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Biotest AG Investor Presentation 2009

Nov 11, 2009

66_rns_2009-11-11_4df7c8d3-e12d-4961-bf23-ddb2d5854cf3.pdf

Investor Presentation

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Biotest Group: Creating Value. Living Values.

Management Presentation

Biotest AGNovember 2009

Biotest Management Presentation November 2009

Biotest at a glance

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Business sectors

Biotest −key figures

  • • Headquarters in Dreieich/Germany (Frankfurt area)
  • • Subsidiaries in 10 countries worldwide
  • • Employees (FTE)*: 2,135 Thereof 41% located outside Germany*
  • • Founded in 1946, IPO in 1987, SDAX in 2007 (preference shares)
  • • Biotest shares:
  • •6,595,242 ordinary shares
  • • 5 133 333 preference shares 5,133,333

Headquarters, Dreieich eadqua e s, e e c

*: as of 30 Sept. 2009

Biotest strategy

  • •Internationalisation
  • •Focus on markets with special needs
  • •Research and development

Target Sustained profitable growth

Biotest Group overview

European production and distribution sites

Additional sites overseas:

  • •USA: Florida ( ), New Jersey ( )
  • • Japan: Tokyo ( )
  • •Distribution also via 138 distributors in

Sales by region (Q1-Q3 2009):

About Biotest – strong track record

  • • Strong revenue growth, particularly in Plasma Proteins business
  • • Plasma Proteins account for 80% of Group's sales in 2008
  • • EBIT increase by 199% from 2004 to 2008

Biotest shares: positive development in 2009

  • • Decline of share price after majority shareholder terminates discussions about shares´s sale
  • •Share price increase triggered by positive news flow positive

Biotest shares and SDAX in 2009 (index)

Shareholder structure

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Ordinary shares: 6.6 mio with voting rights

OGEL GmbH*: 50.03%KSK Biberach*: ~24%Mass. Mutual Life I C* nsurance Comp.*: ~3% Free Float: ~23%

56.4% of total capital, and 100% of voting rights 0% of voting rights

Preference shares: 5.1 miono voting rights, but higher dividend

Free Float: 100%

43.6% of total capital, 0% f i i h

* as of November 2009

Biotest: History and milestones achived

Biotest Group: Creating Value. Living Values.

Financials and highlights of Q1-Q3 2009

Q1-Q3 2009 / Highlights Q3

  • • Bi t t G S l b 12 0% d otest Group ales up by 12.0% an EBIT increased by 3.0%
  • • Confirmation of 2009 Guidance: S l 10% d EBIT t ales +10% anEBIT at € 55m
  • • Medical Diagnostics: Signing of purchase agreement with Bio-Rad Laboratories, Inc.
  • • Zutectra received positive CHMP* opinion for marketing approval in EU
  • • Biotherapeutics: further data demonstrating efficacy of BT-061
  • • Clinical Phase III of IVIG () y US successfull completed
  • • Commissioning of technical plant ongoing in Boca Raton

*: Committee for Medicinal Products for Human Use (CHMP); The positive opinion is based on data available to the EMEA, as part of the centralised approval procedure.

Biotest to sell Medical Diagnostic business to Bio-Rad

  • • Contract signed to sell a major part of the Medical Diagnostics segment to Bio-Rad Laboratories Inc. (Hercules, CA/ US)
  • • Transaction subject to closing conditions, incl. merger approval and is expected to close in first quarter 2010
  • • Bio-Rad will acquire all shares of Biotest Medical Diagnostics GmbH (Dreieich) Rad and Biotest Diagnostics Corporation (Rockaway/ US), as well as the transfusion and transplantation diagnostics business in Biotest Group´s international subsidiaries under an asset deal; H1 revenues of activities to be sold approx. € 21 million
  • •Purchase price: € 45 million
  • • Transfer of assets and certain liabilities, except shareholder loans granted to BMD and BDC of approx. € 16 million

Sales continue to increase, EBIT increase at lower rate

EBIT (in € million)

Plasma Proteins business drives EBIT

EBIT by segments (in € million)

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  • • EBIT of Plasma Proteins segment increased by 6.0 %
  • • Biotherapeutics EBIT influenced by level of maturity of clinical studies
  • • EBIT improvement of Medical Diagnostics due to increased sales in the US

