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Lonza Group Ltd.. (6/19/19). "Press Release: Gamida Cell and Lonza Establish Commercial Manufacturing Agreement for Omidubicel". Basel & Boston, MA.

Region Region Geleen (Gelaen)
  Country Netherlands
Organisations Organisation Lonza Group AG (SWX: LONN)
  Today Lonza Group (Group)
  Group Lonza Group (Group)
  Organisation 2 Gamida Cell Ltd. (Nasdaq: GMDA)
Products Product contract manufacturing (biologicals)
  Product 2 Omidubicel cell therapy (formerly NiCord®)
Index term Index term Gamida Cell–Lonza: cell therapy contract manufacturing, 201906– supply multi-year future commercial production of omidubicel by Lonza in Geleen (NL)
Persons Person Santagostino, Alberto (Lonza 201906 SVP Head of Cell + Gene Technologies at Lonza Pharma + Biotech)
  Person 2 Adams, Julian (Gamida Cell 201906 CEO)
     


> Strategic manufacturing agreement is signed for the future commercial production of omidubicel, a Phase 3 investigational advanced cell therapy designed to enhance the life-saving benefits of hematopoietic stem cell (bone marrow) transplant

> The 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 for anticipated commercial launch


Quote from Alberto Santagostino, SVP Head of Cell & Gene Technologies, Lonza Pharma & Biotech:
“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. We seek to partner with such innovative companies who are pioneering important new treatment options for patients, and we look forward to enabling Gamida Cell to deliver omidubicel at a commercial scale after potential FDA approval.”

Quote from Julian Adams, Chief Executive Officer, Gamida Cell:
“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. 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.”


Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, and Lonza (SWX: LONN) 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 Phase 3 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.


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.


Lonza Contact Details

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 Contact Details

Jaren Irene Madden
Tel +1 617 286 6264
jaren@gamida-cell.com

Krystle Gibbs (media)
Tel +1 508 479 6358
krystle@tenbridgecommunications.com


1Horwitz 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. 2ClinicalTrials.gov identifier NCT02730299. 3ClinicalTrials.gov identifier NCT03173937.


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.


Lonza Group Ltd¦ Muenchensteinerstrasse 38 ¦CH-4002 Basel ¦Switzerland +41 61 316 81 11 ¦ www.lonza.com ¦ media@lonza.com

   
Record changed: 2019-06-25

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