Teva and Lonza announced the decision to abandon their biosimilars development joint venture (JV) earlier today, a little under six months after they began a strategic review of the 2009 partnership citing regulatory uncertainty and unfavourable economic conditions.
Lonza spokesman Dominik Werner told Outsourcing-pharma.com that: "The new regulatory requirements have increased the development costs significantly compared to our initial assumptions and it will also take more time until products reach the market.
"We don’t see any impact on employees through this decision," he added, explaining that manufacturing capacity previously earmarked for the JV "will be filled with alternative products."
The break up comes a month after the European Medicines Agency (EMA) approved its first two biosimilar monoclonal antibody products (MAb) - Remsima and Inflectra - and as the US Food and Drug Administration (FDA) collates responses to the latest draft version of its eagerly anticipated biosimilars guidance.
CMO focus
Lonza’s plan post JV is to focus on its core activities according to COO Stephan Kutzer who said: “We will cease investing in areas that are not strategic to Lonza such as clinical developments and end product commercialization.
He added that: "We intend in the future to limit our role by focusing on our core expertise in the areas of contract manufacturing and cell line development.”
For Israeli drugmaker Teva the decision was more about the JV’s impact on product pipeline.
R&D president Michael Hayden said it allows the firm to “maintain a highly selective approach in our efforts to create a balanced portfolio of biosimilars, biobetters and innovative biologics that align with our overall portfolio and areas of disease focus.”
Lonza site consolidations
News of the JV break up coincided with Lonza’s announcement of plans to try and save CHF100m ($106m) by 2016 by consolidating certain manufacturing operations.
The first facility to close will be Lonza Bioscience’s R&D unit it Saint Beauzire, France which develops DNA and RNA-based micro-organisms detection systems for the drug and food industries. The idea is to wind up operations in Q4 this year.
The other part of the plan impacting Lonza's pharma business is the decision to consolidate microbial biologics operations at the company’s site in Visp, Switzerland and ‘phase down’ activities at its plant in Hopkington, US.