Increase in profit in Q1-Q3 2009

EBT d EAT (i € illi ) EBT an (in million)

  • • Rise in earnings before tax (EBT), due to more favourable financial result as a result of lower interest expenses
  • • Earnings after tax after (EAT) at € 25.1 million
  • • Tax ratio: 30.3% (Q1-Q3 2008 : 30 8%) 30.8%) 25.1

Strong balance sheet

Balance sheet of the Biotest Group ( € ) (in million)

Assets

  • • Higher inventories driven by growth and products which could not be marketed as planed
  • • Higher Trade receivables due to hi h l l i l ihigher sales volumes mainly in the plasma proteins segment

Li bilitiLiabilities

  • • Increase in current financial liabilities, primarily corresponding to working capital development
  • •Equity ratio as of 30 Sept. 2009:

Cash Flow from Operating Activities in € million

Q1 – Q3 : January – September 2009

Long term debt financing secured

Residual term of financial liabilities

(31 December 2008, in € million)

€188 8 million) 120 101.110065.5608028.240020<1 year 1 5 years >5 years 1-5

  • • Financial liabilities as of 31 December 2008: €194.8 million (2007: €188.8
  • • Extension of existing credit line (€40 million) in November 2008
  • • Total credit line expanded by €40 million in May 2009 (maturity of 2 years)
  • • Sufficient flexibility to support further growth

Biotest Group: Creating Value. Living Values.

Plasma Proteins

Plasma Proteins business at a glance

Biotest Plasma Protein products Protein

  • •Global market share: 3%
  • • Market share in relevant markets (GER, AUT, CH, GRE, UK): 14%
  • • Intratect ® market share in GER, AUT, CH: > 13%, in UK: > 9%
  • • World market leader with Cytotect ®and Varitect®
  • • Leading position with Hepatect ® in Europe and Nabi HBTM in USA
  • • Biotest covers full value creation chain: plasma sourcing, production, distribution vertical integration leads to g rationalisation and higher productivity

Plasma Proteins: Production process

Plasma Proteins production – capacity doubled

Biotest production network* Fractionation: p

  • •Plant in Dreieich: 700,000 litres p.a.
  • C t t ith C A F D C F (B l i ) •Contract withC.A.F-D.C.F elgium): up to 300,000 litres p.a.
  • •Facility included in regulatory files
  • •10 year contract
  • •Boca Raton: 400,000 litres p.a.

Immunoglobulins:

  • • Capacity in Dreieich doubled
  • • Capacity expansion in Boca Raton (1 5 tonnes p a from H1/2011) (1.5 p.a.

* In the final construction stages (2010/11)

Status Projekt IVIG and Boca Raton (USA)

IVIG clinical Phase III

  • Clinical phase III study completed
  • Finalization of clinical study report in Dec. 2009

Enlargp y ement of production facilit

  • Construction work part 1 nearly finalised; commissioning of facility has started
  • Completion of production facility (part 1) in Q4 2009
  • Final completion of utility systems and warehouse (part 2) in H1 2010 in
  • Final capacity: 400.000 l fractionation 1.5 t immunoglobulin purification

Registration of IVIG

  • Submission of BLA to FDA in mid 2010
  • Expected approval in H1 2011

Plasma collection – high level of own supply ensures independence and availability of raw material

  • •4 new plasmapheresis centres in 2008 BPC-run plasmapheresis centres in the USA
  • • 21 centres in total worldwide(10 in Europe, 11 in the USA)
  • • L l f l tt i t Level of own supply set to rise to over 45% by the end of 2009:
  • •Less dependent on price fluctuations
  • •Supply of hyperimmune plasma
  • •Production network Europe - USA States with centres at time

New centres opened in the USA in 2008/2009: Santa Fe (NM) Iowa City (IA) (NM),

Plasma Proteins: further growth in sales, but at a slower rate

Plasma Proteins: sales volume (in € million)

  • • Sales in Plasma Proteins jumped by 37% in 2008 (incl. BPC for the first time)
  • • Contribution BPC in 2008: €64.1m
  • • In Q1-Q3 2009 Plasma Protein sales increased by 12.8% to € 294.3 million

New indications and higher

Demand for Plasma Proteins is growing, but at a slower rate

Global IVIG market (in tonnes)

