Bavarian Biotech Mission to Japan

Bavarian Biotech Mission to Japan
8. - 12. October 2012

Bavarian Biotech Mission to Japan
8. - 12. October 2012
Germany
Bavaria
Munich
Bavarian Biotech Cluster:
• 300 biotech & pharma companies
• 5 biotech incubators
• 35 universities, 3 with “elite” or
“excellence “status
t
• 5 university clinics
• 3 Max Planck Institutes (Life Sc.)
• Helmholtz Zentrum München
• 8 Fraunhofer institutes
• 6 national health research centers

Munich Biotech Cluster m 4
The innovative, research-driven life science and biotech industry in Bavaria (Southern
Germany) is growing consistently, striving not only to keep its status as a leading bioregion
in Europe but also to put Bavaria on the global map. The regional R&D
companies are focused on drug development in the field of personalized medicine and
possess a promising and well-filled drug discovery pipeline. The Bavarian Biotechnology
Cluster is supported by innovative companies providing cutting-edge services and a
strong regional representation of internationally acting Clinical Research Organizations.
In 2010, the Munich Biotech Cluster was awarded "Germany´s Leading-Edge Cluster“-
status by the federal government, bringing the potent initiative “m 4 - Personalized
Medicine and Targeted Therapies” to the region. This initiative is now highly active, with
40 R&D projects, and has already led to the first success stories (www.m4.de).
The Bavarian Biotechnology Cluster is coming to Japan in October 2012, with a
delegation of 16 companies - offering innovative biotech R&D technologies as well as
products and services for the life science industry. The delegation members are
available for partnering meetings with Japanese companies in Osaka on October 9 and
in Yokohama on October 10-12 at the Bavarian booth at Bio Japan World Business
Forum 2012 .
Bio M is the organizer of the Japan mission and coordinator of the Bavarian Biotechnology
Cluster and the Munich Biotech Cluster, supporting more than 300 companies and
offering a gateway to the Bavarian biotech industry for partners worldwide.
Bio M ‘s website (www.bio-m.org) provides an overview on the different activities and
actors within the region, including the m 4 initiative, up-to-date news, a company
database, a job forum and much more. Our partner Bayern International (www.bayerninternational.de)
is a service unit of the Bavarian government and supports the mission
by providing a Bavarian booth at Bio Japan.
Bio M Biotech Cluster Development GmbH
Address: Am Klopferspitz 19 a, 82152 Martinsried, Germany
Tel.: +49 (0) 89 899679-0
Fax: +49 (0) 89 899679-79
Contact: Prof. Dr. Horst Domdey, CEO
E-Mail: domdey@bio-m.de
Website: www.m4.de

BAYERN INTERNATIONAL
Bayern International is an export-promotion company of the
Free State of Bavaria for small and medium-sized Bavarian
companies and also responsible for the marketing of Bavaria
as a business location.
Bayern International was founded in 1996 by the state of
Bavaria within the framework of the “Bavarian Future Initiative”
(“Offensive Zukunft Bayern”). It was Germany’s first economic
promotion corporation to be certified pursuant to DIN ISO 9001.
Our staff have long-term experience in the organization and
implementation of export promotion measures and location
marketing. We work in close cooperation with partners from the
government and economic institutions, both in Bavaria and
worldwide. Our project group „Invest in Bavaria“ promotes
Bavaria as an attractive business location.
BAYERN INTERNATIONAL - Bayerische Gesellschaft
für Internationale Wirtschaftsbeziehungen mbH
Address: Landsberger Str. 300, 80687 Munich, Germany
Tel.: +49 (0) 89 660566 -306
Fax: +49 (0) 89 660566-150
Contact: Torsten Wagner, Project Manager
E-Mail: twagner@bayern-international.de
Website: www.bayern-international.de

