Compounder Touts Cheap Alternative to Turing's Daraprim

Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....

By Bronwyn Mixter

Oct. 23 — Imprimis Pharmaceuticals Inc. Oct. 22 said it plans to produce a compounded formulation of pyrimethamine and leucovorin as a low- cost alternative to Turing Pharmaceuticals AG's Daraprim.

Daraprim is the only drug approved by the Food and Drug Administration for a life-threatening infection called toxoplasmosis. Toxoplasmosis can be of major concern for patients with weakened immune systems such as patients with HIV/AIDS, pregnant women and children.

Imprimis said it is now offering compounded formulations of pyrimethamine and leucovorin in oral capsules starting as low as $99 for a 100-count bottle, or less than a dollar per capsule. Imprimis dispenses compounded pharmaceuticals in all 50 states from four facilities located in California, Texas, New Jersey and Pennsylvania, according to its website.

Turing, which is a Swiss company with New York offices, has been under fire for increasing the price of the anti-parasitic drug Daraprim. The company acquired the drug from Impax Laboratories Inc. in August. Turing then increased the price to $750 per pill from $13.50.

“It is indisputable that generic drug prices have soared recently. While we have seen an increase in costs associated with regulatory compliance, recent generic drug price increases have made us concerned and caused us to take positive action to address an opportunity to help a needy patient population,” Mark L. Baum, chief executive officer of Imprimis, said in a release. “While we respect Turing's right to charge patients and insurance companies whatever it believes is appropriate, there may be more cost-effective compounded options for medications, such as Daraprim, for patients, physicians, insurance companies and pharmacy benefit managers to consider.”

Imprimis Program 

Baum said this isn't the first time a sole generic drug supplier has increased the price of a drug to a level that makes it unaffordable. He said that Imprimis is forming a new program called Imprimis Cares, which will make compounded medicines available to physicians and patients at accessible prices.

“Today, some drug prices are simply out of control and we believe we may be able to help control costs by offering compounded alternatives to several sole source legacy generic drugs,” Baum said. “Imprimis Cares and its team of compounding pharmacists will work with physicians and their patients to ensure they have affordable access to the medicines they need from the over 7,800 generic FDA-approved drugs.”

Imprimis said its compounded drug formulations aren't approved by the FDA and may only be prescribed with a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.

Turing's Response 

In a statement provided to Bloomberg BNA Oct. 23, Turing said it “is not concerned with competition in the space.”

“Daraprim is fully FDA approved and continues to be the preferred course of treatment for patients suffering from toxoplasmosis,” the company said. “Turing's top priority continues to be ensuring patients with ready, affordable access to Daraprim. Thanks to our patients' assistance program, nearly all patients can get Daraprim at $10 out of pocket or less per prescription. Qualified patients who can't afford their medicine can receive it at no cost.”

Turing said interested individuals looking for more information about the patient assistance program for Daraprim can visit http://www.daraprimdirect.com/patients.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com