Immunoglobulins: approval of U.S.-IVIG bears significant upward potential

  • • Total volume IVIG world market as of 2008: ~90 tons
  • • USA by far the most important market for IVIG worldwide
  • • Registration of BPC's U.S.-IVIG (comparable to Intratect ®) expected for H1 2011

Sources: MRB, APFA, UBS, Biotest Market Research

US source plasma collection forecast, 1996 - 2013

Source: MRB "The Plasma Fractions market in the United States", 2007; PPTA; own estimates

Plasma sourcing trends in the US

Plasma Centers in US

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  • • Closing of first plasma collection centers in the US
  • • Reduction of opening hours in tcenters
  • • Lower compensation paid to donors
  • • Reduction of plasma collection volumes

*: Highest number since 2003 Source: PPTA

Plasma market analysis

  • • We expect, that plasma sourcing activities will be reduced over time
  • •This will lead to reduction of inventories
  • • It is our assumption, that the plasma market environment will stabilise within the next 1-2 years, and therewith also the pricing sit ti uaon

Plasma Proteins: Q1- Q3 2009 highlights

  • • Market entry in additional European countries after regulatory approval: Human Albumin Hepatect ® Haemoctin ®, , , Haemonine®
  • •Share of international sales up to 77%
  • • Tenders won for the delivery of coagulation factors
  • •R&D projects advanced
  • •Production capacity expanded

Plasma Proteins: ongoing and new product development

European approval expected in 2009 (centralised procedure):

Zutectra Hepatitis B immunoglobulin for prophylactic treatment of reinfection following liver transplantation transplantation, administered subcutaneously – self-medication possible

Approval after 2010:

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Biotest received positive opinion for Zutectra ®

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First subcutaneous injectable • High specific activity of 500 IU/ml HBIG f lf d i i t ti bfor self-aministration by the patient

peutic indication: p

• Prophylaxis of HBV re-infection after liver transplantation

perties:

  • • Subcutaneous injectable HBIG in a pre-filled syringe = ready-for-use

Clinical Results:

• Effective anti-HBs-serum levels achieved in all patients in the registration trial with weekly ®Zutectraapplication, no infection

Timelines:

  • •Positive CHMP* opinion, Sept. 2009
  • • EU Commission approval scheduled for December 2009
  • •Launch in major EU countries in 2010

*Committe for Medicinal Products for Human Use

Biotest is a mayor player in Hepatitis B-Immunoglobulin (HBIG) market

(Marketing Research Bureau, Inc.)

  • • Use of HBIG after transplantation is mandatory
  • • Biotest is world wide market leader with Hepatect ® in Europe and Nabi HBTM in USA
  • • Zutectra® enhances Biotest competence and engagement in the HBIG market
  • • Zutectra® will strengthen and defend current strong market position by preventing possible switch to i.m. and future i.v. drugs
  • • Further Launches for Zutectra® and Nabi HBTM HB already scheduled in attractive world in wide markets

Two ideal therapies designed for acute and maintenance treatment

….. with proven efficacy and safety

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IgM Concentrate

IgM Concentrate is successor product of Pentaglobin®

Lead indication:Sepsis

Current Status:Phase I Study

  • •24 healthy volunteers (18 - 45 years)
  • •Single dose: n = 18 (incl. Placebo); multiple dose: n = 6
  • •Recruitment and treatment of healthy volunteers completed
  • •No major safety issues, no occurrence of SAEs*

Phase II preparation activities ongoing:

  • • Development of synopsis and study protocol (indication, endpoints, sample size)
  • •Preparation of PEI and FDA-Advice in Q1 2010

*: SAE = Serious adverse event

Summary Plasma Proteins: Biotest made significant progress in implementation of its corporate strategy

  • •Biotest will grow the Plasma Proteins segment
  • • P i th U S k t t d d Presence in the U.S. maret extene
  • • Regulatory approval for IVIG expected H1 2011 Market potential for this product in USA estimated to be > \$ 100 m
  • •Strong R&D pipeline: New products and new clinical indications

Biotest: Creating Value. Living Values.

