October 23, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SAN DIEGO – In a direct challenge to Turing Pharmaceuticals, San Diego-based Imprimis Inc. (IMMY) announced Thursday it has developed a compound of pyrimethamine and leucovorin as a low-cost alternative to Daraprim, which recently saw a 5,000 percent price spike.
Imprimis said its combination treatment will have a price tag of $99 for 100 tablets, slightly less than $1 per pill. In contrast, after Turing acquired Daraprim in August for $55 million, it raised the price of the toxoplasmosis treatment from $13.50 per pill to $750 per pill. The company said in a statement that compounded medications “may be appropriate for prescription when a commercially-available medicine does not meet the specific needs of a patient.” Citing the Centers for Disease Control and Prevention (CDC), Imprimis said pyrimethamine works to block folic acid synthesis in the toxoplasmosis parasite. Leucovorin helps to reverse the negative effects on bone marrow caused by this mechanism of action, the company said.
Mark Baum, chief executive officer of Imprimis, said Turing and its CEO Martin Shkreli have the right to charge whatever is “appropriate” for Daraprim, and added that compounded medication provides a more economical alternative to patients, physicians and insurance companies.
In response to the Daraprim alternative, shares of Imprimis’ stock are up 26 percent in pre-market trading.
“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,” Baum said in a statement.
Baum told the San Diego Union-Tribune the company’s formulation is not approved by the U.S. Food and Drug Administration (FDA) and can “legally only be sold through a doctor’s prescription to a specific individual.” Both ingredients in the compound are FDA approved and Imprimis’ compounding operations are inspected by the FDA. Baum said by requiring a prescription for the compound, the company can offer the medication, which is often used by cancer and AIDS patients who are susceptible to toxoplasmosis, at a lower cost. He said seeking FDA approval for the compound would cost millions of dollars.
Daraprim is not the only drug that Imprimis plans to create alternatives to, Baum said. Because of price hikes to long-approved drugs like Daraprim, or Valeant Pharmaceuticals ’s Nitropress and Isuprel, acquired through the Salix Pharmaceuticals, Ltd. deal, which saw price increases of 212 percent and 525 percent, respectively, Imprimis said it is forming a new division to address high prices. The company will form Imprimis Cares, which is “aligned to our corporate mission of making novel and customizable medicines available to physicians and patients today at accessible prices,” Baum said.
“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. 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,” Baum said. “Imprimis Cares, available in all 50 states, will work with all third party insurers, pharmacy benefit managers and buying groups to offer its patient specific customizable compounded drug formulations at prices that ensure accessibility and that provide a reasonable profit for Imprimis. We are here to serve our patients and their physicians. We believe that when we do a great job serving our customers, our shareholders will also benefit.”
