- Following positive Phase 1/2 results in
Vertex’s VX-880 program, Vertex and Lonza announce strategic
manufacturing collaboration -
- Dedicated large-scale facility will support
commercial production of Vertex’s T1D cell therapy portfolio -
- Approximately 300 new jobs anticipated at
Lonza Portsmouth, New Hampshire Site -
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and
Lonza (SIX: LONN) today announced a strategic collaboration to
support the manufacture of Vertex’s portfolio of investigational
stem cell-derived, fully differentiated insulin-producing islet
cell therapies for people with T1D, currently focusing on the
VX-880 and VX-264 programs that are currently in clinical
trials.
Vertex’s first clinical program, VX-880, has already
demonstrated clinical proof-of-concept. In new data released
last week, all six patients treated with VX-880 engrafted islet
cells, produced endogenous insulin (C-peptide), and had improved
glycemic control, while reducing or eliminating insulin use.
Patients with greater than 90 days of follow-up had elimination of
severe hypoglycemic events in the evaluation period.
Vertex’s second approach, VX-264, utilizes the same fully
differentiated insulin-producing islet cells as in VX-880 and is
being studied in a Phase 1/2 clinical trial. In VX-264, the cells
are encapsulated in a proprietary device designed to shield the
cells from the body’s immune system, thereby eliminating the need
for immunosuppression. In a third approach, Vertex’s hypoimmune
program, the same cells are edited to cloak them from the immune
system; this program continues to progress in preclinical
development.
Under the terms of the collaboration, Vertex and Lonza will
partner in the process development and scale-up for the
manufacturing of the product portfolio and co-invest to build a
dedicated new facility in Portsmouth, New Hampshire. Operated by
Lonza, the facility will span more than 130,000 square feet and is
anticipated to create up to 300 new jobs at peak capacity.
Construction is scheduled to begin later this year.
The dedicated facility will complement Lonza’s global cell and
gene technologies manufacturing network, which supports customers
in developing, de-risking, commercializing and scaling their
emerging therapies. Lonza’s scientific, regulatory and
manufacturing expertise, its focus on operational excellence, and
first-hand experience supporting the commercialization of marketed
cell therapy products is expected to accelerate the development and
commercialization of Vertex’s potentially transformative
therapies.
“Vertex’s allogeneic, fully differentiated, insulin-producing
islet cells and the results from the Phase 1/2 VX-880 program
represent a scientific breakthrough that offers the potential to
transform the treatment of T1D,” said Reshma Kewalramani, M.D.,
Chief Executive Officer and President of Vertex. “Establishing this
strategic partnership with Lonza, a world-class manufacturing
organization, is a critical milestone in this journey and
underscores our long-term commitment to patients with T1D.”
“Lonza has a strong history and established reputation for
applying cutting-edge development and manufacturing expertise to
enable the progression of exceptional scientific innovations like
those developed by Vertex,” said Pierre-Alain Ruffieux, Chief
Executive Officer of Lonza. “Vertex has made impressive progress
with its T1D cell therapy program, and we are proud to be the
company’s partner of choice in supporting its ambition to transform
the treatment landscape for this disease.”
About Vertex
Vertex is a global biotechnology company that invests in
scientific innovation to create transformative medicines for people
with serious diseases. The company has multiple approved medicines
that treat the underlying cause of cystic fibrosis (CF) — a rare,
life-threatening genetic disease — and has several ongoing clinical
and research programs in CF. Beyond CF, Vertex has a robust
clinical pipeline of investigational small molecule, mRNA, cell and
genetic therapies (including gene editing) in other serious
diseases where it has deep insight into causal human biology,
including sickle cell disease, beta thalassemia, APOL1-mediated
kidney disease, acute and neuropathic pain, type 1 diabetes and
alpha-1 antitrypsin deficiency.
Founded in 1989 in Cambridge, Mass., Vertex's global
headquarters is now located in Boston's Innovation District and its
international headquarters is in London. Additionally, the company
has research and development sites and commercial offices in North
America, Europe, Australia and Latin America. Vertex is
consistently recognized as one of the industry's top places to
work, including 13 consecutive years on Science magazine's Top
Employers list and one of Fortune’s 100 Best Companies to Work For.
