-Merck KGaA, Darmstadt, Germany licenses two
promising clinical-stage programs targeting DNA damage and repair,
and two novel pre-clinical programs-
-Vertex receives upfront payment of $230
million plus royalties on future sales-
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
announced that it has entered into a licensing agreement with Merck
KGaA, Darmstadt, Germany for the worldwide development and
commercialization of four promising research and development
programs that represent novel approaches to the treatment of
cancer. As part of the agreement, Merck KGaA, Darmstadt, Germany
will license two clinical-stage programs targeting DNA damage and
repair, along with two additional novel pre-clinical programs.
Vertex will receive an upfront payment of $230 million, in addition
to royalties on future net sales. Merck KGaA, Darmstadt, Germany
will assume full responsibility for the development and
commercialization of all the programs.
“The Vertex R&D team has produced a portfolio of
first-in-class compounds with the potential to enhance the therapy
of multiple cancers,” said Jeffrey Leiden, M.D., Ph.D, Chairman,
President and CEO of Vertex. “We are pleased to partner with Merck
KGaA, Darmstadt, Germany, a leader in oncology with exciting
complementary assets that will help fully realize the value of
these unique compounds and accelerate the programs' potential
benefits for patients.”
“With this strategic deal, we significantly strengthen our
oncology pipeline in two attractive areas where we have leading
competence, DNA damage and repair and immuno-oncology - areas which
also have promising therapeutic synergy,” said Belen Garijo, CEO
Healthcare and Member of the Executive Board of Merck KGaA,
Darmstadt, Germany. “This deal underscores our commitment to
accelerate innovation for cancer patients, and we are excited for
the opportunity to build on Vertex's rigorous science and advance
these leading programs.”
The two clinical-stage programs represent first-in-class
approaches to inhibit the DNA repair pathways that are fundamental
to the survival and proliferation of certain cancers:
- An ataxia telangiectasia and Rad3
related (ATR) protein kinase inhibitor program comprised of two
compounds, VX-970 and VX-803. VX-970 is being investigated broadly
through 10 ongoing Phase 1 and Phase 2 trials across a variety of
tumors and patient subtypes expected to be responsive to ATR
inhibition based on biomarker data. Preliminary VX-970 clinical
data were presented at the 2016 American Society of Clinical
Oncology (ASCO) Annual Meeting and the 2016 American Association
for Cancer Research (AACR) Annual Meeting. VX-803 is an orally
dosed ATR inhibitor currently in Phase 1 trials evaluating
escalating doses of VX-803 alone and in combination with
chemotherapy.
- A DNA-dependent protein kinase (DNA-PK)
inhibitor program including the clinical candidate VX-984. A Phase
1 trial is now evaluating escalating doses of VX-984 alone and in
combination with pegylated liposomal doxorubicin in subjects with
advanced solid tumors. Merck KGaA, Darmstadt, Germany will combine
these assets with its existing DNA-PK assets into a single
development program.
The pre-clinical programs include one immuno-oncology program
against an attractive target with first-in-class potential, and a
program against a completely novel target. For both of these
programs, Vertex research has demonstrated efficacy in relevant
pre-clinical models, including demonstration of combination
potential with immune checkpoint inhibition for the immuno-oncology
program. Merck KGaA, Darmstadt, Germany will continue to
characterize the Vertex compounds in these programs with the goal
of taking them forward into the clinic.
The strength of the oncology R&D program at Merck KGaA,
Darmstadt, Germany, including a leading presence in
immunotherapy and DNA damage and repair, demonstrates how the
company is re-imagining the way cancer can be
treated.
The collaboration, and the related $230 million upfront payment,
is subject to the expiration of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act.
About Vertex
Vertex is a global biotechnology company that aims to discover,
develop and commercialize innovative medicines so people with
serious diseases can lead better lives. In addition to our clinical
development programs focused on cystic fibrosis, Vertex has more
than a dozen ongoing research programs aimed at other serious and
life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research
and development sites and commercial offices in the United States,
Europe, Canada and Australia. For seven years in a row, Science
magazine has named Vertex one of its Top Employers in the life
sciences. For additional information and the latest updates from
the company, please visit www.vrtx.com.
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany is a leading science and
technology company in healthcare, life science and performance
materials. Around 50,000 employees work to further develop
technologies that improve and enhance life – from biopharmaceutical
therapies to treat cancer or multiple sclerosis, cutting-edge
systems for scientific research and production, to liquid crystals
for smartphones and LCD televisions. In 2015, Merck KGaA,
Darmstadt, Germany generated sales of €12.85 billion in 66
countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany is the world's
oldest pharmaceutical and chemical company. The founding family
remains the majority owner of the publicly listed corporate group.
Merck KGaA, Darmstadt, Germany holds the global rights to the Merck
KGaA, Darmstadt, Germany name and brand. The only exceptions are
the United States and Canada, where the company operates as EMD
Serono, MilliporeSigma and EMD Performance Materials.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995,
including, without limitation, the statements in the second and
third paragraph of the press release and statements regarding (i)
the upfront payment, which is subject to the expiration of the
waiting period under the Hart-Scott-Rodino Antitrust Improvements
Act, and (ii) potential royalty payments. While Vertex believes the
forward-looking statements contained in this press release are
accurate, these forward-looking statements represent the company's
beliefs only as of the date of this press release and there are a
number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These risks and uncertainties include, among other things, the
risks listed under Risk Factors in Vertex's annual report and
quarterly reports filed with the Securities and Exchange Commission
and available through the company's website at www.vrtx.com. Vertex
disclaims any obligation to update the information contained in
this press release as new information becomes available.
(VRTX-GEN)
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Vertex Pharmaceuticals
IncorporatedInvestors:Michael Partridge,
617-341-6108orEric Rojas, 617-961-7205orZach Barber,
617-341-6470orMedia: mediainfo@vrtx.comNorth
America:Heather Nichols, +1
617-839-3607orEurope & Australia:Megan Goulart, +44
20 3204 5275
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