4SC Discovery
4SC Discovery GmbH is a wholly-owned subsidiary of 4SC AG that offers
technologies and tailored research services covering drug discovery and chemical
optimization through to a preclinical development candidate. The company offers
customers in the pharmaceutical, biotech and chemical industries the cost and timeto-market
benefits that result from a drug discovery and optimization process aided
by 4SC’s proprietary in-silico screening technology, which has been successfully
employed in multiple research collaborations in past and present.
Through the integrated drug discovery platform i2c (idea to candidate) 4SC Discovery
is able to offer a seamless process from early concept through to a preclinical
development candidate. i2c is a strategic collaboration of 4SC Discovery that
complements the company’s own capacities and expertise in computational,
medicinal and analytical chemistry, biology and pharmacology in an ideal way with
Crelux GmbH’s capabilities in protein production, crystallography and INTRACT
screening. The i2c client groups are pharmaceutical companies looking to outsource
part of their early discovery projects and also small and mid-size biotech companies
seeking to complement their own infrastructure. Besides the standard fee-for-service
offerings, i2c also includes research collaborations based on risk sharing models
including milestones and royalties. Collaborations are provided as tailor made
solutions for smaller sized companies and interested pharmaceutical partners.
In addition, 4SC Discovery also applies its comprehensive pharmacological expertise
to investigating new compounds in the areas of cancer and autoimmune disease.
4SC Discovery aims to engage in partnerships with pharmaceutical and biotech
companies to accelerate the development of its research programs and further
advance their commercialization.
4SC Discovery GmbH
Address: Am Klopferspitz 19 a, 82152 Martinsried, Germany
Tel.: +49 (0) 89 700763-74
Fax: +49 (0) 89 700763-29
Contact: Dr. Andrea Aschenbrenner, Head of Customer Relations
and Business Development
E-Mail: andrea.aschenbrenner@4sc.com
Website: www.4sc-discovery.com

Ascenion
Ascenion GmbH is an independent IP asset management company focused on life
sciences. Ascenion advises and supports public research institutions with regard to the
protection and exploitation of their intellectual property (patents, knowledge, materials),
and initiates and mediates license agreements between research institutions and
industry. With Ascenion’s support commercially attractive inventions, materials and
know-how are promptly identified and given appropriate patent protection. Ascenion
finds suitable industrial partners, negotiates licensing and cooperation agreements,
and accompanies start-ups on the road to independence. Ideas thereby lead to new
jobs and products, such as a novel anti-cancer drug or a procedure for identifying
harmful bacteria in drinking water. The proceeds from commercialization flow back to
the research institutions.
Ascenion is the exclusive partner of 24 life-science institutes in the Helmholtz and
Leibniz Associations and of one Medical School, and coordinates technology transfer
for the German National Genome Research Network. Ascenion currently markets
around 750 technologies on behalf of these institutes and closes an average of about
70 agreements between research and industry per year. The team has also coached
numerous spin-offs through their foundation and early growth, and Ascenion holds
equity in 25 of these companies. Ascenion’s headquarters are in Munich, Germany,
with further offices in Berlin, Braunschweig, Hamburg, Hanover and Neuherberg.
Ascenion GmbH
Address: Herzogstr. 64, 80803 Munich, Germany
Tel.: +49 (0) 89 318814-0
Fax: +49 (0) 89 318814-20
Contact: Dr. Christian Stein, CEO
E-Mail: stein@ascenion.de
Website: www.ascenion.de

Aurigon Life Science
AURIGON Life Science is an independent, d privately-owned, German contract t research
institute dedicated to non-clinical services for human and veterinary pharmaceuticals,
food and chemicals.
AURIGON provides a full range of experimental and advisory services. From early
phase product efficacy and safety evaluation to regulatory toxicology and late stage
pre-marketing testing, we cover all areas of non-clinical development. We have
extensive experience in working with a broad variety of molecules. We also specialize
in biologics such as peptides and proteins, antibodies, biosimilars, RNA and DNA,
vaccines and cell therapy.
AURIGON’s studies meet international standards and can be performed in compliance
with GLP or GMP regulations. Our transparent Quality Management System, together
with our continuous pursuit of innovation, guarantees compliance with ever changing
global regulatory requirements.
Services of AURIGON include:
ADME/PK - pharmacology efficacy testing, safety - pharmacology - biological activity
testing, bioassays, batch release - analytics - toxicity testing (genotoxicity, general
toxicology, immunotoxicity, reprotoxicity, carcinogenicity) - consultancy - archiving
AURIGON carefully evaluates your project, from both the scientific and regulatory
aspects, and strives to follow the most appropriate strategy to achieve your milestones
in a time- and cost-effective manner.
• Wherever your innovative therapy target of tomorrow comes from – we support
you in characterization and establishing effective proof of concept studies.
We also support you in the safety assessment for translation into the clinics.
• We are a trusted outsourcing partner for multinational pharmaceutical and
chemical groups, food producers and dynamic biotechnology companies.
Rely on German Principals:
Ihr Ziel ist unsere Aufgabe!
Aurigon Life Science GmbH
Address: Bahnhofstr. 9-15, 82327 Tutzing, Germany
Tel.: +49 (0) 8158 2597-44
Fax: +49 (0) 8158 2597-31
Contact: Dr. Stefan Krawielitzki, Manager Business Development
E Mail: info@aurigon de
E-Mail: info@aurigon.de
Website: www.aurigon.de

