Imprimis Pharma (IMMY) Announces Lower-Cost Option to Valeant's (VRX) Lead Poisoning Treatment

October 17, 2016 8:34 AM EDT
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Imprimis Pharmaceuticals, Inc. (Nasdaq: IMMY) announced the availability of a significantly lower-cost compounded alternative to Valeant's Calcium Disodium Versenate (edetate calcium disodium injection, USP), commonly used to stabilize and treat patients exposed to lead poisoning.

Imprimis' compounded EDTA calcium disodium injection is priced at $495 for a five-day treatment. According to the World Health Organization, dosing for this drug is based on blood lead levels and body surface area and can range from 1000mg to 2000mg or more daily for five days of treatment. Using Valeant's product, the estimated cost of therapy would be $27,000 for a five-day treatment. Imprimis' preservative-free EDTA calcium disodium injectable 300mg/ml formulation is now available here.

Current Food and Drug Administration (FDA) policy permits Imprimis to dispense its EDTA calcium disodium injectable formulation after receipt of a patient-specific prescription. Whereas a vast majority of states allow for hospitals, urgent care centers, poison control centers and physician offices to stock compounded medications for emergency uses, FDA's policy presently makes it virtually impossible to treat patients, such as lead poisoning patients, in emergency situations where medications are needed immediately. Imprimis remains hopeful that FDA will re-evaluate its policy, particularly for emergent care conditions. The only alternatives currently available to healthcare institutions are to purchase and stock Valeant's product or attempt to make it themselves and administer the drug without the necessary battery of safety tests that Imprimis completes prior to dispensing.

Valeant has increased the price of Calcium Disodium Versenate by over 2,700 percent since it acquired the drug as part of its purchase of Medicis in 2013. The original cost was $950 and it increased under Valeant's control to $7,116 in early 2014, with additional increases the same year to its current price of $27,000.

As reported by STATnews, Dr. Timur Durrani, an assistant clinical professor of medicine at the University of California, San Francisco and assistant medical director at the California Poison Control System, commenting about compounding EDTA calcium at his hospital stated, "It's not very viable or practical. It adds a level of complexity … Our hospital purchases the basic ingredients to compound the medication, but not all hospitals do."

Mark L. Baum, CEO of Imprimis, stated, "Consistent with our commitment to take care of patients, particularly those who are most vulnerable in our country, we are pleased to offer a lower-cost alternative to Valeant's Calcium Disodium Versenate, which has seen serious price increases, particularly after the lead poisoning tragedy in Flint, Michigan. We plan to continue to serve patients and payors alike by expanding our Imprimis Cares® portfolio. We are pleased that a growing number of healthcare institution customers and payors are realizing the benefits of our vision of delivering novel medications to physicians and patients at affordable prices. Related to our commitment to patients, we are also planning to provide an update this quarter about our ongoing work on a lower-cost compounded alternative to the EpiPen®."

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