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BeOne Medicines Ltd. 8-K Report, Agreement Terminated (Dec 20, 2018)

Filed December 20, 2018For Securities:ONCBEIGF

Summary

BeiGene, Ltd. (the Company) announced a significant strategic step in its drug development and commercialization efforts. The Company has repurchased the commercialization option for its investigational PARP inhibitor, pamiparib (BGB-290), in China from Merck KGaA. This termination of the License Agreement, effective December 31, 2018, means BeiGene will regain full control over pamiparib's commercialization in China and is relieved of future milestone obligations to Merck KGaA under that agreement. While the payment for this option buy-back is undisclosed, this move signifies BeiGene's intent to manage its key assets independently in a crucial market. In parallel, the Company provided positive updates on its lead anti-PD-1 antibody, tislelizumab. Updated clinical data from a Phase 1A/1B trial were presented at the ESMO Immuno-Oncology Congress. Furthermore, BeiGene announced the enrollment of the first patients in two global Phase 3 clinical trials for tislelizumab. These trials are evaluating tislelizumab in combination with chemotherapy as a first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma and advanced esophageal squamous cell carcinoma, marking a critical advancement in the drug's development pathway for significant cancer indications.

Key Highlights

  • 1BeiGene repurchased the China commercialization option for pamiparib (BGB-290) from Merck KGaA.
  • 2The License Agreement with Merck KGaA for pamiparib in China will terminate effective December 31, 2018.
  • 3BeiGene regains full control of pamiparib's commercialization in China.
  • 4Updated clinical data for tislelizumab (anti-PD-1 antibody) were presented at the ESMO-IO Congress.
  • 5Two global Phase 3 clinical trials for tislelizumab have initiated enrollment.
  • 6These Phase 3 trials evaluate tislelizumab in combination with chemotherapy for first-line treatment of gastric and esophageal cancers.

Frequently Asked Questions

The filing states that the payment for the buy-back of the commercialization option for pamiparib from Merck KGaA is undisclosed. Therefore, the immediate financial impact in terms of cost is not provided in this report. Investors will need to look for future disclosures or financial reports to understand the expense associated with this transaction.

The termination of the License Agreement means BeiGene regains full commercial rights to pamiparib in China and is no longer obligated to make future milestone payments to Merck KGaA under that agreement. This allows BeiGene to independently strategize and execute its commercial plans for pamiparib in the important Chinese market.

The two newly initiated global Phase 3 clinical trials for tislelizumab are evaluating it as a first-line treatment in combination with chemotherapy for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, and for patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.

Updated clinical data from an ongoing Phase 1A/1B trial of tislelizumab were presented at the ESMO Immuno-Oncology Congress. The specifics of the data were detailed in a press release filed as Exhibit 99.1.