Cfm Oskar Tropitzsch
Established in 1788 as 1 st chemical factory in Germany Cfm Oskar Tropitzsch e.K. assists
the chemical, pharmaceutical and biotechnological industry in sourcing and producing
chemical specialties. The core of our work is to supply the product which our customer is
looking for - with the right documentation (customized DMF), the correct quantity from lab
scale to production scale and proper quality. As reliable partner of well-known companies
Cfm Oskar Tropitzsch focus to establish a long-term relation to its customers and suppliers
to support projects from RnD state up to commercial production. To achieve these
challenging goals Cfm Oskar Tropitzsch uses its excellent knowhow and worldwide network
of qualified suppliers.
Finding the best solution! ...it's not just a sentence – it’s our mission!
Cfm Oskar Tropitzsch is specialized in the following core markets:
Biochemicals made by fermentation
Mycotoxins – Antibiotics – Substances for Apoptose (i.e. Geldanamycin, K-252a,
Rapamycin, LL-Z-1640-2)
Phytochemicals
Plant extraction, Plant extracts, standard reference materials
> 800 Medicinal Plants/Herbs (roots, barks, seeds, leaves: dried or fresh)
Extracts as pharmaceutical raw materials (incl. required documents)
Natural Toxins; either from animals directly or natural toxins produced by Peptide Synthesis
(snakes, bees, spiders, scorpions, amphibians).
Contract manufacturing of
APIs – Excipients – Chemical Specialties – Small-scale production (non-GMP, GMP,
including DMF/ASMF establishment)
Cfm Oskar Tropitzsch would be pleased to get in contact with your valuable company and to
start a long term relation. We are looking for customers, but also for suppliers and
CMOs/CROs.
Cfm Oksar Tropitzsch e.K.
Address: Waldershofer Str. 49-51, 95615 Marktredwitz, Germany
Tel: +49 (0) 9231 9619-0
Fax: +49 (0) 9231 9619-60
Contact: Oskar Tropitzsch, CEO
E Mail: oskar tropitzsch@cfmot de
E-Mail: oskar.tropitzsch@cfmot.de
Website: www.cfmot.de

Coriolis Pharma
Science-driven Formulation and Lyophilization Development Services for
Biopharmaceuticals
Coriolis Pharma is a globally operating independent service provider for research and
development of formulations and lyophilization processes of (bio)pharmaceutical drugs
(proteins, peptides, monoclonal antibodies, RNA/DNA etc.) and vaccines.
An interdisciplinary team of highly qualified scientists with many years of experience in
the development of (bio)pharmaceuticals supported by an expert scientific advisory
board provides cutting-edge service and know-how related to the formulation
development of biopharmaceuticals.
This may involve for example formulation development of (pre-)clinical material through
to commercial products, lyophilization processes, stability testing, supply of pre-clinical
material, and innovative analytical l technologies for aggregate analysis and particle
characterization also for trouble shooting (e.g. Dynamic light scattering, Nanoparticle
tracking, Coulter Counter, Archimedes, Analytical ultracentrifugation (AUC)).
Coriolis Pharma has been successfully inspected to perform GMP compliant analysis
using Light Obscuration, Micro-Flow Imaging (MFI), Asymmetric Flow Field Flow
Fractionation (AF4) and Hollow Fiber Flow Field Flow Fractionation (HF5) and has now
received a Certificate of GMP compliance from the competent regulatory agency.
The unique combination of available methods, leading scientific expertise in the fields of
biopharmaceutical formulation development and testing and the ability to offer those
services in compliance with highest quality standards makes Coriolis Pharma an ideal
partner for companies wishing to outsource particle and aggregation characterization of
their biopharmaceutical.
Coriolis Pharma Research GmbH
Biopharmaceutical Research and Development Service
Address: Am Klopferspitz 19, 82152 Martinsried, Germany
Tel: +49 (0) 89 5424498-0
Fax: +49 (0) 89 5424498-22
Contact: Dr. Michael Wiggenhorn, CEO
E Mail: contact@coriolis pharma com
E-Mail: contact@coriolis-pharma.com
Website: www.coriolis-pharma.com

