Bli medlem
Bli medlem

Du är här

2016-06-07

Xbrane Biopharma AB: Xbrane Biopharma initiates scale-up of production of its Ranibizumab biosimilar Xlucane ahead of plan

Press Release

2016-06-07

Xbrane Biopharma AB has entered into an agreement with Biotechpharma UAB
regarding scale-up of the production of Xlucane, Xbrane's Ranibizumab
biosimilar, in GMP approved facility, further process optimization, the
required biochemical characterization and development of the CMC
documentation.

"The development of Xlucane has proceeded faster than expected, enabling us to
proceed from process development in pilot scale earlier than planned. We are
pleased to take the step into production of Xlucane in a by EMA GMP certified
facility. This ensures us to get the material and the head-to-headin-vitro
comparability study required to initiate clinical trials. We have reached an
important milestone in taking our first biosimilar into GMP production", says
Martin Åmark, CEO of Xbrane Biopharma AB."

"We are proud to help Xbrane to achieve its goals and to enter clinical trials
rapidly", comments Vladas Bumelis, CEO Biotechpharma. "The Xlucane-project
fits perfectly to our capabilities to manufacture high-quality
biopharmaceuticals in our cGMP-certified production plant and to execute the
broad analytical characterization based on Biotechpharma's extensive
experience in this field", adds André Markmann, VP Business Development.

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 3rdunder the
name XBRANE and Avanza Bank AB is Xbrane's 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

About Biotechpharma UAB

Biotechpharma UAB is a leading biopharmaceutical CDMO CMO providing fully
integrated process development and GMP-manufacturing services globally.
Biotechpharma has extensive experience in the production of biosimilars and
new biological entities, having 135 employees at its state-of-the-art
facility in Vilnius, Lithuania.

For further information, please contact:

Dr. André Markmann, VP Business Development
bd@biotechpharma.lt

www.biotechpharma.lt

Xbrane Biopharma initiates scale-up of production of Xlucane
http://hugin.info/171873/R/2018396/749164.pdf

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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

HUG#2018396

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.