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Novartis' $2.9B MorphoSys Acquisition Clouded by Blood Cancer Drug Safety Issues
3 June 2024
MorphoSys, a biotech firm, is facing challenges with its drug pelabresib, developed for treating myelofibrosis. The drug has been linked to safety concerns, which may impact its $2.9 billion acquisition by Novartis. According to an investigation by STAT News, there have been several instances where patients treated with pelabresib deteriorated rapidly to acute myeloid leukemia (AML), a more severe condition.
In the Phase III clinical trial involving pelabresib, it was observed that out of 212 subjects, six developed AML compared to only two in the control group. MorphoSys has communicated these safety concerns to the FDA, which is closely monitoring the situation and has issued warnings to physicians participating in the study.
Despite these issues, a MorphoSys spokesperson expressed confidence in the drug's combination with ruxolitinib, stating that the acquisition by Novartis is progressing as planned and is expected to be completed in the first half of 2024. The spokesperson also mentioned that the company does not disclose regulatory interactions publicly.
On the other hand, Novartis has not commented on the acquisition, which has not yet been finalized. Pelabresib is a small molecule inhibitor of BET proteins, which are involved in inflammatory pathways and the formation of abnormal blood cell precursors. The drug is set for regulatory submission in the latter part of 2024.
The potential of pelabresib was a significant factor in the acquisition agreement between Novartis and MorphoSys, which was announced in February 2024. However, mixed results from the Phase III trial, where the drug combination did not significantly improve total symptom scores, have raised concerns. The deal allows Novartis to withdraw if the FDA rejects MorphoSys' application for pelabresib.
MorphoSys is set to present new data on the efficacy and safety of pelabresib at the American Society of Clinical Oncology's annual meeting in Chicago from May 31 to June 4, 2024. The outcome of this presentation could be crucial for the future of the acquisition deal.
In the Phase III clinical trial involving pelabresib, it was observed that out of 212 subjects, six developed AML compared to only two in the control group. MorphoSys has communicated these safety concerns to the FDA, which is closely monitoring the situation and has issued warnings to physicians participating in the study.
Despite these issues, a MorphoSys spokesperson expressed confidence in the drug's combination with ruxolitinib, stating that the acquisition by Novartis is progressing as planned and is expected to be completed in the first half of 2024. The spokesperson also mentioned that the company does not disclose regulatory interactions publicly.
On the other hand, Novartis has not commented on the acquisition, which has not yet been finalized. Pelabresib is a small molecule inhibitor of BET proteins, which are involved in inflammatory pathways and the formation of abnormal blood cell precursors. The drug is set for regulatory submission in the latter part of 2024.
The potential of pelabresib was a significant factor in the acquisition agreement between Novartis and MorphoSys, which was announced in February 2024. However, mixed results from the Phase III trial, where the drug combination did not significantly improve total symptom scores, have raised concerns. The deal allows Novartis to withdraw if the FDA rejects MorphoSys' application for pelabresib.
MorphoSys is set to present new data on the efficacy and safety of pelabresib at the American Society of Clinical Oncology's annual meeting in Chicago from May 31 to June 4, 2024. The outcome of this presentation could be crucial for the future of the acquisition deal.
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