Gilead and Merck Announce Agreement to Jointly Develop and Commercialize Long-Acting, Investigational Treatment Combinations of Lenacapavir and Islatravir in HIV
March 15, 2021 6:45 am ET
Collaboration to Focus on Oral and Injectable Formulations of Lenacapavir and
Agreement Brings Together Potentially Complementary Medicines in Late-Stage
Development with the Goal to Provide Innovative, Long-Acting Treatments in HIV
Foster City, Calif. and Kenilworth N.J. – March 15, 2021 – Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE:
MRK), known as MSD outside the United States and Canada, today announced that they have entered into an agreement to
co-develop and co-commercialize long-acting treatments in HIV that combine Gilead’s investigational capsid
inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor,
islatravir, into a two-drug regimen with the potential to provide new, meaningful treatment options for people
living with HIV.
Islatravir and lenacapavir are both potentially
first-in-class medicines in late-stage clinical trials, with significant clinical data generated to date. Both
medicines have long half-lives and have demonstrated activity at low dosages in clinical studies, which support
development as an investigational combination regimen with long-acting formulations, both oral and injectable.
The first clinical studies of the oral combination
are expected to begin in the second half of 2021. Under the terms of the agreement, Gilead and Merck will work as
partners, sharing operational responsibilities, as well as development, commercialization and marketing costs, and
any future revenues.
Merck and Gilead seek to build on their legacies
of transforming HIV care by focusing on long-acting therapies, which may represent a meaningful innovation in HIV
drug development. While daily, single-tablet regimens are available for people living with HIV, options that would
allow for less frequent, oral dosing or infrequent injections rather than daily dosing have the potential to address
preference considerations, as well as issues associated with adherence and privacy.
As the field of HIV treatment evolves, long-acting
therapies may provide additional options for people living with HIV and their physicians that will help continue to
put the needs of individuals at the center of their own care.
“At Merck, we are resolute in our commitment to
advancing the care of people living with HIV as part of our mission to save and improve lives,” said Kenneth C.
Frazier, chairman and chief executive officer, Merck. “This collaboration with Gilead brings together two companies
dedicated to the fight against HIV to develop potential new long-acting treatment options, and is an important step
forward in our strategy to harness the full potential of islatravir for the treatment of HIV.”
“Through this agreement with Merck, Gilead is
reinforcing its long-term role in transforming HIV care,” said Daniel O’Day, chairman and chief executive officer,
Gilead Sciences. “Our work in HIV over the past decades has been shaped by listening to people living with HIV and
the physicians who treat them. Now we are taking the same approach with long-acting therapies, combining the most
advanced science from both companies to accelerate progress.”
Lenacapavir and islatravir, alone and in
combination, are investigational and not approved anywhere globally. Their safety and efficacy have not yet been
Terms of the Collaboration
Under the terms of the agreement, Gilead and Merck will
co-develop and co-commercialize long-acting products to treat people living with HIV that combine Gilead’s
proprietary investigational capsid inhibitor, lenacapavir, and Merck’s proprietary investigational nucleoside
reverse transcriptase translocation inhibitor, islatravir. The collaboration will initially focus on long-acting
oral formulations and long-acting injectable formulations of these combination products, with other formulations
potentially added to the collaboration as mutually agreed.
Across the oral and injectable formulation
programs, Gilead and Merck will share global development and commercialization costs 60%/40%, respectively. For
long-acting oral products, Gilead will lead commercialization in the U.S. and Merck will lead commercialization in
the EU and rest of the world. For long-acting injectable products, Merck will lead commercialization in the U.S. and
Gilead will lead commercialization in the EU and rest of the world.
Gilead and Merck will co-promote in the U.S. and
other certain major markets. Merck and Gilead will share global product revenues equally until product revenues
surpass certain pre-agreed per formulation revenue tiers. Upon passing $2 billion a year in net product sales for
the oral combination, the revenue split will adjust to 65% Gilead and 35% Merck for any revenues above the
threshold. Upon passing $3.5 billion a year in net product sales for the injectable combination, the revenue split
will adjust to 65% Gilead and 35% Merck for any revenues above the threshold.