Biotherapeutics

Biotherapeutics: investment in projects with potential

Common features of Biotest's monoclonal antibodies

  • •High medical need
  • •Rapidly growing markets
  • •Blockbuster potential

Lead indications

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Rheumatoid Arthritis and Psoriasis –a huge and growing market

\$ Market volume (in US \$ million)

  • After approval: significant market share is realistic

BT-061 − Specific mode of action addressing key regulatory function of the human immune system

Clinical development BT-061 Overview

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Study 967 single dose Psoriasis:

Blinded PASI course for all dosing groups* including p p lacebo patients

0.5 mg and 2.5 mg single iv dose with a pronounced and long lasting PASI response up to 75 days after single dose application

PASI = Psoriasis Area and Severity Index) *evaluation of 25 mg sc dose level ongoing

Monotherapy Rheumatoid Arthritis:

Status of Study 962

  • • B d d fi di i d Broa dose nding iv an d sc
  • •Most effective dose iv: 2 mg
  • Sc: comparable efficacy at 50 mg
  • •Higher sc doses currently under evaluation in ongoing study sc ongoing study

Study 971 MTX-Combination Rheumatoid Arthritis:

ACR response after multiple applications (Part I)*

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*Data cut off: September 2009, Unblinded Data from Interim Analysis (n=40)

Study 971 MTX-Combination Rheumatoid Arthritis:

Kinetic of ACR70 response (%) of BT-061 Compared to other biothera peutic1 (TNFα anta gonist, no direct com parison 2 p p ( g p )

BT-061: summary clinical results

Psoriasis :

• Pronounced and long-lasting reduction of PASI scores observed in single dose psoriasis study at very low doses (0 5 mg iv 2 5 mg iv) study low (0.5 iv, 2.5

Rheumatoid Arthritis:

  • •Competitive ACR20, 50, 70 responses at 2 mg iv and 50 mg sc
  • • Higher response rates anticipated by further dose optimization and by prolongation of treatment period
  • • Still sharp increase of ACR responses at week 9: further improvement expected ih i d d wit h continued treatment
  • •Typical plateaus of ACR response observed for biologics not reached yet*

*expected plateaus: ACR20 after 3 months; ACR50 after 4 months; ACR70 after 6 months PASI = Psoriasis Area and Severity Index)

BT-061: clinical development Next steps

Rheumatoid Arthritis:

  • • Ongoing Phase II combination trial (+ MTX):
  • treatment of additional p g atients with 50 m g sc in combination with MTX
  • • New Phase II clinical trial planned:
  • inclusion of more patients (200-300) in relevant dose levels
  • extension of treatment period up to 3 month

broadening efficacy and safety data base

Psoriasis:

  • • Phase II clinical trial (48 patients) submitted:
  • first patient expected to be included in December 2009
  • finalization of dose-finding (focus on sc administration)
  • repeated weekly dosing and extension of treatment period up to 8 weeks

higher response rates expected

Partnering for BT-061: process started successfully, positive response

Biotest strategy:

Co-development and co-marketing with "big bigpharma" from clinical Phase III onwards

  • •Start of partnering process successful
  • • Global pharmaceutical groups approached ("big pharma")
  • •Predominantly positive response
  • •Close interactions with selected companies
  • • F th d t ill b b itt d (Q4/2009) Further ata willbe sumitte
  • •Request of non-binding offer
  • •Agreement expected in H1/2010

BT-062 : good tolerability, first indications of efficacy

1American Society of Haematology, Dec. 2009

  • • BT-062: specific and highly effective immunotoxin: t i t di t hi h ffi toxin part medi ates g h efficacy antib d t di t tib ody part medi ates high specificity
  • • Phase Study ose esca at o study pat e ts t I Study: Dose escalation study in patie nts with relapsed or relapsed/refractory Multiple Myeloma
  • • Clinical trials in 4 cancer centres in the US, open label, repeatd i l d te d single dose
  • • Indications of efficacy already with low dosages:
  • Di i h l d i i f Disease progression alte in some patients for several months
  • Seventh dose level completed (maximal tolerated dose identified)
  • publication of first data on scientific congress1

Based on positive results from Phase I trial, a US- based multidose trial (Phase I/IIa) has been submitted in October 2009

Multiple Myeloma unmet need and high market potential

Survival rates for MM patients in the USA

(Source: SEER Cancer Statistics Review,1975 - 2004) (Source: Company data and Biotest analysis 2009)

Sales of novel targeted MM therapies (in US\$ million)

