AMGEN

Amgen was one of the first biotechnology companies successfully to bring products to market. Jonathan Buisson looks at how it is making the transition to being a fully fledged pharmaceutical company with new products awaiting regulatory approval

Jonathan Buisson is on the staff of The Pharmaceutical Journal

Amgen was blessed twice in its early days by having two successful products developed using recombinant technology. Recombinant human erythropoietin alfa (epoietin, Epogen/Eprex), launched in 1989 for treating anaemia due to chronic renal failure and dialysis, and recombinant human granulocyte-colony stimulating factor (filgrastim, Neupogen), launched in 1991 for treating neutropenia.

"Both drugs were taken up very quickly by physicians and they brought enormous success to the company, ensuring its financial stability through the 1990s. During this time the company expanded rapidly. However, in the mid-to-late 1990s a few products which had been in development failed to materialise. Now we have a healthy product development pipeline with three new products expected in the next two years," Mr Kevin Young, Amgen’s country manager for the United Kingdom and Ireland, told me.

In shape and form Amgen now looks like a normal pharmaceutical company, rather than a biotechnology start up. It has a market capitalisation of around $70bn and sales of $3bn a year, putting it in or near the top 10 companies.

"We are a company in transition. We are trying to retain the innovative and entrepreneurial strengths of a biotechnology company but, at the same time, put in place the discipline and systems necessary for a world-wide organisation of 7,000 people. This is one of our chief executive’s biggest problems to solve," says Mr Young.

UK operations and new drugs

Amgen’s base for the UK and Ireland is at Cambridge science park, Cambridge. There are two operations at the site: European clinical research and commercial. The European clinical research centre employs around 350 people conducting phase II, III and IV trials and deals with functions such as clinical research monitoring, statistical analysis and regulatory submissions to both European and American authorities. The commercial division employs around 80 people working in sales and marketing, finance and management.

Amgen has two products currently being assessed by the European Medicines Evaluation Agency. If approved, they could be launched this year.

The first of these is a variation on the theme of Amgen’s first successful product. Darbepoietin alfa, or novel erythropoiesis stimulating protein (NESP), is a hyperglycosylated analogue of recombinant human erythropoietin (epoietin). The addition of two extra oligosaccaride chains has produced a larger molecule with greater metabolic stability and a half-life three times longer than epoietin.

In clinical trials, subcutaneous or intravenous administration of NESP has produced similar clinical results to epoietin but with weekly, or even fortnightly, dosing compared with thrice-weekly dosing for the existing product.

A marketing authorisation application has been submitted for the treatment of anaemia associated with renal failure and dialysis. If approved, the product could be launched under the name Aranesp in the first half of this year. Mr Young said that a lot of the clinical development of NESP had been carried out in the UK. Further clinical work was being carried out with NESP in anaemia associated with cancer.

The second product is a disease-modifying antirheumatic drug (DMARD), a recombinant form of the naturally occuring interleukin-1 receptor antagonist (IL-1RA). In a clinical trial subcutaneous administration of IL-1RA showed modest anti-inflammatory effects and a significant slowing of the rate of joint damage. Subject to regulatory approval, this product could be launched by the end of this year, probably under the name Anakinra.

Amgen is also studying the use of IL-1RA in combination with PEGylated soluble tumour necrosis factor receptor type I (sTNF-RI), which it is hoped may give synergistic effects. So far this has only been studied in animals and sTNF-RI alone is in phase II trials for rheumatoid arthritis.

Research in the UK

The United Kingdom has historically been seen as a good place to conduct clinical trials because of its system of general medical practitioners. Is this still true today?

"Our research is all in hospital-based specialties, but the UK is still a good place to do trials because the people here are motivated to take part in them. However, there are obstacles. For multisite trials, those involving work at more than four sites, there is a need to obtain centralised ethical committee approval as well as local ethical approval. This takes time, and time is the enemy in research and development. I have heard of companies which will only do trials with a maximum of four centres in the UK to avoid this."

The Government’s pharmaceutical industry competitive taskforce is looking into this area.

What effect is the National Institute for Clinical Excellence having on the UK pharmaceuticals market?

"On a commercial front, the NICE continues to be a very obstructive body for the uptake of new products. It is attenuating uptake even for breakthrough products such as ours. For example, the per capita use of Neupogen is lower in the UK than in France or Germany.

Psychologically, the NICE is casting a shadow over new products, Mr Young feels.

"The pharmacists we deal with know whether a product is being looked at, or is waiting to be looked at, by the NICE."

Pricing of new drugs is also important for pharmaceutical companies.

"British hospital pharmacists are very creative and demanding when it comes to getting best price and value from their purchases. The commercial element of the marketing mix is mightily important."

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