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Serono gets EU green light for major drug launch

Serono CEO Bertarelli hopes the launch will reflect favourably on future earnings prospects. Keystone Archive

Europe’s biggest biotech company, Serono, has won European Union marketing approval for its new psoriasis drug, Raptiva – potentially its third most important product.

This content was published on September 23, 2004 - 13:17

The go-ahead means the Geneva-based firm can press ahead with plans to launch the skin disease treatment in several European countries by the end of the year.

Jean-Hilaire Saurat, Geneva University Hospital

A new era is opening in the treatment of psoriasis.

Jean-Hilaire Saurat, chairman of the dermatology department at Geneva University Hospital, said the EU green light heralded “a new era” in the treatment of psoriasis.

“Biological treatments such as Raptiva give us new hope of providing patients with improved therapies that will be easier to manage and will provide effective and safe, long-term control of their condition,” said Saurat.

Raptiva, which inhibits the binding of immune system cells to other cells, is the first new biological treatment for psoriasis to be authorised for marketing in the EU.

Its target market is people with moderate to severe chronic plaque psoriasis – the most common form of the disease – for whom other systemic treatments or phototherapy have proved inadequate or inappropriate.

Raptiva is expected to reduce Serono’s dependence on multiple sclerosis drug Rebif, which currently accounts for around 45 per cent of sales but is coming under increased pressure from competitors.

Head start

The company estimates that peak annual sales could total $250-400 million (SFr314-502 million).

It has already been approved for use in a number of other countries, including the United States.

“This is their most important near-term new product launch – the next new product to market is Serono's proprietary psoriasis drug, onercept, expected to be launched in 2007,” said Carl-Heinz Koch, an analyst at Swiss private bank Lombard, Odier, Darier Hentsch.

“The EU go-ahead was expected, but it is still good news. One other drug failed to get approval from Europe after being cleared in the US a few years ago, and that had caused some people to question whether Raptiva would be ultimately approved in Europe,” he told swissinfo.

Koch said that, as the first biological treatment for psoriasis on the European market, Raptiva clearly gave Serono a “head start” on the competition.

There are an estimated seven million psoriasis patients in Europe, but the potential market for Raptiva is primarily made up of those who are classified as both high-risk and moderate to severe – approximately ten per cent of the total number.

Serono shares dropped slightly during early trading in Zurich on Thursday, in line with an overall downward trend in Swiss and European share prices.

swissinfo, Chris Lewis

In brief

Serono has been given the go-ahead to market Raptiva, which is already available in the US, across Europe.

Medical experts have welcomed the first biologically-based European treatment for skin disease psoriasis.

The move should reduce Serono’s dependence on one product, multiple sclerosis drug Rebif, which accounts for 45% of sales.

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Key facts

Serono is Europe’s largest biotech company and number three worldwide.
Psoriasis, for which there is no known cure, is a disease that occurs when skin cells grow abnormally.
Raptiva, a humanised therapeutic antibody that is designed to inhibit the binding of immune system cells to other cells, has already been licensed for use in the US.

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