Beyond the potential combinations of lenacapavir
and islatravir, Gilead will have the option to license certain of Merck’s investigational oral integrase inhibitors
to develop in combination with lenacapavir. Reciprocally, Merck will have the option to license certain of Gilead’s
investigational oral integrase inhibitors to develop in combination with islatravir. Each company may exercise its
option for an investigational oral integrase inhibitor of the other company following completion of the first Phase
1 clinical trial of that integrase inhibitor. Upon exercise of an option, the companies will split development cost
and revenues, unless the non-exercising company decides to opt-out. Both companies currently have oral once-weekly
integrase inhibitors in preclinical development.
Cowen & Company LLC is acting as financial
advisor to Gilead. Hogan Lovells and White & Case, LLP are serving as legal counsel to Gilead. Morgan, Lewis
& Bockius and Gibson Dunn are serving as legal counsel to Merck.
About Islatravir (MK-8591)
Islatravir (formerly MK-8591) is Merck’s
investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) that exhibits both translocation
inhibition (which prevents nucleotide binding and incorporation to the DNA chain, resulting in immediate chain
termination) and delayed chain termination (which prevents nucleotide incorporation even in the event of
translocation). Islatravir is currently being evaluated for the treatment of HIV-1 infection in combination with
other antiretrovirals, including the ILLUMINATE clinical trials program for oral, once-daily treatment. Islatravir
is also being studied for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a single agent across a variety of
formulations, including the IMPOWER clinical trials evaluating an oral once-monthly regimen. In 2012, Merck licensed
islatravir (4’-ethynyl-2-fluoro-2’-deoxyadenosine or EFdA) from the Yamasa Corporation based in Choshi, Japan.
Lenacapavir is a novel investigational capsid
inhibitor that interrupts the activity of HIV capsid, a protein that surrounds and protects the virus’ genetic
material and essential enzymes. In in vitro studies, lenacapavir interrupts multiple distinct stages of the
viral lifecycle, potentially preventing the virus from becoming infectious and gaining access to uninfected cells.
The safety, efficacy and dosing of lenacapavir are
being evaluated in multiple ongoing clinical studies. Data presented at AIDS 2020 from the ongoing Phase 1 study
support subcutaneous every six-month administration of lenacapavir for both HIV treatment and prevention studies.
During IDWeek 2020, the company announced it would be evaluating the use of lenacapavir among cisgender women as an
injectable PrEP option administered every six months. An additional lenacapavir for PrEP study in men who have sex
with men and persons of trans experience is planned. Both studies are expected to begin in 2021.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical
company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of
creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and
treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35
countries worldwide, with headquarters in Foster City, California.
For more than 30 years, Gilead has been a leading
innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure
research. Today, millions of people living with HIV globally receive antiretroviral therapy provided by Gilead or
one of the company’s manufacturing partners.
For more than 130 years, Merck, 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 in pursuit of our mission to save and improve lives. We demonstrate
our commitment to patients and population health by increasing access to health care through far-reaching policies,
programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases
that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal
diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more
information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
For more than 35 years, Merck has been committed
to scientific research and discovery in HIV, and we continue to be driven by the conviction that more medical
advances are still to come. Our focus is on pursuing research that addresses unmet medical needs and helps people
living with HIV and their communities. We remain committed to working hand-in-hand with our partners in the global
HIV community to address the complex challenges that hinder continued progress toward ending the epidemic.
Gilead Forward-Looking Statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks,
uncertainties and other factors, including the risk that Gilead may not realize any anticipated benefits from this
collaboration; difficulties or unanticipated expenses in connection with the collaboration and the potential effects
on Gilead’s revenues and earnings; the ability of the companies to initiate and complete clinical trials involving
the combinations of lenacapavir and islatravir and other investigational oral integrase inhibitors in the
anticipated timelines or at all; the possibility of unfavorable results from ongoing and additional clinical trials,
including other Gilead trials involving lenacapavir; the ability of the companies to successfully co-develop and
co-commercialize long-acting HIV treatments; uncertainties relating to regulatory applications and related filing
and approval timelines, including the risk that regulatory authorities may not approve such applications in the
anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its
use; and the possibility that the companies may make a strategic decision to terminate this collaboration. These
risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other
risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2020, as filed
with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
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
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 the global outbreak of novel coronavirus disease (COVID-19); 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
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 2020 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).
Source: Merck & Co., Inc.