Unveils “Positively Committed” Campaign at
International AIDS Society Conference
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, announced today that the company's commitment to HIV and
AIDS, which started with a research and development program
initiated in the mid-1980s during the early years of the epidemic,
is now entering its fourth decade. To commemorate Merck's 30 years
of commitment in this area, the company is launching a new effort,
“Positively Committed.” The campaign highlights the company’s
contributions, including the development of innovative therapies to
address the unmet medical needs of people infected with HIV-1.
“The global health community has made significant progress in
the fight against HIV and Merck is proud of our role in this fight,
starting at the outset of the epidemic, and continuing to this
day,” said Daria J. Hazuda, vice president and therapeutic area
head, infectious disease and vaccines. “Although antiretroviral
therapy has advanced the management of HIV-1, much work remains to
be done. We will continue to collaborate with scientists,
clinicians, patient advocates and the global health community as we
work together towards a common goal of eradicating this
disease.”
Legacy of Commitment
- In the mid-1980s, soon after the public
health community first coined the term “AIDS” to describe this
emerging epidemic, Merck began its HIV/AIDS research. Merck
researchers were the first to describe the chemical structure of
the protease enzyme, and published the findings immediately to
encourage further research efforts. Merck researchers then
developed CRIXIVAN® (indinavir sulfate), an HIV protease inhibitor,
which was approved by the European Medicines Agency and the U.S.
Food and Drug Administration (FDA) in 1996. At the time, the FDA's
approval of CRIXIVAN (indinavir sulfate) was the fastest approval
in FDA history.
- In 1997, Merck's clinical study of
CRIXIVAN was the first to show that a combination of antiretroviral
medicines could provide prolonged suppression of HIV RNA. Today,
CRIXIVAN in combination with antiretroviral agents is indicated for
the treatment of HIV infection.
- In 1999, Merck introduced efavirenz, a
non-nucleoside reverse-transcriptase inhibitor (NNRTI), which was
developed by Merck and DuPont Pharmaceuticals. Merck retained the
rights to market efavirenz in select markets outside the U.S.
Today, efavirenz is one of the most commonly prescribed
antiretroviral therapies worldwide.
- In the early 1990s, Merck was the first
to demonstrate that inhibition of the HIV-1 integrase enzyme—which
is required for HIV replication—was possible, and that inhibiting
the integrase protein reduced replication and spread of the virus.
This research advancement led to the development of ISENTRESS®
(raltegravir). In 2007, the approval of ISENTRESS introduced a new
class of treatments, HIV-1 integrase strand transfer inhibitors.
Today, ISENTRESS is indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection in
patients four weeks of age and older. The use of other active
agents with ISENTRESS is associated with a greater likelihood of
treatment response.
In addition, since the mid-1980s shortly after the HIV virus was
identified, Merck pursued one of the largest HIV vaccine research
programs, culminating in a large-scale trial that illustrated the
difficulty of developing a successful HIV vaccine.
Merck's research efforts today include programs to develop novel
HIV treatment and prevention technologies, and collaborations on
approaches to address HIV latency and eradication.
Research is only one part of our comprehensive strategy to
address unmet needs in HIV. Merck also has sought to increase
access to our HIV medicines, particularly in resource limited
settings.
“Effective treatments for HIV-1 infection were a distant hope in
the 1980s, but collaborative scientific discovery and effective
advocacy have made them possible today," said Dr. Julie Gerberding,
executive vice president, strategic communications, global public
policy, and population health at Merck. “I'm proud that Merck is
committed to sustaining our contributions to the treatment of this
infection around the world.”
Addressing the Challenge of HIV/AIDS through
Collaboration
Since the inception of its HIV/AIDS research program 30 years
ago, Merck has recognized the global impact of HIV/AIDS in
developing countries where economic, social and political factors
impede access to education, care and treatment. The Merck
Foundation has partnered with governments, non-governmental
organizations and various other stakeholders, contributing more
than $122 million over the past 15 years to support intervention
programs, strengthen healthcare capacity and improve access to
treatment. In addition, Merck has provided access strategies, such
as differential pricing and voluntary licensing, to enhance access
to treatment in these communities.
This year, Merck partnered with the Medicines Patent Pool to
provide access to raltegravir for infants and children from four
weeks to under 12 years of age in low- and middle-income developing
countries.
Ongoing Commitment Continues
Merck's steadfast dedication to patients living with HIV
continues, and is a part of our broader, sustained commitment to
developing medicines and vaccines to fight a broad range of
infectious diseases.
Selected Safety Information for ISENTRESS
(raltegravir)
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 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 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 (raltegravir) 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 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 (raltegravir)
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 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 for oral
suspension in additional countries around the world. Please refer
to the Prescribing Information for ISENTRESS for information about
dosage and administration for each formulation.
