Xbrane and STADA included cooperation agreement for Xlucane

Press release

2018-07-12

Xbrane Biopharma AB («Xbrane») and STADA Arzneimittel AG («STADA») has entered into a cooperation agreement regarding Xlucane, a

Lucentis® (ranibizumab) biosimilar medicinal product.

If the agreement

The cooperation between the Xbrane and MYTH » is based on a cooperation agreement which means that the companies will contribute to the development costs and share profits from the commercialization equally in a 50/50 split. To enter into this agreement, STADA to pay 7.5 million EUR to Xbrane at the signing. In close consultation and agreement with STADA, Xbrane will be responsible for the development of the product until the application for marketing approval to the EMA (European Medicines Agency) and FDA (US Food and Drug Administration) is submitted, and to provide the finished pharmaceutical product. STADA will hold market approval, and be responsible for the sales and marketing of the product in all the territories included in the agreement. The cooperation agreement covers Europe, the united states and parts of the markets in MENA and APAC.

The road in the future

The next step in the development of Xlucane is the initiation of the pivotal phase I/III clinical study. Xbrane has agreed on the study design with the EMA and the FDA and designated a leading CRO (Contract Research Organization) that will carry out the study which aims to demonstrate the similarity with Lucentis®. The study will include a large number of patients with the wet form of AMD (age-related macular degeneration) in 16 countries.

Martin Åmark, CEO of Xbrane, commented: «We are very excited to enter into this agreement with STADA. STADA is a strong player and has extensive experience in the distribution and marketing of biosimilar medicinal products. We could not have found a better partner for cooperation and commercialization of Xlucane.»

Anders Tullgren, Chairman of the board of Xbrane, commented: «the Cooperation with STADA is a significant achievement and opportunity for Xbrane and it confirms Xbranes unique expertise in biosimilarutveckling. This transaction will contribute significantly, both in terms of funding and expertise for the development of Xlucane and help us to accelerate the development of our biosimilarportfölj and the journey towards becoming a larger player in the rapidly growing biosimilarmarknaden.»

Dr. Claudio Albrecht, CEO of STADA, commented: «the Cooperation with Xbrane with its highly experienced development specialists, this means a great opportunity for STADA to accelerate the expansion of our biosimilarportfölj and strengthen our position in this segment.»

If Xlucane

Xlucane is a biosimilar medicinal product on the VEGFa inhibitor ranibizumab (Lucentis®). Lucentis® is used in the treatment of serious eye diseases, primarily neovaskulär age-related macular degeneration (wet AMD), diabetes-related macular degeneration (DME) and retinal venocklusioner (RVO). All these conditions result in impaired eyesight, and in the case of no treatment, can lead to blindness. VEGFa inhibitor binds tillgångsfaktorn VEGFa and thus prevents the abnormal growth of blood vessels resulting in impaired vision in patients. Xbrane estimates that the global prevalence of these indications amount to about 60 million patients, of which the 1.5-2.5 million are receiving treatment with VEGFa inhibitors. Thus there is a significant group who are not offered treatment for these eye diseases, primarily driven by the high cost for the originator product, which increases the possibilities of lower-priced biosimilar medicinal products. In 2017 amounted to Lucentis® global sales to about EUR 2.8 billion.

Advisor

The Fullford Group, a London-based adviser in the Life Science transactions, has been the exclusive advisor to the Xbrane in this transaction.

Xbrane will hold a webinar related to this transaction, 17 July, 10.00, 2018. A separate invitation will be sent out.

The information in this press release is such that Xbrane Biopharma AB (publ) is obliged to publish under the EU marknadsmissbruksförordning (EU) no 596/2014. The information was submitted, through the following contact person in the government, for publication on 12 July 2018 there is a 17:00.

For further information, please contact:

Xbrane Biopharma AB

Martin Åmark, MD

M: +46 (0) 763-093 777

E: martin.amark@xbrane.com

Susanna Helgesen, CFO/IR

M: +46 (0) 708-278 636

E: susanna.helgesen@xbrane.com

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

About Xbrane

Xbrane Biopharma AB is a biotechnology company that develops, manufactures and produce biosimilar medicinal products. Xbrane has a patented proteinproduktionsplattform for the development of biosimilar medicinal products and world-leading expertise in biosimilar medicinal products. Xbranes headquarters are located in Solna just outside Stockholm and the company has research and development facilities take in Sweden and in Italy. Xbrane is listed on Nasdaq First North since 3 February 2016 under the ticker symbol XBRANE. Avanza Bank AB is Xbranes Certified adviser. For more information please visit

www.xbrane.com

.

  

If STADA

STADA Arzneimittel AG is a publicly listed bolad with headquarters in Bad Vilbel, Germany. The company strategy is based on three pillars, which consist of generic, non-over-the-counter OTC products and special drugs, in particular, biosimilar medicinal products. Globally, STADA is represented in about 30 countries with approximately 50 subsidiaries. The company’s trademarked products such as Grippostad and Ladival, is among the best selling in the respective product category in Germany. For fiscal year 2017, achieved STADA a right. sale of 2 255,3 million, just. earnings before interest, tax gains/ impairment (EBITDA) on 433,9 million and a just. results on 195,6 million. On december 31, 2017, had the STADA 10 176 employees globally.

PM Xbrane and STADA included cooperation agreement for Xlucane

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Xbrane Biopharma AB via Globenewswire

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