Regeneron will secure global rights to Libtayo from Sanofi in exchange for upfront payment of $900 million, plus royalties and potential future milestone payments
18 different investigational treatment combinations with Libtayo currently being evaluated in 22 clinical trials
TARRYTOWN, NY, USA I June 2, 2022 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced its intent to purchase Sanofi’s stake in the Regeneron and Sanofi collaboration on Libtayo® (cemiplimab), providing Regeneron with exclusive worldwide development, commercialization and manufacturing rights to the medicine. The transaction is subject to merger control clearance outside the United States and is expected to close in the third quarter of 2022. Once the transaction has closed, Regeneron will record 100% of global net sales and expenses for the Libtayo program.
Libtayo, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells. It is currently approved by regulatory authorities in more than two dozen countries, including by the U.S. Food and Drug Administration (FDA) as cemiplimab-rwlc monotherapy treatment for certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC). Libtayo is a leading and first-in-class PD-1 inhibitor for the treatment of approved non-melanoma skin cancers and is considered a standard of care.
Regulatory reviews are also underway for Libtayo in combination with chemotherapy as a first-line treatment in advanced NSCLC in multiple markets, including the U.S. and European Union, where approvals would provide promising opportunities to extend the medicine’s reach. It is also currently being studied with 18 investigational agents in 22 clinical trials for a variety of difficult-to-treat cancers. These combinations include numerous assets from Regeneron, including its antibody targeting the LAG-3 checkpoint receptor, and several assets from its collaborators.
“This strategic acquisition is a major step towards Regeneron’s goal of becoming a global oncology leader, centered on Libtayo as an important choice in settings where PD-1 inhibitors can be used as monotherapy and, excitingly, in potential new combinations with our differentiated and diverse pipeline of oncology assets,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. “In 2021, Libtayo was approved for two new monotherapy indications in the U.S. and EU and global net product sales increased 32% year-over-year, providing a strong foundation for our multi-faceted oncology strategy and helping to maximize the potential value of our pipeline.”
Regeneron and Sanofi entered into the Immuno-oncology License and Collaboration Agreement in 2015. Pursuant to this agreement, the companies currently split Libtayo’s worldwide operating profits equally and co-commercialize Libtayo in the U.S., with Sanofi solely responsible for commercialization outside the U.S.
Under the terms announced today, Sanofi will transfer the rights to develop, commercialize and manufacture Libtayo entirely to Regeneron, on a worldwide basis, over the course of a defined transition period. Upon closing of the transaction, Regeneron will make an upfront payment of $900 million to Sanofi, which will be entitled to receive an 11% royalty on worldwide net sales of Libtayo. Sanofi will also be entitled to a $100 million regulatory milestone payment upon the first approval by either the FDA or European Commission of Libtayo in combination with chemotherapy for first-line treatment of certain patients with NSCLC, as well as sales-related milestone payments of up to $100 million in total over the next two years.
Pursuant to the agreement, Regeneron will accelerate reimbursement of the development balance associated with Regeneron and Sanofi’s separate Antibody Collaboration. Regeneron will increase from 10% to 20% the share of its profits that are paid to Sanofi to reimburse Sanofi-funded development expenses, until Regeneron’s share of the total cumulative development costs incurred under the collaboration has been reached.
Updates to 2022 GAAP and non-GAAP financial guidance as a result of this transaction will be provided following its successful completion. Assuming a third quarter 2022 close, there will be no financial or accounting impact to second quarter 2022 results.
Regeneron Investor Call Information
Participants may access today’s conference call live via webcast on the ‘Investors and Media’ page of Regeneron’s website at https://investor.regeneron.com/events-and-presentations. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.
About Libtayo
Libtayo, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in Canada. In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Outside of the U.S., the generic name for Libtayo in its approved indication is cemiplimab.
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
Select Approved Indications
In the U.S., Libtayo is an FDA-approved prescription medicine used to treat people with:
— A type of skin cancer called advanced CSCC that has spread or cannot be cured by surgery or radiation.
— A type of skin cancer called BCC:
- That cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog inhibitor (HHI), or cannot receive treatment with an HHI.
- That has spread (metastatic BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
— A type of lung cancer called NSCLC. Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1” and your tumor does not have an abnormal “EGFR”, “ALK” or “ROS1” gene.
It is not known if Libtayo is safe and effective in children.
In Canada, Libtayo has received full or conditional approval for similar indications to the U.S., with the exception of metastatic BCC. Libtayo is also approved in Canada for the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic therapy to treat recurrent or metastatic disease.
About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one fifth of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn).
