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 £70 million (€79 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 Åmark, Xbrane CEO.

1) NHS Framework Agreement for the supply of Ranibizumab for the NHS in England - Contracts Finder
2) STADA and Xbrane obtain British approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis®
3) STADA & Xbrane launch ranibizumab to support patient access | STADA
4) 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.


STADA information for journalists:
STADA Arzneimittel AG - Media Relations
Stadastrasse 2-18, 61118 Bad Vilbel - Germany
Phone: +49 (0) 6101 603-165
E-Mail: press@stada.de
Or visit us on the Internet at www.stada.com/press
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STADA information for capital market participants:
STADA Arzneimittel AG - Investor & Creditor Relations
Stadastrasse 2-18, 61118 Bad Vilbel – Germany
Phone: +49 (0) 6101 603-4689
Fax: +49 (0) 6101 603-215
E-mail: ir@stada.de
Or visit us on the Internet at www.stada.com/investor-relations

Xbrane Investor and Media Contact:
Martin Åmark
IR@xbrane.com
Phone: +46 (0) 763-093 777