Bridging

theory and

know-howSince 1956

AS

CHEMICAL RESEARCH LABORATORYCLAUSON-KAAS

Transparency

Timely delivery

innOvaTiOn

lead Time

cO

mm

iTm

enTFOcUs

N

N

N

N Pd

F5C6 C6F5

C6F5F5C6

O

OC2H5

OC2H5

O(CH2)6COOH

H

H

OH

O

Cl

COCH3

R

NH2

F

O

OH

COOHOR

HOOH

N

O

CH3

H3C

inTegriTy

ded

ica

TiO

n

The founder of our company, Dr Niels Clauson-Kaas, started his career at the universities in Copenhagen, Zürich and Haifa. In 1949 he was offered a position as head of an industrial organic synthesis laboratory in Denmark. In 1956 he decided to start his own company focused on research and development in organic synthesis, providing contract services to the chemical industry.

Over the years Niels Clauson-Kaas headed a group of highly competent and dedicated chemists – and together they created an inspiring and innovative environment, today known as Niels Clauson-Kaas A/S. From the very beginning his dedication, scientific approach, lab craftsmanship and focus on customers were, and still are, an inspiration to all employees. This may be the reason why Niels Clauson-Kaas A/S, over the years, has been able to develop a smooth work-flow with a very strong focus on results, timely delivery and cutting edge documentation.

Niels Clauson-Kaas’ reputation as an outstanding chemist was a true asset to the company. Despite his position as founder and CEO, he remained a chemist and a scientist at heart, working at the lab bench throughout his career.

In 1983, a foundation was established to facilitate the buyout of Niels Clauson-Kaas. The objective was evident: To build a sustainable company, and continue to have an inspiring work environment.

This was the beginning of a new era. With emphasis still on organic chemistry, focus was put on a more aggressive marketing strategy. Niels Clauson-Kaas A/S expanded from being a regional player, primarily doing business in Scandinavia and Switzerland, to an international player on the European, North American and Japanese markets.

THE STOry SO FAr

Two reactions named after Niels Clauson-Kaas Niels Clauson-Kaas’ research within furan and pyridine chemistry resulted in the development of new transformations in organic chemistry. The above reaction is known as the ’The Clauson-Kaas Pyrrole Synthesis’ and the reaction below is in Houben-Weil’s ’Metoden der Organischen Chemie’, named ’Der Clauson-Kaas Übergang’.

Niels Clauson-Kaas, Dr.techn.h.c. and Dr.scient.h.c., (1917-2003) was an outstanding chemist. He held a Master of Science Degree from the Technical University of Denmark (1940) as well as from the University of Copenhagen (1943).

O CHO

Oxidation CHO

O

CHO

N

OH

NH2

Der Clauson-Kaas Übergang

NH2

OMeO OMe+

N

The Clauson-Kaas Pyrrole Synthesis

3

THE COMPANy

4

For more than half a century, Niels Clauson-Kaas A/S has served the global life science industry in the field of organic chemistry r&D on a contract basis. The company has developed from its start in 1956 with only a few chemists to the current staff of 28 highly qualified individuals, including organic chemists, analytical chemists as well as quality assurance and production staff.

Since the start of the company, our business has been within organic chemistry. We have a stringent focus on process development and pilot production of advanced stage intermediates and Active Pharmaceutical Ingredients (APIs) for pre-clinical and/or clinical trials.

This focus has given Niels Clauson-Kaas A/S a unique position. Today, we are known and appreciated for our ability to supply state-of-the-art services, and to meet the deadlines and quality agreed to with our clients, understanding that timely delivery is crucial.

All new projects are carefully screened prior to acceptance. We benefit from our vast experience gained from more than 1,100 projects for more than 170 clients over the past fifty years. To our clients, our acceptance is an assurance that we have taken all reasonable perspectives into consideration, and that we are ready to do the job.

Dialogue and communication are keystones when cooperating with our clients. All communication is coordinated through our Project Managers, who address all information regarding the project in an open-minded and transparent environment.

Our facilities of 1,200 sq. m. (13,000 sq. ft.) consist of a large, well-equipped synthesis laboratory, an analytical laboratory completely renovated and expanded in 2005, and a multi-purpose, modern pilot plant operated under cGMP.

NIELS CLAUSON-KAAS A/S

Discovery Development Development Development Development Market Introduction

Medicinal Chemistry

Client

Pre-Clinical Studies Clinical Phase 1 Clinical Phase 2 Clinical Phase 3 On-Going Production

Client

Niels Clauson-Kaas A/S is situated north of Copenhagen, the capital of Denmark, and in the heart of Medicon Valley, which is the hub of the North European Life Science industry.

Covering both the Swedish and the Danish coasts of Øresund, Medicon Valley has developed into one of the most important clusters within the pharma and biotech industries worldwide.

