Clovis Oncology and Lonza Celebrate Grand Opening of New Monoplant for Rubraca ® (rucaparib)
- Dedicated small-molecule commercial manufacturing line starts production at Lonza’s Visp (CH) site
- New line provides Clovis Oncology with secure product supply for their ovarian cancer drug Rubraca® (rucaparib)
- Innovative operating model and technology reduces production lead time and costs
Basel (CH), 4 October 2018 – Clovis Oncology Inc. (NASDAQ:CLVS) and Lonza conducted a grand opening ceremony today at Lonza’s Visp (CH) site to celebrate the opening of a new, dedicated production train for Rubraca® (rucaparib), Clovis’ U.S.- and EU-approved drug for several ovarian cancer indications. Clovis Oncology CEO and President Patrick Mahaffy and Lonza Pharma & Biotech COO Marc Funk toured the new facility and spoke to staff and guests and highlighted the potential of this new therapy for patients.
Under a long-term agreement, the new, state-of-the-art monoplant enables security of supply and flexibility to rapidly meet changes in market demand for rucaparib. During construction of the Clovis monoplant, Lonza manufactured rucaparib in its existing production trains at Visp, providing Clovis dedicated and uninterrupted access to capacity. This tailored supply strategy supports Lonza active pharmaceutical ingredient (API) customers’ specific needs during development, commercialization and ongoing market supply.
Lonza constructed the new production train for rucaparib, an oral, small molecule inhibitor of PARP1, PARP2 and PARP3, using 20 years’ experience in commercial-scale, high-containment manufacturing. The new facility offers leading-edge technologies including extensive automation and on-line analytical monitoring designed to enable real-time release testing. This approach facilitates process monitoring and consistency and gives Clovis Oncology faster and agile delivery, with optimized cost of goods.
“This partnership is a great example of how we can support commercial stage biotech companies through innovation in manufacturing technology and flexible business models,” said Marc Funk, COO Lonza Pharma & Biotech. “Lonza continues to invest in infrastructure for the safe and efficient production of highly potent active pharmaceutical ingredients (HPAPIs).”
“Rubraca® offers a new treatment option for women with recurrent ovarian cancer, and in addition we are exploring Rubraca® in other indications, including prostate and bladder cancer, where Rubraca® may offer additional treatment options for patients in need,” stated Patrick Mahaffy, CEO and President of Clovis Oncology. “Our partnership with Lonza and the opening of this dedicated facility should allow the continued availability of Rubraca® to patients who may benefit from its use, now and in the future.”
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