Merck Announces Collaboration with the Medicines Patent Pool to Expand Access to Pediatric Formulations of Raltegravir in Developing Countries
February 24, 2015 3:00 am ET
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
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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.
Merck
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