SAN DIEGO, July 23, 2013 /PRNewswire/ -- Imprimis
Pharmaceuticals, Inc. (NASDAQ:IMMY), which is focused on the
commercialization of drug formulations utilizing the FDA 505(b)(2)
drug development pathway, today announced that as part of the
recently announced Buderer Drug Company Asset Purchase Agreement,
Imprimis acquired intellectual property for IPI-120, a novel drug
formulation of both tranexamic acid, a synthetic derivative of the
amino acid lysine, and an antibiotic. The company's recently-filed
patent application combines tranexamic acid with an antibiotic so
as to provide the clotting effects along with protection or
treatment against infection in a transdermal, local intra-wound
application or intra-cavity instillation formulation.
Imprimis believes that IPI-120, a locally-acting drug candidate,
can reduce or stop bleeding while at the same time prevent or treat
infection. As a wound healing product, IPI-120 could help patients
with genetic and acquired bleeding disorders. Lower strength
IPI-120 formulations for OTC applications may also be used to stop
bleeding and prevent or treat infection in common wounds, cuts and
bruises.
Tranexamic acid, which is approved in intravenous and oral
dosage forms, is frequently used in surgeries with high risk of
blood loss such as cardiac, liver, vascular and large orthopedic
procedures. Imprimis believes that IPI-120 may have important
application in targeted compromised populations of patients with
bleeding disorders, such as hemophilia patients, and may qualify as
an orphan drug development candidate.
IPI-120 was created by a pharmacist interested in offering a
transdermal wound management product that not only acted as an
antibiotic, but that also helped control bleeding. Imprimis
believes that IPI-120 has the ability to be a true "next
generation" functional antibiotic and wound management
product.
The US wound care market is expected to reach nearly
$21 Billion by 2015, from
$16.8 Billion in 2012. 7 million
Americans suffer from chronic wounds and the market is
expected to grow in part due to the aging U.S. population and
ongoing proliferation of diabetes and other chronic illnesses.
Imprimis CEO Mark L. Baum said, "We are pleased to have
completed our initial feasibility work, including a review of the
IP landscape, for this important 'functional antibiotic' drug
development opportunity. The culmination of the initial phase of
the IPI-120 program was the recent filing of a patent to protect
what we believe is a unique opportunity to develop a drug where
there is a large unmet need in the marketplace, both for patients
who suffer from bleeding and clotting disorders as well as the
opportunity to use our core IP to develop formulations for the OTC
wound healing and management market."
Baum added, "Invented at the Buderer Drug Company, a compounding
pharmacy in Ohio, IPI-120 has been
used by patients in a real world setting under the supervision of a
physician. This unique clinical experience, the resulting patient
experience, along with the market potential of IPI-120 gives this
formulation a distinct advantage as we consider its commercial
pathway."
Imprimis Chief Medical Officer Dr. Joachim Schupp explained,
"Control of bleeding and infection is an integral part of the wound
healing process. The normal blood clotting process depends on the
interplay of various proteins in the blood. Bleeding disorders may
be caused by reduced levels or absence of blood-clotting proteins,
known as clotting factors or coagulation factors. A reduction in
those clotting factors is found in genetic disorders, such as
hemophilia A (Factor VIII), hemophilia B (Factor IX) and von
Willebrand disease (vW Factor). Bleeding disorders can also be
acquired such as in end stage liver disease, acute leukemia or
Vitamin K deficiency. The transdermal, local intra-wound
application or intra-cavity instillation of a novel pharmaceutical
composition such as IPI-120 could become a valuable treatment
option for conditions with high risk of bleeding and infections
with a potential lower risk of systemic side effects."
Imprimis VP of Corporate Development Gary Seelhorst commented,
"Our analysis of the market denotes that this combination
formulation may provide an excellent opportunity to greatly affect
the bleeding and clotting disorder market which is expected to grow
from $8.5 Billion in 2011 to
$11.4 Billion in 2016 as well as the
much larger over-the-counter (OTC) wound care market. Further, the
applications in emergency medicine could be profound because
transexamic acid is already being used in that capacity. Our
proposed formulation in combination with an antibiotic could offer
ease-of-use benefits as well."
Mark L. Baum, CEO of Imprimis
concluded, "The addition of IPI-120 to Imprimis's growing 505(b)(2)
pipeline is a further step to broaden our ability to develop
proprietary drug formulations with a real world clinical
experience, from strong relationships we are forging with
pharmacist and physician drug developers across the United States."
About Imprimis Pharmaceuticals, Inc.
Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY) is a specialty
pharmaceutical company focused on the commercial development of
drug formulations utilizing the FDA 505(b)(2)drug development
pathway. Through its exclusive strategic relationship with the
largest compounding pharmacy organization in North America as well as through a growing
network of commercial development relationships with pharmacists
and physicians across the United
States, Imprimis expects to use proprietary drug delivery
technologies, proven drug formulations and proprietary market data
to identify and pursue pharmaceutical development opportunities
where there is a significant unmet medical need. Imprimis'
most near term drug candidate, Impracor, is a Phase III product
candidate that utilizes its patented Accudel topical cream
formulation to deliver the active drug ketoprofen, a non-steroidal
anti-inflammatory drug (NSAID), through the skin directly into the
underlying tissues where the drug exerts its localized
anti-inflammatory and analgesic effects. For more information,
visit http://imprimispharma.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
Imprimis' 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 obtain intellectual property
protection for its assets, including newly acquired intellectual
property, the success of additional research and development
activities related to potential product candidates, its ability to
raise additional funding, its ability to acquire, develop or
commercialize new products and to enter into strategic alliances
and transactions, uncertainties inherent in pre-clinical
studies and clinical trials, unexpected new data, safety and
technical issues, 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 filed with the SEC. 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.
Contact: Josh Berg
Imprimis Pharmaceuticals, Inc.
(858) 704-4041
SOURCE Imprimis Pharmaceuticals, Inc.