Xbrane and STADA partner with Bausch + Lomb for commercialization of Xlucane in the United States and Canada

Corporate Information English IR mfn-ci-other mfn-regulatory-mar Press Release Regulatory
  • Xbrane Biopharma AB (publ) (”Xbrane” or the "Company”) (Nasdaq Stockholm: XBRANE) and STADA Arzneimittel AG (STADA) license to Bausch + Lomb the US and Canadian commercial rights to Xlucane, a Lucentis® biosimilar candidate the companies are co-developing.
  • Bausch + Lomb will pay a license fee consisting of a mid single-digit million USD up-front payment and milestones subject to regulatory approval and launch and then share gross profits from sales.
  • Xbrane and STADA will share all proceeds received from Bausch + Lomb 50/50.

Xbrane, a leading Nordic biosimilar developer, and its co-development partner STADA, a European generics, biosimilar and healthcare specialist, has entered into an exclusive licensing agreement with Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC), to commercialize Xlucane, a Lucentis® (ranibizumab) biosimilar candidate, in the United States and Canada. The companies aim to obtain regulatory approval of all currently approved indications for Lucentis® in both the United States and Canada.

STADA and Xbrane will be jointly responsible for finalizing development in the United States and Canada. Xbrane will also provide commercial supply. Bausch + Lomb will be responsible for the sales, marketing and all other commercialization efforts for the biosimilar candidate in the United States and Canada following regulatory approval.

“We continue to make good progress in developing Xlucane for North American markets. Bausch + Lomb has a very strong brand recognition and reputation amongst ophthalmologists and an existing sales infrastructure to leverage. We are excited to finalize the final steps towards marketing approval and together with our partners, bring the product to patients with severe eye diseases in dire need for cost efficient VEGFa inhibitors in the United States and Canada,” said Martin Åmark, CEO of Xbrane Biopharma.

“We are convinced that biosimilar ranibizumab has strong commercial potential in North America,” explained STADA CEO Peter Goldschmidt. “With its deep relationships with eye care professionals in North America, and an effective salesforce already in place to promote their comprehensive Pharmaceuticals portfolio, we believe that Bausch + Lomb is the ideal partner to broaden access to this ophthalmic treatment in North America.”

“Through this agreement with STADA and Xbrane, we will be able to leverage our extensive expertise and heritage in the North American ophthalmic market,” said Yolande Barnard, vice president and general manager, U.S. Pharmaceuticals, Bausch + Lomb. “We believe that, once approved, this biosimilar ranibizumab candidate will be an excellent addition to our comprehensive eye health portfolio and further deliver on our commitment of continuing to expand and improve upon our ophthalmic portfolio for our customers and their patients.”

Under the terms of the licensing agreement, Bausch + Lomb will make a mid-single digit million USD up-front payment and will pay further milestone payments subject to approval and launch of the product in the United States. Xbrane and STADA will also be entitled to a share of gross profits from sales of the product by Bausch + Lomb. Xbrane and STADA will share equally in the proceeds they receive from Bausch + Lomb.

About Xbrane Biopharma
Xbrane Biopharma AB develops biological drugs based on a platform technology that provides significantly lower production costs compared to competing systems. Xbrane’s leading product Xlucane, a Lucentis® biosimilar candidate, addresses the €10.4b ophthalmic VEGFa inhibitor market. Xlucane is in phase III and launch is expected mid-2022. Xbrane has additionally four biosimilars in its pipeline targeting €8.7b in originator sales. Xbrane’s head office is in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE. For more information, visit www.xbrane.com.

About Bausch + Lomb
Bausch + Lomb, a Bausch Health Companies Inc. company, is a leading global eye health organization that is solely focused on helping people see. Its core businesses include over-the-counter products, dietary supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures and markets one of the most comprehensive product portfolios in the industry, which is available in approximately 100 countries. For more information, visit www.bausch.com.

About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a two pillar strategy consisting of generics, including specialty pharmaceuticals and non-prescription consumer health products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2019, STADA achieved adjusted Group sales of EUR 2,608.6 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 625.5 million. As of December 31, 2019, STADA employed 11,100 people worldwide. For more information, visit www.stada.com.

Contact information for journalists:

Xbrane
Martin Åmark, CEO/ IR 
M: +46 (0) 763-093 777
E: martin.amark@xbrane.com

Susanna Helgesen, CFO
M: +46 (0) 708-278 636
E: susanna.helgesen@xbrane.com

Bausch + Lomb
Media Contacts
Sam Ewing
M: +1 (917) 415-3842
E: sam.ewing@zenogroup.com

STADA
STADA Arzneimittel AG
Media Relations
Stadastrasse 2-18
61118 Bad Vilbel – Germany
T: +49 (0) 6101 603-165
E: press@stada.de
www.stada.com/press

Contact information for capital market participants:
STADA Arzneimittel AG
Investor & Creditor Relations
Stadastrasse 2-18
61118 Bad Vilbel – Germany
T: +49 (0) 6101 603-4689
E: ir@stada.de
www.stada.com/press