Please see full Prescribing Information, including Medication Guide.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
SOURCE: Regeneron Pharmaceuticals
Post Views: 67
Regeneron will secure global rights to Libtayo from Sanofi in exchange for upfront payment of $900 million, plus royalties and potential future milestone payments
18 different investigational treatment combinations with Libtayo currently being evaluated in 22 clinical trials
TARRYTOWN, NY, USA I June 2, 2022 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced its intent to purchase Sanofi’s stake in the Regeneron and Sanofi collaboration on Libtayo® (cemiplimab), providing Regeneron with exclusive worldwide development, commercialization and manufacturing rights to the medicine. The transaction is subject to merger control clearance outside the United States and is expected to close in the third quarter of 2022. Once the transaction has closed, Regeneron will record 100% of global net sales and expenses for the Libtayo program.
Libtayo, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells. It is currently approved by regulatory authorities in more than two dozen countries, including by the U.S. Food and Drug Administration (FDA) as cemiplimab-rwlc monotherapy treatment for certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC). Libtayo is a leading and first-in-class PD-1 inhibitor for the treatment of approved non-melanoma skin cancers and is considered a standard of care.
Regulatory reviews are also underway for Libtayo in combination with chemotherapy as a first-line treatment in advanced NSCLC in multiple markets, including the U.S. and European Union, where approvals would provide promising opportunities to extend the medicine’s reach. It is also currently being studied with 18 investigational agents in 22 clinical trials for a variety of difficult-to-treat cancers. These combinations include numerous assets from Regeneron, including its antibody targeting the LAG-3 checkpoint receptor, and several assets from its collaborators.
“This strategic acquisition is a major step towards Regeneron’s goal of becoming a global oncology leader, centered on Libtayo as an important choice in settings where PD-1 inhibitors can be used as monotherapy and, excitingly, in potential new combinations with our differentiated and diverse pipeline of oncology assets,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. “In 2021, Libtayo was approved for two new monotherapy indications in the U.S. and EU and global net product sales increased 32% year-over-year, providing a strong foundation for our multi-faceted oncology strategy and helping to maximize the potential value of our pipeline.”
Regeneron and Sanofi entered into the Immuno-oncology License and Collaboration Agreement in 2015. Pursuant to this agreement, the companies currently split Libtayo’s worldwide operating profits equally and co-commercialize Libtayo in the U.S., with Sanofi solely responsible for commercialization outside the U.S.
Under the terms announced today, Sanofi will transfer the rights to develop, commercialize and manufacture Libtayo entirely to Regeneron, on a worldwide basis, over the course of a defined transition period. Upon closing of the transaction, Regeneron will make an upfront payment of $900 million to Sanofi, which will be entitled to receive an 11% royalty on worldwide net sales of Libtayo. Sanofi will also be entitled to a $100 million regulatory milestone payment upon the first approval by either the FDA or European Commission of Libtayo in combination with chemotherapy for first-line treatment of certain patients with NSCLC, as well as sales-related milestone payments of up to $100 million in total over the next two years.
Pursuant to the agreement, Regeneron will accelerate reimbursement of the development balance associated with Regeneron and Sanofi’s separate Antibody Collaboration. Regeneron will increase from 10% to 20% the share of its profits that are paid to Sanofi to reimburse Sanofi-funded development expenses, until Regeneron’s share of the total cumulative development costs incurred under the collaboration has been reached.
Updates to 2022 GAAP and non-GAAP financial guidance as a result of this transaction will be provided following its successful completion. Assuming a third quarter 2022 close, there will be no financial or accounting impact to second quarter 2022 results.
Regeneron Investor Call Information
Participants may access today’s conference call live via webcast on the ‘Investors and Media’ page of Regeneron’s website at https://investor.regeneron.com/events-and-presentations. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.
About Libtayo
Libtayo, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in Canada. In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Outside of the U.S., the generic name for Libtayo in its approved indication is cemiplimab.
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
Select Approved Indications
In the U.S., Libtayo is an FDA-approved prescription medicine used to treat people with:
— A type of skin cancer called advanced CSCC that has spread or cannot be cured by surgery or radiation.
— A type of skin cancer called BCC:
- That cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog inhibitor (HHI), or cannot receive treatment with an HHI.
- That has spread (metastatic BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
— A type of lung cancer called NSCLC. Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1” and your tumor does not have an abnormal “EGFR”, “ALK” or “ROS1” gene.
It is not known if Libtayo is safe and effective in children.
In Canada, Libtayo has received full or conditional approval for similar indications to the U.S., with the exception of metastatic BCC. Libtayo is also approved in Canada for the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic therapy to treat recurrent or metastatic disease.
About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one fifth of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn).
Please see full Prescribing Information, including Medication Guide.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
SOURCE: Regeneron Pharmaceuticals
Post Views: 67
