Theramex UK Ltd announces a license and supply agreement with Enzene Biosciences Limited, for the registration and commercialisation of denosumab, an antiresorptive treatment for osteoporosis, a biosimilar of reference medicine Prolia®, in Europe, the UK, Switzerland, and Australia

FOR MEDICAL BUSINESS/INDUSTRY TRADE MEDIA ONLY

London, 10th June 2021:  Theramex, a leading global speciality pharmaceutical company dedicated to women and their health, announced that it has entered into an agreement to register and commercialise denosumab from Enzene Biosciences Limited, Pune, India, for use in Europe, the UK, Switzerland, and Australia. Denosumab, a biosimilar of the reference medicine Prolia ^®, is an antiresorptive treatment for osteoporosis with sales in these markets of close to €1 billion⁹ in 2020.  Enzene will exclusively supply the finished product to Theramex for the duration of the agreement.

Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone. Denosumab is administered by a single subcutaneous injection once every six months.

Robert Stewart, Chief Executive Officer at Theramex said, “The addition of this biosimilar to our existing portfolio continues our strategic determination to improve access and affordability of important treatments to patients. The care and good management of bone health is critical to Theramex. From our recently launched Vitamin D small gel capsule that is easy to take, to our a gastric resistant third-generation bisphosphonate that allows patients to take their medication with or without food, and our cost-efficient teriparatide biosimilar with an easy to use pre-filled syringe, we are helping to improve the quality of life for women.”

Himanshu Gadgil, Whole-Time Director at Enzene said, “Enzene is dedicated to the development of affordable treatment options for patients. As such, I am delighted that Enzene and Theramex will be working together to provide women in Europe, the UK, Switzerland, and Australia with access to denosumab, a biosimilar treatment for osteoporosis.”

About Theramex

With a broad portfolio of innovative and established brands covering contraception, fertility, Menopause and Osteoporosis, we support women at every stage of their lives. Our commitment is to listen 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 innovative and effective solutions that care for and support women as they advance through each stage of their lives.

About Enzene Biosciences Limited

Enzene, a subsidiary of Alkem Laboratories Ltd., is an innovation driven biotech company. Based in Pune, India. Its focus lies in producing biosimilars, novel biologics, synthetic peptides and phytopharmaceuticals, using innovative manufacturing technologies, with an aim to disrupt the cost barrier. Enzene also offers a range of CDMO and CMO services for biologics.

Notes to Editor: About osteoporosis

Osteoporosis remains largely underdiagnosed and undertreated, resulting in a large number of fractures.

• It is a significant health issue – affecting ~200 million people worldwide²
• Osteoporosis affects more women than men and risk increases with age³
• After the menopause women start to lose bone at a faster rate, raising the risk for women who have had an early menopause or hysterectomy³
• One in three women aged over 50 will suffer a fragility fracture⁴
• Up to a third of patients treated with bisphosphonates (one in three) take their bisphosphonate with food, which may increase fracture risk¹
• Hip, spine and wrist fractures are the most common fractures, which have a debilitating impact on daily activities and quality of life⁴ 
• After a spine fracture mortality decreased over a 5-year period by up to 16% per year⁵
• Vertebral fractures can lead to back pain, loss of height, deformity, immobility, QoL, and activities of daily living^6,7,8

Contact:

For Theramex: Andrew Bradley, Head of Communications andrew.bradley@theramex.com / +44 (0)7864 167962 www.theramex.com

For Enzene Biosciences Ltd: Dr. Tarun Chawla, Head of Business Development bd@enzene.com www.enzene.com / www.alkemlabs.com

References:

1. Vytrisalova et al CLIMACTERIC 2015;18:608–616
2. Noh JY, Yang Y and Jung H. Molecular mechanisms and emerging therapeutics for osteoporosis. Int J Mol Sci. 2020; 21, 7623 DOI: 10.3390/ijms21207623
3. IOF. Risk Factors. https://www.osteoporosis.foundation/patients/about-osteoporosis/risk-factors Last accessed: April 2021
4. IOF Compendium of Osteoporosis. 25^th September 2019. www.osteoporosis.foundation/sites/iofbonehealth/files/2020-01/IOF-Compendium-of-Osteoporosis-web-V02.pdf Last accessed: April 2021
5. Johnell O et al. Mortality After Osteoporosis Fractures. Osteoporos Int 15, 38-42 (2004)
6. Nevitt MC et al. (1998), Ann Intern Med 128:793.
7. Lips P et al  (1999), Osteoporos Int 10:150.
8. Tosteson AN et al , (2001), Osteoporos Int 12:1042
9. 2020 MIDAS sales figures Q1-Q4