HERTFORDSHIRE, England and
PITTSBURGH, March 2, 2018 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced
that it will launch two new HIV treatments, Symfi Lo™
and Cimduo™, which were approved in February by the
U.S. Food and Drug Administration (FDA). Mylan anticipates
introducing Symfi Lo in the coming weeks and Cimduo in the second
quarter of this year. These upcoming launches will extend Mylan's
global antiretroviral (ARV) platform and help address the high cost
of HIV treatment in the U.S. Total spending for HIV medications in
the U.S. exceeds $20 billion
annually, and HIV is a top cost driver for many healthcare payers,
such as Medicaid.
Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil
fumarate) 400 mg/300 mg/300 mg tablets is a once-daily,
single-tablet regimen (STR) and is indicated as a complete regimen
for the treatment of human immunodeficiency virus type 1 (HIV-1)
infection in adult and pediatric patients weighing at least 35 kg.
Cimduo™ (lamivudine and tenofovir disoproxil fumarate)
300 mg/300 mg tablets is a once-daily combination of two
nucleo(t)side reverse transcriptase inhibitors and is indicated in
combination with other antiretroviral agents for the treatment of
human immunodeficiency virus type 1 (HIV-1) infection in adults and
pediatric patients weighing at least 35 kg.
"As the world's largest supplier of antiretrovirals by volume,
Mylan is deeply committed to expanding access to treatment for
people living with HIV," said Mylan CEO Heather Bresch. "For a decade, we have helped
transform the level of access to high-quality, affordable HIV
medications in developing countries. We are excited to bring that
same passion to the U.S. with the upcoming launches of Symfi Lo and
Cimduo and help deliver significant savings to the healthcare
system."
In 2017, HIV was the category with highest pharmacy spend for
Medicaid, the third highest for health exchange plans and the fifth
highest for commercial plans.1 According to IQVIA, total
spending on HIV drugs has more than tripled since 2007, outpacing
the approximate 60% growth in overall drug spending.
To help reduce the high cost of HIV treatment in the U.S, Symfi
Lo's list price will be discounted significantly from the wholesale
acquisition cost (WAC) of any other STR on the U.S. market today.
Cimduo's list price will likewise be at a significant discount to
any other tenofovir-based double combination product on the U.S.
market today.
Lactic acidosis and hepatomegaly with steatosis, including fatal
cases, have been reported with the use of nucleoside analogues
including lamivudine and tenofovir disoproxil fumarate. Severe
acute exacerbations of hepatitis B have been reported in patients
who are co-infected with hepatitis B virus and HIV who have
discontinued lamivudine and tenofovir disoproxil fumarate.
Evolving the Science with a New, Low-dose Option
Symfi Lo is an STR formulated with a 400 mg dose of efavirenz,
which is one-third less than the dose originally approved in 1998.
The fixed-dose combination was recommended by the World Health
Organization in 2016 as an alternative first-line therapy for
adults living with HIV infection. In addition, Mylan has sold the
product overseas since March 2017,
upon receipt of Tentative Approval by FDA under the U.S.
President's Emergency Plan for AIDS Relief (PEPFAR) program.
Worldwide, Mylan supplied the regimen to more than one million
patients in 2017.
"Symfi Lo and Cimduo bring to the U.S. the innovations Mylan has
pioneered in the delivery and dosage forms of ARVs used by millions
of patients in high-burden countries around the world. We are proud
of our continued investments in R&D and manufacturing for ARVs,
and we are excited to extend the value of these to Americans living
with HIV," said Mylan President Rajiv
Malik. "In particular, we believe the option to take a lower
dose of efavirenz in a single-tablet regimen with Symfi Lo will be
a welcome addition for patients and providers."
According to the Kirby Institute's ENCORE1 study, 400 mg
efavirenz was found to be non-inferior to 600 mg efavirenz when
combined with tenofovir and emtricitabine in adults with HIV-1
infection who had never undergone treatment.2 Symfi Lo
is the second efavirenz-based STR approved by the FDA and the first
to use the lower dose of efavirenz.
Mylan's Commitment to the HIV/AIDS Patient Community
Mylan is the world's largest supplier by volume of HIV/AIDS
therapies. More than 40% of the 20 million patients on treatment
worldwide depend on a Mylan product every day. For more than a
decade, Mylan has been a leader in providing access to quality,
dependable and affordable ARVs in 100 countries around the world.
This includes introducing in 2009 the first generic
one-tablet-once-a-day combination for developing countries – only
three years after the originator product launched in the U.S. Since
that time, Mylan has been the first to market with nearly half of
the new products tentatively approved by the FDA under PEPFAR.
Mylan was also the first generic drug maker to develop for low- and
middle-income countries a heat-stable version of a drug critical
for second-line regimens, and is the leading worldwide supplier of
pediatric ARVs, including taste-masked and dispersible
formulations. Mylan has long been a supporter of the patient
community through the sponsorship of free community HIV/AIDS
testing and clinical research. Learn more about Mylan's work with
infectious disease here. Watch this video to learn more about
Mylan's commitment to people living with HIV/AIDS.
This press release includes statements that constitute
"forward-looking statements", including with regard to: Mylan
announcing that in the coming weeks it will launch two new HIV
treatments, Symfi LoTM and CimduoTM, which were approved in
February by the FDA; that these upcoming launches will extend
Mylan's global ARV platform and help address the high cost of HIV
treatment in the U.S.; and that Mylan will launch Symfi Lo and
Cimduo at a list price approximately 40% less than the wholesale
acquisition cost of competing products. 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: success of clinical
trials and our or our partners' ability to execute on new product
opportunities; any regulatory, legal or other impediments to our or
our partners' ability to bring products to market; other risks
inherent in product development; the scope, timing, and outcome of
any ongoing legal proceedings, including government investigations,
and the impact of any such proceedings on our or our partners'
businesses; actions and decisions of healthcare and pharmaceutical
regulators, and changes in healthcare and pharmaceutical laws and
regulations, in the United States
and abroad; the impact of competition; strategies by competitors or
other third parties to delay or prevent product introductions; the
effect of any changes in our or our partners' customer and supplier
relationships and customer purchasing patterns; any other changes
in third-party relationships; changes in the economic and financial
conditions of the businesses of Mylan or its partners;
uncertainties and matters beyond the control of management; and the
other risks detailed in Mylan'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 7,500 marketed products around the
world, including antiretroviral therapies on which more than 40% of
people being treated for HIV/AIDS globally depend. We market our
products in more than 165 countries and territories. We are one of
the world's largest producers of active pharmaceutical ingredients.
Every member of our approximately 35,000-strong workforce is
dedicated to creating better health for a better world, one person
at a time. Learn more at Mylan.com. We routinely post information
that may be important to investors on our website at
investor.mylan.com.
1
http://lab.express-scripts.com/lab/drug-trend-report/2017-dtr
2 Efficacy of 400 mg efavirenz versus standard 600 mg
dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a
randomised, double-blind, placebo-controlled, non-inferiority
trial;
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62187-X/abstract
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SOURCE Mylan N.V.