Regeneron Pharmaceuticals, Inc. and Sanofi Launch Major New Immuno-Oncology Collaboration
Jul 28 15
Regeneron Pharmaceuticals, Inc. and Sanofi entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the emerging field of immuno-oncology. As part of the agreement, the two companies will jointly develop a programmed cell death protein 1 (PD-1) inhibitor currently in Phase 1 testing and plan to initiate clinical trials in 2016 with new therapeutic candidates based on ongoing, innovative preclinical programs. Sanofi will make an upfront payment to Regeneron of $640 million, and the companies will invest $1 billion for discovery through proof of concept (POC) development (usually a Phase 2a study) of monotherapy and novel combinations of immuno-oncology antibody candidates to be funded 25% by Regeneron ($250 million) and 75% by Sanofi ($750 million). The companies have also committed to equally fund an additional $650 million (or $325 million per company) for development of REGN2810, a PD-1 inhibitor. In addition, Sanofi will pay Regeneron a one-time milestone of $375 million in the event that sales of a PD-1 product and any other collaboration antibody sold for use in combination with a PD-1 product exceed, in the aggregate, $2 billion in any consecutive 12-month period. Finally, the two companies have agreed to re-allocate $75 million (over three years) for immuno-oncology antibodies from Sanofi's $160 million annual contribution to their existing antibody collaboration, which otherwise continues as announced in November 2009. Beyond the committed funding, additional funding will be allocated as programs enter post-POC development. The new agreement covers both monoclonal antibodies and new bi-specific antibodies, a variation of standard antibody therapeutics in which two distinct targets within the body can be bound by the same molecule, usually the cancer cell and an immune cell. Regeneron has developed a novel and flexible manufacturing platform that enables efficient production of bi-specific antibodies that are otherwise similar to natural antibodies. Beyond PD-1, other programs in preclinical development include antibodies to lymphocyte-activation gene 3 (LAG3), glucocorticoid-induced tumor-necrosis-factor-receptor-related protein (GITR) and a programmed death ligand (PD-L1) inhibitor. Finally, the collaboration is advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments. The framework of the new immuno-oncology collaboration is as follows: Regeneron will be responsible for discovery, antibody generation and development through POC, at which time Sanofi will have the ability to opt-in to further development and commercialization. In the existing antibody collaboration, Sanofi has the opportunity to opt-in at the time of an Investigational New Drug application (IND); The companies will alternate serving as the lead development and commercialization organization after Sanofi opts-in to an antibody program; For programs where Regeneron is the lead, including REGN2810, Regeneron will serve as the U.S. commercial lead, including recording U.S. sales, and the companies will equally fund post-POC development. Sanofi will record sales and serve as the commercial lead for all countries outside the U.S.; Sanofi will retain the right to co-promote in the U.S. and Regeneron will retain the right to co-promote outside the U.S. For programs where Sanofi is the lead, Sanofi will serve as the U.S. commercial lead and fund 100% of post-POC development, with Regeneron reimbursing up to 50% of such costs through the IO collaboration development balance, which represents the amount of development funding that Regeneron is obligated to repay out of its share of profits as described below. Sanofi will record sales and serve as the commercial lead for all countries outside the U.S. Regeneron will retain the right to co-promote in the U.S. and outside the U.S. Sanofi and Regeneron will share equally in worldwide profits from sale of collaboration immuno-oncology antibodies; As in the existing antibody agreement, Regeneron will repay the immuno-oncology collaboration development balance from its share of overall profits of the immuno-oncology antibodies, in an annual amount equal to 10% of the Regeneron share of profits. The exclusive collaboration to discover and develop potential monotherapy or novel combination immuno-oncology antibody candidates through POC will last five years with an ability to extend the collaboration for selected ongoing programs for an additional three years. The agreement does not include Chimeric Antigen Receptors. Additional terms, including potential therapeutic targets or mechanisms, were not disclosed.
Regeneron and Sanofi Announce FDA Approval of Praluent® (alirocumab) Injection
Jul 24 15
ReRegeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein (LDL) cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. Praluent is the first and only PCSK9 inhibitor approved in the U.S. and is available in two different doses (75 mg and 150 mg). Both doses of Praluent are available in a single 1 milliliter (mL) injection delivered in a single-dose prefilled pen or syringe that patients self-administer every two weeks. The approval of Praluent was based on data from the pivotal Phase 3 ODYSSEY program, which showed consistent, positive results compared to placebo, which included current standard of care therapy (statins). In the ODYSSEY LONG TERM trial which evaluated Praluent 150 mg every two weeks, Praluent reduced LDL cholesterol by 58% versus placebo at week 24 when added to current standard of care, including maximally tolerated statins. In ODYSSEY COMBO I, Praluent 75 mg every two weeks as an adjunct to statins reduced LDL cholesterol by an additional 46% compared to placebo at week 12. At week 24 in the same trial, Praluent reduced LDL cholesterol by 43% compared to placebo. In this study, if additional LDL cholesterol lowering was required based on pre-specified criteria at week 8, Praluent was up-titrated to 150 mg at week 12 for the remainder of the trial. 83% of patients remained on their initial 75 mg dose.
Regeneron Pharmaceuticals, Inc., Sanofi - Special Call
Jul 24 15
To discuss on Praluent® (alirocumab) Injection for the treatment of high LDL cholesterol in adult patients