Not only is this position powered by local entrepreneurs emerging from one of the seven universities, or by the huge number of pharmaceutical/biotech companies in the area – global players have seen the opportunities as well. Easy access to highly skilled employees and talent has attracted increasing numbers of global life science companies to Copenhagen and Malmø.

SEEK TALENT WHErE TALENT IS

By courtesy of Medicon Valley and Copenhagen Capacity.www.mediconvalley.com

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Good Manufacturing PracticeMany of the products we develop are either advanced stage intermediates or Active Pharmaceutical Ingredients for pre-clinical and/or clinical trials, and are produced in accordance with cGMP.

Niels Clauson-Kaas A/S is committed to operating in compliance with GMP as defined by the ICH Q7 GMP Guide for Active Pharmaceutical Ingredients (APIs), and rules Governing Medicinal Products in the European Union, Vol. 4, Part II, concerning APIs for use in clinical trials.

Appropriately staffed Quality Assurance and Quality Control functions are important parts of our GMP system. Our Quality Assurance activities comprise our internal SOP system, e.g. training of personnel, controlled production documentation and release/approval decisions and investigations. Our system is constantly being updated, among others by client audits. More than 75 external QA groups from the pharma and biotech industries have audited our QA system over the past 20 years. Niels Clauson-Kaas A/S holds a GMP certificate issued by the Danish Medicines Agency, available on our corporate website:www.clauson-kaas.com.

CommunicationAt Niels Clauson-Kaas A/S we understand the importance of communication and documentation.

Throughout any project, our clients are regularly briefed by progress reports, and all projects are concluded with a summary report. Copies of all GMP documentation are provided to our clients following product release.

WE Try HArDEr

Technology TransferNiels Clauson-Kaas A/S can support the transfer of the developed technology to any third party chosen by the client. In addition, we can recommend several established API manufacturers around the world with whom we have successfully worked.

Intellectual PropertyOur position is quite clear. The entire intellectual property resulting from the development program belongs to the client. Any former intellectual property owned by Niels Clauson-Kaas A/S will be made available to the client on a royalty free basis.

EnvironmentWe care about the environment around us – and the people working with us. Therefore, we take all necessary precautions to protect the environment and to minimize the impact of our work on our employees. Niels Clauson-Kaas A/S operates in accordance with applicable laws and regulations in Denmark, as well as those within the European Community.

Waste ControlAll hazardous waste, whether in solid, liquid or gaseous form is collected and sent for treatment at an authorized waste disposal site.

We Care about the eNViroNMeNT around us – and the people working with us

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Niels Clauson-Kaas A/S has a well-equipped, state-of-the-art synthesis laboratory used for conducting process development and small-scale, non-GMP manufacture. The lab consists of ten fume cupboards and two walk-in hoods equipped with up to 20 L glass flasks.

Niels Clauson-Kaas A/S has developed a vast knowledge pool within the area of organic chemistry over the past fifty years, and our internal system setup safeguards all information. All lab notes throughout the years are stored in our central archive, and through an internal reaction database consisting of more than 7,800 reactions conducted in-house, we have easy access to valuable references of previously developed chemistry.

In addition, we have on-line access to various chemical databases, including but not limited to STN databases and CrossFire Beilstein.

SyNTHESIS LABOrATOry

Well-eqUippeD synthesis laboratory

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Project ManagementWhen it comes to project management, we aim at setting the highest standards within the industry. Over the years we have developed a system, in which one chemist has the overall responsibility for project management from the very start of a project right to delivery of the product to the client.

This way of seeing project management in a matrix organisation ensures a seamless flow through the process steps, where all information is gathered by the Project Manager.

The Project Manager is also responsible for keeping the project on track, as well as for transferring information between the client and our team through the whole project.

ANALyTICAL LABOrATOry

STaTe-of-THe-arT analytical laboratory10

Niels Clauson-Kaas A/S has a modern, well-equipped analytical laboratory, which was completely renovated and expanded in 2005.

Our analytical laboratory instrumentation includes HPLC, GC and LC-MS. In connection with process development and API manufacture, we can offer development and validation of analytical test methods as well as stability studies according to ICH guidelines. Some analyses, such as residue on ignition, heavy metals, NMr, Ir, microbiological tests, and elemental analysis are carried out by external laboratories, all audited by Niels Clauson-Kaas A/S.

STaTe-of-THe-arT analytical laboratory11

PILOT PLANT

Niels Clauson-Kaas A/S has its own modern, multi-purpose pilot plant, operated under GMP. The pilot plant consists of five production lines equipped with glass or glass-lined reactors ranging from 40-280 L plus a 160 L stainless steel reactor used for cryogenic reactions.The pilot plant consists of three production rooms, two drying rooms, several storage areas and utility rooms.

