Sanofi Secures Exclusive Rights to PI3Kδ/γ Dual Inhibitor Copiktra in Emerging Markets; CSPC Pharmaceutical Group Expected to Launch in China by 2021
Jul 27, 2019 16:34
CST Updated
16:34
Sanofi
Pharmaceutical R&D Developer
Verastem Oncology
Small Molecule Kinase Inhibitor Developer
July 27, 2019/BioonBIOON/--U.S. biopharmaceutical company Verastem Oncology recently announced an agreement with Sanofi, granting Sanofi the rights to develop and commercialize the targeted anticancer drug Copiktra (duvelisib) for the treatment of allTumorexclusive rights to the indication. Copiktra is an oral phosphoinositide 3-kinase (PI3K) inhibitor, and this drug is approved in the United StatesFDAThe first approved dual PI3K-δ and PI3K-γ inhibitor.
Under the terms of the agreement, Verastem Oncology will receive a $5 million upfront payment and will be eligible for up to $42 million in development and sales milestone payments, as well as double-digit percentage royalties based on future net sales of Copiktra within the licensed territory. Sanofi will obtain exclusive rights to develop and commercialize Copiktra and will hold the marketing authorization and product license for Copiktra in the licensed territory. Sanofi will also have the right to certain global development andClinical TrialsCollaboration with Verastem Oncology.
David Khougazian, Head of Sanofi Genzyme China and Emerging Markets, stated: “As a leader in specialized care, we welcome partnerships with the potential to deliver value for patients and caregivers. This agreement adds an oncology drug with an innovative mechanism of action to our pipeline, bringing significant new hope to patients with hematologic malignancies who have high unmet medical needs. Collaborating with Verastem Oncology to develop and commercialize Copiktra aligns with our goal of providing better patient care and expanding our presence in emerging markets.”Tumorbusiness in the field.”
Copiktra isFDAThe first approved dual inhibitor of PI3K-δ and PI3K-γ, with duvelisib as its active pharmaceutical ingredient. Duvelisib is an oral targeted inhibitor of phosphoinositide 3-kinase (PI3K) that simultaneously inhibits the activity of PI3K-δ and PI3K-γ, two protein kinases that support the survival and proliferation of malignant B cells.
In September 2018, Copiktra received U.S.FDAApproved for the treatment of relapsed or refractory chronic lymphocytic leukemia in patients who have previously received at least two therapiesLeukemiaor adult patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL). In addition, Copiktra has also been approvedFDAAccelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior therapies. The accelerated approval for the FL indication is based on overall response rate data; further full approval will be contingent upon the verification and characterization of clinical benefit in confirmatory studies. The prescribing information for Copiktra includes a Boxed Warning regarding fatal and serious toxicities, including infections, diarrhea or colitis, cutaneous reactions, and pneumonitis.
It is worth noting that in September 2018, CSPC Pharmaceutical Group signed a $45 million agreement with Verastem to obtain exclusive rights for the development and commercialization of Copiktra in the Chinese market. According to CSPC’s first-quarter performance report released at the end of May this year, the marketing authorization application for Copiktra in China has been accepted, with approval for market launch expected in 2021.
Copiktra Active Pharmaceutical Ingredient Duvelisib: Molecular Structure (Top) and Mechanism of Action (Bottom)
In June this year, Verastem presented the latest data on Copiktra for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) at the 24th European Hematology Association Annual Congress (EHA 2019), including post hoc analysis data from the Phase III DUO study. The results showed that Copiktra treatment rapidly increased lymphocyte counts and led to lymph node reduction, with 86% of patients achieving a lymph node response. Furthermore, the analysis revealed that the dose adjustments applied in the study could be used to effectively manage adverse events in patients with CLL/SLL receiving Copiktra.
In addition, Verastem, Inc. at the 15th International Conference on Malignant LymphomaConferenceData from two supportive Phase I clinical studies (NCT01476657, NCT0278362) on Copiktra for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) were presented at ICML 2019. Relapsed or refractory PTCL is associated with a poor prognosis; most therapies induce response rates of less than 30%, and the median progression-free survival (PFS) is less than 6 months. Data from the two studies showed that in patients receiving duvelisib monotherapy at a dose of 75 mg twice daily, as well as in those receiving it as lead-in monotherapy prior to romidepsin, the overall response rates (ORR) were 54% and 44%, respectively, and the complete response rate (CR) ranged from 15% to 22%. Notably, in patients receiving duvelisib at a dose of 25 mg twice daily as lead-in monotherapy prior to bortezomib, the ORR was 57%. (Bioon.com)