ELLA Biotech
ELLA Biotech, an independent and privately owned company founded in
October 2004, is focused on the production of high quality and special
oligonucleotides – following quality standards which you would appreciate
and expect in your own lab.
We offer an extremely reliable service for the custom synthesis of
oligonucleotides according to the needs and ideas of our customers.
The ELLA-Team shares several decades of experience in oligonucleotide
synthesis and combines an interdisciplinary mix of skills essential for a
smooth running synthesis lab: Nucleic acid chemists, biologists,
technicians for equipment maintenance and lab managers experienced in
oligonucleotide production according to DIN EN ISO 9001:2008
regulations.
Our product portfolio includes primers and probes for diagnostics in
compliance with ISO 13485:2003 and ISO 9001:2008 standards, highquality
long oligonucleotides (e.g. aptamers) and also randomized
oligonucleotides using trinucleotides (Trimers).
ELLA Biotech GmbH
Address: Am Klopferspitz 19, 82152 Martinsried, Germany
Tel: +49 (0) 89 7093-9316
Fax: +49 (0) 89 7093-9440
Contact: Iris Heigl, Marketing & Sales
E-Mail: irisheigl@ellabiotech.com
Website: www.ellabiotech.com

FGK Clinical Research
FGK Clinical Research GmbH is a Europe-based full service Contract
Research Organization offering the complete range of clinical
development and consulting services to pharmaceutical, biotechnology
and medical device companies. Employing more than 80 highly-skilled
and experienced professionals, FGK operates from Munich on local and
global projects, covering clinical studies in Phases I to IV. FGK has
extensive experience in all major therapeutic areas and clinical research
fields allowing it to effectively design, manage and analyze development
programs and clinical trials. FGK has subsidiaries in Prague, Warsaw,
Budapest and London.
We offer full service for the conduct of clinical trials including clinical trial
management and clinical monitoring, regulatory submissions,
biostatistics, data management, medical writing, quality assurance,
pharmacovigilance and consulting services.
FGK Clinical Research GmbH
Address: Heimeranstr. 36, 80339 Munich, Germany
Tel.: +49 (0) 89 893119-22
Fax: +49 (0) 89 893119-20
Contact: Dr. Edgar J. Fenzl, CEO
E-Mail: edgar.fenzl@fgk-cro.com
Website: www.fgk-cro.com
com

FGK Representative Service
FGK Representative Service GmbH was founded in order to meet the
legal requirements of sponsor companies which do not have a
subsidiary within the European Union for the purpose of performing
clinical research projects in the European Union. Such legal
representative for clinical drug trials or authorized representative for
medical device trials fulfils the obligation that the sponsor companies
must be established or represented in the European Union according
to the Clinical Trials Directive 2001/20/EC.
FGK represents its partners in all member states of the EU for drug
and medical device trials to enable submissions of regulatory
applications to the European authorities and ethics committees. FGK
also represents overseas companies for all applications in drug
authorizations and orphan drug designations.
FGK also provides the service of "local representation" for Switzerland
via their subsidiary in Zug, Switzerland.
FGK Representative ti Service GmbH
Address: Heimeranstr. 36, 80339 Munich, Germany
Tel.: +49 (0) 89 893119-22
Fax: +49 (0) 89 893119-20
Contact: Dr. Edgar J. Fenzl, CEO
E-Mail: edgar.fenzl@fgk-rs.com
Website: www.fgk-rs.com

