Bausch + Lomb licenses exclusive rights from STADA and Xbrane to a biosimilar candidate for Lucentis (ranibizumab) in the United States and Canada
BRIDGEWATER, NJ., BAD VILBEL, Germany, and SOLNA, Stockholm, May 06, 2020 - Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC), has entered into an exclusive licensing agreement with STADA Arzneimittel AG and its development partner, Xbrane Biopharma AB, a leading Nordic biosimilar developer (Nasdaq Stockholm: XBRANE), to commercialize in the United States and Canada a biosimilar candidate to Lucentis (ranibizumab) that is currently in development. The companies aim to obtain all currently approved indications for Lucentis in both the United States and Canada.
European generics and consumer healthcare leader STADA and Xbrane will be jointly responsible for finalizing development of the biosimilar, currently known as Xlucane. 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.
"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."
"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."
"We continue to make good progress in developing biosimilar ranibizumab 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.
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. STADA and Xbrane will also be entitled to a share of gross profits from sales of the product by Bausch + Lomb, and will share equally in the proceeds they receive from Bausch + Lomb.
About Bausch + Lomb
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., 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.
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 EUR10.4b ophthalmic VEGFa inhibitor market. Xlucane is in phase III development. Xbrane has additionally four biosimilars in its pipeline targeting EUR8.7b in originator sales. Xbrane's head office is in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE. For further information, please visit www.xbrane.com.
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of Bausch Health and STADA management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in Bausch Health's most recent annual or quarterly report and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health and STADA undertake no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
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