Novartis announced this week that it has agreed to make a voluntary public takeover offer to acquire MorphoSys AG, a Germany-based, global biopharmaceutical company developing innovative medicines in oncology. The deal, which is subject to customary closing conditions, including a minimum acceptance threshold of 65% of outstanding shares tendered in the takeover offer and regulatory approvals, expands and complements Novartis’ oncology pipeline, one of its priority therapeutic areas while also enhancing Novartis global footprint in hematology.
Upon completion of the deal, Novartis will own pelabresib (CPI-0610), a novel and potentially practice changing treatment option with a well-tolerated safety profile provided in combination with ruxolitinib for patients with myelofibrosis (MF). And it will also include tulmimetostat (CPI-0209), an early-stage investigational dual inhibitor of enhancer of zeste homolog 1 and 2 (EZH1 and EZH2) proteins currently being tested in patients with solid tumors or lymphomas.
Pelabresib (combined with ruxolitinib) recently met its primary endpoint of spleen volume reduction in the Phase 3 MANIFEST-2 study in JAK inhibitor-naive MF patients. The combination also demonstrated favorable trends in symptom improvement as evidenced by key secondary endpoints of absolute and 50% change in total symptom score (TSS) at week 24 compared to baseline. All four clinical hallmarks of disease in myelofibrosis – splenomegaly, disease-associated symptoms, anemia, and bone marrow fibrosis – were improved with the pelabresib and ruxolitinib combination. In the earlier Phase 2 MANIFEST trial, the third arm of the study with a patient population comparable to MANIFEST-2, showed durable improvements in both spleen volume and total symptom score up to week 602. A regulatory filing with the U.S. FDA is planned for the second half of this year.
Pelabresib is an investigational small molecule designed to promote anti-tumor activity by selectively inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. And pelabresib is also being studied in patients with essential thrombocythemia (ET) – which is currently in Phase 2 in the second line of treatment. Besides pelabresib, MorphoSys’ pipeline also includes a broad portfolio of partnered assets – of which some are in partnership with Novartis – including ianalumab (VAY736) which is studied across multiple immunological diseases and in hematology.
Under the agreed deal, which has been unanimously approved by the Board of Directors of both companies, Novartis will make a voluntary public takeover offer for all no-par value bearer shares of MorphoSys AG for €68 per share (or an aggregate of €2.7 billion).
The deal is subject to customary closing conditions, including acceptance of the takeover offer by at least 65% of MorphoSys AG’s outstanding shares and receipt of regulatory approvals and is expected to close in the first half of 2024. Until the transaction closes, MorphoSys AG will continue to operate as a separate, independent company.
KEY QUOTE:
“We are excited about the opportunity of bringing pelabresib, a potential next-generation treatment combined with ruxolitinib, to people living with myelofibrosis, a rare and debilitating form of blood cancer. With the planned acquisition of MorphoSys, we aim to further strengthen our leading pipeline and portfolio in oncology, adding to our capabilities and expertise. Building on our long-standing development partnership with MorphoSys, we look forward to continuing our work together to realize the full impact and value of their investigational medicines for patients with unmet needs.”
- Shreeram Aradhye, M.D., President, Development and Chief Medical Officer of Novartis
