MorphoSys’ Myelofibrosis Drug Results Cast Doubt on Novartis Acquisition Deal

German biopharmaceutical company MorphoSys’ $2.9 billion acquisition deal with Novartis may be in jeopardy due to reports regarding safety problems with its investigational myelofibrosis drug pelabresib. The drug—a small-molecule blocker of bromodomain and extra-terminal domain (BET) proteins—was a primary motivator for the agreement between the two companies, which Novartis announced in February 2024.

According to a report from STAT, anonymous investigators involved with the drug’s phase 3 study have stated that six out of the 212 patients in the pelabresib treatment arm “rapidly progressed” from myelofibrosis to acute myeloid leukemia (AML) after receiving pelabresib vs only two patients within the control group.

In November 2023, MorphoSys revealed mixed results from the phase 3 study. When using the drug with the JAK inhibitor ruxolitinib, there was an improvement in the percentage of patients with at least a 35% drop in spleen volume. However, the combined treatment did not improve the total symptom score.

While Novartis told media they cannot comment on the deal at this time, a MorphoSys spokesperson said that the proposed acquisition is “advancing steadily” and that they expect the deal to close in the first half of 2024.

The agreement, however, allows Novartis to drop out if the US Food and Drug Administration rejects MorphoSys’s bid to file an application for pelabresib. MorphoSys plans to present updated data on the drug at the upcoming American Society of Clinical Oncology annual meeting on May 31-June 4, 2024.

Reference

Manalac T. Safety Concerns with MorphoSys’ blood cancer drug could mar $2.9B Novartis buy: STAT. BioSpace. April 29, 2024. Accessed May 8, 2024. https://www.biospace.com/article/safety-concerns-with-morphosys-blood-cancer-drug-could-mar-2-9b-novartis-buy-stat/