HYGLOS
Hyglos GmbH is a biotech company located in Biotechnologie Zentrum Bernried (BZB),
Munich area, Germany. Applying our proprietary technology we develop and produce highly
specific phage derived recombinant proteins for detection of bacteria and anti-microbial
applications. The resulting products are used in food safety testing, removal of microbial
contaminations, human diagnostics as well as research applications.
In the field of endotoxin detection Hyglos has introduced a ground-breaking new technology
called EndoLISA®. Endotoxins are specifically bound to the microtiter plate and interfering
substances are completely removed by a wash procedure. The endotoxin content is
quantified by means of recombinant Factor C and a fluorescent substrate. EndoLISA®
overcomes limitations of the currently used methods, such as LAL test. The advantages of
this assay include the very broad measurement range, the pH tolerance range and the
exceptional tolerance regarding buffer components such as salts, organic solvents,
detergents and protease inhibitors. The new test offers reliable results and complete test
solutions including all components needed for endotoxin detection.
Concerning endotoxin removal we provide outstanding technology to our customers from
biopharmaceutical research and industry. Based on endotoxin-specific recombinant phage
proteins applied for affinity chromatography, EndoTrap® reliably removes endotoxins from
aqueous solutions of e.g. proteins, antibodies, vaccines, nucleic acids, buffers and various
other substances with excellent sample recovery rates for maximized research and downstream
results. The EndoTrap® technology is currently the most powerful and convenient
solution for endotoxin removal available and can easily be scaled up for lab research and
industrial applications. For industrial application a regulatory support file is available.
The Hyglos food microbiology product portfolio focuses on innovative bacteria capture
systems targeting foodborne pathogens such as Listeria and EHEC. Magnetic particles
coated with phage derived binding molecules are used to enrich bacteria from complex
matrices. The technology offers outstanding bacterial capture performance and improves
quality of microbiological testing as well as reduced time to result.
Hyglos GmbH is certified according to ISO 9001:2008 and ISO 13485:2003 + AC:2007.
HYGLOS GmbH
Address: Am Neuland 3, 82347 Bernried, Germany
Tel.: +49 (0) 8158 9060-0
Fax: +49 (0) 8158 9060-210
Contact: Dr. Wolfgang Mutter, General Manager
E-Mail: wolfgang.mutter@hyglos.de
g g @ yg
Website: www.hyglos.de

Intana Bioscience
Intana Bioscience GmbH, based in Martinsried near Munich, is a privately
owned service provider company, founded in Sept 2008 with currently 8
employees.
Intana Bioscience GmbH offers interaction analysis based on a single molecule
sensitive spectroscopic approach called Fluorescence Cross Correlation
Spectroscopy (FCCS).
By analyzing the diffusional behavior of molecules in solution, FCCS allows to
determine the concentration of the interacting molecules, their size and their
binding state and to calculate precisely the dissociation- and rate constants.
The approach can be used to profile and investigate compounds, peptides,
proteins, nucleic acids, antibodies and any target-ligand interaction label free
and in high throughput.
Supply with sufficient amounts of purified and active target protein has shown to
be one of the pitfalls in classical assay development. Additionally purified
proteins do not represent the physiological situation of a cell in which a future
drug is supposed to unfold its effect. In contrast, FCCS can be applied in
cellular lysates and living cells to determine affinity and kinetics of biomolecular
interactions and bridges the gap between cellular and biochemical assays. It
therefore represents a highly efficient approach to support the development of
selective inhibitors for targeted therapies.
Customers benefit from short assay development time, in depth interaction
analysis and assay conditions that mimic the natural environment of a drug.
Intana Bioscience GmbH
Address: Lochhamer Str. 29 a, 82152 Martinsried, Germany
Tel.: +49 (0) 89 8955-72802
Fax: +49 (0) 89 8955-7281
Contact: Dr. Stefan Hannus, Director & CSO
E-Mail: stefan.hannus@intana.de
Website: www.intana.de

