Introduction of Cerezyme Scheduled for 1997


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Patients in the UK, now on Ceredase enzyme replacement therapy, will be receiving the new recombinant form of the drug, Cerezyme, by the end of 1997. Untreated patients awaiting the new drug are also included in this commitment made in November 1996 by Mr Henri Termeer, President and Chief Executive Officer of Genzyme Corporation, the producer of the two drugs.

'We plan to commence introducing Cerezyme into the UK during the first quarter of 1997,' said Mr Termeer at a meeting held on 20 November 1996 with Executive members of the Gauchers Association and three leading UK doctors in the field of Gauchers disease. 'This is our commitment. By the end of the year, I can categorically say that everyone will be on Cerezyme. The first to receive the new drug will be those in most clinical need.'

The meeting, called by the Gauchers Association's Chairman Jeremy Manuel, during Mr Termeer's brief visit to the UK was attended by Prof Timothy Cox, Addenbrooke's Hospital, Cambridge, Dr Pram Mistry, Royal Free Hospital, London and Dr Ashok Vellodi, Great Ormond Street Hospital for Sick Children, London. These three clinical centres along with King's College Hospital, London, and the Royal Manchester Children's Hospital treat the majority of British Gauchers patients.

Mr Termeer told the meeting that the US Food and Drug Administration (FDA) had given its approval on 24 October 1996 to manufacture the synthetic drug Cerezyme in Genzyme's new manufacturing plant located in Boston. 'However we still need a secondary approval to distribute the drug.' (This final approval was granted by the FDA in December 1996).

Genzyme received FDA approval to market Cerezyme from a small plant in May 1994. Since then, the company has been able to supply a small number of patients with the recombinant drug, while supplying the rest with Ceredase.

'We have four reactors at our new plant which will provide the new drug and up to now only two have run at any one time. It takes three months to produce the drug from start to finish and we hope that by the end of 1997 we will have full production.' Mr Termeer said that he expected regulatory approval for Cerezyme to be granted by mid 1998 in about 50 countries outside the USA.

He added that Genzyme was increasing its investment in gene therapy, the next stage in treating Gauchers disease.

Mr Termeer voiced his concern for patients in other countries, for instance the Indian sub-continent and Eastern Europe, who were unable to obtain treatment. Jeremy Manuel said that the Gauchers Association was aware of the problem and had been approached by families from overseas in their quest for help. 'While recognising that our primary role is to represent sufferers and their families in the UK and Ireland, we are keen to assist Gauchers sufferers throughout the world to receive necessary treatment in any way we can,' Jeremy added.


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Source: Gauchers News February 1997.

© Copyright Gauchers Association 1997