Collaboration Aims to Maximize the Potential
of PARP and MEK Inhibitors in Combination with PD-L1/PD-1
Medicines, Based on Growing Scientific Evidence That These
Combinations Offer New Potential for the Treatment of a Range of
Tumor Types
AstraZeneca and Merck Will Independently
Develop and Commercialize LYNPARZA and Potential Medicine
Selumetinib in Combinations with Companies’ Respective PD-L1/PD-1
Immuno-Oncology Medicines IMFINZI and KEYTRUDA
Collaboration Will Significantly Expand the
Potential of LYNPARZA, the World’s First and Leading PARP
Inhibitor, as a Monotherapy and as a Backbone of Combination
Treatments for Multiple Cancer Types; Agreement Also Includes
AstraZeneca’s Selumetinib, a MEK inhibitor
The Companies Will Share Development and
Marketing Costs Equally, as well as Gross Profits from LYNPARZA and
Selumetinib
AstraZeneca and Merck & Co., Inc., (NYSE: MRK), known as MSD
outside of the United States and Canada, today announced that they
have entered a global strategic oncology collaboration to
co-develop and co-commercialize AstraZeneca’s LYNPARZA (olaparib)
for multiple cancer types. LYNPARZA is an innovative,
first-in-class oral poly ADP ribose polymerase (PARP)
inhibitor currently approved for BRCA-mutated ovarian cancer in
multiple lines of treatment.
LYNPARZA’s pipeline has grown significantly in the last few
years, with 14 indications currently being developed across several
tumor types, including breast, prostate and pancreatic cancers. The
strategic collaboration is expected to further increase the number
of treatment options available to patients.
The companies will develop and commercialize LYNPARZA jointly,
both as monotherapy and in combination trials with other potential
medicines. Independently, the companies will develop and
commercialize LYNPARZA in combinations with their respective PD-L1
and PD-1 medicines, IMFINZI (durvalumab) and KEYTRUDA
(pembrolizumab).
The companies will also jointly develop and commercialize
AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of
MEK, part of the mitogen-activated protein kinase (MAPK) pathway,
currently being developed for multiple indications including
thyroid cancer.
Pascal Soriot, chief executive officer of AstraZeneca, said:
“Our strategic collaboration builds on scientific evidence that
PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors
for a range of tumors. By bringing together the expertise of two
leading oncology innovators, we will accelerate LYNPARZA’s
potential to become the preferred backbone of many immuno-oncology
combination therapies as the world’s first and leading PARP
inhibitor. This is a truly exciting step and we are pleased to work
with Merck, a company that shares our passion for science to
deliver new medicines for cancer patients.”
Kenneth C. Frazier, chief executive officer of Merck, said:
“This global collaboration between AstraZeneca and Merck, two
oncology leaders, will increase the possibilities for patients to
have more treatment options for more cancers. Merck continues to
build its leadership in immuno-oncology with KEYTRUDA as
foundational in monotherapy and combination therapy, and this
collaboration expands our oncology leadership into the growing
targeted therapies of PARP and MEK inhibitors. We look forward to
working with AstraZeneca to create greater value for patients and
shareholders than if both companies worked independently.”
Financial considerationsUnder the terms of the agreement,
AstraZeneca and Merck will share the development and
commercialization costs for LYNPARZA and selumetinib monotherapy
and non-PD-L1/PD-1 combination therapy opportunities. Gross profits
from LYNPARZA and selumetinib product sales generated through
monotherapies or combination therapies will be shared equally.
Merck will fund all development and commercialization costs of
KEYTRUDA in combination with LYNPARZA or selumetinib. AstraZeneca
will fund all development and commercialization costs of IMFINZI in
combination with LYNPARZA or selumetinib.
AstraZeneca will continue to manufacture LYNPARZA and
selumetinib.
As part of the agreement, Merck will pay AstraZeneca up to $8.5
billion in total consideration, including $1.6 billion upfront,
$750 million for certain license options and up to an additional
$6.15 billion contingent upon successful achievement of future
regulatory and sales milestones.
Merck expects to book its share of product sales of LYNPARZA and
selumetinib, net of commercialization costs, as Alliance Revenue
and its share of development costs associated with the
collaboration as part of its Research & Development
expense.
The collaboration agreement was completed upon signing on July
26, 2017.
About LYNPARZALYNPARZA (olaparib) is an innovative,
first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor
that may exploit tumour DDR pathway deficiencies to preferentially
kill cancer cells. LYNPARZA is the foundation of AstraZeneca’s
industry-leading portfolio of potential new medicines that target
DDR mechanisms in cancer cells. LYNPARZA is currently approved by
regulatory health authorities in the EU for use as monotherapy for
the maintenance treatment of adult patients with
platinum-sensitive, relapsed BRCA-mutated (germline and/or
somatic), high-grade serous epithelial ovarian, fallopian tube or
primary peritoneal cancer, who are in response (complete or
partial) to platinum-based chemotherapy. It is also approved in the
US as a monotherapy for patients with deleterious, or suspected
deleterious, germline BRCA-mutated (as detected by a US FDA test)
advanced ovarian cancer, who have been treated with three or more
lines of chemotherapy.
The Company recently presented positive results for LYNPARZA
from its Phase III OlympiAD trial that showed a
statistically-significant and clinically-meaningful improvement in
progression-free survival for patients treated with LYNPARZA
tablets (300mg twice daily), compared to treatment with physician’s
choice of a standard of care chemotherapy. OlympiAD, a randomised,
open label, multi-centre Phase III trial assessing the efficacy and
safety of LYNPARZA in patients with HER2-negative metastatic breast
cancer with germline BRCA1 or BRCA2 mutations, which are predicted
or suspected to be deleterious, was the first positive Phase III
trial to evaluate the efficacy and safety of PARP inhibitor beyond
ovarian cancer. LYNPARZA is currently being investigated in another
separate non-metastatic breast cancer Phase III trial called
OLYMPIA. This trial is still open and recruiting patients
internationally.
LYNPARZA generated Product Sales in 2016 of $218 million.
About SelumetinibSelumetinib, licensed by AstraZeneca
from Array BioPharma Inc. in 2003, inhibits the MEK enzyme in the
RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumour from
growing. Selumetinib is in Phase III development for differentiated
thyroid cancer, for which it was granted Orphan Drug Designation by
the FDA in May 2016.
Selumetinib is also being tested in a separate Phase II trial in
patients with paediatric neurofibromatosis type-1, and in a Phase I
trial with patients suffering from advanced solid tumours.
Merck’s Focus on CancerOur goal is to translate
breakthrough science into innovative oncology medicines to help
people with cancer worldwide. At Merck, helping people fight cancer
is our passion and supporting accessibility to our cancer medicines
is our commitment. Our focus is on pursuing research in
immuno-oncology and we are accelerating every step in the journey –
from lab to clinic – to potentially bring new hope to people with
cancer.
As part of our focus on cancer, Merck is committed to exploring
the potential of immuno-oncology with one of the fastest-growing
development programs in the industry. We are currently executing an
expansive research program that includes more than 500 clinical
trials evaluating our anti-PD-1 therapy across more than 30 tumor
types. We also continue to strengthen our immuno-oncology portfolio
through strategic acquisitions and are prioritizing the development
of several promising immunotherapeutic candidates with the
potential to improve the treatment of advanced cancers.
For more information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About MerckFor 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., USAThis 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).
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Merck & Co., Inc.Media Contacts:Tracy Ogden,
908-740-1747orPamela Eisele, 267-305-3558orInvestor Contacts:Teri
Loxam, 908-740-1986orAmy Klug, 908-740-1898
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