INTERLAB
INTERLAB looks forward to meeting Biotech and Pharmaceutical companies planning and per-
forming clinical trials in Phases II or III. As a centralized laboratory INTERLAB is experienced in
supporting these research companies directly or via contract research organizations (i.e. CROs).
INTERLAB is an independent CENTRAL LABORATORY supporting regional, international and
global clinical trials for pharmaceutical and biotechnology companies. INTERLAB has developed
into a worldwide network of central laboratories dedicated to clinical research covering Europe,
North and South America, Australia, Africa and Asia including India and China. The international
head office is located in Munich, Germany.
INTERLAB provides full-service analytical and logistical support as well as a wide range of
routine and esoteric testing methods at highest quality standards
• Professional project managers (with PhD degree) coordinate all activities worldwide
• Study-specific instruction manuals and customized requisition forms
• Visit-specific kits to ease sample handling at sites, incl. monitoring of expiry dates & kit re-supply
• Cost-effective shipment logistics worldwide: ambient, refrigerated, frozen conditions
• Flexible data management and transfer
• All lab data collected worldwide in one single global database
• Same layout for all laboratory reports worldwide
• Storage capabilities: -20°C, -70°C, -80°C, liquid nitrogen
Analytical methods in all therapeutic areas are available: clinical chemistry and hematology –
endocrinology and genetics, PCR – microbiology and virology – immunology and serology –
histopathologyand cytology – toxicology and drug assays, incl. LC-MS/MS
More than 1,500 different methods are available.
In Europe, over 15,000 samples are processed daily by a staff of over 300; over 50,000 samples
per day and over 6,000 staff worldwide – a strong global laboratory network
Standard operating procedures (SOPs) reflect the requirements of GCP and EN/EC/ISO15189,
EN 45,001 and ISO 9002
Periodic cross-validation and internal audits of all partner laboratories
Same global SOPs for study setup and data communication
INTERLAB central lab services - worldwide GmbH
Address: Bayerstraße 53, 80335 Munich, Germany
Tel.: +49 (0) 89 741393-0
Fax: +49 (0) 89 741393-39
Contact: Dr. Hermann Schulz, CEO
E-Mail: info@interlab.de
Website: www.interlab.de

IRIS Biotech
IRIS Biotech is specialized in reagents for Drug Discovery, Drug Delivery, Diagnostics and
Biocatalysis. We have specific know-how and production capabilities to manufacture and
supply products from the following areas from grams to multi-ton lots:
1. Starting Materials for Peptide Synthesis, Peptidomimetic and Medicinal Chemistry
Protected Amino Acids, Coupling Reagents, Linkers and Resins, Natural and Unusual Amino
Acids and Building Blocks used in Peptide Synthesis, Peptidomimetic and Medicinal Chemistry.
2. Technologies for Drug Delivery
With more than 500 different products we carry the worldwide largest portfolio of PEGylating
reagents from short monodisperse to long polydispersepoly (ethylene glycol) derivatives.
PASylation is a modern technology, in order to improve the pharmacokinetic properties of
biopharmaceuticals produced by recombinant techniques.
PGA Poly (glutamic acid) is a modern drug carrier system providing the advantages of polymer
therapeutics also to small drug molecules.
Multifunctional Dendrimers are sophisticated carrier tools in modern applications like
Personalized Medicine and Combination Therapy.
3. Reagents for Life Sciences and Diagnostics
Enzyme Substrates and Special Proteins, Diagnostic and Biochemistry Tools
Natural Products, with biological and pharmacological activity, like immunsuppressiva:
Aflatoxines, Cyclosporines, Geldanamycin, Rapamycin, etc.)
Carbohydrates (Derivatives of Arabinose, Galactose, Glucose, Xylose, etc.)
Dyes and Fluorescent labels for Peptide Synthesis and Molecular Biology
4. Biocatalysis
We offer a wide range of unusual and innovative enzymes, immobilised enzymes and enzyme
carriers for modern biocatalysis.
The goal of our visit in Japan …
is to establish contact to customers working in the areas of our activities. We would like to talk to
scientists and related personal of R&D and production departments in companies working in the
areas peptides, medicinal chemistry, diagnostics and Life Sciences and pharmaceutical industry
in general.
Iris Biotech GmbH
Address: Waldershofer Str. 49-51, 95615 Marktredwitz, Germany
Tel.: +49 (0) 9231 9619-73
Fax: +49 (0) 9231 9619-99
Contact: Annick Vancolen, Sales Manager
E Mail: annick vancolen@iris biotech de
E-Mail: annick.vancolen@iris-biotech.de
Website: www.iris-biotech.de