Our Pilot Plant Manager has headed our facility for more than 20 years. His responsibilities include: Equipment qualification, maintenance program, equipment cleaning program and personnel training.

The pilot plant is staffed by both chemical engineers and technicians. When a project is transferred from the laboratory to the pilot plant, the responsible Project Manager is in charge and actively participates in the transfer, assisted by the pilot plant staff.

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13

AUSTRALIA:

David Bull Laboratories

Peptech Limited

DENMARK:

Action Pharma A/S

Benzon Pharma A/S

BKG Pharma

Brüel & Kjær

Bukh Meditec A/S

Carlbiotech A/S

Carlsberg Laboratory

Cheminova A/S

Convex

Danisco A/S

Dumex A/S

Esbjerg Kemi A/S

Exiqon A/S

Ferring A/S

Finseninstituttet

Grindsted Products A/S

H. Lundbeck A/S

Kemisk Værk Køge A/S

LifeCycle Pharma A/S

Litex A/S

Miljøstyrelsen

Neurokey A/S

NeuroSearch A/S

Novo Nordisk A/S

Nunc A/S

Osteologix A/S

Pantheco A/S

Pharmacia A/S

Pharma-Medica A/S

PNA Diagnostics A/S

radiometer

risø DTU

Sadolin & Holmblad A/S

Santaris Pharma A/S

Statens Serum Institut

TopoTarget A/S

FINLAND:

Farmos Group

Hormos Medical Oy

K.S.V. Chemicals

Kemira Oy

Orion Corporation Farmos

Star Oy

Veitsiluoto Oy

FRANCE:

Centre de recherche Merrell Int.

Finorga S.A.

NicOx S.A.

PPG Sipsy

GERMANY:

Alvetra GmbH

Girindus GmbH

HOLLAND:

Broomchemie

Océ-Andeno

Shilton Chemicals BV

IRELAND:

Pilmar Pharmaceuticals Ltd

ISRAEL:

Abic Ltd

NST

Plantex Ltd

ITALY:

Farchemia S.r.l.

JAPAN:

Chukan Butsu Ltd

Menicon Co. Ltd

Sankyo Company, Ltd

Takeda Industry Co., Ltd

NORWAY:

Amersham Health AS

Nycomed Amersham

SPAIN:

Laboratories Ferrer, S.L.

SWEDEN:

AstraZeneca AB

Biovitrum AB

Chemical Dynamics Development AB

Cortendo AB

DuPont Chemoswed

GE Healthcare AB

GS Development AB

Medivir AB

Mölnlycke AB

Nobel Chemicals AB

Perstorp AB

Pharmacia Fine Chemicals AB

rexolin Chemicals AB

SWITZERLAND:

Ciba-Geigy AG

Cilag-Chemie AG

Lonza Ltd

Sandoz Pharma

Seloc Pharma AG

UNITED KINGDOM:

Apin Chemicals Ltd

AstraZeneca

Beecham Group Ltd

Prosidion Ltd

USA:

Agouron Pharmaceuticals, Inc.

Alcon Laboratories, Inc.

Aldrich Chemical Company, Inc.

Allergan, Inc.

Allos Therapeutics, Inc.

Alza Corporation

Anadys Pharmaceuticals, Inc.

BrainCells, Inc.

Bristol Laboratories

Bristol-Myers Squibb

Chiron Corporation

Collaborative research Inc.

CollaGenex Pharmaceuticals, Inc.

DavosPharma

Entremed, Inc.

Exelixis, Inc.

Gliatech Inc.

Hana Biosciences, Inc.

Hollis-Eden Pharmaceuticals, Inc.

Kalypsys, Inc.

Kosan Biosciences, Inc.

Ligand Pharmaceuticals, Inc.

Magainin Pharmaceuticals Inc.

Panacos Pharmaceuticals, Inc.

Paratek Pharmaceuticals, Inc.

Protarga, Inc.

reata Pharmaceuticals, Inc.

roche Palo Alto LLC

Sigma Chemical Company

Smith Kline & French Laboratories

Targeted Genetics Corporation

Telik, Inc.

Texas Biotechnology Corp.

Tigris Pharmaceuticals, Inc.

Tularik, Inc.

TrACK rECOrD

14

AS

CHEMICAL RESEARCH LABORATORYCLAUSON-KAAS

NIELS CLAUSON-KAAS A/Srugmarken 28DK-3520 FarumDenmark

Phone: +45 4495 1881Fax: +45 4495 1855info@clauson-kaas.dkwww.clauson-kaas.dk

RepresentativesUSA and CANADADavos Chemical CorporationNew JerseyPhone: +1 201 995 0070Fax: +1 201 995 0071info@davos.comwww.davos.com

JAPANChukan Butsu Ltd., OsakaPhone: +81 6 6231 5127Fax: +81 6 6222 5126info@chukan.co.jp

www.chukan.co.jp