Shire: ‘Baxalta brings us world-class manufacturing network’

Shire will retain Baxalta’s biologics expertise and continue assessing its manufacturing network following the completion of its $32bn acquisition, expected next month.

After a failed acquisition attempt last August, the board of directors at Baxalta accepted a $32bn (€27.6bn) bid in January from the rare disease-focused biopharma firm Shire.

The deal is expected to close early next month following a shareholder vote scheduled for May 27 and regulatory approval, Shire’s CEO Flemming Ornskov told stakeholders last Friday, and an integration plan is fully underway based on what he described as “an inverted pyramid approach.”

The top level involves those areas where change is most limited - customer-facing employees, salesforces and patient support organisations – he explained, but the next level is manufacturing.

“Biologics manufacturing requires a highly specialized skill set and Baxalta brings us a world-class manufacturing organisation. We aim to retain expertise wherever possible,” he said.

“Baxalta is already in the middle of a network reassessment and we will continue to carefully review the manufacturing network over time and ensure that geographies are aligned so we're operating in the most efficient manner,” Flemming continued.

Baxalta recently began shifting to an outsourcing model for at least its biosimilars business, offloading the Brooklyn Park, Minnesota facility it bought from Genmab in 2013 to Takeda in January, while Shire itself has invested heavily in-house.

Only two weeks ago the firm announced it intended to build a $400m bioproduction plant in County Meath, Ireland, complementing its internal manufacturing facilities in Massachusetts.

At the time the megamerger was announced, manufacturing cost-saving synergies were expected to be around $100m.

Human plasma derivation

Baxalta does have a vast infrastructure of plasma collection and fractionation manufacturing infrastructure, which could provide a second-source supply for Cinryze, Shire's half-billion dollar-a-year Hereditary Angioedema (HAE) drug acquired from Viropharma in 2014.

Cinryze is derived from human plasma – sourced exclusively from the US – and is produced using a series of precipitation, filtration and chromatography steps. 

Last year, Shire inked a license agreement with Belgian contract manufacturer Sanquin to support a Cinryze manufacturing tech transfer to a second source supplier.