For company updates and to learn more about Vertex's history of
innovation, visit www.vrtx.com or follow us on Facebook,
Twitter, LinkedIn, YouTube and Instagram.
(VRTX-GEN)
About Lonza
Lonza is a preferred global partner to the pharmaceutical,
biotech and nutrition markets. We work to enable a healthier world
by supporting our customers to deliver new and innovative medicines
that help treat a wide range of diseases. We achieve this by
combining technological insight with world-class manufacturing,
scientific expertise and process excellence. Our business is
structured to meet our customers' complex needs across four
divisions: Biologics, Small Molecules, Cell & Gene and Capsules
& Health Ingredients. Our unparalleled breadth of offerings
across divisions enables our customers to commercialize their
discoveries and innovations in the healthcare industry.
Founded in 1897 in the Swiss Alps, today, Lonza operates across
five continents. With approximately 17,500 full-time employees, we
comprise high-performing teams and individual talent who make a
meaningful difference to our own business, as well as to the
communities in which we operate. The company generated sales of CHF
6.2 billion with a CORE EBITDA of CHF 2.0 billion in Full-Year
2022. Find out more at www.lonza.com
Follow @Lonza on LinkedIn
Follow @LonzaGroup on Twitter
Vertex Special Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended, including, without limitation, statements by Reshma
Kewalramani, M.D. and Pierre-Alain Ruffieux in this press release,
our plans to build a manufacturing facility with our collaborators
to support clinical and commercial production of Vertex’s
investigational T1D cell therapy portfolio, anticipated benefits of
the collaboration with Lonza, including potential acceleration of
the development and commercialization of Vertex’s therapies,
expectations for the new manufacturing facility, including the
creation of up to 300 new jobs, plans and expectations for our T1D
programs, including study designs and potential benefits of our
products, and anticipated investments in the facility and
construction timelines. 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 risks
and uncertainties that could cause actual events or results to
differ materially from those expressed or implied by such
forward-looking statements. Those risks and uncertainties include,
among other things, that construction of the manufacturing facility
may be delayed, that data from a limited number of patients may not
be indicative of final clinical trial results, that data from the
company's development programs, including its programs with its
collaborators, may not support registration or further development
of its compounds due to safety and/or efficacy, or other reasons,
that internal or external factors could delay, divert, or change
our plans and objectives with respect to our research and
development programs, and other risks listed under the heading
“Risk Factors” in Vertex's most recent annual report and subsequent
quarterly reports filed with the Securities and Exchange Commission
(SEC) and available through the company's website at
www.vrtx.com and on the SEC’s website at www.sec.gov.
You should not place undue reliance on these statements or the
scientific data presented. Vertex disclaims any obligation to
update the information contained in this press release as new
information becomes available.
Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in Basel, Switzerland, and
is listed on the SIX Swiss Exchange. It has a secondary listing on
the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza
Group Ltd is not subject to the SGX-ST’s continuing listing
requirements but remains subject to Rules 217 and 751 of the SGX-ST
Listing Manual.
Certain matters discussed in this news release may constitute
forward-looking statements. These statements are based on current
expectations and estimates of Lonza Group Ltd, although Lonza Group
Ltd can give no assurance that these expectations and estimates
will be achieved. Investors are cautioned that all forward-looking
statements involve risks and uncertainty and are qualified in their
entirety. The actual results may differ materially in the future
from the forward-looking statements included in this news release
due to various factors. Furthermore, except as otherwise required
by law, Lonza Group Ltd disclaims any intention or obligation to
update the statements contained in this news release.
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version on businesswire.com: https://www.businesswire.com/news/home/20230626022835/en/
Vertex Investors: InvestorInfo@vrtx.com Susie
Lisa, CFA: +1 617-341-6108 or Manisha Pai: +1 617-961-1899 or
Miroslava Minkova: +1 617-341-6135
Media: mediainfo@vrtx.com or U.S.: +1 617-341-6992 or
Heather Nichols: +1 617-839-3607 or International: +44 20 3204
5275
Lonza Victoria Morgan Head of External
Communications Lonza Group Ltd Tel +41 61 316 2283
victoria.morgan@lonza.com
Lyle Wheeler Investor Relations Lonza Group Ltd Tel +41
79 154 9522 lyle.wheeler@lonza.com
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