Shire pulls out of biosimilar development
- Shire has ended its biosimilars program and terminated agreements with Coherus BioSciences and Momenta Pharmaceuticals, handing back the rights to Phase 3 biosimilars for Enbrel (etanercept) and Humira (adalimumab), respectively.
- Coherus has regained rights to CHS-0214, a biosimilar to Enbrel (etanercept), which has completed Phase 3 studies in chronic plaque psoriasis and rheumatoid arthritis. A European submission for marketing approval is planned for the fourth quarter of 2016. Baxalta had licensed development and commercial rights for the candidate in Europe, Canada, Brazil, the Middle East and elsewhere; Daiichi Sankyo has rights in Japan, and this agreement remains in place.
- Unlike the Coherus agreement, rights to the Momenta biosimilar will be handed back over the next year. Under the terms of the 2011 agreement with Momenta, Shire will continue to fund the development of the Humira biosimilar, M923, over that time. Momenta will present topline results of the ongoing Phase 3 trial in chronic plaque psoriasis in late 2016.
Back in June, Shire shelled out $32 billion for the biopharma company Baxalta and it has spent the last few months trimming the newly combined company.. The aim is to achieve $300 million in savings during 2016, and $700 million by 2020.
The reshaping to achieve $210 million in R&D cost cuts began with slicing away eight drug development programs, four from each company. The process has continued to further streamline the company and refocus on Shire's original focus of rare diseases with the return of two Phase 3 biosimilar programs to their originators, Coherus BioSciences and Momenta Pharmaceuticals.
"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," says Denny Lanfear, president and CEO of Coherus BioSciences, in a statement.
Analysts agree this could be a win for Coherus, which now has two anti-inflammatory biosimilar candidates that could draw more potential partners.
"With Shire now returning the rights to CHS-0214, Coherus could be better positioned as the company now has two anti-TNF biosimilars post-phase III and heading toward potential commercialization in the next few years, setting up an opportunity for a partner to come in and take either CHS-1420 or CHS-0214, or maybe even more attractive...take both," wrote Maxim analyst Jason Kolbert in a note to investors.
While a positive for Coherus, Kolbert doesn't believe this will have the same impact for Momenta, which might have trouble shouldering the litigation costs on its own. "With Shire now returning M923 rights, Momenta now has no big pharma partner in the biosimilar Humira race just as the legal battles over IP are heating up, which could extend potential commercial launches out to 2022, particularly for Amgen (FDA approved Amjevita last week) and Momenta (phase III data late 2016)," he wrote.
In a statement to BioPharma Dive, Shire said: "After careful consideration, Shire has decided to end its biosimilars programs, which were inherited when Shire combined with Baxalta earlier this year. With this strategic decision, the company will be able to further align its focus and resources on these core strategic areas."
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