SAN DIEGO, Oct. 29, 2015 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a specialty pharmaceutical company focused on the development and commercialization of proprietary compounded drug therapies, announced that it has commenced construction on the company’s Allen, Texas compounding pharmacy and plans to register the pharmacy with the U.S. Food and Drug Administration (FDA) as a 503B sterile outsourcing facility under the Drug Quality and Security Act (DQSA) of 2013. The DQSA was signed into law by President Obama on November 27, 2013 and created a new pathway, in which a compounding pharmacy can register with the FDA as an outsourcing facility.
Once the Allen, Texas facility commences operations as an outsourcing facility, physicians, hospitals and ambulatory surgical centers will have the opportunity to prescribe and receive certain of Imprimis’ proprietary compounded formulations with greater ease and without the time delays associated with the current requirement of providing patient-specific prescriptions and related shipping times. Imprimis’ Texas facility is expected to be completed and dispensing certain prescriptions as an outsourcing facility on or before February 1, 2016. In the meantime, the pharmacy will continue its current operations without disruption of service during construction.
Mark L. Baum, CEO of Imprimis stated, “We believe this is the future for sterile compounding pharmacies and we have been advocates of the new law and increased FDA oversight to ensure public confidence in quality and patient safety. Fortunately, our Allen, Texas facility was a very good candidate for a low cost upgrade to a 503B outsourcing facility given the quality of the existing compounding infrastructure we recently purchased. We have begun renovations and purchased the equipment required for our Allen, Texas pharmacy to serve as an outsourcing facility at a cost of less than $200,000. We plan to initially use this location for our HLA compounded formulation prescribed for interstitial cystitis (IC) and later expand to include our ophthalmology Dropless Therapy injectable and LessDrops combination topical eye drop compounded formulations. IC is emergent in nature and patients don’t have the luxury of waiting for their medication to be prescribed, dispensed and arrive days later. The disease process and patient experience for this condition mandates that the patient have immediate access to this medication when prescribed. Our new Allen, Texas facility will also be helpful to our ophthalmology customers. Once it begins operations as an outsourcing facility, physicians, ambulatory surgical centers and hospital customers, and their patients, will appreciate the convenience of having the ability to order an inventory of our proprietary compounded formulations for immediate office use.”
The company intends to open and qualify its larger, state of the art Roxbury, New Jersey outsourcing facility during the first quarter of 2016.
Currently, all Imprimis formulations may be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.
ABOUT IMPRIMIS PHARMACEUTICALS
San Diego-based Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a national leader in the development, production and dispensing of novel compounded pharmaceuticals. The company’s business primarily consists of four therapeutic segments including ophthalmology, urology, sinus and integrative medicine. Imprimis dispenses compounded pharmaceuticals in all 50 states from four facilities located in California, Texas, New Jersey and Pennsylvania. For more information about Imprimis, please visit the corporate website at www.ImprimisPharma.com.
SAFE HARBOR
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 risks and uncertainties related to our ability to register and renovate our Allen, Texas and Roxbury, New Jersey outsourcing facilities in a timely fashion or at all, our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing its formulations; risks related to its 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 its formulations; our ability to obtain intellectual property protection for its assets; its ability to accurately estimate its 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 its 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.
CONTACTS
Investor Contact:
Bonnie Ortega
bortega@imprimispharma.com
858.704.4587
Media Contact:
Deb Holliday
deb@pascalecommunications.com
412.877.4519
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SOURCE Imprimis Pharmaceuticals, Inc.
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