NDA Regulatory Service
NDA Group is a leading European regulatory and pharmacovigilance consultancy. We
offer advice throughout the lifecycle of a new drug, from development and approval, to
post approval activities.
Our team of over 100 European-wide specialist consultants, in collaboration with our
unique Regulatory and HTA Advisory Boards, are on hand to give you the best advice
and support to get new drugs to the market, and keep them there.
Based in Germany, Sweden and the UK, NDA supports drug companies in Europe, as
well as global organisations seeking EU regulatory and pharmacovigilance advice.
Our expertise spans four main areas:
1.Strategic and operational – we can support clients with high level strategic advice,
right through to hands-on operational requirements.
2.All substances and therapeutic areas – Our experts span every part of the pharmaceutical
industry and what’s needed to get your drug to market, in a tailor-made
fashion. This includes small molecules, biopharmaceuticals and advanced therapies
3.Unique and completely impartial advice – The NDA Advisory Board gives clients
top-level advice from some of Europe’s leading regulatory, HTA and pharmacovigilance
experts. Clients are further supported by an experienced team of over 100
project managers, subject-matter-experts, ex-regulators and advisers from across the
industry. Our advice is honest, direct and delivered in a manner clients can understand.
4.National and global capability – our team has the expertise to support any EU
regulatory, HTA and pharmacovigilance requirement, whether you are based in Europe,
the Americas, Asia or Emerging Markets.
NDA Regulatory Service GmbH
Address: Weihenstephaner Straße 28, 81673 Munich, Germany
Tel.: +49 (0) 89 3585-4000
Fax: +49 (0) 89 3585-4010
Contact: Monika Eck-Schaupp, Deputy Managing Director
E-Mail: munich@ndareg.com
Website: www.ndareg.com

PRIAXON
Priaxon is a drug discovery company that uses a unique, proprietary
technology platform for the development of small molecule therapeutics.
PriaXplore® employs novel computational and synthetic approaches to
address protein protein interactions (PPIs) in a highly innovative and
efficient way. The technology has successfully been applied for the
development of inhibitors of the MDM2-p53 interaction, which were
partnered with Boehringer-Ingelheim on a co-development basis. With the
recently founded Priaxon Inc. at the Fox Chase Cancer Center Priaxon
has access to all the high class assays in oncology, which strengthens the
biological competence and capacity of the company essentially.
Besides several internal programs in the field of apoptosis Priaxon has
developed a special business model: Priaxon works on own risk on targets
coming from a partner. The success criteria concerning the developed
compounds have to be mutually agreed. The partner has a right of
preemption on a pre-negotiated contract basis. The exclusivity concerning
the project is guaranteed. Hitting the pre-negotiated criteria triggers an outlicensing
contract, which has to be mutually agreed before the start of the
project. The biological screening of the compounds is carried out by the
partner on the basis of a MTA. I would be glad to discuss opportunities for
co-development and possible collaborations on a flexible business basis.
PRIAXON AG
Address: Gmunder Str. 37 – 37a, 81379 Munich, Germany
Tel.: +49 (0) 89 4521308-0
Fax: +49 (0) 89 4521308-22
Contact: Dr. Christoph Burdack , CSO
E-Mail: burdack@priaxon.de
@p
Website: www.priaxon.com

