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Focussing on medical benefits – Nycomed to reorient its activities

An “ambassador” strategy for dual innovative power: The research-based pharmaceutical company Nycomed has come up with a new research and development concept for the development of promising drugs and clinical products. The company intends to place increasing emphasis on licensing and to enter into more intensive cooperation with external partners. The company hopes that this new orientation will be of particular benefit to patients.

Dr. Monika Baudler-Klein, head of Nycomed's Global Pipeline Sourcing team © Nycomed

The core of Nycomed's new company philosophy is a shift from in-house development to filling the product portfolio with products from external partners. The company hopes that this change will make it more flexible. The company envisages that only 20 percent of  clinical projects will come from in-house research. "Our objective is to license at least three development projects in advanced clinical phases and integrate them into our product pipeline, at the same time as our own research department contributes one or two product candidates," said Prof. Paul-Georg Germann, head of Nycomed's Research and Proof of Concept Development department. We particularly hope that this will help us close the gap which will arise at the end of 2009 as a result of the patent expiry of our best-seller, pantoprazole.

Transformation into a scouting organisation

An important pillar of the Nycomed model is the close cooperation between the “Pipeline Sourcing” and “Business Development” departments. The “Pipeline Sourcing” team, which brings together scientists and physicians and is spread between the cities of Constance (Germany), Taastrup (Denmark) and Florham Park (USA), will use active scouting to find innovative ideas and promising preparations, which it will then evaluate for medical potential, risk and technical feasibility. The “Business Development” team will coordinate contacts with business partners and assess the economic aspects of product candidates.

“The close interaction between these two areas is very important for us. And the medical benefit of the licensing opportunities is clearly in the foreground,” emphasised Dr. Monika Baudler-Klein, head of the Global Pipeline Sourcing group established in 2007. The team of 25 is in charge of tracking down between 300 and 400 project ideas, evaluating up to 120 of the ideas in technical and medical terms from which it will chose 10 to 20 for detailed evaluation and due diligence with the aim of implementing at least three new development projects per year in the internal development process.

Comprehensive project scouting through the establishment of networks

The search for new projects and therapeutic concepts will be done using an “ambassador” concept, which is rather like a snowball system. The company hopes to establish contacts with potential partners from universities, research institutions, biotechnology and pharmaceutical companies by using an international network of Nycomed staff, who, besides their principal scientific or medical activities, will be active as Pipeline Sourcing ambassadors or scouts. “Our goal is to turn Nycomed into a scouting organisation, where all employees use their personal networks in order to come up with new product ideas for the company. The decisive advantage of this is that a sourcing team like this, which in comparison with large pharmaceutical companies is relatively small, is able to cover a broad spectrum of innovative regions and thus learn about ongoing development projects very early,” said Dr. Monika Baudler-Klein who hopes that the establishment of an active network of this kind will considerably increase the company’s access to worldwide innovation.

Focusing on “near market-ready” and patient-friendly products

In the Nycomed laboratories there is huge focus on the development of patient-friendly products © Nycomed

Nycomed will focus particularly on the licensing of projects in late clinical phases. "We want to concentrate on products that have the potential to enter the market in a few years' time," said Dr. Monika Baudler-Klein, further explaining that "this step is a consequence of the large number of projects failing in the early phase of development, something that is partly due to the difficulty of transferring preclinical data to humans and the high requirements for efficacy and safety in clinical practice. "The probability of identifying a potential target in the early phases of development is about 1:20000, in Phase II, the probability of success increases to 40 percent and in Phase III, 60%," said Prof. Paul-Georg Germann, also highlighting that the company still has plans to take on promising early development projects, either by licensing validated targets or through highly effective lead structures.

Another important pillar of Nycomed's new R&D concept is its shift from big blockbuster projects to smaller products and to the more intensive search for market niches. "This reorientation is based on our experience that big pharmaceutical products in particular, have to clear many administrative obstacles before they are finally approved for marketing. Therefore, the costs associated with placing products on the market have increased considerably over the last few years. I think that by focusing on medical niches, where less comprehensive clinical development programmes are adequate, makes sense both in medical as well as economic terms," said Dr. Monika Baudler-Klein. The new model also attaches great importance to the medical benefit of the products. "We only want to advance projects and substances that have high value for patients and which are reimbursed by the health insurance companies," said Prof. Paul-Georg Germann. Nycomed intends to pursue its new research and development strategy in the core therapeutic areas, gastroenterology, respiratory diseases, inflammation, pain therapy, osteoporosis, but is also open to attractive development approaches in other therapeutic areas.

Implementation of the new concept has already started

One example of the implementation of Nycomed’s new strategy is the drug teduglutide, which is currently in clinical Phase III. This is an external product with a high medical benefit for indications other than the big blockbuster ones. An analogue of the natural glucagon-like peptide 2 (GLP-2) is used for the treatment of short bowel syndrome, which affects about 30,000 people worldwide. According to a licensing agreement with the American biopharmaceutical company NPS Pharmaceuticals, Nycomed will further develop the drug, which is given in the form of daily injections that are expected to lead to a significant growth of the bowel lining.

“One of the major medical benefits of the drug is that it improves the absorption of nutrients and fluids, thereby potentially enabling sufferers to stop relying on artificial feeding,” said Dr. Monika Baudler-Klein. “This leads to a considerably improvement in quality of life, as sufferers would normally lose a lot of weight and have to be fed with a probe. In turn, this leads to considerable savings for the healthcare system.

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