SAN DIEGO, May 2, 2016 /PRNewswire/ -- Imprimis
Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company
focused on the development and commercialization of proprietary and
customizable drug formulations, today announced the availability of
the company's new patent-pending customizable delayed-release (DR)
tiopronin formulations as a lower-cost therapeutic alternative to
FDA-approved Thiola®. Thiola, FDA-approved as a 100mg tablet,
is composed of tiopronin as its sole active drug ingredient and is
commonly prescribed for the prevention of cystine kidney stone
formation in patients who do not respond to dietary changes and
increased fluids. Physicians and their cystinuria patients
may now choose from one of two lower-cost compounded alternatives
to Thiola.
The company offers two customizable compounded choices:
- Tiopronin DR, which is comprised of the active ingredient
tiopronin along with a cellulose-based FDA-approved delayed release
agent. This formulation is available in various customizable
doses including 200mg and 250mg capsules.
- Tiopronin-K DR is comprised of the active ingredient tiopronin
along with potassium citrate in a delayed release capsule, for
those patients who have had their potassium citrate dosing
titrated. Potassium citrate is the first-line alkalinizing
drug for the treatment of cystinuria. According to the
National Organization for Rare Disorders, in addition to chelating
medications such as tiopronin, potassium citrate is often
co-prescribed and taken separately to make the urine more alkaline,
potentially reducing cystine crystallization and stone
formation.
Imprimis' tiopronin compounded formulations may not only
significantly lower the cost of cystinuria treatments but also
allow patients, for the first time, to reduce the number of pills
they consume on a daily basis for this chronic genetic disease.
Imprimis' exclusive NDC code for tiopronin should allow
patients and their insurance companies to experience a reduction of
at least 60% in costs compared to the FDA-approved Thiola per 100mg
dose. Many health insurance plans cover compounded drugs and
patients not covered will benefit from the Imprimis Cares
patient access program. Finally, many insurance companies and
pharmacy benefit managers have developed or are developing programs
to provide patients with lower-cost alternatives to certain
FDA-approved branded and generic drugs.
Commitment to Patient Access
Imprimis is committed to the company's mission, vision and
values of providing patients with affordable access to the
medications they need. As with the company's other lower-cost
compounded alternatives, this new alternative to Thiola resulted
from the needs of patients, physicians and payors.
Significant increases in drug prices, coupled with an increasing
number of higher deductible drug benefit plans and some insurance
companies simply refusing to cover the costs altogether, are making
it difficult for many patients to gain affordable access to the
medications they need. Imprimis plans to continue to expand
its Imprimis Cares formulary and introduce additional drug
formulations for patient populations that may not have available
alternatives to increasingly expensive FDA-approved
medications.
Commitment to Quality
Imprimis is committed to providing high quality medications
compounded at FDA-inspected and PCAB-accredited facilities.
All active drug ingredients used as components of the
formulations are FDA-approved and manufactured to a USP Monograph
or a similarly accepted national or international standard.
Federal and state oversight is a part of every aspect of the
Imprimis drug supply chain from raw material acquisition to
production, testing and dispensing. We strive to meet and/or
exceed all quality standards for the formulations we dispense and
are committed to transparency to our customers when it comes to
batch and lot testing performed, including providing sterility test
results for each order we dispense for sterile compounded
drugs.
How to Order:
- Cystinuria patients or prescribing physicians, please dial toll
free: (866) 551-7195
- Order forms are available
at http://imprimiscares.com/formulations/
Mark L. Baum, CEO of Imprimis,
stated, "Cystinuria patients regularly complain about the number of
pills they have to take each day and the cost of tiopronin, branded
as FDA-approved Thiola, which is the gold standard drug used to
treat this chronic genetic disease. Because of the price increase
following Retrophin's acquisition of Thiola, some insurance
companies no longer cover Thiola. As a result, some patients
have been switched to other treatments such as the off-label use of
Captropril®, an FDA-approved drug for hypertension and heart
failure. Some patients make trips to Canada for Cuprimine® (penicillamine) as an
alternative to Thiola. They travel to Canada for Cuprimine because it also
experienced a significant price increase when Valeant
Pharmaceuticals raised the price from $888 to $26,189, an
increase of almost 2,850 percent. Unfortunately,
approximately 50 percent of all patients taking penicillamine
experience adverse reactions and have to stop taking the
medication. The bottom line is that the cystinuria community
needs access to affordable supplies of tiopronin and that is
exactly what we are making available."