Selected Safety Information for CRIXIVAN (indinavir
sulfate)
CRIXIVAN is contraindicated in patients with clinically
significant hypersensitivity to any of its components. CRIXIVAN, a
CYP3A4 inhibitor, also is contraindicated with the following drugs
due to the potential for elevated plasma concentrations of these
drugs, which may lead to serious and/or life-threatening reactions:
alfuzosin, amiodarone, dihydroergotamine, ergonovine, ergotamine,
methylergonovine, cisapride, lovastatin, simvastatin, pimozide,
Revatio (sildenafil, for treatment of pulmonary arterial
hypertension), oral midazolam, triazolam, alprazolam.
ALERT: Find out about medicines that should
NOT be taken with CRIXIVAN.
Nephrolithiasis/urolithiasis has occurred with therapy with
CRIXIVAN. The cumulative frequency of nephrolithiasis is
substantially higher in pediatric patients (29%) than in adult
patients (12.4%; range across individual trials: 4.7%–34.4%). The
cumulative frequency of nephrolithiasis events increases with
increasing exposure to CRIXIVAN; however, the risk over time
remains relatively constant. In some cases,
nephrolithiasis/urolithiasis has been associated with renal
insufficiency or acute renal failure, pyelonephritis with or
without bacteremia. If signs or symptoms of
nephrolithiasis/urolithiasis occur (including flank pain, with or
without hematuria or microscopic hematuria), temporary interruption
(e.g., 1–3 days) or discontinuation of therapy may be considered.
Adequate hydration is recommended in all patients treated with
CRIXIVAN (indinavir sulfate).
Acute hemolytic anemia, including cases resulting in death, has
been reported in patients treated with CRIXIVAN. Once a diagnosis
is apparent, appropriate measures for the treatment of hemolytic
anemia should be instituted, including discontinuation of
CRIXIVAN.
Hepatitis including cases resulting in hepatic failure and death
has been reported in patients treated with CRIXIVAN. Because the
majority of these patients had confounding medical conditions
and/or were receiving concomitant therapy(ies), a causal
relationship between CRIXIVAN and these events has not been
established.
New onset diabetes mellitus, exacerbation of pre-existing
diabetes mellitus and hyperglycemia have been reported during
post-marketing surveillance in HIV-infected patients receiving
protease inhibitor therapy. Some patients required either
initiation or dose adjustments of insulin or oral hypoglycemic
agents for treatment of these events. In some cases, diabetic
ketoacidosis has occurred. In those patients who discontinued
protease inhibitor therapy, hyperglycemia persisted in some
cases.
Initiation of CRIXIVAN, a CYP3A inhibitor, in patients receiving
medications metabolized by CYP3A or initiation of medications
metabolized by CYP3A in patients already receiving CRIXIVAN, may
increase plasma concentrations of medications metabolized by CYP3A.
Initiation of medications that inhibit or induce CYP3A may increase
or decrease concentrations of CRIXIVAN, respectively. These
interactions may lead to:
- Clinically significant adverse
reactions, potentially leading to severe, life-threatening, or
fatal events from greater exposures of concomitant
medications.
- Clinically significant adverse
reactions from greater exposures of CRIXIVAN.
- Loss of therapeutic effect of CRIXIVAN
and possible development of resistance.
Consider the potential for drug interactions prior to and during
CRIXIVAN therapy; review concomitant medications during CRIXIVAN
therapy; and monitor for the adverse reactions associated with the
concomitant medications.
Caution should be exercised if CRIXIVAN is used concurrently
with atorvastatin or rosuvastatin. Titrate the atorvastatin and
rosuvastatin doses carefully and use the lowest necessary dose with
CRIXIVAN. Caution should be used with coadministration of CRIXIVAN
and parenteral midazolam. Particular caution should be used when
prescribing sildenafil, tadalafil, or vardenafil in patients
receiving indinavir. Coadministration of CRIXIVAN with these
medications is expected to substantially increase plasma
concentrations of sildenafil, tadalafil, and vardenafil and may
result in an increase in adverse events, including hypotension,
visual changes, and priapism, which have been associated with
sildenafil, tadalafil, and vardenafil.
Concomitant use of CRIXIVAN (indinavir sulfate) and St. John’s
Wort (Hypericum perforatum) or products containing St. John’s Wort
is not recommended. Coadministration of CRIXIVAN and St. John’s
Wort has been shown to substantially decrease indinavir
concentrations and may lead to loss of virologic response and
possible resistance to CRIXIVAN or to the class of protease
inhibitors.
Indirect hyperbilirubinemia has occurred frequently during
treatment with CRIXIVAN and has infrequently been associated with
increases in serum transaminases.
