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CAMBIUM BIO LIMITED — Capital/Financing Update 2014
Jan 21, 2014
64666_rns_2014-01-21_555bd589-02ba-4a2b-8489-b53a55088b9c.pdf
Capital/Financing Update
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PRESS RELEASE
Regeneus partners with Lonza for manufacturing CryoShot Canine cell therapy product for US FDA trial
Sydney, Australia – 22 January 2014
Regenerative medicine company, Regeneus (ASX: RGS), announced today that Lonza, the world’s largest manufacturer of stem cells will manufacture Regeneus’ off-the-shelf cell therapy, CryoShot® Canine, for registration in the US.
“It is very exciting to be partnering with Lonza, a global manufacturer with specialist experience in manufacturing stem cells to the quality standards that the US and European regulators require for product registration”, said Dr Duncan Thomson, Head of Veterinary Health at Regeneus. “We view this as the start of a long-term relationship in which Lonza will manufacture CryoShot for the world wide canine market. Our clinical trial work in Australia has been rewarding and it is now time to begin registration of the CryoShot product in the US and European markets.”
The cells will be manufactured at the Lonza facility in Walkersville, Maryland and then distributed to the participating trial veterinarian clinics.
CryoShot Canine is an off-the-shelf allogeneic cell therapy product for the treatment of musculoskeletal conditions in dogs and is currently under pre-registration trial in Australia. The cell therapy is produced from a small amount of adipose (fat) tissue derived from a donor animal. The tissue is processed and cultured to isolate and increase the regenerative cells before being cryogenically frozen and stored in liquid nitrogen. It is delivered to veterinary clinics cryogenically frozen and then thawed for injection by the treating veterinarian.
This follows the Regeneus company announcement on 14 November 2013 that Regeneus can proceed with the commercialisation of its novel canine cancer vaccine in the USA.
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Media contact:
Clare Serafini Communications Manager, Regeneus Ltd T: +61 2 9499 8010
M: +61 (0)417 299 081 E: [email protected] or visit: www.regeneus.com.au
Investor contact:
Sandra McIntosh Company Secretary T: +61 2 9499 8010 E: [email protected]
77 Ridge Street, Gordon, NSW 2072 • PO Box 20, Gordon, NSW 2072 Ph: +61 2 9499 8010 • Fax: +61 2 9499 8020 • www.regeneus.com.au • ABN 13 127 035 358
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About Regeneus:
Regeneus (ASX: RGS) is an Australian regenerative medicine company that develops and commercialises innovative cell-based therapies using its proprietary cell technologies with a focus on treating musculoskeletal, oncology and other inflammatory conditions in humans and animals.
About Lonza:
Founded in 1897 in the Swiss Alps, Lonza today is one of the world’s leading life sciences companies. Lonza harnesses science and technology to create products that make people’s lives safer and healthier and that enhance the overall quality of life and well-being. The products range from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from Vitamin B compounds and other nutritional ingredients to the custom development of agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Lonza today is a truly global company, with more than 40 manufacturing and R&D facilities and 10,000 employees worldwide. The company is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients. The core competencies that span these segments are advanced manufacturing and quality control systems, superior regulatory expertise, in-depth market knowledge, and extensive technical customer-support and R&D capabilities.
LONZA GROUP AG-REG LONN: SIX Swiss Ex
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77 Ridge Street, Gordon, NSW 2072 • PO Box 20, Gordon, NSW 2072 Ph: +61 2 9499 8010 • Fax: +61 2 9499 8020 • www.regeneus.com.au • ABN 13 127 035 358