STADA is awarded as one out of two suppliers of ranibizumab in an NHS England Framework Agreement.
Via a strategic partnership, STADA and Xbrane co-developed Ximluci ranibizumab biosimilar; Xbrane is responsible for product supply, STADA for commercialization. Biosimilar competition on ranibizumab has the potential to broaden patient access and create significant savings for the NHS in England.
Bad Vilbel; Solna -STADA och Xbrane Biopharma AB (Nasdaq Stockholm: XBRANE) are now supplying Ximluci (ranibizumab biosimilar) in England via a National Health Service (NHS) England Framework Agreement.
Partners STADA and Xbrane announced in January 2023 1) that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) had granted a marketing authorization for Ximluci (ranibizumab), a biosimilar referencing Lucentis. Under the co-development agreement in operation since 2018, STADA is responsible for commercializing Ximluci across Europe, while Xbrane is responsible for commercial supply of the product. The parties are sharing profits generated from sales of the product equally. In early April 2023, the partners announced the launch of Ximluci in several European countries 2).
Ximluci is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders, including wet age-related macular degeneration (wet AMD), diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in adults.
According to the UK's Macular Society, nearly 1.5 million people in the UK have macular disease, of which age-related macular degeneration is the most common condition, generally present in people aged over 55. AMD is the biggest cause of sight loss in the UK, affecting more than 600,000 people 3).
STADA's UK affiliate Thornton and Ross is one two companies awarded in NHS Framework Agreement 4) that covers a substantial portion of clinical demand for ranibizumab in England. While the nominal total value of this supply contract, which runs from 1 April 2023 to 31 March 2024, is GBP70 million (EUR79 million), the actual value to STADA and Xbrane will depend on multiple factors, including the ability to capture share within the market segment covered by the Framework Agreement.
'Supplying ranibizumab to the NHS represents a further opportunity for STADA to improve patient access through competition on specialty medicines, and thereby deliver on our purpose of Caring for People's Health as a Trusted Partner,' commented STADA's Global Head of Specialty, Bryan Kim.
'We are proud of our partner STADA being awarded as supplier under this important framework agreement. Ximluci will, during the coming 12 months, generate significant savings to the UK healthcare system and broaden accessibility to patients,' stated Martin Amark, Xbrane CEO.
NHS Framework Agreement for the supply of Ranibizumab for the NHS in England - Contracts Finder
STADA and Xbrane obtain British approval for Ximluci (ranibizumab) biosimilar referencing Lucentis
STADA & Xbrane launch ranibizumab to support patient access | STADA
Macular conditions - Macular Society
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2022, STADA achieved group sales of EUR 3,797.2 million and reported earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 884.7 million. As of 31 December 2022, STADA employed 13,183 people worldwide.
Contact:
Martin Amark
Email: IR@xbrane.com
Tel: +46 (0) 763-093 777
About Us
Xbrane Biopharma AB develops biological drugs based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane has a portfolio of biosimilar candidates targeting EUR 53 billion in estimated annual peak sales of the respective reference product. The lead candidate Ximluci is granted market authorization approval in Europe and was launched during the first quarter 2023. Xbrane's head office is in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE.
XBRANE BIOPHARMA AB 
