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®."
About Imprimis Pharmaceuticals
Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a pharmaceutical company dedicated to producing and dispensing high quality innovative compounded medications in all 50 states. The company's unique business model drives patient access and affordability to many critical medicines. Headquartered in San Diego, California, Imprimis owns and operates three dispensing facilities located in California, New Jersey and Pennsylvania. For more information about Imprimis, please visit the corporate website at www.ImprimisRx.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Imprimis' filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at www.sec.gov. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
All Imprimis compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.
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SOURCE Imprimis Pharmaceuticals, Inc.