UPDATE 1-Europe approves high-price gene therapy

Posted: November 3, 2012 at 3:44 am

* European Commission clears Glybera for ultra rare disease

* UniQure drug is first gene therapy to reach market in West

* Glybera likely to cost around $1.6 million per patient

* Final EU approval follows positive recommendation in July (Adds interview with company CEO, pricing details, background)

By Ben Hirschler

LONDON, Nov 2 (Reuters) - European officials have approved the Western world's first gene therapy drug from a small Dutch biotech company, in a milestone for the novel medical technology that fixes faulty genes.

The formal clearance from the European Commission paves the way for a launch next summer of the treatment for an ultra rare genetic disease that will cost around 1.2 million euros ($1.6 million) per patient, a new record for pricey modern medicines.

After more than 20 years of experiments and a series of disappointments, the EU approval of Glybera, which treats the genetic disorder lipoprotein lipase deficiency (LPLD), is a significant boost for the gene therapy field.

Joern Aldag, chief executive of Amsterdam-based uniQure, said more such treatments would follow and argued a high price was justified because gene therapy restored natural body function and did not just offer a short-term fix.

"This provides higher benefit to patients than the classical protein replacement strategy and this is why we think we should be fairly and adequately compensated," he said in a telephone interview on Friday.

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UPDATE 1-Europe approves high-price gene therapy

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