LONDEN–(BUSINESS WIRE)– Theramex, een toonaangevend wereldwijd gespecialiseerd farmaceutisch bedrijf dat zich toelegt op de gezondheid van vrouwen, is een overeenkomst aangegaan met Enzene Biosciences Limited voor de ontwikkeling, registratie en commercialisering van een biosimilar van Roche’s referentiegeneesmiddel RoActemra® (Tocilizumab). Tocilizumab, in combinatie met Methotrexaat (MTX), is geïndiceerd voor de behandeling van reumatoïde artritis. Het is de bedoeling dat het vanaf 2026 op de markt wordt gebracht in Europa, het VK, Zwitserland en Australië.

Het product Tocilizumab van Theramex zal beschikbaar zijn in parenterale injectieflacons, subcutane voorgevulde spuiten en auto-injectoren. Het referentieproduct RoActemra® is geïndiceerd voor de behandeling van ernstige, actieve en progressieve reumatoïde artritis (RA) bij volwassenen die niet eerder zijn behandeld met methotrexaat; matige tot ernstige volwassen patiënten met RA die niet goed/intolerant hebben gereageerd op DMARD’s of anti-TNF’s; actieve systemische juveniele idiopathische artritis bij patiënten van 1 jaar en ouder die onvoldoende reageerden op eerdere therapie met NSAID’s en systemische corticosteroïden; juveniele idiopathische polyartritis bij patiënten van 2 jaar en ouder die niet reageren op MTX; behandeling van reuzencelarteritis bij volwassenen; en chimere antigeenreceptor (CAR) T-cel-geïnduceerd ernstig of levensbedreigend cytokine-afgiftesyndroom (CRS) bij volwassenen en pediatrische patiënten van 2 jaar en ouder.

Theramex Announces an Agreement with Enzene Biosciences Limited for the Development and Commercialisation of Tocilizumab, a Biosimilar for the Treatment of Rheumatoid Arthritis

LONDON–(BUSINESS WIRE)– Theramex, a leading global speciality pharmaceutical company dedicated to women’s health, has entered into an agreement with Enzene Biosciences Limited to develop, register and commercialise a biosimilar drug of Roche’s reference medicine RoActemra® (Tocilizumab). Tocilizumab, in combination with Methotrexate (MTX), is indicated for the treatment of rheumatoid arthritis. It is planned to be commercialised from 2026 in Europe, the UK, Switzerland, and Australia.

Theramex’s Tocilizumab product will be available in parenteral vials, subcutaneous prefilled syringes and autoinjectors. The reference product RoActemra® is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate; moderate to severe RA adult patients who have not responded well/intolerant to DMARDs or Anti-TNFs; active systemic juvenile idiopathic arthritis in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids; juvenile idiopathic polyarthritis in patients 2 years of age and older unresponsive to MTX; treatment of Giant Cell Arteritis in adults; and chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.

Rheumatoid arthritis is a chronic condition that causes pain, swelling and stiffness in the joints. The condition usually affects the hands, feet and wrists. There may be periods where symptoms become worse, known as flares. A flare can be difficult to predict, but with treatment it’s possible to decrease the number of flares and minimise or prevent long-term damage to the joints. Some people with rheumatoid arthritis also experience problems in other parts of the body, or more general symptoms such as tiredness and weight loss¹.

“Rheumatoid arthritis affects more women than men, so the addition of this biosimilar drug to our existing Rheumatology portfolio continues our strategic determination to improve access and affordability of important treatments for women. We are excited to expand our focus in Rheumatology to now include rheumatoid arthritis to help even more patients with bone diseases and joint pain”, said Theramex CEO Robert Stewart.

Dr. Himanshu Gadgil, Enzene’s Whole Time Director said, “The development of Enzene’s Tocilizumab, through our innovative efforts in the manufacturing of monoclonal antibodies, marks another highlight in a series of endeavours driven by our mission to provide affordable and expanded access to crucial medicines. Our partnership with Theramex bolsters our mission to bring affordable healthcare to patients across the world”.

About Theramex

Theramex is a leading global speciality pharmaceutical company dedicated to women and their health. We support women at every stage of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis. Our commitment is to listen to and understand our patients, serve their needs and offer healthcare solutions to help improve their lives. Our vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through every stage of life.

About Enzene Biosciences Ltd.

Enzene is an innovation-driven biotech company, a subsidiary of Alkem Laboratories Ltd. (One of the top five pharmaceutical companies in India*) located in Pune, India. Enzene’s focus lies in producing biosimilars, novel biologics, synthetic peptides and phytopharmaceuticals. Enzene also offers a range of biologics CDMO and CMO services.

(*as per the latest IQVIA data of MAT July 2021)

For more information on Enzene Biosciences Ltd., please visit www.enzene.com

For more information on Alkem Laboratories Ltd., please visit www.alkemlabs.com

¹ https://www.nhs.uk/conditions/rheumatoid-arthritis/

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Contacts

Theramex

Jesús López | Associate Director, Communication & Digital | Jesus.Lopez@Theramex.com

Enzene Biosciences Ltd.

For media enquiries,

Dr. Tarun Chawla

Head – Business Development & Business Operations

Enzene Biosciences Ltd.

For any further enquiries, please reach out to: bd@enzene.com