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Presentación de PowerPoint - mAbxience

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CONFIDENTIAL INFORMATION
Transcript
Page 1: Presentación de PowerPoint - mAbxience

CONFIDENTIAL INFORMATION

Page 2: Presentación de PowerPoint - mAbxience

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.

Page 3: Presentación de PowerPoint - mAbxience

Executive

overview

Page 4: Presentación de PowerPoint - mAbxience

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.

Page 5: Presentación de PowerPoint - mAbxience

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

20

10

20

12

20

14

Page 6: Presentación de PowerPoint - mAbxience

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

Page 7: Presentación de PowerPoint - mAbxience

mAbxience

set up and

strategy

Page 8: Presentación de PowerPoint - mAbxience

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

Page 9: Presentación de PowerPoint - mAbxience

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.

Page 10: Presentación de PowerPoint - mAbxience

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

Page 11: Presentación de PowerPoint - mAbxience

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

Page 12: Presentación de PowerPoint - mAbxience

Our partners

Page 13: Presentación de PowerPoint - mAbxience

Thank you


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