Mr. Baum continued, "Most cystinuria patients require
approximately 1,000mg of tiopronin daily. This equates to
taking 10 tablets of 100mg Thiola each day. Before we entered
the market, physicians, patients, insurance companies, and other
healthcare institutions faced a choice - to pay the owner of the
FDA-approved medicine the price they desired and in many cases take
10 or more of their tablets a day or switch to an alternative drug
that may not work as well. That has changed. The cystinuria
community now has an alternative – a new therapeutic choice and a
new lower-cost source for tiopronin."
About Cystinuria and Thiola®
Cystinuria is an inherited disease that causes stones made of
the amino acid cystine to form in the kidneys, bladder and/or
urethra. There are an estimated 10,000 to 12,000 patients in
the U.S. who suffer from this chronic condition and 4,000 to 5,000
of them may be candidates for Thiola. In 2014, Retrophin LLC
and its CEO at the time, Martin
Shkreli, acquired the licensing rights of Thiola from
Mission Pharmacal Company and increased the price of Thiola 2,000%
from $1.50 per tablet to $30 per tablet, resulting in cystinuria
patients having to grapple with their treatment costs which may
exceed more than an estimated $100,000 per year. Since Mr.
Shkreli's departure from Retrophin, the high price of Thiola
remains intact.
About the Imprimis Cares™ Program
The Imprimis Cares program and its team of compounding
pharmacists will work with physicians and their patients to ensure
they have affordable access to the medicines they need by
compounding customizable therapeutic alternatives using the over
7,800 FDA-approved drugs as components. The Imprimis
Cares program, available in all 50 states, will work with all
third party insurers, pharmacy benefit managers and buying groups
to offer its patient-specific customizable compounded drug
formulations at affordable prices that ensure accessibility.
For more information, please visit www.ImprimisCares.com.
Imprimis is reviewing partnership opportunities to clinically
develop additional proprietary formulations under its Imprimis
Cares program for patient populations that may not have
available alternatives to increasingly expensive FDA-approved
medications. Interested insurance companies, pharmacy benefit
managers (PBMs), physicians, patients, and other interested parties
may request information regarding the company's new tiopronin DR
compounded formulations and other Imprimis Cares
formulations at http://imprimisCares.com/contact/ or contact
Gary Seelhorst, Vice President of
Business Development at gseelhorst@imprimispharma.com.
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 company's
corporate website at www.ImprimisPharma.com.
Imprimis compounded formulations are not FDA approved and may
only be prescribed pursuant to a physician prescription for an
individually identified patient consistent with federal and state
laws governing compounded drug formulations.
Thiola® is a registered trademark of Mission Pharmacal
Company. Imprimis is not affiliated with Mission Pharmacal
Company nor Thiola®. Thiola® is an FDA-approved drug.
Please consult with your physician regarding which prescription
options are most suitable for your specific needs.
Cuprimine® is a registered trademark of Valeant
Pharmaceuticals International, Inc. or its affiliates.
Imprimis is not affiliated with Valeant Pharmaceuticals
International, Inc. or Cuprimine®. Cuprimine® is an
FDA-approved drug. Please consult with your physician
regarding which prescription options are most suitable for your
specific needs.
Capoten® is a registered trademark of Par Pharmaceutical,
Inc. Imprimis is not affiliated with Par Pharmaceutical,
Inc. Capoten® is an FDA-approved drug. Please consult
with your physician regarding which prescription options are most
suitable for your specific needs.
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 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
Business Development Contact:
Gary Seelhorst
gseelhorst@imprimispharma.com
858.704.4111
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.