Presentación de PowerPoint - mAbxience
Transcript of Presentación de PowerPoint - mAbxience
CONFIDENTIAL INFORMATION
In mAbxience we work to ensure that each product is
similar to the original, with the same genetic fidelity, and
with the precision of a human footprint.
We do this to secure quality and efficiency; it is not a
goal, it is our work methodology, which marks each of our decisions. We call it Fingerprint-like, biosimilars by
design.
Executive
overview
mAbxience: a biotechnology
company
mAbxience is a totally independent
entity specialising in the research,
development and manufacture of
complex biotech products, biosimilar
monoclonal antibodies.
mAbxience is committed to
manufacture products meeting most
stringent global quality and regulatory
norms at an affordable price.
We have a pipeline of 6 biosimilars, 5 of
them monoclonal antibodies in
Oncology and Rheumatoid Arthritis.
Two mAbs are in the late stage clinical
studies, as well as three in the
developmental phase, which we plan
to bring to the market in the next future.
mAbxience
collaborated with a
global CRO for
development
activities for
selected products.
Initiated construction
of mAbxience drug
substance and a
drug product facility
(SINERGIUM Biotech),
both in Buenos Aires,
Argentina.
Production began
in mAbxience
Buenos Aires and
clinical trials of first
product initiated.
mAbxience acquires
100% of
biopharmaceutical
plant Genhelix focused
on R&D activities in León
(Spain).
Rituximab, the first
mAbxience biosimilar
commercialized
in Argentina, is
launched.
mAbxiencehistory
20
09
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10
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12
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14
mAbxience pipeline
Reference product
TargetWorldwide
sales billion $Main
indicationStatus
Rituximab MabThera® CD20 $ 7.9 blNo HogdkinLymphoma
On market (Argentina)
Bevacizumab Avastin® VEGF $ 6.9 blColorectal
CancerClinic
Palivizumab Synagis®Respiratory
SyncitialVirus (RSV)
$ 1.0 blPrevention of
RSV risk population
Preclinical
Etanercept Enbrel® TNF $ 8.7 blRA and
psoriasisPreclinical
Adalimumab Humira® TNF $ 9.3 bl RA Preclinical
rFVIII - - $ 6.2 bl Hemophilia A Preclinical
mAbxience
set up and
strategy
Own R&D activities including:
▶ Cell line development in third parties
▶ Process Development
▶ Full Characterization
▶ In vivo Pre-Clinical trials
▶ Clinical Trial Manufacturing
mAbxience business model
mAbxience’s team in collaboration with CMO’s
Strategic technology collaboration
Manufacturing:
▶ Manufacturing in our own sites and external CMOs
Licensing model:
▶ Licensing out before clinical trials with the following conditions:
• Milestone payments + Clinical Trial cost sharing + supply at % of net selling price
mAbxience has acquired 100% of the Genhelix
biopharmaceutical development plant in Spain.
The operation is one of the biggest investments ever made
by a Spanish company in a biotechnology project.
mAbxience plant organization
mAbxience B. AiresFirst production plant of
monoclonal antibodies in South America. Started operations in 2012
mAbxience B. Aires Strategic partner
to fill and finish highly complex
biopharmaceuticals products:
SINERGIUM Biotech
mAbxience LeónEuropean R&D Center
and manufacturingfacilities for monoclonal antibodies
Experienced
leadership team
Dr. Hugo SigmanFounder
Carlos Bañado Managing Director
mAbxience benefits from the
experience of a multidisciplinary team
of more than 100 experts working in
various countries and different areas
Our partners
Thank you