Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced an agreement with the Medicines Patent Pool
(MPP) to license its pediatric formulations of raltegravir for use
in treating HIV-1 infection in infants and children from four weeks
to under 12 years of age in developing countries. This is the MPP’s
first agreement to provide access to an HIV integrase inhibitor for
use in combination HIV therapy for infants and children in this age
range. The agreement also allows for development of novel pediatric
formulations of raltegravir and novel combinations. Raltegravir is
marketed by Merck as ISENTRESS® (raltegravir). In the United
States, ISENTRESS is indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection in
patients four weeks of age and older.
“This agreement with the MPP has been established to provide
access to raltegravir to HIV-infected children in developing
countries where the burden of HIV infection is highest, including
sub-Saharan Africa,” said Jackie Neilson, general manager and
global commercial leader for the HIV Franchise, Merck. “This builds
upon Merck’s three-decade long commitment to both innovation and
access to address the global HIV epidemic.”
Raltegravir is the only integrase inhibitor approved for use in
infants and children as young as four weeks in the United States
and European Union. Pediatric formulations of raltegravir are
available as chewable tablets (25 mg and 100 mg) and granules for
oral suspension (single-use 100 mg packets).
Merck is providing the MPP a royalty-free license for the
development of pediatric formulations of raltegravir—chewable
tablets and granules for oral suspension—for infants and children
from four weeks to under 12 years of age. The agreement is designed
to improve access to raltegravir for pediatric populations in low-
and middle-income countries with significantly high rates of
pediatric HIV, totaling 92 countries. In addition to providing
expanded access, the agreement allows for development of new
pediatric formulations of raltegravir, in support of the “Global
Pediatric Antiretroviral Commitment-to-Action” announced by the
United States President’s Emergency Plan for AIDS Relief (PEPFAR),
the Pediatric HIV Treatment Initiative (PHTI), and the Global Fund
to Fight AIDS, Tuberculosis and Malaria, to accelerate the
development of new, high-priority pediatric antiretroviral
co-formulations.
“MPP is pleased to have Merck on board as a new private sector
partner working with us on pediatric programs,” said Greg Perry,
executive director, MPP. “Raltegravir adds to our arsenal of
pediatric licenses in supporting better options for children in
low- and middle-income countries and can benefit the most neglected
sub-segment: infants and toddlers less than three years of
age.”
Despite efforts to eliminate pediatric HIV, it is estimated that
there are 3.2 million children infected with HIV worldwide and
almost 800 die every day because of lack of access to treatment and
care. In fact, it is estimated that less than a quarter of all
children infected with HIV worldwide are receiving antiretrovirals.
Therefore, it is critical to develop innovative formulations to
meet this unmet medical need while ensuring access to these
therapies. As such, the World Health Organization (WHO) guidelines
have listed raltegravir as an important product needed for certain
pediatric populations.
For 30 years, Merck has demonstrated its commitment to improved
access to HIV medicines through longstanding efforts including
differential pricing, voluntary licensing, public-private
partnerships, philanthropic programs, and continued research and
development efforts in HIV. For more information about Merck’s
corporate responsibility in HIV, visit
www.merckresponsibility.com/access-to-health/infectious-diseases/hiv-aids/.
Selected Safety Information
Severe, potentially life-threatening and fatal skin reactions
have been reported. This includes cases of Stevens-Johnson
syndrome, hypersensitivity reaction and toxic epidermal necrolysis.
Immediately discontinue treatment with ISENTRESS (raltegravir) and
other suspect agents if severe hypersensitivity, severe rash, or
rash with systemic symptoms or liver aminotransferase elevations
develops and monitor clinical status, including liver
aminotransferases closely.
Immune reconstitution syndrome can occur, including the
occurrence of autoimmune disorders with variable time to onset,
which may necessitate further evaluation and treatment.
ISENTRESS (raltegravir) chewable tablets contain phenylalanine,
a component of aspartame, which may be harmful to patients with
phenylketonuria.
Coadministration of ISENTRESS with drugs that are strong
inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1
may result in reduced plasma concentrations of raltegravir.
Coadministration of ISENTRESS with drugs that inhibit UGT1A1 may
increase plasma levels of raltegravir.
Coadministration of ISENTRESS and other drugs may alter the
plasma concentration of raltegravir. The potential for drug-drug
interactions must be considered prior to and during therapy.
