HERTFORDSHIRE, England and
PITTSBURGH, Aug. 29, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced that its U.S. subsidiary will
launch the first generic to EpiPen® Auto-Injector
(epinephrine injection, USP) at a list price of $300 per generic EpiPen® two-pack
carton, which represents a discount of more than 50% to the Mylan
list price, or wholesale acquisition cost ("WAC"), of the branded
medicine. The authorized generic will be identical to the branded
product, including device functionality and drug formulation. Mylan
expects to launch the product in several weeks, pending completion
of labeling revisions. Upon launch, the product will be available
as a two-pack carton in both 0.15 mg and 0.30 mg strengths. Mylan
also intends to continue to market and distribute branded
EpiPen®.
Mylan CEO Heather Bresch
commented, "We understand the deep frustration and concerns
associated with the cost of EpiPen® to the patient, and
have always shared the public's desire to ensure that this
important product be accessible to anyone who needs it. Our
decision to launch a generic alternative to EpiPen® is
an extraordinary commercial response, which required the
cooperation of our partner. However, because of the complexity and
opaqueness of today's branded pharmaceutical supply chain and the
increased shifting of costs to patients as a result of high
deductible health plans, we determined that bypassing the brand
system in this case and offering an additional alternative was the
best option. Generic drugs have a long, proven track record of
delivering significant savings to both patients and the overall
healthcare system. The launch of a generic EpiPen®,
which follows the steps we took last week on the brand to
immediately reduce patients' out-of-pocket costs, will offer a
long-term solution to further reduce costs and ease the burden and
complexity of the process on the patient."
Bresch continued, "Ensuring access to medicine is absolutely the
core of Mylan's mission and has been since our founding 55 years
ago. Mylan currently markets approximately 600 products in the
U.S., saving our healthcare system hundreds of millions of dollars
annually. We also are committed partners to the allergy community
and take our responsibilities to serving these patients very
seriously. Today's action further demonstrates this
commitment."
To enhance affordability for the broadest patient population
possible, both the augmented patient assistance program and the
$300 savings card announced last week
will remain in place for the brand product. The $300 My EpiPen Savings Card® acts as cash at the
pharmacy and is available at epipen.com/savings. People interested
in learning more about the patient assistance program should
contact Mylan's Customer Relations team at 800-395-3376. Mylan also
will continue its EpiPen4Schools® program.
In addition, Mylan intends to initiate a direct ship program in
conjunction with the launch of the generic at the $300 generic list price. Mylan also continues to
fight for enhanced access to epinephrine auto-injectors through
other measures, such as inclusion of the product on the federal and
private insurance preventive drug lists, which could potentially
eliminate all co-pays.
Importantly, Mylan remains fully committed to continuing to meet
the needs of this under-served patient population. This includes
investing in education and awareness about anaphylaxis, a
life-threatening allergic reaction. These efforts have proven vital
to ensuring patients are aware of their risk, prepared in the event
anaphylaxis occurs, and have access to epinephrine auto-injectors
whenever and wherever they need them, at an affordable cost.
About EpiPen® (epinephrine
injection, USP) Auto-Injector
EpiPen® (epinephrine injection, USP) and
EpiPen Jr® (epinephrine injection, USP)
Auto-Injectors are used for the emergency treatment of
life-threatening allergic reactions. Each EpiPen
2-Pak® and EpiPen Jr
2-Pak® contains two single auto-injectors,
instructions for use and a training device, with no drug product or
needle, to help patients become familiar with the administration
technique. EpiPen® Auto-Injector should be
administered immediately at the first sign of an anaphylactic
reaction. EpiPen® Auto-Injector is not a
substitute for emergency medical treatment. Patients should
seek emergency medical attention immediately following
administration. For more information about
EpiPen® Auto-Injector,
visit epipen.com.
About Mylan
Mylan is a global pharmaceutical company committed to setting
new standards in healthcare. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 2,700 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world depend.
We market our products in more than 165 countries and territories.
Our global R&D and manufacturing platform includes more than 50
facilities, and we are one of the world's largest producers of
active pharmaceutical ingredients. Every member of our more than
40,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com
Indications
EpiPen® (epinephrine injection, USP) 0.3 mg and
EpiPen Jr® (epinephrine injection, USP) 0.15 mg
Auto-Injectors are for the emergency treatment of life-threatening
allergic reactions (anaphylaxis) caused by allergens, exercise, or
unknown triggers; and for people who are at increased risk for
these reactions. EpiPen® and EpiPen Jr® are
intended for immediate administration as emergency supportive
therapy only. Seek immediate emergency medical help right away.
Important Safety Information
Use EpiPen® or EpiPen Jr® Auto-Injectors
right away when you have an allergic emergency (anaphylaxis).
Get emergency medical help right away. You may need further
medical attention. Only a healthcare professional should give
additional doses of epinephrine if you need more than two
injections for a single anaphylactic episode. EpiPen® or
EpiPen Jr® should only be injected into the
middle of your outer thigh (upper leg), through clothing if
necessary. Do not inject into your veins, buttocks, fingers, toes,
hands or feet. Hold the leg of young children firmly in place
before and during injection to prevent injuries. In case of
accidental injection, please seek immediate medical treatment.
Rarely, patients who have used EpiPen® or EpiPen
Jr® may develop an infection at the injection site
within a few days. Some of these infections can be serious. Call
your healthcare professional right away if you have any of the
following at an injection site: redness that does not go away,
swelling, tenderness, or the area feels warm to the touch.
Tell your healthcare professional about all of your medical
conditions, especially if you have asthma, a history of depression,
thyroid problems, Parkinson's disease, diabetes, high blood
pressure or heart problems, have any other medical conditions, are
pregnant or plan to become pregnant, or are breastfeeding or plan
to breastfeed. Be sure to also tell your healthcare professional
all the medicines you take, especially medicines for asthma. If
you have certain medical conditions, or take certain medicines,
your condition may get worse or you may have longer lasting side
effects when you use EpiPen® or EpiPen
Jr®.
Common side effects include fast, irregular or "pounding"
heartbeat, sweating, nausea or vomiting, breathing problems,
paleness, dizziness, weakness, shakiness, headache, feelings of
over excitement, nervousness or anxiety. These side effects usually
go away quickly if you lie down and rest. Tell your healthcare
professional if you have any side effect that bothers you or that
does not go away.
Please see the full Prescribing Information and Patient
Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For additional information, please contact us at
800-395-3376.
EpiPen®, EpiPen Jr®, EpiPen
2-Pak®, EpiPen Jr 2-Pak®,
EpiPen4Schools® and My EpiPen Savings
Card® are registered trademarks owned by Mylan
Inc.
© 2016 Mylan Specialty L.P. All rights reserved.
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SOURCE Mylan N.V.