HERTFORDSHIRE, England and
PITTSBURGH, Dec. 16, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the launch of the authorized
generic for EpiPen® (epinephrine injection, USP)
Auto-Injector at a wholesale acquisition cost (WAC) of $300 per epinephrine injection, USP two-pack,
which is more than 50% lower than the WAC of EpiPen
2-Pak® Auto-Injectors. The authorized generic, which
will reach pharmacies starting next week, has the same drug
formulation and device functionality as EpiPen Auto-Injector, a
product that has been on the market for nearly 30 years, and is
administered in the same way.
Patients and healthcare professionals can learn more at
MyGenericEAI.com.
Mylan CEO Heather Bresch
commented, "Americans are rightfully concerned about rising drug
prices, and now more than ever patients and families across this
country are standing at the pharmacy counter struggling to pay for
their medications. While it is important to understand the outdated
and complex system that determines what someone pays for medicine
in the U.S., hardworking families don't need an explanation, they
need a solution. This is why we took decisive action with our
EpiPen product and have launched the first generic version at half
the WAC price. This unprecedented action, along with the
enhancements we made to our patient access programs, will help
patients and provide substantial savings to payors.
"Unfortunately, families will continue to face sticker shock for
medications and may be forced to make difficult choices until the
pharmaceutical pricing system is reformed to address the increasing
shift of costs directly to consumers. Pharmaceutical pricing is too
far removed from the patient at the pharmacy counter and not
designed for today's increasingly consumerized healthcare system.
Every day, escalating out-of-pocket costs impact a new patient
population; however, this broader systemic issue will not be solved
in a meaningful and sustainable way by our industry's one-off,
reactive responses. This is an issue that will impact virtually
every family on a high deductible plan, regardless of what medicine
they are taking. That is why it is critical that all industry
participants and government leaders come together to seize the
opportunity to make fundamental changes to the system to ensure
access to medicine.
"Making quality medicines and making them accessible to patients
has been our mission since Mylan began in West Virginia more than 55 years ago. As one
of the world's largest generics companies, our medicines filled one
out of 13 of all prescriptions in the U.S. last year – the
equivalent of 21 billion doses – which is more than Pfizer, Merck,
AstraZeneca, J&J, Sanofi and GSK combined. We will continue to
do our part to fight for changes that will make a difference in the
lives of patients and remain deeply committed to serving patients
in the severe allergy community by working to ensure that everyone
who needs an EpiPen has access to one."
The authorized generic will be available starting next week
through retail channels. Mylan will maintain its commitment to the
severe allergy community and will have a salesforce of
approximately 275 representatives selling the product. To further
increase access to treatment, Mylan has launched an additional
patient purchase option at $300 per
two-pack. Mylan also is offering a savings card for eligible
patients with commercial health insurance, providing up to
$25 off the out-of-pocket cost for
the authorized generic. Additionally, Mylan will continue to offer
its patient assistance program to support uninsured and
underinsured patients. More information about these programs can be
found on Mylan.com/EpiPenAccess.
The authorized generic for EpiPen Auto-Injector is available in
0.15 mg and 0.3 mg strengths.
Forward-Looking Statements
This press release includes statements that constitute
"forward-looking statements," including that the launch of the
first generic version of EpiPen®, along with the
enhancements Mylan made to its patient access programs, will help
patients and provide substantial savings to payors; Mylan will
continue to do its part to fight for changes that will make a
difference in the lives of patients and remains deeply committed to
serving patients in the severe allergy community by working to
ensure that everyone who needs an EpiPen has access to one; the
authorized generic for EpiPen® will be available
starting next week through retail channels; Mylan will maintain its
commitment to the severe allergy community and will have a
salesforce of approximately 275 representatives selling the
product; and Mylan will continue to offer its patient assistance
program to support uninsured and underinsured patients. These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Because such
statements inherently involve risks and uncertainties, actual
future results may differ materially from those expressed or
implied by such forward-looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to: any changes in or difficulties with our inventory of,
and the ability to manufacture and distribute, the authorized
generic for EpiPen® Auto-Injector; the potential impact
of any change in patient access; the effect of any changes in our
customer and supplier relationships and customer purchasing
patterns; other changes in third-party relationships; the impact of
competition; changes in the economic and financial conditions of
the businesses of the Company; the scope, timing, and outcome of
any ongoing legal proceedings and the impact of any such
proceedings on our business; any regulatory, legal, or other
impediments to our ability to bring our products to market; actions
and decisions of healthcare and pharmaceutical regulators, and
changes in healthcare and pharmaceutical laws and regulations, in
the United States and abroad; our
ability to protect our intellectual property and preserve
intellectual property rights; expected or targeted future financial
and operating performance and results; other uncertainties and
matters beyond the control of management; and the other risks
detailed in the Company's filings with the Securities and Exchange
Commission. Mylan undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
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
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
Important Safety Information
Use Epinephrine Injection, USP 0.3 mg or Epinephrine Injection,
USP 0.15 mg 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.
Epinephrine Injection, USP Auto-Injector 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 Epinephrine Injection, USP
Auto-Injector 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 Epinephrine Injection, USP
Auto-Injector.
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.
Indications
Epinephrine Injection, USP 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. Epinephrine
Injection, USP Auto-Injectors are intended for immediate
administration as emergency supportive therapy only. Seek immediate
emergency medical help right away.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit fda.gov/medwatch or call
1-800-FDA-1088.
For additional information, please contact us at
800-395-3376.
EpiPen® and EpiPen 2-Pak® are registered
trademarks owned by Mylan Inc.
© 2016 Mylan Specialty L.P. All rights reserved.
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SOURCE Mylan N.V.