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Shire eyes 6 product launches by end of 2006

British firm reports a third-quarter net loss after TKT acquisition charges

British-based Shire Pharmaceuticals said it aims to launch six new products by the end of 2006, after reporting a third-quarter net loss of $624.2m (£352m) due to higher costs of developing new drugs and charges related to its recent acquisition of US biotech Transkaryotic Therapies (TKT).

The company said potential 2006 launches for NRP104 and Daytrana for attention deficit hyperactivity disorder (ADHD) and I2S for Hunter syndrome, a rare hereditary disorder, could bump up marketing costs to $700m next year from $640m in 2005.

However, analyst Frances Cloud at Nomura described the chances of the firm launching six products in the next 14 months were "quite unrealistic".

"In the projections, it is assumed that the Food and Drug Administration (FDA) will approve everything outright on or before the PDUFA [Prescription Drug Users Fee Act] date," she said. "By looking at average statistics coming out of the FDA itís pretty clear that the FDA does not approve things by the PDUFA dates. It very often issues an approvable letter and asks for new data."

Shire also said it would continue to protect its best-selling ADHD drug, Adderall XR, from generic competition. It has filed lawsuits against Barr Pharmaceuticals and Impax Laboratories, alleging that their respective products infringe one of Adderall XRís patents.

Cloud said that of all Shireís new products, NRP104 had the most potential to be a big-selling drug: "It will replace Adderall if it gets to market."

In the nine months to September 30, Shire made a pre-tax profit of $430m ($344m) on turnover of $1.13bn ($989m).

30th September 2008

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