Press release
2016-09-07
Xbrane has completed the production and performed quality control of the first commercial batches of Spherotide. The value of the produced batches is approximately SEK 7 million, according to an agreement with the company's distribution partner in the Middle East.
Payment will be received upon delivery, which will occur when Xbranes Italian production facility receives GMP approval (Good Manufacturing Practice) from AIFA, the Italian Medicines Agency, expected during the first quarter of 2017.
Xbrane estimates an annual sale of approximately SEK 85 million at full penetration in the relevant countries in the Middle East. Previously launched generic drugs on that market have reached full penetration within two to three years after launch.
The original product, Decapeptyl, which Spherotide addresses, has annual global sales of approximately SEK 4 billion. Launch of Spherotide in Europe and the United States is planned for the end of 2018.
"With the successful production of the first commercial batches of Spherotide we confirm that our Italian production facility is of the highest quality regarding manufacturing technology and know-how, and that we are able to sell what we produce in the facility. Xbranes production facility in Italy has the capacity to produce the entire global market need for Spherotide without major investments. "said Martin Åmark, CEO of Xbrane Biopharma AB.
About Xbrane
Xbrane is a commercial phase Swedish biopharmaceutical company specialized in High Demand Complex Generics. Xbrane has world leading expertise in developing generics for injectable controlled release drugs and proprietary high-yield protein expression technology for the development of biosimilars. The goal is to become a global leader within the company's portfolio of High Demand Complex Generics. Xbranes's headquarter is located in Stockholm and the company's in-house research and development facilities are in Sweden and Italy. Xbrane is listed at Nasdaq First North since February 3rd under the name XBRANE and Avanza Bank AB is Xbranes certified advisor. For more information see www.xbrane.com.
For further information, please contact:
Martin Åmark
Chief Executive Officer
M: +46 (0) 763-093 777
E: martin.amark@xbrane.com
This information is information that Xbrane Biopharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:30 September 7 2016.