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Shire gives up on Momenta-partnered Humira biosimilar

Will fund programme for another 12 months while divesting ongoing activities to Momenta

ShireShire has called time on collaboration with Momenta Pharmaceuticals on the development of a biosimilar version of AbbVie's Humira.

Momenta said Shire took the decision after a "comprehensive portfolio assessment" that followed its $32bn acquisition of Baxalta in June. Momenta's Humira clone - called M923 - was licensed by Baxalta's former parent Baxter in a $452m deal signed in 2011.

The decision also follows the news that Amgen has just bagged FDA approval for Amjevita, the first Humira (adalimumab) biosimilar to be given a green light in the US.

The collaboration will end in 12 months, with Shire continuing to fund the biosimilar programme while it transfers all ongoing clinical, regulatory and commercialization activities to Momenta. A phase III trial of M923 in chronic plaque psoriasis is due to report results before the end of the year.

Momenta chief executive Craig Wheeler said Shire's decision is "a significant opportunity for us to capture additional value from this programme".

M923 is the lead biosimilar candidate in the Shire collaboration. The company has previously said it is targeting first regulatory submission for approval in 2017 and a first commercial launch as early as 2018.

Humira is a $14bn brand for AbbVie, and given the size of the opportunity it is unsurprising that several companies are vying for a slice of the biosimilar market.

Samsung Bioepis is in pole position in Europe having filed for approval of its SB5 biosimilar in July, while Sandoz, Merck KGaA and FujiFilm/Kyowa Hakko Kirin have candidates in phase III trials. Zydus Cadila and Torrent Pharma already sell Humira biosimilars in India.

In a regulatory filing Momenta said it received $33m in upfront fees from Baxter after the deal was signed, as well as $12m in technical and development milestone payments in connection with the UK Medicines and Healthcare Products Regulatory Agency's acceptance of a clinical trial application for M923.

Momenta is already booking revenues from sales of Sandoz' Glatopa, a generic version of Teva's multiple sclerosis drug Copaxone (glatiramer acetate), and plans to launch its own version next year.

It also has a biosimilar collaboration with generics giant Mylan covering six biologics, headed by M834, a biosimilar version of Bristol-Myers Squibb's rheumatoid arthritis drug Orencia (abatacept).

Article by
Phil Taylor

28th September 2016

From: Research

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