Shire bails out of Baxalta biosimilars, ends Coherus, Momenta deals


Rare disease-focused Shire ($SHPG) is returning rights to both the biosimilars that were in the Baxalta pipeline. The news of Shire’s exit from biosimilars isn’t particularly surprising given its dedication to rare disease drug development, which is almost the polar opposite.

It’s been almost three months since the Shire-Baxalta deal closed in early June. As part of that vision, Shire committed to double-digit, top-line revenue growth with total revenue to exceed $20 billion by 2020. At the Baxalta transaction close, 65% of revenues from the combined company were expected to come from rare diseases.

Biosimilars weren’t a part of that vision, so Shire has returned rights to the two that Baxalta had in development. These were a Humira (adalimumab) biosimilar being developed with Momenta Pharmaceuticals ($MNTA) and an Enbrel (etanercept) biosimilar from Coherus BioSciences ($CHRS).


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Shire will continue to fund the Humira biosimilar from Momenta, M923, for 12 months, which is required as part of the 2011 collaboration agreement. The pharma is transferring all ongoing clinical, regulatory and commercialization activities to Momenta.

The company expects to have top-line Phase III data for M923 later this year; it’s currently in the pivotal trial in chronic plaque psoriasis patients as compared with Humira.

As for Coherus, it’s regained rights from Shire to CHS-0214 etanercept in Europe, Canada, Brazil, the Middle East and other territories. The company said it plans to license rights to the biosimilar candidate in Europe; it expects to submit CHS-0214 to European regulators during the fourth quarter.

“These reacquired geographical rights fit well with our existing U.S. CHS-0214 rights, and we now have the opportunity to license throughout Europe, U.S. and other key commercial geographies two complimentary anti-TNF assets--CHS-0214, an Enbrel biosimilar candidate and CHS-1420, a Humira biosimilar candidate,” said Coherus President and CEO Denny Lanfear in a statement.

Both Momenta and Coherus gained a bit in early trading on the news.

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