Reports of tubulointerstitial nephritis with medullary
calcification and cortical atrophy have been observed in patients
with asymptomatic severe leukocyturia (>100 cells/high-power
field). Patients with asymptomatic severe leukocyturia should be
followed closely and monitored frequently with urinalyses. Further
diagnostic evaluation may be warranted, and discontinuation of
CRIXIVAN should be considered in all patients with severe
leukocyturia.
Immune reconstitution syndrome has been reported in patients
treated with combination antiretroviral therapy, including
CRIXIVAN. During the initial phase of combination antiretroviral
treatment, patients whose immune system responds may develop an
inflammatory response to indolent or residual opportunistic
infections (such as Mycobacterium avium infection, cytomegalovirus,
Pneumocystis jiroveci pneumonia (PCP), or tuberculosis), which may
necessitate further evaluation and treatment. Autoimmune disorders
(such as Graves' disease, polymyositis, and Guillain-Barré
syndrome) have also been reported to occur in the setting of immune
reconstitution; however, the time of onset is more variable, and
can occur many months after initiation of treatment.
There have been reports of spontaneous bleeding in patients with
hemophilia A and B treated with protease inhibitors.
In patients with hepatic insufficiency due to cirrhosis, the
dosage of CRIXIVAN should be lowered because of decreased
metabolism of CRIXIVAN. Patients with renal insufficiency have not
been studied.
Redistribution/accumulation of body fat including central
obesity, dorsocervical fat enlargement (buffalo hump), peripheral
wasting, facial wasting, breast enlargement, and "cushingoid
appearance" have been observed in patients receiving antiretroviral
therapy. The mechanism and long-term consequences of these events
are currently unknown. A causal relationship has not been
established.
CRIXIVAN should not be coadministered with rifampin.
Coadministration of CRIXIVAN with rifampin may lead to loss of
virologic response and possible resistance to CRIXIVAN or to the
class of protease inhibitors or other coadministered antiretroviral
agents.
Coadministration of CRIXIVAN with atazanavir is not recommended.
Both drugs are associated with indirect (unconjugated)
hyperbilirubinemia. Combinations of these drugs have not been
studied.
Alteration in dose or regimen with various HIV antiviral agents
or other agents may be recommended based on drug interaction
studies or predicted interaction. See Table 9 of the Precautions,
Drug Interactions Section of the Prescribing Information for
details.
There are no adequate and well-controlled studies in pregnant
patients. CRIXIVAN should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. To
monitor maternal-fetal outcomes of pregnant patients exposed to
CRIXIVAN, an Antiretroviral Pregnancy Registry has been
established. Physicians are encouraged to register patients by
calling 1-800-258-4263.
Selected adverse reactions of severe or life-threatening
intensity and of unknown drug relationship reported by patients
treated with CRIXIVAN/AZT/3TC in ACTG 320 were: fever (3.8%),
nausea (2.8%), nephrolithiasis/urolithiasis (2.6%), headache
(2.4%), asthenia/fatigue (2.4%), anemia (2.4%), abdominal pain
(1.9%), difficulty breathing/dyspnea/shortness of breath (1.8%),
cough (1.6%), vomiting (1.4%), rash (1.1%), back pain (0.9%), and
diarrhea (0.9%).
About CRIXIVAN (indinavir sulfate)
CRIXIVAN 200 mg and 400 mg capsules in combination with
antiretroviral agents are indicated for the treatment of HIV
infection. This indication is based on two clinical trials of
approximately one year duration that demonstrated: 1) a reduction
in the risk of AIDS-defining illnesses or death; 2) a prolonged
suppression of HIV RNA. CRIXIVAN does not cure HIV infection, does
not reduce the transmission of HIV, and should only be taken in
combination with other drugs for HIV. Please refer to the
Prescribing Information for CRIXIVAN for information about dosage
and administration.
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 of Merck & Co., Inc.,
Kenilworth, NJ, USA
This news release of Merck & Co., Inc., Kenilworth, NJ, USA
(the “company”) 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 the company’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 healthcare
legislation in the United States and internationally; global trends
toward healthcare cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’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 the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company 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 the company’s 2014
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 (raltegravir) for Oral
Suspension at
http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_ifu.pdf
Please see Prescribing Information for CRIXIVAN (indinavir
sulfate) at
http://www.merck.com/product/usa/pi_circulars/c/crixivan/crixivan_pi.pdf
and Patient Information for CRIXIVAN at
http://www.merck.com/product/usa/pi_circulars/c/crixivan/crixivan_ppi.pdf
Brand names used are trademarks of their respective
owners.
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MerckMedia:Pam Eisele, 267-305-3558orCarmen de Gourville,
267-305-4195orInvestor:Joe Romanelli, 908-740-1986orJustin Holko,
908-740-1879
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