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2016-10-31

Xbrane Biopharma AB: Xbrane Biopharma AB ("Xbrane") has received scientific advice regarding regulatory and clinical aspects of the planned submission of a Mark

Press release

2016-10-31

Xbrane has received advice from BfArM, the German Federal Institute for Drugs
and Medical Devices, with regards to the clinical and regulatory aspects of
the Company's planned submission of a Marketing Authorization Application
(MAA) for Spherotide 1-month formulation for the European Union. A Market
Authorization in EU would enable Xbrane to sell and market Spherotide in
Europe and would serve as a base and facilitator for the approval process in
other regions.

The MAA will, according to the advice received by BfArM, be supported by a
single pivotal clinical trial in prostate cancer patients. The clinical
efficacy of Spherotide will be measured as testosterone suppression under
castration level by day 28. The secondary endpoints as suggested by Xbrane
were all accepted by BfArM. Xbrane estimates that the clinical trial will
involve 150-170 prostate cancer patients and to be initiated first half of
2017. In accordance with Xbrane's commercialization strategy for Spherotide
the study shall be co-funded by the future European sales and marketing
partner.

"We are happy to gain support for our regulatory and clinical strategy in
discussions with BfArM. The advice was pragmatic and concrete and we are very
confident that the discussed thresholds for efficacy are achievable. This
allows us to proceed with all activities required for finalizing the MAA for
the European Union, " Martin Åmark, CEO Xbrane Biopharma

Xbrane plans to file a MAA under the hybrid pathway, directive 2001/83/EC
article 10 (3), following the decentralized procedure with Germany as the
Reference Member State (RMS), and including other main European countries.

Spherotide is a generic to the drug Decapeptyl® with global sales of
approximately SEK 4 billion. It is a formulation with long acting effect
after injection with the active substance triptorelin and is used primarily
in the treatment of prostate cancer, endometriosis and uterine fibroids. The
drug is based on encapsulation of the active substance in biodegradable
microspheres that degrade in the body after injection and create a long
acting effect. Spherotide is the only generic to Decapeptyl®.

About Xbrane Biopharma AB

Xbrane is a commercial phase Swedish biopharmaceutical company specialized in
High Demand Biosimilars and long acting injectables. Xbrane has world leading
expertise in developing generics for long acting injectable drugs and
proprietary high-yield protein expression technology for the development of
biosimilars. 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 3rdunder 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 October 31 2016.

Press release - Xbrane recieves scientific advice from BfArM
http://hugin.info/171873/R/2052815/768341.pdf

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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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