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Shire to close small molecule plant

Published on 14/04/09 at 11:16am

Shire Pharmaceuticals is shutting down a US production facility and will outsource the production to contract manufacturers DSM.

The measure is part of Shire's ongoing programme of shifting the in-house manufacture of small molecule medicines to external contractors

The UK drugmaker said production at the Rosewood Technology Park in Owings Mills, Maryland will be scaled down progressively over the next three years with the loss of 260 employees, while it looks for a buyer for the unit.

Owings Mills was purchased in 2002 as part of the acquisition of Atlantic Pharmaceuticals and makes Shire's big selling attention-deficit hyperactivity drug Adderall XR, as well as other small molecules such as Carbatrol for epilepsy and Pentasa for ulcerative colitis.

The facility also makes Shire's newer ADHD drug Vyvanse, which will be co-promoted by GlaxoSmithKline in the US following an agreement announced on 31 March by the two firms.

The transition to outsourced manufacturing should be simple, Shire spokesman Matt Cabrey told Pharmafocus: as "many of these medicines are already manufactured by contract manufacturers in a secondary manufacturing position."

Shire has always adopted a strategy of mirroring in-house ('primary') manufacturing of each of its medicines with secondary manufacturing by contractors "to ensure availability of that medicine in case there is an interruption at one of the manufacturing sites," explained Cabrey.

He stressed the shift to outsourcing only affects Shire's small-molecules business and has no bearing on Shires emerging biologics activities, which stem from its Human Genetic Therapies unit (HGT).

"[This phasing out of our Owings Mills] plant does not affect in any way the ongoing construction of the new, highly-specialised facility in Lexington, Massachusetts," said Cabrey.

The Lexington plant is expected to be completed in 2011 and will manufacture HGT's enzyme replacement therapies, including Elaprase for Hunter syndrome and Fabry disease treatment Replagal.

"The strategy in our HGT business is to manufacture these therapies in-house because in biologics the process is the product, and it is the unique cell line of our HGT business that makes this a differentiating capability," said Cabrey.

"It is also more difficult to outsource this type of manufacturing," he added.


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