BT-063: competitive advantages due to unique mode-of-action

BT-063 lead indication

  • •Systemic Lupus Erythematosus (SLE)
  • • Hi g y, h medical need: SLE incurable today, no new approval since ~ 40 years
  • • 2.5 million patients are suffering from SLE worldwide today

Mode-of-action

  • • BT-063 positively modulates the immune 063 system in this indication
  • • Few other biologics in development: mostly anti B cell antibodies

Clinical development

• Phase I trial has started in healthy volunteers healthy in October 2009

BT-063: expected SLE market development

  • •Market without specific or curative agents –
  • •Novel immunomodulatory agents will develop the SLE market

Market share of SLE therapies (in %) Market%)

Outlook Biotherapeutics: reach new development stage

Significant progress with all projects

BT-061:

  • •clear proof-of-concept in RA and Psoriasis
  • •last patient of Phase I / IIa clinical trial in Psoriasis recruited
  • •additional Phase II trial in Psoriasis will start in Dec. 2009
  • • new Phase II trial in RA with 200-300 pts will be submitted in H1/2010
  • •partnering process ongoing

BT-062:

  • •first indications of efficacy from dose dose-escalating study escalating
  • •multidose trial submitted in October 2009

BT-063:

  • •Phase I trial started in September 2009 trial
  • •first healthy volunteers treated

Production:

S tf f ti f l l tib di •et-up o f own manufacturing o f monoclonal antibodies progressing well at BPC

Biotest Group: Creating Value. Living Values.

Microbiological Monitoring and Medical Diagnostics

Microbiological Monitoring: Biotest leading supplier

Reagents and system solutions for:

  • •Hygiene Monitoring
  • •Detection of germs and particles

Main Products:

  • •Microbiological air samples (RCS)
  • •Air Particle Counters (APC)
  • •S f i di t (OKI) Surface germ indicators
  • •heipha culture media

Market Position:

  • •Among top 5 worldwide
  • •Market share 8-10%

Microbiological Monitoring continues to perform well

  • • Sales increase in Q1-Q3 2009: €31.3 million (+9.1%);
  • • Complex and high quality standards require high quality products
  • •Pooling R&D activities at the Eppelheim site
  • • R&D: focus on solutions for the paperless laboratory

Medical Diagnostics: reagents and system solutions

Transfusion

Id ifi i f bl d Identification of blood groups Search for antibodies

Main products:

  • • TANGO®optimo
  • •Erytype
  • •Solidscreen
  • • Manual Test Reagents

Competitive position:

  • •No. 4 worldwide
  • • Market share: 4% (Europe: 6-7%)
  • •Competitors:
  • Biorad
  • Immucor
  • Ortho
  • Diagast

Transplantation

T i f tiTyping of tissues - Tepnel

  • •HLA Serology
  • • HLA DNA Tests(ELPHA, SSP)
  • • HLA Antibody diagnostic

  • •No. 4 worldwide

  • • Market share: 8%
  • • Competitors:
  • One Lambda
  • Invitrogen
  • T l

Medical Diagnostics: improved business trend, but situation remains difficult

  • • Difficult market conditions in Europe, USA remains an attractive market
  • • Approval of manual reagents facilitates presence as full-service provider in the USA
  • • Sales increase in Q1-Q3 2009 to € 36.3 million (+9 0%) (+9.0%) – however sales and profit however, profit development remain unsatisfactory
  • • Purchase Agreement signed with Bio-Rad; Closing of the transaction is expected in Q1/2010

Outlook 2009

Our goals for the year 2009:

  • •Increase in sales of about 10 %, EBIT on last year´s level at 55 € m
  • • EBIT 2009 on level of 2008 due increased pricing pressure in plasma protein segment, potential exchange rate impact and unabsorbed facility costs resulting from expansion of production capacity
  • • Economic crisis has had no significant impact to date – however, increased vig y ilance is necessary

Creating Value. Living Values.

Biotest – sustained company value

  • •Successful operations
  • •Growth opportunities
  • •Pipeline with strong potential
  • • S d fi i Sounfinancing
  • • Highly qualified and committed employees

Disclaimer

This document contains forward-looking statements on overall economic developments 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 not intend to update the forward-looking statements and assumes no obligation to do so.

All comparative figures relate to the corresponding last year's period, unless stated otherwise.

