Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that new data from the company’s HIV
portfolio and pipeline are scheduled to be presented at the 9th IAS
Conference on HIV Science (IAS 2017). Presentations include
late-breaker abstracts from two Phase 3 pivotal clinical trials –
Week 96 data from ONCEMRK, a study evaluating once-daily
ISENTRESS® HD (raltegravir) in combination with other
antiretroviral agents in previously untreated adult patients with
HIV-1 infection, and Week 48 data from DRIVE-AHEAD, a study
evaluating doravirine (MK-1439), an investigational non-nucleoside
reverse transcriptase inhibitor (NNRTI) as part of a fixed dose
regimen containing doravirine (DOR), lamivudine (3TC), and
tenofovir disoproxil fumarate (TDF) compared to a regimen
containing efavirenz (EFV), emtricitabine (FTC), and TDF in
previously untreated adult patients with HIV-1 infection. In
addition, a late-breaker abstract will be presented of a Phase 1
study of MK-8591, Merck’s investigational nucleoside reverse
transcriptase translocation inhibitor (NRTTI) in adult patients
with HIV-1 infection. IAS 2017 is taking place in Paris, France,
from July 23-26, 2017.
“Merck has never wavered in our commitment to addressing the
treatment needs of people living with HIV, and the data to be
presented at IAS 2017 on our portfolio and our pipeline reflect
that commitment,” said Dr. George Hanna, associate vice president,
clinical research, Merck Research Laboratories.
In the United States, once-daily ISENTRESS HD was approved by
the Food and Drug Administration (FDA) on May 26, 2017, in
combination with other antiretroviral agents, for the treatment of
HIV-1 infection in adults, and pediatric patients weighing at least
40 kg, who are treatment-naïve or whose virus has been suppressed
on an initial regimen of ISENTRESS 400 mg given twice daily.
ISENTRESS HD is administered as a 1200 mg once-daily dose, given
orally as two 600 mg film-coated tablets. On May 18, 2017,
the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) adopted a positive
opinion recommending approval of the once-daily dose of ISENTRESS
(ISENTRESS 600 mg as it will be known outside the United States) in
combination with other antiretroviral medicinal products, for the
treatment of HIV-1 infection in adults and pediatric patients
weighing at least 40 kg. The recommendation is under review by the
European Commission for marketing authorization in the European
Union with a decision on approval expected in the second half of
2017.
Select Late-Breaker Abstracts at IAS
2017:
- Abstract # TULBPEB20: Raltegravir (RAL)
1200 mg once daily (QD) versus RAL 400 mg twice daily (BID), in
combination with tenofovir disoproxil fumarate/emtricitabine
(TDF/FTC), in previously untreated HIV-1 infection through week 96
- Late-breaker poster, Tuesday, July 25,
12:30 – 14:30 CET, Poster Exhibition
- Abstract # TUPDB0202LB: Single doses as
low as 0.5 mg of the novel NRTTI MK-8591 suppress HIV for at least
seven days
- Late-breaker poster discussion,
Tuesday, July 25, 13:00 – 14:00 CET, Havana Amphitheater
- Abstract # TUAB0104LB: Fixed dose
combination of doravirine/lamivudine/TDF is non-inferior to
efavirenz/emtricitabine/TDF in treatment-naïve adults with HIV-1
infection: week 48 results of the Phase 3 DRIVE-AHEAD study
- Late-breaker oral presentation,
Antiretroviral Therapy – ART: Season Two, Tuesday, July 25, 14:30 –
16:00 CET, Le Grand Amphithéâtre
About Doravirine
Doravirine (MK-1439) is an investigational NNRTI being evaluated
by Merck for the treatment of HIV-1 infection. Doravirine is being
evaluated in several ongoing studies as a once-daily fixed dose
combination with 3TC and TDF or individually for use in combination
with other antiretroviral agents. Phase 3 studies include
DRIVE-AHEAD, a trial comparing DOR/3TC/TDF to EFV/FTC/TDF in
previously untreated adult patients; DRIVE-FORWARD, a trial
comparing doravirine (DOR) to once-daily ritonavir-boosted
darunavir (DRV+r), each administered in combination with
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or
abacavir/lamivudine (ABC/3TC), in previously untreated adult
patients; and DRIVE-SHIFT, a trial evaluating a switch to
DOR/3TC/TDF in people who are currently virologically suppressed on
another antiretroviral regimen. Other ongoing Phase 2 studies
include an evaluation of DOR/3TC/TDF in previously untreated
patients with transmitted resistance to NNRTIs and in people
switching from efavirenz due to intolerability.
