Wyeth's $1.5 billion (€1.4 billion) biotech plant in Dublin is 90 per cent complete, but rheumatoid arthritis sufferers must wait until 2005 to reap the benefits of the company's popular Enbrel drug which it will produce, the plant director said yesterday.
Mr Reg Shaw, managing director of the Wyeth BioPharma Campus on the outskirts of Dublin, said construction should be completed by the autumn of this year. Work on the project, said to be the biggest of its type in the world, began two years ago.
But Mr Shaw said commercial distribution from Ireland of Enbrel, which is in short supply in those markets where it is licenced in Europe and the United States, could not begin until the second quarter of 2005.
A new plant to manufacture Enbrel in Rhode Island received US regulatory approval in December, but Mr Shaw said that had only partially eased the supply bottleneck, which the Irish plant was intended to resolve.
After commissioning and validating the facility, Mr Shaw said regulators would then have to certify that the plant met standards, with European approval expected in the second quarter of 2005.
"In other words, that's the first period we can actually ship product from the facility," he said.
Enbrel sales totalled $856 million in 2001, but supply is considered severely constrained. When this problem is resolved, it is expected to capture a much bigger share of the estimated $8 billion to $9 billion global market for such treatments.
Mr Shaw said Wyeth would store any output made before 2005 at the plant, which represents a huge investment by Wyeth in what potentially is one of the world's biggest selling drugs. The treatment, in the form of an injectable powder, was developed by Immunex and is co-marketed by Wyeth and Amgen.
"The way we state it here is that it's the largest integrated biopharmaceutical investment in the world," Mr Shaw said.
The greenfield project is one of the biggest commercial construction projects ever undertaken in Ireland.
Pharmaceuticals account for $26 billion of Irish exports, making them number two only to the IT sector and are likely to overtake the sagging computer and software industry in a year or two, the Government estimates.
For Wyeth, the biotech facility is its fourth major investment in Ireland since 1974, and the most ambitious.
Mr Shaw said the plant, which will eventually employ 1,300 people, will be able to turn out 12-14 million 25 mg vials of the freeze-dried Enbrel protein.
Manufacturing Enbrel uses massive quantities of water to grow the protein in enormous 12,500-15,000 litre vats. The huge volume is filtered and refined down to an injectable amount.
