Sanofi Pays Regeneron $462M to Restructure Immuno-Oncology Collaboration and Exit Broader R&D Pact

Sanofi and Regeneron recently announced that the two companies have restructured their global immuno-oncology discovery and development agreement. The parties entered into an immuno-oncology collaboration agreement in 2015, under which Sanofi paid a $640 million upfront payment and committed to spending up to $750 million to conduct clinical proof-of-concept projects. The agreement was originally scheduled to expire in mid-2020.

This revision provides for the collaborative development of two bispecific antibody programs in clinical stages. The amended agreement allows Regeneron to retain all rights to its other immuno-oncology discovery and development programs, while granting Sanofi greater flexibility to independently advance its early-stage immuno-oncology pipeline.

Pursuant to the terms of the restructuring agreement:

1) Sanofi will pay Regeneron $462 million, representing the outstanding balance payable under the original immuno-oncology agreement, including Sanofi’s share of the costs for the immuno-oncology discovery projects in the fourth quarter of 2018, up to $120 million in development costs for two selected clinical-stage bispecific antibodies, and termination fees for other projects under the initial immuno-oncology agreement.

2) Sanofi has the option to join the BCMAxCD3 and MUC16xCD3 bispecific antibody programs upon proof of concept achievement or exhaustion of allocated funds.

3) Regeneron will invest $70 million to further develop the BCMAxCD3 bispecific antibody for multiple myeloma, and $50 million to further develop the MUC16xCD3 bispecific antibody for cancers expressing mucin-16.

4) Upon election to opt in, Sanofi will lead the development and commercialization of the BCMAxCD3 bispecific antibody and fund 100% of the development costs, while Regeneron will receive up to 50% compensation from the collaborative profits. Sanofi and Regeneron will equally share global profits.

5) Upon opting in, Regeneron will lead the development of the MUC16xCD3 bispecific antibody and spearhead its commercialization in the U.S. market. Both parties will share development costs and global profits equally. Sanofi will lead commercialization in markets outside the United States.

6) The ongoing development and commercialization collaboration between the two parties on the PD-1 cancer immunotherapy Libtayo (cemiplimab-rwlc) is not affected by the amended Discovery and Development Agreement.

7) Regeneron retains full rights to the company’s other immuno-oncology programs.

Based on the immuno-oncology licensing and collaboration agreement reached in 2015, Sanofi and Regeneron have successfully developed Libtayo and obtained U.S. FDA approval for its indication in advanced cutaneous squamous cell carcinoma (CSCC). In the European Union, the regulatory application for Libtayo has also been submitted. Currently, the two parties are advancing joint clinical programs to investigate the role of Libtayo in various other cancers, including potential pivotal clinical trials for lung cancer, cervical cancer, and skin cancer.

Sanofi stated in a press release that the restructuring agreement “increases the flexibility to independently advance its early-stage immuno-oncology pipeline,” enabling Sanofi to redirect its committed funding to other collaborations and internal projects.

Some analysts say it remains to be seen whether the restructuring of this agreement signifies a more efficient use of Sanofi’s R&D budget. In recent years, Sanofi has relied heavily on partners such as Alnylam and Regeneron to supply breakthrough therapies that its internal teams have struggled to discover and develop. However, Sanofi has begun discussing internal reforms and is scaling back from key partnerships, particularly its collaboration with Regeneron.(SinaPharmaceuticalsCompiled/Newborn)

Source: Sanofi pays Regeneron $462M to exit immuno-oncology R&D pact

Source: Sina Medical News