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January 8, 2018 6:30 am ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the U.S. Food and Drug Administration (FDA) has
accepted for review two New Drug Applications (NDAs) for doravirine, the
company’s investigational non-nucleoside reverse transcriptase inhibitor
(NNRTI) for the treatment of HIV-1 infection in adults. The NDAs include
data for doravirine (DOR) as a once-daily tablet for use in combination
with other antiretroviral agents, and for use of doravirine with
lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a once-daily
fixed-dose combination single tablet as a complete regimen
(DOR/3TC/TDF). The FDA has set a target action date of Oct. 23, 2018,
for both applications under the Prescription Drug User Fee Act (PDUFA).

“Since the earliest days of the epidemic, Merck has sustained our
commitment to research and meeting the needs of people living with HIV.
Doravirine was engineered by our research team to provide a meaningful
new treatment approach and address unmet medical needs in the treatment
of HIV-1 infection,” said Dr. George Hanna, associate vice president,
global clinical development, Merck Research Laboratories. “We have been
pleased with the clinical findings to date and look forward to working
with the FDA as it reviews our applications.”

The NDAs are based upon the findings at Week 48 of two ongoing Phase 3
trials, DRIVE-FORWARD and DRIVE-AHEAD, evaluating the efficacy and
safety of doravirine and the fixed-dose combination regimen of
DOR/3TC/TDF, respectively. These data were previously presented at CROI-2017
and IAS
2017, respectively.

About Doravirine

Doravirine (MK-1439, DOR) is an investigational NNRTI being evaluated by
Merck for the treatment of HIV-1 infection. DOR is being evaluated in
several ongoing clinical trials both as a once-daily single-entity
tablet in combination with other antiretroviral agents in a tailored
regimen, and as a once-daily fixed-dose combination (DOR/3TC/TDF) in a
complete single tablet regimen. Phase 3 trials include DRIVE-FORWARD, a
trial comparing DOR to once-daily ritonavir-boosted darunavir (DRV+r),
each administered in combination with FTC/TDF or abacavir (ABC)/3TC, in
treatment-naïve adults; DRIVE-AHEAD, a trial comparing DOR/3TC/TDF to
EFV/FTC/TDF in treatment-naïve adults; and DRIVE-SHIFT, a trial
evaluating a switch to DOR/3TC/TDF in HIV-1 infected adults who are
currently virologically suppressed on another antiretroviral regimen.
Other ongoing Phase 2 clinical trials include an evaluation of
DOR/3TC/TDF in treatment-naïve adults with transmitted resistance to
NNRTIs and in individuals switching from EFV due to intolerability.

About DRIVE-FORWARD

DRIVE-FORWARD is a multicenter, double-blind, randomized non-inferiority
trial in which 769 treatment-naïve adults with HIV-1 infection received
either DOR (100 mg) or DRV+r (800 mg +100 mg), both administered orally
once-daily in combination with either TDF/FTC or ABC/3TC. The primary
endpoint of the clinical trial was the proportion of participants with
HIV-1 RNA less than 50 copies/mL at Week 48. Secondary endpoints
included an evaluation of the effects of DOR and DRV+r on fasting serum
lipids, change from baseline in CD4+ T-cell count, and evaluation of
safety and tolerability. The trial consists of a 96-week double-blind
treatment period (base study) and an open label extension after
participants complete the base study. For further information regarding
DRIVE-FORWARD please visit www.clinicaltrials.gov

clinical trial registry number NCT02275780.

About DRIVE-AHEAD

DRIVE-AHEAD is an ongoing Phase 3 multicenter, double-blind, randomized,
active comparator-controlled clinical trial evaluating the safety and
efficacy of a once-daily, single-tablet, fixed-dose combination
consisting of DOR/3TC/TDF (100mg/300mg/300mg) versus a once daily,
single-tablet, fixed-dose combination of EFV/FTC/TDF (600mg/200mg/300mg)
in treatment-naïve HIV-1 infected adults. The primary endpoint of the
clinical trial was the proportion of participants with HIV-1 RNA less
than 50 copies/mL at Week 48. The primary safety endpoint was the
proportion of participants with neuropsychiatric adverse events through
Week 48 in the following pre-specified categories: dizziness, sleep
disorders and disturbances, and the inability to think clearly or
concentrate. Secondary endpoints included an evaluation of the effects
of DOR/3TC/TDF and EFV/FTC/TDF on fasting serum lipids, change from
baseline in CD4+ T-cell count, and evaluation of safety and
tolerability. The trial consists of a 96-week double-blind treatment
period (base study) and an open label extension after participants
complete the base study. For further information regarding DRIVE-AHEAD
please visit www.clinicaltrials.gov

clinical trial registry number NCT02403674.

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. For more information, visit www.merck.com
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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).

Merck
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