Takeda Targets Leukaemia Market with Blockbuster $1.3B Deal, Rivaling Novartis' Scemblix

With a deal valued at up to $1.3 billion, Takeda might acquire a "potentially best-in-class" third-generation BCR-ABL tyrosine kinase inhibitor (TKI) that could compete with Novartis' Scemblix.Takeda said in a press release, Thanks to an agreement with Ascentage Pharma, Takeda may later choose to in-licence the Chinese biotech's olverembatinib, which is being developed for chronic myeloid leukaemia (CML) along with “other haematological cancers.” If the option is exercised, Takeda can obtain licensing for global development and commercialization rights in all regions except Greater China and Russia.

Ascentage will receive a $100 million signing payment and could earn up to $1.2 billion in milestones, along with “double-digit royalties” on annual sales, according to an announcement by the Chinese pharmaceutical company. Additionally, Takeda will invest $75 million in Ascentage as a minority equity investment, a Takeda spokesperson informed FiercePharma via email.

 Although Takeda now has the option to license the drug, the decision will depend on meeting certain undisclosed development milestones, as stated by a media representative. The timing will be determined by the clinical development schedule, which Ascentage currently manages.

 Olverembatinib is already approved in China as the first third-generation BCR-ABL1 inhibitor and the only treatment for CML patients with T315I mutations. It is specifically approved for TKI-resistant chronic-phase or accelerated-phase CML patients with the T315I mutation.

Takeda also said that “Outside of China, the med holds an FDA fast-track designation and an orphan drug designation from the European Medicines Agency. TKIs have already greatly impacted CML treatment ever since Novartis’ Gleevac, the first approved TKI, turned a “once fatal diagnosis into a manageable condition, according to the Leukaemia and Lymphoma society. Still, there remains an unmet need for patients whose disease is resistant or refractory to those therapies or who develop difficult-to-treat mutations stemming from the treatments.”

Teresa Bitetti said in a statement, “Takeda has a long history of driving important treatment advances for patients, particularly those with haematological cancers facing treatment gaps.” Ascentage aims to utilise the global commercial expertise" of its partner, CEO Dajun Yang, M.D., mentioned in the release. Olverembatinib is about to start a global registrational phase 3 study, known as POLARIS-2, targeting previously treated adult patients with chronic-phase CML, with or without the T315I mutation. The FDA approved the trial in February, and it is scheduled to begin in the first six months of this year.

 Novartis is also aiming to address the unmet needs left by traditional TKIs. Their newer drug, Scemblix, has received conditional FDA approval for third-line treatment of CML. Now, following a phase 3 study where it outperformed its predecessor Gleevac with faster and more profound molecular response rates, Novartis is seeking to position Scemblix as a first-line treatment option.