Roche to exit four EU and US sites in small molecule network shake-up

Specialised drugs made using flexible technologies are the future for Roche’s small molecule portfolio, the firm says as it restructures its production network.

The Swiss Pharma Giant is looking to exit from manufacturing facilities in Ireland, Spain, Italy and the US, over the next five years as it refocuses its small molecule portfolio on lower volume specialised medicines requiring novel production technologies.

“The four sites support our mature portfolio of small molecules,” Roche spokesperson Claudia Schmitt told in-Pharmatechnologist.com. “This commercial portfolio is at the end of its lifecycle, resulting in a declining demand overall.”

CHF 300m investment in Swiss plant

Despite the cuts, Schmitt told us Roche remains committed to growing its small molecule portfolio.

“Our small molecules pipeline is very promising in terms of the number of NMEs, resulting in an average of one launch per year. Those new products have new technology requirements that cannot be matched with existing assets.

“To ensure the long-term success of the organization, we need to evolve our business set-up in the small molecule area by addressing the volume and portfolio changes as well as technology requirements.”

In 2014, the firm invested $135m into two small molecule facilities in Basel, Switzerland and Roche says it is now plunging a further CHF 300m ($300m) into a new production plant at its nearby Kaiseraugst site.

“The new facility in Kaiseraugst will be designed to handle a wide range of technologies for late stage development and commercial production in a flexible way to develop and launch small molecule compounds,” Schmitt said.

She continued, saying it is too early to specify which compounds will be the first to be made at the facility but added the first commercial product is expected by 2021.

$1.6bn restructuring hit

The sites to be divested are: Clarecastle, Ireland, an API production plant acquired in 1994 when Syntax became part of Roche; a bulk API facility in Florence, South Carolina; and two formulation plants in Leganés in Spain and Segrate in Italy.

The Pharma firm will take a CHF 1.6bn ($1.6bn) restructuring hit but hopes to sell the sites and minimise job loss.

“We are looking into divestment options for the respective sites as the best way to ensure long-term sustainable employment for our colleagues,” Schmitt said. “We will approach only very reputable companies, and will have more clarity about divestment options by the end of Q2 2016.”

The products made at the four sites will be transferred to third-party manufacturers, she added.

“It is normal business practice to place such products with contract manufacturers.”