Date: 2016-09-27
Type of information: Termination of the agreement
Compound: CHS-0214 (investigational etanercept biosimilar)
Company: Coherus Biosciences (USA - CA) Baxalta (USA - IL), now part of Shire (UK - USA)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases
Type agreement: development commercialisation
Action mechanism: biosimilar/TNF alpha inhibitor/fusion protein. Etanercept is an anti-tumor necrosis factor (TNF) agent. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
CHS-0214 has successfully completed two Phase 3 studies, one in chronic plaque psoriasis, data released in November 2015, and one in rheumatoid arthritis, data released in January 2016. Data from these Phase 3 studies as well as two pivotal clinical pharmacokinetic studies will support the MAA. Coherus has partnered with Daiichi Sankyo for the development and commercialization of CHS-0214 in Japan.
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Details: * On September 27, 2016, Coherus BioSciences announced that it has regained from Shire all development and commercial rights previously licensed for CHS-0214 etanercept, a biosimilar candidate to Enbrel®, for Europe, Canada, Brazil, the Middle East and other territories. Reconveyance of CHS-0214 rights to Coherus results from Shire’s strategic portfolio review, following its June 2016 acquisition of Baxalta and includes no present or future payments from Coherus. As of June 30, 2016, Coherus’ condensed consolidated balance sheet reflected deferred revenue of $85.8 million and $76.8 million for a contingent payment in the event Coherus commercially launched CHS-0214 in the United States under the Shire collaboration. As a result of the termination agreement with Shire, Coherus expects to recognize the $162.6 million as collaboration and license revenues in 2016.
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