Coadministration or staggered administration of aluminum and/or
magnesium hydroxide-containing antacids and ISENTRESS is not
recommended.
Rifampin, a strong inducer of UGT1A1, reduces plasma
concentrations of ISENTRESS. Therefore, the dose of ISENTRESS for
adults should be increased to 800 mg twice daily during
coadministration with rifampin. There are no data to guide
coadministration of ISENTRESS with rifampin in patients below 18
years of age.
The most commonly reported (≥2%) drug-related clinical adverse
reactions of moderate to severe intensity in treatment-naïve adult
patients receiving ISENTRESS compared with efavirenz were insomnia
(4% vs 4%), headache (4% vs 5%), nausea (3% vs 4%), fatigue (2% vs
3%), and dizziness (2% vs 6%) respectively. In
treatment-experienced adult patients receiving ISENTRESS, the most
commonly reported (≥2%) drug-related clinical adverse reactions of
moderate to severe intensity and at a higher incidence compared
with placebo was headache (2% vs <1%). In both studies,
intensities were defined as: Moderate (discomfort enough to cause
interference with usual activity); or Severe (incapacitating with
inability to work or do usual activity). In treatment-experienced
pediatric patients 4 weeks through 18 years of age receiving
ISENTRESS, the frequency, type and severity of drug-related adverse
reactions were comparable to those observed in adults.
Grade 2-4 creatine kinase laboratory abnormalities were observed
in subjects treated with ISENTRESS. Myopathy and rhabdomyolysis
have been reported. Use with caution in patients at increased risk
of myopathy or rhabdomyolysis, such as patients receiving
concomitant medications known to cause these conditions and
patients with a history of rhabdomyolysis, myopathy or increased
serum creatine kinase.
Rash occurred more commonly in treatment-experienced subjects
receiving regimens containing ISENTRESS + darunavir/ritonavir
compared to subjects receiving ISENTRESS without
darunavir/ritonavir or darunavir/ritonavir without ISENTRESS.
However, rash that was considered drug related occurred at similar
rates for all 3 groups. These rashes were mild to moderate in
severity and did not limit therapy; there were no discontinuations
due to rash.
ISENTRESS (raltegravir) should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
There are no adequate and well-controlled studies in pregnant
women. In addition, there have been no pharmacokinetic studies
conducted in pregnant patients.
To monitor maternal-fetal outcomes of pregnant patients exposed
to ISENTRESS, an Antiretroviral Pregnancy Registry has been
established. Physicians are encouraged to register patients by
calling 1-800-258-4263.
About ISENTRESS
ISENTRESS is Merck's integrase inhibitor for the treatment of
HIV-1 infection in adult and pediatric patients ages four weeks and
older and weighing at least 3 kg as part of combination HIV
therapy. ISENTRESS works by inhibiting the insertion of HIV-1 DNA
into human DNA by the integrase enzyme and has demonstrated rapid
antiviral activity. Inhibiting integrase from performing this
essential function limits the ability of the virus to replicate and
infect new cells. ISENTRESS is now approved as part of combination
therapy in more than 76 countries for use in treatment-naïve adult
patients with HIV-1 and in more than 115 countries for use in
treatment-experienced adult patients with HIV-1. ISENTRESS, in
combination therapy, for use in children and adolescents with HIV-1
ages two years and older has also been approved for use in 46
countries, and ISENTRESS (raltegravir) oral suspension for infants
at least four weeks of age is approved for use in 31 countries.
Merck is continuing to move forward with filings of ISENTRESS
(raltegravir) for oral suspension in additional countries around
the world.
About Merck
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside the United States and
Canada. Through our prescription medicines, vaccines, biologic
therapies and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access
to healthcare through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes “forward-looking statements” within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of Merck’s
management and are subject to significant risks and uncertainties.
If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; Merck’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Merck’s 2013 Annual
Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for ISENTRESS
(raltegravir) at http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_pi.pdf,
Patient Information for ISENTRESS at
http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_ppi.pdf
and Instructions for Use of ISENTRESS for Oral Suspension at
https://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_ifu.pdf.
MerckMedia:Pam Eisele, 267-305-3558Ian McConnell,
908-740-1921orInvestors:Joe Romanelli, 908-740-1986Justin Holko,
908-740-1879
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