Intern Reporter Zhu Xinxin
Edited by Xie Xin
On October 13, BeOne Medicines announced that Bristol-Myers Squibb (BMS) has issued a notice to terminate the agreement regarding ABRAXANE (nab-paclitaxel). Bristol-Myers Squibb stated that it provided 180 days' advance notice to withdraw ABRAXANE from the portfolio of products marketed or distributed in the region.
In response, BeOne Medicines stated to Jiemian News on October 14 that the company has been actively collaborating with Bristol-Myers Squibb-Celgene to resolve the issue as soon as possible and restore the supply of ABRAXANE. Additionally, other products under the partnership sold in China will not be affected.
Bristol-Myers Squibb cited two reasons for terminating the agreement in the notice:
- Due to the National Medical Products Administration's decision to suspend the import, sale, or use of ABRAXANE in China on March 25, 2020, it is unable to manufacture ABRAXANE globally;
- Second, following the termination of production in Illinois, the Phoenix, Arizona facility became the primary manufacturing site for ABRAXANE. However, in July of this year, media fill tests at the relevant facilities within the Phoenix plant failed. Despite the implementation of corrective and preventive actions (CAPA), subsequent test results remained unsatisfactory. The Phoenix facility has suspended all ABRAXANE-related manufacturing activities and has notified the U.S. Food and Drug Administration (FDA).
BeOne Medicines announced that Bristol-Myers Squibb has not yet informed it of the timeframe during which it will be unable to produce ABRAXANE at its Phoenix facility, or whether it has the capacity to manufacture ABRAXANE at other facilities. The company is willing to cooperate with Bristol-Myers Squibb to help the Phoenix manufacturing plant or other qualified facilities resume the supply of ABRAXANE to patients in China as soon as possible. Therefore, BeOne Medicines believes that the reasons cited in the notice do not constitute valid grounds for terminating the agreement. Describing the notice as "a tactical strategy adopted by Bristol-Myers Squibb to mitigate damages," the company will formally challenge the termination of the agreement.
This also marks the latest challenge to the $1.393 billion collaboration agreement previously reached between Celgene and BeOne Medicines, following Bristol-Myers Squibb's acquisition of Celgene. In 2017, BeOne Medicines entered into a global collaboration with Celgene, whereby BeOne Medicines obtained exclusive licensing rights in China for three Celgene products: ABRAXANE (albumin-bound paclitaxel), Revlimid (lenalidomide), and Vidaza (azacitidine); Celgene, in turn, secured exclusive rights to develop and commercialize BeOne Medicines' PD-1 inhibitor tislelizumab for solid tumor indications in the United States, Europe, Japan, and multiple countries and regions outside Asia.
However, in early 2019, Bristol-Myers Squibb announced the official completion of its acquisition of Celgene. Since Bristol-Myers Squibb already owned the PD-1 antibody Opdivo, in June 2019, BeOne Medicines announced that it had reached an agreement with Celgene,Termination of the Global Collaboration Between the Parties Regarding BeOne Medicines' Investigational Anti-PD-1 Antibody Tislelizumab。Celgene pays BeOne Medicines $150 million in compensation for the termination of the collaboration.
At the time, BeOne Medicines stated that its collaboration with Celgene regarding the commercialization rights for ABRAXANE, REVLIMID, and VIDAZA in China would not be affected. BeOne Medicines continues to hold the 10-year sales rights for the aforementioned three products in China.
However, on March 25, 2020, the National Medical Products Administration (NMPA) announced that during an overseas on-site inspection of the manufacturing facilities for Celgene's Paclitaxel for Injection (Albumin-Bound), it was found that certain key production facilities for the product did not meet the basic requirements for drug production quality management in China, with issues such as inadequate aseptic control measures during the manufacturing process, failing to comply with the requirements of the 《Good Manufacturing Practice for Drugs (2010 Revision)》,Therefore, it is hereby announced that the import, sale, and use of the originator Paclitaxel for Injection (Albumin-Bound) (ABRAXANE) manufactured by Celgene are suspended.。
At the time, BeOne Medicines stated that it has been collaborating with Bristol-Myers Squibb to restore the supply of ABRAXANE to the Chinese market as soon as possible, which includes Bristol-Myers Squibb's remediation efforts at the existing manufacturing facility, as well as the submission of an application to utilize another of its production plants for supply to China. On August 16 of this year, Bristol-Myers Squibb also informed BeOne Medicines that it plans to submit a supplemental application in the fourth quarter of this year to register the new facility as a manufacturing site for ABRAXANE in the Chinese market, with preliminary expectations that the application may be approved by the National Medical Products Administration (NMPA) in the fourth quarter of 2022.
However, according to Bristol-Myers Squibb, it will opt to directly terminate the agreement due to the new facility's failure to pass acceptance inspection. It is evident, nonetheless, that given the direct competition between Bristol-Myers Squibb and BeOne Medicines in the oncology market, and considering that nab-paclitaxel is a critical oncology drug indicated for multiple common cancers, Bristol-Myers Squibb, acting in its own strategic interest, clearly does not wish for these commercial benefits to fall into a competitor's hands. This is particularly relevant given that BeOne Medicines' R&D pipeline includes multiple combination therapy indications pairing its blockbuster PD-1 inhibitor, tislelizumab, with nab-paclitaxel.
However, as of press time, Bristol-Myers Squibb has not yet responded to the matter.