Lonza constructing dedicated suite to make Clovis breakthrough mAb

By Dan Stanton contact

- Last updated on GMT

Related tags: Food and drug administration, Lonza

Lonza constructing dedicated suite to make Clovis breakthrough mAb
Lonza will construct a dedicated suite to produce commercial supply of rucaparib API on behalf of Clovis Oncology.

In February 2013, Lonza entered into a contract with Clovis to supply clinical supplies of its ovarian cancer candidate rucaparib.

But this latest agreement, announced by the Boulder, Colorado-headquartered biotech in an SEC filing this week, will see the Swiss CMO “construct, in an existing Lonza facility, a production train that will be exclusively dedicated to the manufacture of the rucaparib API.”

According to the terms of the contract, Lonza will also manufacture and store an advanced intermediate to be used in the subsequent production of the rucaparib API, and Clovis will pay fixed fees on a per kilogram basis for quantities of both.

“Until the dedicated facility is completed and operationally qualified, Lonza will manufacture the rucaparib API in existing Lonza facilities at pricing established in the Agreement.”

Clovis’ lead candidate rucaparib is an oral inhibitor of poly (ADP-ribose) polymerase (PARP) being developed to treat ovarian cancer. The product was granted US FDA Breakthrough Therapy designation in April 2015​.

The contract expires at the end of 2025.

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