Disclaimer
•
This document contains forward-looking statements on overall economicdevelopment as well as on the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on current plans,
estimates, forecasts and expectations of the company and thus are subject to risks and elements of uncertainty that could result in deviation of actual developments from expected developments.
•
The forward looking statements are only valid at the time of publication Biotest does•
The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.Big Success for Biotest's Biotherapeutics:
Biotest and Abbott signed a
Biotest and Abbott signed a
"Licence, Development and Commercialization
Licence, Development and Commercialization
Agreement"
to ensure the further development as well as later on production
and worldwide marketing and sales of BT-061
Biotest and Abbott Global Agreement towards BT-061
• Biotest receives upfront payment of USD 85 million
• Biotest will be eligible to milestone payments pending completion of certain development regulatory commercial and sales milestones
development, regulatory, commercial and sales milestones
• Total Potential Milestone Payments USD 395 million
•
Total Deal Value: USD 480 million
• Biotest will receive royalty payments on net sales achieved outside Europe EU51)
• For Europe EU5 cost/profit split agreed
• Partnership Structure
• Joint development by Biotest and Abbott
• Biotest to co promote BT 061 in Germany France United Kingdom Italy Spain
• Biotest to co-promote BT-061 in Germany, France, United Kingdom, Italy, Spain
• Abbott will have exclusive global rights to commercialize BT-061 outside the EU5
• Biotest Pharmaceuticals Corp. to manufacture product for clinical trials
• Abbott and Biotest will share responsibility for commercial production
BT-061: Compound Specifics and Development Status
• Monoclonal antibody that activates regulatory T cells
• Humanization by CDR grafting
• Non-depleting
• Species specificity: binds only to a special epitope on h CD4
human CD4
• No activation of effector T cells
P i i ffi d f d f h II li i l
• Promising efficacy and safety data of phase II clinical trials in Rheumatoid Arthritis (RA) and Psoriasis (PS)
BT 061 H
th P t
ti l t M di ll Diff
ti t
i
BT-061 Has the Potential to Medically Differentiate via
Efficacy and Safety
G d f t fil ft t t t f 350 bj t
• Good safety profile after treatment of approx. 350 subjects
conventional anti CD4 mAbs
Unique Mode of Action of BT-061:
Comparison to Conventional CD4 mAbs
BT-061
non-depleting depleting
(e.g. HuMax-CD4*)
ADCC
conventional anti-CD4 mAbs
CDC ADCC Depletion +
+/
-Blockade of CD4 function required-
-
+ Activation of TregsActivation of T helper cells
+
--
-Efficacy not sufficient
Doses required for clinical
efficacy (iv) 100 - 1000 mg iv
high efficacy already at 100-2000 fold lower
doses (0.5 - 2.5 mg iv) 50 - 500 mg iv
Efficacy not sufficient for clinical success in autoimmune disease
Market Environment in Rheumatoid Arthritis and
Psoriasis
Rheumatoid Arthritis Market:
1Continuous Growth until 2014 Driven by Biologics
12$)
TNF inhibitors Non-TNF (Biologics & NCE) Others
8 10 (bn US $
CAGR: 4.7%
6 8 et volume 4 Mark e 0 2 1 = MM7; 7 major markets2009 2014 Source: Decision Resources 2011 NCE: new chemical entities
Largest Products in RA in 2010 in MM7
1(bn US $)
Enbrel (Wyeth/Pfizer) Remicade (Centocor/J&J) Humira (Abbott) Orencia (BMS)
ENBREL (Pfizer/Amgen) HUMIRA (Abbott/Eisai)
