicate that Ariad is “more concerned with profits than with its patients.”
Sanders and Cummings have demanded responses to their questions, which include information on foreign pricing of Iclusig, patient assistance and coupon programs, tax deductions Ariad has taken relating to any assistance programs, dosing questions concerning discontinued dosage strengths and quantities per prescription and also a total expense report related to the development and sales of Iclusig.
“In the interest of patients and taxpayers, we are interested in learning more about the impact that the escalating price and restrictions on product availability have had,” Sanders and Cummings wrote in their letter.
In a statement on Ariad’s website, the company said it has received the letter and plans to respond to the request. In the same statement, reaffirmed its commitment to discovering and developing treatments for patients with rare cancer.
“The company recognizes the high cost of innovative oncology drugs and believes in the importance and efficacy of its products. Importantly, to achieve its mission, Ariad has invested more than $1.3 billion in R&D and accumulated losses of approximately $1.4 billion since the company was founded, which have not been recovered. In 2015, Ariad generated $119 million in total revenue and invested $171 million, or 143 percent of revenue, in R&D. After years of risk-taking and research, the company has brought its first product to market serving a very small and seriously ill group of cancer patients. ARIAD remains fully committed to developing critical therapies for unserved and underserved small patient populations suffering from rare cancers,” Ariad said in its statement.
While Ariad is under fire for pricing of the drug, the company is seeking to expand the use of Iclusig. Iclusig is involved in several clinical trials, including the OPTIC-2L trial, a Phase III study in patients with chronic-phase chronic myeloid leukemia (CP-CML) who did not respond to imatinib. It is also currently enrolling patients in the OPTIC trial of Iclusig to evaluate three different doses of the drug in patients with refractory CP-CML. In September, Iclusig was approved in Japan for the treatment of chronic myeloid leukemia (CML) resistant or intolerant to preceding drug treatment and relapsed or treatment resistant Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
Ariad is not the only company to come under fire in recent months for price increases. Mylan NV has been excoriated for the price of its EpiPen Auto-Injector and Quebec-based Valeant has been before Congress for the prices of some of the drugs it acquired from other companies. Of course at the center of it all is “pharma bro” Martin Shkreli, the former CEO of Turing Pharmaceuticals who became the poster boy of price increases after his former company jacked the price of toxoplasmosis treatment Daraprim by 5,000 percent after it acquired the drug for $55 million.
