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Date: 11th November 2002
CMC Biopharmaceuticals A/S and Lundbeck A/S form strategic partnership

Long-term strategic partnership agreement implies considerable increase in CMC Biopharmaceuticals' activities.

CMC Biopharmaceuticals and Lundbeck have signed a long-term strategic partnership agreement, according to which CMC Biopharmaceuticals is to analyse, develop and manufacture the active ingredients used in new protein-based drugs developed by Lundbeck.

The agreement results in a significant increase in the activities and turnover of CMC Biopharmaceuticals. Following this agreement and other sales contracts it has been necessary to expand the CMC's facilities at the Symbion Science Park hereunder to establish production facilities for clinical production of biopharmaceuticals. In August 2003 CMC Biopharmaceuticals will move to a new state-of-the art development and production centre in the Copenhagen area, Denmark. By then, CMC Biopharmaceuticals expects to have about one hundred employees, the majority of whom will be senior scientists and technicians with broad pharmaceutical industrial experience.

The agreement between CMC Biopharmaceuticals and Lundbeck reflects the increasing specialisation that is currently taking place in the pharmaceutical and biotechnological industries. The specialisation is a result of the recently completed mapping of the human genome. The mapping has provided important new knowledge about thousands of proteins, each of which plays a role in the human organism and each of which may therefore be important in the combating of diseases.

Extensive global research is currently taking place in the field of new protein-based drugs. Seen in a European context, Denmark has a considerable number of these drug candidates in the pipeline. The basic research in and the formulation of the active ingredients of the new drugs mainly take place in large, well-established pharmaceutical companies and in new biotech companies.

CMC Biopharmaceuticals is specialising in process development of active pharmaceutical ingredients - from the laboratory shake flask stage to actual large scale production. First stage is to produce material for the necessary clinical trials. Subsequent production will be extended to industrial scale. The process is advanced and complex in terms of quality and technology and calls for extensive biopharmaceutical knowledge and know-how. Globally, these factors are scarce.

Consequently an increasing number of pharmaceutical companies are now outsourcing this part of their development and production - which is the areas that are CMC Biopharmaceuticals' core competencies.

Lone F¿nss Schr¿der, who is responsible for finance and business development in the Board of Management of CMC Biopharmaceuticals, says: "Lundbeck is an extremely professional company with extensive knowledge and competence in their field of industry, and we are very proud of this agreement, which we consider to be a seal of approval for the quality of CMC's services. It will contribute significantly to paving the way for further activity with other large pharmaceutical companies".

Anders Vinther, who is responsible for quality in the Board of Management of CMC Biopharmaceuticals, describes the pharmaceutical market as follows: "In the future, pharmaceutical development will not only be a question of effective, targeted process development, but equally much a question of being able to document the entire process flow from the choice of cell line to timely market production at the right documentation level. If a company fails to document activities at the right time in the development stage it may have dire consequences in relation to the approval of a new drug. Regulatory requirements are becoming increasingly strict, but this is precisely the area where CMC is at the forefront of developments".

Claus Br¾strup, Executive Vice President, Research & Development at Lundbeck, says: "I am convinced that more and more pharmaceutical companies will adopt an outsourcing strategy similar to that chosen by Lundbeck, the main reason obviously being that the many pharmaceutical companies do not posses sufficient expertise such as the expertise offered by CMC Biopharmaceuticals. I am really pleased that this expertise is available in Denmark, since it is a major step forward in terms of placing the Danish Medicon Valley on the pharmaceutical world map".

For further information:
CMC Biopharmaceuticals A/S, Board of Management:
Lone Fønss Schr¿der, (business development/finance), tel: +45 29488410
Anders Vinther (quality/cGMP), tel: +45 29488404

Lundbeck A/S:
Claus Brøstrup, Excecutive Vice President, Research & Development

tel: +45 36301311

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