Celgene Buys The Rights To BeiGene’s Checkpoint Inhibitor

BeiGene will acquire Celgene’s commercial operations in China and exclusive license to Celgene’s China cancer commercial portfolio.

AsianScientist (July 18, 2017) – US-headquartered Celgene Corporation has bought the rights to BGB-A317, BeiGene’s investigational anti-programmed cell death protein 1 (PD-1) inhibitor.

Upon closing, BeiGene will receive upfront licensing fees totaling US$263 million. In addition, Celgene will acquire an equity stake in BeiGene by purchasing 32.7 million, or 5.9 percent, of BeiGene’s ordinary shares at US$4.58 per share, or US$59.55 per BeiGene’s American Depositary Shares (ADS), representing a 35 percent premium to an 11-day volume-weighted average price of BeiGene’s ADS. BeiGene is eligible to receive up to US$980 million in development, regulatory and sales milestone payments and royalties on future sales of BGB-A317.

BGB-A317 is an advanced clinical-stage investigational PD-1 inhibitor, which has been dosed in over 500 patients. Initial clinical data suggest that BGB-A317 is well tolerated and exhibits anti-tumor activity across a range of solid tumor types. BGB-A317 has high affinity and specificity for PD-1 and may be differentiated from the currently approved PD-1 antibodies through an engineered Fc region, potentially minimizing interactions with other immune cells that may exert a negative impact on effector T-cell function.

BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of solid tumor cancers. It is currently in two pivotal trials in China and global pivotal studies of BGB-A317 are planned for 2018.

BeiGene will retain exclusive rights for the development and commercialization of BGB-A317 for hematological malignancies globally and for solid tumors in Asia (with the exception of Japan). BeiGene will acquire Celgene’s commercial operations in China and gain an exclusive license to commercialize Celgene’s approved therapies in China, namely ABRAXANE®, REVLIMID® and VIDAZA®.

In addition, BeiGene is granted licensing rights in China to CC-122, under the same terms and conditions as the approved commercial products. CC-122 is a next generation CelMOD currently in development by Celgene for lymphoma and hepatocellular carcinoma. BeiGene plans to expand manufacturing and commercial operations in China in preparation for the potential approvals of BGB-A317 and future innovative therapies developed by BeiGene in greater China.

“The acquisition of BGB-A317 significantly accelerates and expands our opportunity to develop and deliver novel T-cell checkpoint inhibitor-based therapies in solid tumor cancers to patients worldwide and adds to our ongoing PD-L1 FUSION™ program in hematological malignancies,” said Mr. Mark J. Alles, Chief Executive Officer of Celgene.

“This strategic partnership with Celgene is a transformational event for BeiGene, transitioning us into a commercial-stage company and preparing us well for the future potential launch of our internally developed compounds, some of which are already in pivotal trials in China,” said Mr. John V. Oyler, Co-founder, CEO, and Chairman of BeiGene.

The transactions have been approved by the boards of directors of Celgene and BeiGene. Both companies expect to complete the transaction during the third quarter of 2017, subject to the expiration or termination of applicable waiting periods under all applicable antitrust laws and satisfaction of other usual and customary closing conditions.

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Source: Celgene; Photo: Shutterstock.
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