SIRION BIOTECH
SIRION Biotech was founded in 2006 in Munich and maintains offices in
Tokyo and New Hampshire. It stands for sophisticated cell modeling and
viral vector platforms. These enable much improved target identification
and compound screening in the drug, the food & cosmetic industries. Its
technology has over the years been validated in more than 250
commercial projects with more than 70 academic and industrial
organizations worldwide. As a result, primary cell immortalizations are
being technically advanced, so are the recombinant construction of
adenovirus serotype vectors serving for gene therapy applications and
novel vaccines.
Specifically, SIRION Biotech is offering a satisfaction guarantee on gene
knockdowns of nearly 100% (RNAiONE), cell lines with built-in reporter
genes (SenCELL), next generation cell models with high on-target
knockdowns. VariCHECK represents an inducible expression system for
the functional analysis of protein variants. Ready-to-use-kits offer up to
50-fold transduction enhancement (AdenoBOOST) or convenient and
reliable vector cloning & purification within just 4 weeks (AdenoONE).
Commercial arrangements range from fee-for-service over exclusive rights
on single clones all the way to milestone & licensing arrangements. The
latter are suited for longer term complex product developments in the
areas of gene therapy and vaccines. Molecular biologists experienced in
the field stand ready for project discussions in Europe, Japan and USA.
SIRION BIOTECH GmbH
Address: Am Klopferspitz 19, 82152 Martinsried, Germany
Tel.: +49 (0) 89 70096199-15
Fax: +49 (0) 89 70096199-8
Contact: Dr. Christian Thirion, CSO
E-Mail: thirion@sirion-biotech.com
Website: www.sirion-biotech.com

SuppreMol
SuppreMol, a privately held biopharmaceutical company, is developing novel proteins to treat
autoimmune diseases and allergy. The company is pioneering the development of soluble Fc
gamma receptors (FcγRs) and other immunomodulatory molecules and antibodies for alternative
treatment strategies that have the potential to readjust the balance of the immune system.
SuppreMol’s lead candidate SM101 is a recombinant, soluble, non-glycosylated version of the
Fc gamma receptor IIB (FcγRIIB) and has received orphan drug designation in the US and
Europe for Primary Immune Thrombocytopenia (ITP). Recent Phase Ib results in ITP have shown
SM101 to be safe, well tolerated and efficacious in a dose-dependent manner. Subsequent
Phase IIa and IIb trials in Europe and the US will be initiated iti t in 2012. In 2011 SuppreMol started
t a Phase IIa randomized, double-blind clinical trial with SM101 in patients suffering from Systemic
Lupus Erythematosus (SLE). In preclinical studies SM101 has shown strong efficacy by
decreasing inflammation and immune reactions. These data suggest that SM101 also has
potential in Rheumatoid Arthritis (RA) and other B cell-driven autoimmune diseases.
To strengthen its platform of selective immunoregulators, SuppreMol is working on antibody
programs targeting Fc receptors and other immunomodulatory molecules that interfere at earlier
stages of a disease. Fc gamma receptors IIB (FcγRIIB) γ are the sole inhibitory receptors on
immune cells and, when co-crosslinked with activating receptors such as B cell receptor or Fc
epsilon receptors, inhibit the activation of B cells or basophils/mast cells. SuppreMol’s nonblocking
anti-FcγRIIB antibodies SM201 and SM301 are utilizing that mechanism and recruit
further inhibitory FcγRIIB into the cluster to effectively downregulate the exaggerated immune cell
responses in autoimmune diseases and allergy. SM401, a monoclonal antibody against IL-3, has
demonstrated in a murine model for Rheumatoid Arthritis (RA) that it significantly reduces
progression and severity of the disease. At the same time, levels of inflammatory cytokines such
as IL-6 and TNF-alpha alpha, which are reduced by several established RA drugs, are also lowered.
Using a newly developed IL-3 diagnostic assay, SuppreMol expects to successfully develop a
biomarker for the stratification of RA patients.
SuppreMol was founded as a spin-off from the laboratory of Prof. Dr. Robert Huber, Nobel Prize
in Chemistry 1988, at the Max Planck Institute for Biochemistry in Martinsried, Germany. To date
SuppreMol has raised €35.8 million through private investors and €11.7 million in project funding.
SuppreMol GmbH
Address: Am Klopferspitz 19, 82152 Martinsried, Germany
Tel.: +49 (0) 89 30905068-0
Fax: +49 (0) 89 30905068-68
Contact: Dr. Robert Phelps, Head of BD and Licensing
E Mail: phelps@suppremol com
E-Mail: phelps@suppremol.com
Website: www.suppremol.com