REMICADE (Centocor/J&J/MSD) ORENCIA (BMS)
•
Abbott one of the major0 6
Rituxan (Roche)MABthera (Roche)RITUXAN (Genentech/Biogen Idec)
j players
3.1
0.5
0.6
2.0
1.6
1 = MM7; 7 Major MarketsRheumatoid Arthritis Product Sales Forecast for MM7
1Patent Expiries after 2014 Generates Pressure on anti-TNFs
14
)
TNF inhibitors Non-TNF (Biologics & NCE)2 Others
10 12
(bn US $
)
• Patent expiries from
2014 onwards
• Price pressure from
6 8
t volume
• Price pressure from
Biosimilars expected
2 4 6 Marke t 0 2 1 = MM7; 7 Major Markets 2 = NCE: new chemical entities Source: Decision Resources 2011Rheumatoid Arthritis Product Sales Forecast for MM7
1Innovative Products Needed in Rheumatoid Arthritis
14
)
TNF inhibitors Non-TNF (Biologics & NCE)2 Others
10 12
(bn US $
)
• Patent expiries from
2014 onwards
• Price pressure from
6 8
t volume
• Price pressure from
Biosimilars expected
2 4 6 Marke tHigh level of importance of
new innovative products:
t
i i
di l
d
0
2
• meet remaining medical need
• keep high price on the basis
of medical differentiation
1 = MM7; 7 Major Markets 2 = NCE: new chemical entities Source: Decision Resources 2011
• Many candidates stopped within last two years due to lack of clear differentiation
Competitive Environment
y pp y
• Pipeline dominated by "me too" candidates
• Only few innovative products in development, but required to further improve patient safety
improve patient safety and efficacy Orencia Rituxan Actemra BT-061 (Biotest) Orencia Cimzia Golimumab (Centocor/J&J) TNF-Kinase Inhibitors
IL-17 Inhibitors
GAP
Remicade (Centocor/J&J) Humira (Abbott) Cimzia (UCB) TNF-Inhibitors IL-17 Inhibitors
IL-6 Inhibitors only few candidates in late-stage clinical d l t Enbrel (Wyeth/Pfizer) (Centocor/J&J) B-cell Inhibitors T cell Inhibitors development Approved Filed Phase III Phase II Phase I Pre-clinical Development stage
Biotest's Biotherapeutics portfolio
BT-061 BT-062 BT-063
Blockage of
immuno-regulatory cytokine with key role in pathogenesis of SLE Activated Tregs mediate
modulation of T effector cells Tumor-activated payload (TAP) technology
Potential Indications
•
Systemic Lupus E th t (SLE) Potential Indications•
Rheumatoid Arthritis•
P i i Potential Indications•
Multiple Myeloma•
S lid t Erythematosus (SLE)•
Oncology•
Psoriasis•
Other autoimmune diseasesBiotest : Future corporate structure
Biotest AG
Microbiological M i i Medical BiotherapeuticsPlasma Proteins Monitoring
Diagnostics Biotherapeutics Plasma Proteins -Immunoglobu-lines Monoclonal Antibodies ("mAb"): Plasma Proteins
Sold to Bio-Rad Sold to Merck KGaA lines - Hyper-immuno-globulines - Clotting Factors Albumin - BT-061 - BT-062 - BT-063 - Albumin
Focus on Pharma Biotest will be a specialized pharmaceutical
company with focus on Plasma Proteins and company with focus on Plasma Proteins and Biotherapeutics
Biotest: a specialized pharmaceutical company
Biotest AG
Pharmaceuticals
Divisions
Plasma Proteins Extension into: • Clinical Development Biotherapeutics • USA • Spain • Brazil • new indications • Clinical Development ongoing • Production at BPC • New patents • License Agreement• new products • License Agreement
Sales*: € 412.5 m R&D*: - € 27.9 m Sales*: € 0.0 m R&D*: - € 21.1 m EBIT*: € 73.4 m EBIT*: - € 21.7 m
*
FY 2010Thank you
Contact
Investor Relations Biotest AG:
Dr. Monika Buttkereit
Head of Investor Relations
Phone: +49 (0) 6103 801 4406 Phone: +49 (0) 6103 - 801 -4406 Fax: +49 (0) 6103 - 801 -347