BASEL, Switzerland & BOSTON–(BUSINESS WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune
therapeutics company, and Lonza (SWX: LONN), an integrated healthcare
solutions provider, today announced that the companies have entered into
a strategic manufacturing agreement. The agreement provides for the
future commercial production after potential FDA approval of omidubicel,
Gamida Cell’s investigational advanced cell therapy currently in
clinical development designed to enhance the life-saving benefits of
hematopoietic stem cell (bone marrow) transplant. An international,
randomized Phase 3 study of omidubicel in patients with hematologic
malignancies is currently ongoing, and omidubicel has not yet been
approved for marketing in the United States or any other jurisdiction.
This agreement follows a successful multi-year clinical manufacturing
relationship and provides Gamida Cell with a path to commercial supply
of omidubicel. Under this multi-year agreement, Lonza will construct and
dedicate production suites at its Geleen, NL site, for the anticipated
commercial launch. Additionally, the agreement enables Gamida Cell to
increase the number of dedicated production suites over time to ensure
commercial supply. Gamida Cell also has the option of expanding further
into Lonza’s global cell and gene therapy manufacturing network.
“Gamida Cell and Lonza have had a strong relationship for the clinical
supply of omidubicel, and we are pleased to extend our relationship as
we prepare to potentially bring omidubicel to patients in a commercial
setting after potential FDA approval,” stated Julian Adams, chief
executive officer of Gamida Cell. “The ability to reliably provide an
advanced cellular therapy to patients is critical, and this agreement
provides Gamida Cell with access to a top-tier manufacturing site for
the long-term commercial supply of omidubicel after potential FDA
approval. Additionally, this agreement enables the supply of commercial
product as we plan for the build out of Gamida Cell’s own
commercial-scale cGMP manufacturing facility to augment production.”
“This agreement is an example of our long-term manufacturing partnership
capabilities and efforts to drive the industrialization of the cell
therapy industry. Our cell therapy experience and expertise will enable
us to best support Gamida Cell at this important phase in the
development of omidubicel,” said Alberto Santagostino, SVP, head of cell
& gene technologies at Lonza. “We seek to partner with such innovative
companies who are pioneering important new treatment options to patients
and look forward to enabling Gamida Cell to deliver omidubicel at a
commercial scale after potential FDA approval.”
About Lonza
Lonza is an integrated solutions provider that creates value along the
Healthcare Continuum®. Through our Pharma Biotech & Nutrition
segment and our Specialty Ingredients segment businesses, we harness
science and technology to serve markets along this continuum. We focus
on creating a healthy environment, promoting a healthier lifestyle and
preventing illness through consumers’ preventive healthcare, as well as
improving patient healthcare by supporting our customers to deliver
innovative medicines that help treat or even cure severe diseases.
Patients and consumers benefit from our ability to transfer our pharma
know-how to the healthcare, hygiene and fast-moving consumer goods
environment and to the preservation and protection of the world where we
live.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected
global company with more than 100 sites and offices and approximately
15,500 full-time employees worldwide at the end of 2018. The company
generated sales of CHF 5.5 billion in 2018 with a CORE EBITDA of CHF 1.5
billion. Further information can be found at www.lonza.com.
About Gamida Cell
Gamida Cell is a clinical-stage biopharmaceutical company committed to
developing advanced cell therapies with the potential to cure blood
cancers and rare, serious hematologic diseases. We are leveraging our
proprietary nicotinamide-based, or NAM-based, cell expansion technology
to develop product candidates designed to address the limitations of
cell therapies. For additional information, please visit www.gamida-cell.com.
About Omidubicel
Omidubicel (formerly known as NiCord®), the company’s lead
clinical program, is an advanced cell therapy under development as a
potential life-saving allogeneic hematopoietic stem cell (bone marrow)
transplant solution for patients with hematologic malignancies (blood
cancers). Omidubicel is the first bone marrow transplant product to
receive Breakthrough Therapy Designation from the U.S. Food and Drug
Administration and has also received Orphan Drug Designation in the U.S.
and EU. In a Phase 1/2 clinical study, omidubicel demonstrated rapid and
durable time to engraftment and was generally well-tolerated.1
A Phase 3 study evaluating omidubicel in patients with leukemia and
lymphoma is ongoing in the U.S., Europe and Asia.2 Omidubicel
is also being evaluated in a Phase 1/2 clinical study in patients with
severe aplastic anemia.3 The aplastic anemia investigational
new drug application is currently filed with the FDA under the brand
name CordIn®, which is the same investigational development
candidate as omidubicel. For more information on clinical trials of
omidubicel, please visit www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and efficacy
has not been evaluated by the U.S. Food and Drug Administration or any
other health authority.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements as that term is
defined in the Private Securities Litigation Reform Act of 1995,
including with respect to potential FDA approval of omidubicel and the
commercial production thereof, which statements are subject to a number
of risks, uncertainties and assumptions, including, but not limited to
the scope, progress, expansion and results of Gamida Cell’s clinical
trials, FDA review of the data generated thereby and Gamida Cell’s
ability to commercialize omidubicel following any potential FDA
approval. In light of these risks and uncertainties, and other risks and
uncertainties that are described in the Risk Factors section of Gamida
Cell’s public filing on Form 20-F, filed with the SEC on February 25,
2019, and other filings that Gamida Cell makes with the SEC from time to
time (which are available at http://www.sec.gov),
the events and circumstances discussed in such forward-looking
statements may not occur, and Gamida Cell’s actual results could differ
materially and adversely from those anticipated or implied thereby. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Gamida Cell as of the
date of this release.
_________________________
1 Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al.
Phase I/II study of stem-cell transplantation using a single cord blood
unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb
10;37(5):367-374.
2 ClinicalTrials.gov identifier
NCT02730299.
3 ClinicalTrials.gov identifier NCT03173937.
Contacts
Lonza:
Dirk Oehlers
Investor Relations Officer
Lonza
Group Ltd
Tel +41 61 316 8540
dirk.oehlers@lonza.com
Dr. Sanna Fowler
Head of Public Relations
Lonza Pharma
& Biotech
Tel +41 61 316 8929
sanna.fowler@lonza.com
Constance Ward
Head External Communications
Lonza Group
Ltd
Tel +41 61 316 8840
constance.ward@lonza.com
Gamida Cell:
Jaren Irene Madden
jaren@gamida-cell.com
1-617-286-6264
Krystle Gibbs (media)
krystle@tenbridgecommunications.com
508-479-6358