Imprimis Optimistic After Congressional Passage of the Drug Quality and Security Act
SAN DIEGO, Nov. 19, 2013 /PRNewswire/ — Imprimis Pharmaceuticals, Inc. (IMMY), a pharmaceutical company focused on commercializing novel drug formulations invented by physicians and pharmacists through their clinical experience with patients, today voiced support for the U.S. Senate’s approval of the Drug Quality and Security Act (H.R. 3204), which clarifies and strengthens the regulatory framework for compounding pharmacies.
“Passage of this Bill by the Senate by a voice vote, after the House’s approval in September, has the promise of being a good step forward for patients, physicians, pharmacists and third-party payers,” said Mark L. Baum, Chief Executive Officer of Imprimis. “The Bill respects the rights of compounding pharmacies to serve their communities in nearly the same way they did prior to the passage of the Bill, while clarifying and strengthening laws related to drug compounding.”
The Drug Quality and Security Act, which must be signed into law by President Obama, addresses several public concerns about compounding pharmacies. Importantly, under the Bill a pharmacy engaged in preparing sterile compounded drug formulations may voluntarily elect to register as an “outsourcing facility,” a new entity permitted to compound large quantities of drug formulations on the U.S. Food and Drug Administration’s drug shortage list, and other formulations compounded with drug substances that are on a “clinical need” list to be established by the FDA, without a prescription, as well as distribute these formulations out of state without limitation. Entities voluntarily registering as outsourcing facilities would be subject to GMP requirements and regular FDA inspection. The Bill also provides for better communication between state and federal regulators and mandates that drugs prepared by outsourcing facilities bear a label indicating they were compounded.
Baum continued, “More and more, patients expect personalized medicines or drugs that are specifically designed for their individual needs. Compounding pharmacies, whether in neighborhoods or hospitals across America, deliver personalized medicines … today. Our fundamental goal at Imprimis is patient access to personalized medicine, including increasing the number of prescriptions that are compounded. We believe the best way to make this happen is to address perceived quality issues related to compounding and work with the third-party payer market. While the vast majority of compounding pharmacists operate under the highest of standards and are vitally important to their communities, this Bill takes a positive step in the right direction to encourage increased quality throughout the industry. If compounding pharmacies embrace the trend towards increasing quality, we believe the result will be more patients gaining access to vitally important compounded drug formulations.”
Working alongside leading physicians and compounding pharmacists, Imprimis has acquired intellectual property for proprietary formulations in four key therapeutic areas: Ophthalmology, Wound Management, Urology and Pain. The company plans to begin development and commercialization activities in these areas in 2014, while continuing to advance the expansion of its proprietary compounded drug and drug delivery vehicle formulations.
“What we aim to do is take small ideas from the clinical interaction between pharmacists, physicians and their patients and turn them into big ideas for the greater patient and physician community,” Baum said. “Our hope is that this legislation will ultimately benefit patients by increasing access to life saving medications and other lower cost compounded drug options, all made to the highest standards.”
ABOUT IMPRIMIS PHARMACEUTICALS
Imprimis Pharmaceuticals, Inc. (IMMY) is a pharmaceutical company focused on the commercial development of novel drug formulations and drug delivery technologies. Imprimis believes in the power of the clinical interaction of one patient, one physician and one pharmacist to build novel therapeutic approaches that have broad market appeal. Imprimis assesses drug formulations created by pharmacists and physicians for a specific patient’s use using a proprietary and rigorous evaluation process, the Asset Review Methodology (ARM(TM)), in order to assess potential for commercialization. Following this evaluation process, which may include additional clinical development, Imprimis may choose to pursue FDA approval for a drug formulation through the FDA’s Section 505(b)(2) development pathway, or make its treatment options available to the market through pharmacy compounding. In addition, Imprimis expects to seek partnerships with wholesalers in order to make its drug delivery technologies available to compounding pharmacies across North America. The Company’s current focus is in the Ophthalmology, Wound Management, Urology and Pain therapeutic areas.
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 Imprimis’ ability to acquire, develop, commercialize and market new formulations and technologies, enter into strategic alliances and transactions, including arrangements with pharmacies, physicians and healthcare organizations, commercialize its formulations and technologies, obtain intellectual property protection for its assets, accurately estimate its expenses and cash burn, and raise additional funds, as well as the success of additional research and development activities related to its formulations and technologies, the projected size of the potential market for its technologies and formulations, unexpected new data, safety and technical issues, regulatory and market developments impacting compounding pharmacies 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.
Mark L. Baum
SOURCE Imprimis Pharmaceuticals