Baxalta and Momenta part ways on adalimumab biosimilar

Biosimilars/News | Posted 04/11/2016 post-comment0 Post your comment

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 27 September 2016 that it would regain rights to its candidate adalimumab biosimilar M923 from Baxalta, a spinoff company from Baxter International.

Acquisition Fall Off V13F07

The news follows Shire’s completion of its US$32 billion merger with Baxalta in June 2016. Shire apparently ‘exercised its right to terminate its collaboration agreement with [Momenta]’ ‘based on a comprehensive portfolio assessment’ by Shire ‘following the acquisition of Baxalta’.

The two companies entered into a global collaboration agreement to develop and commercialize up to six biosimilars back in December 2011 [1]. According to this, the agreement will terminate 12 months following the notice and Shire will continue to be obligated to fund the M923 programme until termination. In addition, Momenta stated that ‘Shire will begin to work to transfer all ongoing clinical, regulatory and commercialization activities to Momenta’.

No mention was made of the other biosimilars included in the original collaboration agreement. However, UK-based Shire has also returned the rights for an etanercept candidate biosimilar (CHS-0214) to Coherus BioSciences and is reportedly ‘stepping away from biosimilars’.

Baxalta and Momenta announced the start of a phase III clinical trial for their adalimumab biosimilar (M923) in patients with chronic plaque psoriasis back in October 2015. They were planning to have their first regulatory submission in 2017 and launch the biosimilar in 2018 [2].

Related article
Baxter and Coherus amend biosimilar etanercept collaboration

References
1. GaBI Online - Generics and Biosimilars Initiative. Baxter and Momenta make biosimilars deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 4]. Available from: www.gabionline.net/Biosimilars/News/Baxter-and-Momenta-make-biosimilars-deal
2. GaBI Online - Generics and Biosimilars Initiative. Baxalta and Momenta start phase III trial for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 4]. Available from: www.gabionline.net/Biosimilars/News/Baxalta-and-Momenta-start-phase-III-trial-for-adalimumab-biosimilar

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.

Source: Momenta

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010