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Clyde & Co Advises FibroGen On USD350m Product Development Collaboration With AstraZeneca.

13 September, 2013

 

Clyde & Co advised biotechnology company, FibroGen, on its strategic collaboration with AstraZeneca to develop and commercialise FG-4592, a first-in-class oral compound in late stages of development.

 

Through this collaboration, FibroGen and AstraZeneca will undertake the extensive FG-4592 Phase III development program for the US, and with Phase III trials in China. The anticipated regulatory filings are expected in China in 2015 and the US in 2017.

 

Once commercialised, FG-4592 will be used in the treatment of anaemia associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD).

 

The Clyde & Co team, led by Shanghai partner Michael Cripps, advised on all Chinese aspects of the deal including advising on IP licensing, transactional documents and distribution, production & milestone agreements.

 

Under the transaction structuring, AstraZeneca will provide FibroGen with a committed upfront and subsequent non-contingent payments totalling USD 350 million, as well as potential future development related milestone payments of up to USD 465 million. AstraZeneca will lead the US commercialisation of FG-4592, with FibroGen undertaking specified promotional activities in the ESRD segment in this market. The companies will also co-commercialize FG-4592 in China where FibroGen will be responsible for clinical trials, regulatory matters, manufacturing and medical affairs, and AstraZeneca will oversee promotional activities and commercial distribution.

 

Michael Cripps said: “We are delighted to have worked with FibroGen on the China aspects of this collaboration and to assist FibroGen to meet their target of launching the product in 2015 in China, at least 2 years earlier than any other market.”

 

Chris Chung, Executive Director and Project Leader at FibroGen said: “Michael’s counsel and feedback during this process has been invaluable to us and we thank him and the team for their judgement, expertise, candour and responsiveness to us as a client.”

 

Cooleys are advising on US aspects on the collaboration.

 

 

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