Shire Terminates a Couple of Biosimilar Deals Made by Baxalta

Shire Terminates a Couple of Biosimilar Deals Made by Baxalta September 27, 2016
By Mark Terry, Breaking News Staff

After a strategic review of its portfolio after its acquisition of Baxalta this year, Shire has terminated two biosimilar deals, one with Momenta Pharmaceuticals and the other with Coherus Biosciences.

After six months of wheeling and dealing, Bannockburn, Illinois-based Baxalta agreed to an acquisition by Dublin-based Shire in January of this year. Now, after evaluating Baxalta’s portfolio, Shire ended its collaboration agreement with Momenta, based in Cambridge, Massachusetts. Shire signed the deal in 2011, to collaborate on developing and commercializing M923, a biosimilar of Humira (adalimumab). As part of the termination, Shire is obligated to fund the program for the next 12 months until the deal is officially ended.

“Baxalta has been a strong collaborative partner and we thank them for their efforts in advancing this important program through late-stage clinical development,” said Craig Wheeler, Momenta’s president and chief executive officer, in a statement. “We view Shire’s decision as a significant opportunity for us to capture additional value from this program for the Company and its shareholders. We remain very excited about the potential for our biosimilar Humira candidate and look forward to reporting top-line results of the current Phase III trial of M923 in late 2016.”

AbbVie ’s Humira is a blockbuster treatment for rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. M023 is being evaluated in a Phase III trial in chronic plaque psoriasis.

Shire also terminated a deal with Redwood City, California-based Coherus for CHS-0214 etanercept, a biosimilar candidate to Enbrel.

Amgen ’s Embrel is used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis (AS) and moderate to severe plaque psoriasis. CHS-0214 has completed two Phase III studies, one for chronic plaque psoriasis, and the other for rheumatoid arthritis. These are being used to support regulatory submissions in Europe. Coherus has also partnered with Daiichi Sankyo to develop the drug in Japan.

“Good companies properly exercise discipline around their chosen strategic focus, and we are very grateful to our colleagues at Baxalta and Shire for their assistance in advancing the CHS-0214 Enbrel biosimilar program,” said Denny Lanfear, Coherus’ president and chief executive officer, in a statement. “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. We remain on track for submission of a CHS-0214 Marketing Authorization Application (MAA) to the European Medicines Agency in the fourth quarter of 2016.”

At its six-month mark this year, Coherus’ condensed consolidated balance sheet showed deferred revenue of $85.8 million and $76.8 million from a contingent payment related to a commercial launch of CHS-0214 in the U.S. Now that the deal has been terminated, Coherus plans to recognize the $162.6 million this year as collaboration and license revenue.

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