SAN DIEGO, April 12, 2016 /PRNewswire/ -- Imprimis
Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company
focused on the development and commercialization of proprietary and
customizable drug formulations, announced today that it has filed
for registration of its ImprimisRx TX pharmacy, located in
Allen, Texas, with the U.S. Food
and Drug Administration (FDA) as a 503B outsourcing facility.
The Drug Quality and Security Act (DQSA), signed into law on
November 27, 2013, created this
pathway in which a compounding pharmacy can voluntarily register
with the FDA as an outsourcing facility under Section 503B of the
federal Food, Drug and Cosmetic Act, comply with the DQSA and avail
itself of the operational benefits the law provides.
The ImprimisRx TX facility will make and distribute compounded
drugs according to current good manufacturing practices (cGMP),
which are the same standards used for the manufacture of
FDA-approved drugs. ImprimisRx TX will initially distribute
the company's proprietary sterile Dropless Therapy® injectable
formulations, which are administered following ocular surgery,
primarily cataract surgery. Once operating as an outsourcing
facility, ophthalmologists will have the ability to simply order
the quantities they need for inventory and office use, without
providing patient specific information that is required today.
The company expects to begin distributing from the facility
towards the end of the second quarter of this year.
Mark L. Baum, CEO of Imprimis,
stated, "This is an important milestone for our growing
company. We believe transitioning our Dropless
Therapy® injectable formulations to an outsourcing
facility environment is good for our number one constituent – our
patients. And if it is good for our patients, it is good for
Imprimis and its shareholders. Importantly, operating as a
503B outsourcing facility should create new revenue opportunities
by simplifying the ordering process with existing and new potential
customers, including hospitals, group purchasing organizations, and
surgery centers, that desire, or in some cases, require purchasing
from an FDA-registered outsourcing facility. According to
internal research and an April 2015
third party market research report, adoption of our core
ophthalmology formulations is expected to increase as a result of
moving to an outsourcing facility and once customers are no longer
required to provide patient-specific prescriptions."
Mr. Baum concluded, "We believe increased adoption of cGMP
production standards, the same manufacturing standards that
FDA-approved drugs are held to, will ensure public confidence in
quality and patient safety for compounded drugs. We have also
been engaged in efforts to improve the DQSA so that more compounded
drugs are made in a cGMP environment. We fully expect that
the FDA will remain a supportive partner as outsourcing facilities
continue to operate and build quality-made finished pharmaceuticals
under FDA scrutiny. We look forward to being a part of the
outsourcing facility community and using the provisions of the DQSA
to better serve the many thousands of patients we serve each
week."
Other than drugs compounded at a registered outsourcing
facility, 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.
ABOUT IMPRIMIS PHARMACEUTICALS
Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a national
leader in the development, production and dispensing of novel
compounded pharmaceuticals. The company's two business programs,
Imprimis Cares™ and Custom Compounding Choice™, focus
on patient outcomes and affordability by offering high quality
custom compounded drugs in all 50 states. Headquartered in
San Diego, California, Imprimis
owns and operates four dispensing 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 Imprimis' ability to make commercially
available its compounded formulations and technologies in a timely
manner or at all; physician interest in prescribing its
formulations; risks related to its compounding pharmacy operations;
its ability to enter into other strategic alliances, including
arrangements with pharmacies, physicians and healthcare
organizations for the development and distribution of its
formulations; its 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.
Investor Contact
Bonnie
Ortega
bortega@imprimispharma.com
858.704.4587
Media Contact
Paul
Rabin
paul@pascalecommunications.com
516.503.0271
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SOURCE Imprimis Pharmaceuticals, Inc.