Date: 2017-08-31
Type of information: Development agreement
Compound: BGB-A317, Celgene's approved therapies in China (Abraxane®, Revlimid®, Vidaza®) and pipeline agent CC-122
Company: BeiGene (China) Celgene (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: development - commercialisation
Action mechanism:
- monoclonal antibody/immune checkpoint inhibitor/immunomodulator. BGB-A317 is an investigational humanized monoclonal antibody designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.
- CC-122 is a next generation CelMOD currently in development by Celgene for lymphoma and hepatocellular carcinoma.
Disease: solid tumors
Details:
- • On August 31, 2017, BeiGene announced the closing of its global strategic oncology collaboration with Celgene. The collaboration was announced on July 5, 2017.
- • On July 5, 2017, Celgene and BeiGene entered into a strategic collaboration to develop and commercialize BeiGene's investigational anti-programmed cell death protein 1 (PD-1) inhibitor, BGB-A317, for patients with solid tumor cancers in the United States, Europe , Japan and rest of world outside Asia . 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 ).
- BGB-A317 is currently in two pivotal trials in China , and global pivotal studies of BGB-A317 are planned for initiation in 2018. Celgene and BeiGene will collaborate in the global development of BGB-A317. In addition, BeiGene retains the right to develop BGB-A317 in hematology and in combination with its other portfolio compounds.
- BeiGene will acquire Celgene's commercial operations in China and gain an exclusive license to commercialize Celgene's approved therapies in China - Abraxane® (paclitaxel protein-bound particles for injectable suspension), Revlimid® (lenalidomide), Vidaza® (azacitidine).
- In addition, BeiGene is granted licensing rights in China to CC-122, under the same terms and conditions as the approved commercial products.
- 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 .
- Celgene will maintain a strategic and R&D presence in China dedicated to long-term commercial activities, regulatory affairs and clinical development of new therapies in the country. Celgene will also continue supporting BeiGene with management of the Revlimid® Risk Minimization Program.Upon closing, BeiGene will receive upfront licensing fees totaling $263 million , and 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 $4.58 per share, or $59.55 per BeiGene's American Depositary Shares (ADS), representing a 35% premium to an 11-day volume-weighted average price of BeiGene's ADS. BeiGene is eligible to receive up to $980 million in development, regulatory and sales milestone payments and royalties on future sales of BGB-A317.
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.
Financial terms:
- Upon closing, BeiGene will receive upfront licensing fees totaling $263 million , and 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 $4.58 per share, or $59.55 per BeiGene's American Depositary Shares, representing a 35% premium to an 11-day volume-weighted average price of BeiGene's ADS. BeiGene is eligible to receive up to $980 million in development, regulatory and sales milestone payments and royalties on future sales of BGB-A317.
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