Abzena and UGA Biopharma Partner to Develop a Cell Line Expressing a Biosimilar Therapeutic for Multiple Sclerosis

Abzena plc (AIM: ABZA, 'Abzena' or the 'Group'), the life sciences group providing integrated solutions and technologies enabling the development and manufacture of biopharmaceutical products, and UGA Biopharma GmbH, a cell line development specialist, announce the completion of the development of a biosimilar cell line to treat Multiple Sclerosis (MS).

The partnership centred around the development of an NS0 (murine myeloma) manufacturing cell line, expressing a high quality, fully biosimilar antibody therapeutic. The cell line was developed and validated using Abzena’s integrated expert knowledge in cell line development and bioanalytics and was guided by UGA Biopharma’s in-depth knowledge and experience in the development of cell lines for biosimilar drugs.

UGA will join an expanding field of companies looking to capitalise on the patent expiry of several blockbuster drugs over the coming years.

The originator therapeutic is undisclosed but it is currently being used in the treatment of MS. It had worldwide sales of approximately $1.9bn in 2016.

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Notes to Editors

About Multiple Sclerosis (MS)

MS is a chronic condition where the sheath covering nerve fibres in the brain and spinal cord becomes damaged, slowing or blocking electrical signals from the brain reaching the eyes, muscles and other parts of the body. It affects approximately 2.3 million people worldwide. In the UK, there were 127,000 people with MS in 2010 and that number has been growing by around 2.4% per year, due to people with MS living longer. In the US, there are in excess of 400,000 people with MS and this rate is growing by 2.6% per annum.

About Abzena

Abzena (AIM: ABZA) provides proprietary technologies and complementary services to enable the development and manufacture of biopharmaceutical products.

The term ‘ABZENA Inside’ is used by Abzena to describe products that have been created using its proprietary technologies and are being developed by its partners, and include Composite Human Antibodies™ and ThioBridge™ Antibody Drug Conjugates (ADCs). Abzena has the potential to earn future licence fees, milestone payments and/or royalties on ‘ABZENA Inside’ products.

Abzena offers the following services and technologies across its principal sites in Cambridge (UK), San Diego, California (USA) and Bristol, Pennsylvania (USA):

• Immunology research studies, including immunogenicity assessment of candidate biopharmaceutical products;
• Protein engineering to create humanized antibodies and deimmunised therapeutic proteins;
• Cell line development for the manufacture of recombinant proteins and antibodies;
• Contract process development and GMP manufacture of biopharmaceuticals, including monoclonal antibodies and recombinant proteins for preclinical and clinical studies;
• Contract synthetic chemistry and bioconjugation research services, focused on antibody-drug conjugates (ADCs);
• Proprietary site-specific conjugation technologies and novel payloads for ADC development; and
• GMP manufacturer of ADC linkers, payloads & combined linker-payloads.

For more information, please see www.abzena.com

About UGA Biopharma

UGA Biopharma is a Germany-based, full contract service R&D provider in the field of mammalian cell line development. UGA` s proven core expertise is the development of cell lines for biosimilar and biotherapeutic manufacturing. The UGA offering includes:

SERVICES:

• Cell line development of research cell banks for pharmaceutical manufacturing (different CHO host cell lines available)
• Upstream process development (USP) and downstream process development (DSP)
• Contract analytical service
• Tech transfer and process implementation consulting
• Training in cell line development and culture techniques

PRODUCTS:

• Ready-to-use research cell banks for biosimilar manufacturing including fermentation, DSP and analytical-method protocols
• New cost-effective and GMP-compliant cell-culture basal media for high yields (chemically defined, suitable for biopharma production) - free test sample available; feed A and B in development, launch expected in Q3/2017
• Proprietary CHO host cell line, expression vectors and CHO mock cell lines available for out-licensing

For more information, please see www.ugabiopharma.com

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Abzena plcJohn Burt, Chief Executive OfficerorJulian Smith, Chief Financial Officer[phone]orInstinctif PartnersMelanie Toyne Sewell / Alex Shaw[phone] Biopharma GmbHLars Kober,Chief Executive Officer[phone]