Novartis’ €2.7 Billion Investment in MorphoSys Hits Setback as Safety Signal Delays Key Drug Filing
Novartis’ recent acquisition of MorphoSys aimed to bring promising therapies like the myelofibrosis drug pelabresib to market, but an unexpected safety signal has created turbulence. Pelabresib, a BET inhibitor showing mixed results in clinical trials, now faces scrutiny over increased rates of “malignant transformation,” where myelofibrosis escalates into aggressive cancers like acute myeloid leukemia (AML).
Key Issues and Timeline Adjustment
Novartis acquired MorphoSys in early 2024 following a phase 3 readout that showed pelabresib reduced spleen volume but did not significantly improve symptoms, achieving mixed success on critical endpoints. Initial plans projected regulatory filings in the U.S. and Europe by mid-2024, but Novartis CEO Vas Narasimhan announced that 48-week data would be essential to finalize these plans.
When 48-week results became available, the company revealed new hurdles. Data indicated a concerning safety signal requiring additional follow-up to assess both the risk profile and regulatory pathway for pelabresib. According to Narasimhan, “longer follow-up time is needed” to consult with health authorities on a path forward for pelabresib in myelofibrosis.
Financial Impact and Reassessment
The delay caused Novartis to reassess the overall value of MorphoSys, leading to an $800 million impairment in its third-quarter financial results. This impairment reflects adjustments made prior to Novartis’ completed buyout of MorphoSys’ minority shareholders. These delays come as Novartis has been exploring other avenues in MorphoSys’ portfolio, though pelabresib remains a primary asset.
The company is also weighing the potential need for additional studies to secure safety and efficacy data for pelabresib. If required, these studies could delay filings by an estimated two years, extending the timeline for any potential market launch.
Broader Pipeline Revisions at Novartis
Pelabresib’s delay isn’t the only pipeline adjustment Novartis disclosed in its recent updates. The company announced a halt on developing the blood pressure and heart failure candidate XXB750 following internal scientific assessments. Additionally, Novartis ended phase 3 development of ligelizumab, a food allergy drug, and withdrew from autoimmune hepatitis research for ianalumab, though ianalumab continues in trials for Sjögren’s syndrome and lupus.
Industry Perspective and Next Steps
The setback for pelabresib, while disappointing, underscores the complexities of navigating novel therapies through clinical trials and regulatory processes, especially in high-stakes areas like oncology. With promising preclinical results and early data on pelabresib’s spleen volume reduction, Novartis will continue monitoring patients and conducting further analysis to address the safety signal.
Moving forward, Novartis will consult with health authorities to determine if additional studies are required to make pelabresib market-ready. Should these follow-up trials confirm the drug’s potential while managing safety concerns, pelabresib could still become a valuable option for patients facing myelofibrosis and its related complications.
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References:
- Novartis’ acquisition of MorphoSys
- Novartis Q3 Financial Results
