Baxalta and Momenta part ways on adalimumab biosimilar

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Baxalta and Momenta part ways on adalimumab biosimilar

Biosimilares/Novedades | Posted 04/11/2016 0 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.

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].

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

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Source: Momenta