About MK-8591
MK-8591 (formerly known as EFdA) is Merck’s investigational
nucleoside reverse transcriptase translocation inhibitor (NRTTI)
currently being evaluated in early stage clinical trials for the
treatment of HIV infection. It inhibits HIV reverse transcriptase
through multiple mechanisms that are different from any approved
anti-HIV medicines, including traditional nucleoside reverse
transcriptase inhibitors (NRTIs). MK-8591 is being evaluated for
its potential to be administered as part of a daily or an extended
duration dosing regimen.
About ISENTRESS (raltegravir)
Approved in 2007, ISENTRESS was the first integrase inhibitor
developed for the treatment of HIV-1 infection. ISENTRESS is one of
the regimen options recommended by the Department of Health and
Human Services – in combination with other antiretroviral agents –
as a first-line therapy in treatment-naïve HIV-1 infected adults.
ISENTRESS chewable tablets and oral suspension, each in combination
therapy, are approved to treat pediatric patients aged at least
four weeks of age, and weighing less than 20 kg.
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 approved as part of combination therapy in 112
countries for treatment of HIV-1 infection in adult patients.
ISENTRESS, in combination therapy, for use in children and
adolescents with HIV-1 aged two years and older has also been
approved for use in 69 countries, and ISENTRESS oral suspension for
infants at least four weeks of age is approved for use in 33
countries.
Selected Safety Information about ISENTRESS HD (raltegravir)
and 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 or ISENTRESS HD
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.
Co-administration of ISENTRESS or ISENTRESS HD with drugs that
induce uridine diphosphate glucuronosyltransferase (UGT) 1A1 may
result in reduced plasma concentrations of raltegravir.
Co-administration of ISENTRESS or ISENTRESS HD with drugs that
inhibit UGT1A1 may increase plasma levels of raltegravir.
Co-administration of ISENTRESS or ISENTRESS HD and other drugs
may alter the plasma concentration of raltegravir. The potential
for drug-drug interactions must be considered prior to and during
therapy. Co-administration or staggered administration of aluminum
and/or magnesium hydroxide-containing antacids and ISENTRESS or
ISENTRESS HD is not recommended. Co-administration of ISENTRESS HD
with calcium carbonate antacids, tipranavir/ritonavir, or
etravirine is also not recommended.
During co-administration with rifampin, the recommended dosage
of ISENTRESS in adults is 800 mg twice daily. Rifampin, a strong
inducer of UGT1A1, reduces plasma concentrations of ISENTRESS.
There are no data to guide co-administration of ISENTRESS with
rifampin in patients below 18 years of age.
Co-administration with rifampin is not recommended with
ISENTRESS HD.
The impact of other strong inducers of drug metabolizing enzymes
on raltegravir is unknown (e.g., Carbamazepine, Phenobarbital, and
Phenytoin). Co-administration of ISENTRESS or ISENTRESS HD with
other strong inducers is not recommended.
The most commonly reported (≥2 percent) drug-related clinical
adverse reactions of moderate to severe intensity in
treatment-naïve adult patients receiving ISENTRESS compared with
efavirenz were headache (4 percent vs. 5 percent), insomnia (4
percent vs. 4 percent), nausea (3 percent vs. 4 percent), dizziness
(2 percent vs. 6 percent), and fatigue (2 percent vs. 3 percent),
respectively. The most commonly reported (≥2 percent) clinical
adverse reactions of all intensities (Mild, Moderate, and Severe)
in treatment-naïve adult patients receiving ISENTRESS HD compared
with ISENTRESS through 48 weeks included abdominal pain, diarrhea,
vomiting, and decreased appetite. Intensities were defined as
follows: Mild (awareness of sign or symptom, but easily tolerated);
Moderate (discomfort enough to cause interference with usual
activity); or Severe (incapacitating with inability to work or do
usual activity).
Grade 2–4 creatine kinase laboratory abnormalities were observed
in subjects treated with ISENTRESS or ISENTRESS HD. Myopathy and
rhabdomyolysis have been reported with ISENTRESS. 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.
There is a pregnancy exposure registry that monitors pregnancy
outcomes in women exposed to ISENTRESS or ISENTRESS HD during
pregnancy. Healthcare providers are encouraged to register patients
by calling the Antiretroviral Pregnancy Registry (APR) at
1-800-258-4263.
Women infected with HIV-1 should be instructed not to breastfeed
if they are receiving ISENTRESS or ISENTRESS HD due to the
potential for HIV transmission.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world's most challenging diseases.
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 health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer's disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us on Twitter, Facebook,
Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. 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.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. 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; 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 2016
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) and ISENTRESS HD (raltegravir) at
http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_pi.pdf,
Patient Information for ISENTRESS and ISENTRESS HD (raltegravir) at
http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_ppi.pdf.
The Instructions for Use also are available at
http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_ifu.pdf
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267-305-4195orInvestors:Teri Loxam, 908-740-1986orAmy Klug,
908-740-1898
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