Shire move for rival Dyax pays off as major drug wins US approval

SHIRE’S $5.9bn (£4.6bn) purchase of rival rare disease specialist Dyax two years ago has paid off after US authorities approved the most valuable drug in the company’s pipeline.

The move will also come as a relief to Japanese pharmaceuticals giant Takeda, which is in the process of acquiring Shire for £46bn and for whom approval of this potential blockbuster drug was deemed an important step towards sealing the deal.

The American Food and Drug Administration (FDA) gave the go-ahead to the drug, Takhzyro, late on Thursday. It is a treatment for hereditary angioedema (HAE), a genetic illness that causes random attacks of severe swelling in parts of the body and can be life threatening. It occurs in between one in 10,000 and one in 50,000 people and is classified as a rare disease.

Takhzyro, which is injected once every two weeks, proved hugely successful in clinical trials, reducing monthly attacks in patients by up to 87pc, while 77pc suffered no attacks at all.

Jack Scannell, a European pharmaceuticals research analyst at UBS, said: “We struggle to recall a drug for a rare and serious disease that posted as impressive phase three data as Takhzyro.”

Shire’s acquisition of Dyax two years ago was a defensive move because the smaller biotech’s pipeline, and Takhzyro in particular, rivalled many parts of Shire’s portfolio.

Shire has two existing treatments for HAE. Cinryze is preventive, while Firazyr relieves symptoms after patients have suffered an attack. Takhzyro is more convenient for patients as it is administered less frequently and it is also more effective.

Anthony Castaldo, president of the US Hereditary Angioedema Association, said: “HAE attacks are painful, debilitating, and potentially life threatening. Takhzyro provides the HAE community with a new option.”

The medication could also help to offset any decline in sales of Firazyr as it loses its patent exclusivity next year. It will also go head to head with a similar, already marketed, HAE drug called Haegarda, which was developed by US pharmaceutical company CSL Behring.

Shire has not revealed the price tag for Takhzyro, but it will not come cheap.

According to UBS, some HAE patients take more than $1m worth of medication each year.