Analysts Conference

Contact and Financial Calendar 2010

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Biotest Plasma Proteins premium products

Intratect®

Human immunoglobulin for Th ti i di ti intravenous use (IVIG)

Therapeutic indications:

  • • Replacement therapy in:
  • 1.Primary Immunodeficiency Syndromes
  • 2.My yp y eloma or chronic lymphocytic leukaemia
    1. Children with congenital AIDS and recurrent infections
  • • Treatment of autoimmune diseases: ITP (idiopathic thrombocytopenic purpura) Guillain purpura), Guillain-Barré-Syndrom, and Kawasaki Syndrom

Properties:

  • •St t t t Storage at room temperature
  • •Well tolerated (Sugar free)
  • •Ready-for-use solution

Clinical trial:

  • • Phase III trial in chronic idiopathic pain syndrom completed
  • • Laboratory parameters are currently evaluated to id tif di ti l t th t li k d t itiidentify predictive clusters that are linked to positive outcome

Pentaglobin® / IgM-Concentrate

IgM-enriched immunoglobulin for severe bacterial infections

Therapeutic indications:

  • • Adjunctive therapy of severe bacterial infections in addition to antibiotic therapy immuno
  • • Immunoglobulin replacement in immunocompromised patients

Properties:

  • • U i i li i ti f th d th i Unique in elimination of pathogens and their toxins
  • • Excellent immunomodulator for controlling inflammation and severe bacterial infectionsinfections
  • •Excellent tolerability

Clinical trial:

I Mg -C tt oncentrate i li i l Ph I in clinical Phase I: Further developed IgM-enriched immunoglobulin

Hepatect®

Human Hepatitis B immunoglobulin manufactured from plasma of donors with high

Therapeutic indications:

  • • Prophylaxis against hepatitis B (HBV) in adults and children over 2 years who have not been vaccinated and who are at risk ofanti-HBs antibody titres infection
  • • Prophylaxis of HBV re-infection after liver transplantation (gold standard)
  • • P t h l i ft Post exposure prophylaxis after exposure to HVB, e.g. needle stick injuries
  • • HBV prophylaxis in newborns from HBV carrier mothers

Properties:

  • •Ready-for-use solution
  • •Sugar-f i t il free, isotonic low-salt l ti lt solution
  • • Natural function and activity of specific immunoglobulins is preserved

Cytotect®

Human CMV immunoglobulin manufactured from plasma of donors with high CMV antibody titres

Therapeutic indications:

• Prophylaxis against the clinical manifestation of CMV infections in immunosuppressed patients especially transplant recipients patients,

Properties:

  • •Ready-for-use solution
  • •Sugar-free isotonic low free, low-salt solution salt
  • • Orphan Drug Designation for prevention and treatment of congenital CMV-infections (p ) Europe, U.S., CH)

Clinical trial:

  • • Phase III study to prevent CMV infection in children of mothers who acq py uired a primary CMV infection during pregnancy
  • • Ongoing process to optimise recruitment and study procedures

Haemoctin® / Haemonine®

Chromatographically purified, double virus inactivated coagulation factors concentrated from plasma 2.

Therapeutic indications:

  • • Prevention and treatment of bleeding in:
  • 1.Haemophilia A (Haemoctin®)
  • 2 Haemophilia B (Haemonine®) Haemophilia (Haemonine )

Properties:

  • •High viral safety standard
  • •Stable for two years at room temperature
  • • Haemoctin contains a high level of von Willebrand factor (VWF)
  • • Haemoctin has been shown to be efficacious in FVIII inhibitor therapy - in general VWF-containing FVIII preparations are the first choice in i hibit t t t ith hi h d f inhibitor treatment with high dosages of FVIII.

Zutectra® −increased patient compliance

Human Hepatitis B immunoglobulin for subcutaneous administration. Manufactured from plasma of donors with high anti-HBs antibody titres. Properties:

Therapeutic indications (after approval):

• Prophylaxis of HBV re-infection after liver transplantation

  • • Subcutaneous administration – ready for self-administration by patients
  • •Ready-for-use solution in pre filled syringe
  • •High specific activity of 500 IU/ml

Safe and convenient HBV re and re-infection infection prophylaxis for liver transplant patients

Clinical trial:

  • • Ph III t d l t d d b itt d f Phase III study completed and submitted for a centralised European authorisation procedure
  • • Approval expected end of 2009