Novartis sheds MorphoSys staff, sites after pelabresib delay

Novartis has said it will shut down two MorphoSys sites in Germany and the US, with the loss of around 330 jobs, after announcing a major delay to the biotech's lead programme pelabresib.

The decision – reported in German media outlet WirtschaftsWoche and confirmed by the Swiss pharma group today – comes as part of the integration process that follows Novartis' $2.9 billion acquisition of MorphoSys, which was announced in February and completed in May. The sites in Munich and Boston will be shut down by the end of next year.

At the time the acquisition was announced, Novartis highlighted pelabresib, a BET inhibitor that recently generated mixed results in a phase 3 trial in blood disorder myelofibrosis (MF), and dual EZH1/EZH2 inhibitor tulmimetostat in phase 1/2 for solid tumours as the programmes driving its interest.

Since then, however, the pelabresib programme has run into problems. In October, Novartis confirmed that it would delay filing for approval of the drug after reviewing 48-week data from the phase 3 MANIFEST-2 trial of the BET inhibitor, saying "longer follow-up time is needed to determine, in consultation with health authorities, the regulatory path" for the programme.

It had been planning to file marketing applications for pelabresib in the US and Europe in the middle of 2024.

However, the additional follow-up – alongside reports of a safety signal with pelabresib that is still being investigated by Novartis – has led to suggestions by Novartis' chief executive, Vas Narasimhan, that the filing could be held back until 2027 or even longer.

Novartis revealed in its third-quarter results update that it had taken an $800 million charge related to the pelabresib programme, but also said it remains committed to the drug.

In MANIFEST-2, adding pelabresib to therapy with Novartis/Incyte's JAK inhibitor Jakafi (ruxolitinib) – a standard first-line therapy for the chronic blood cancer – achieved the primary objective of a statistically significant improvement in the proportion of patients with a 35% or greater reduction in spleen volume after 24 weeks' treatment.

However, MorphoSys' drug was unable to achieve the key secondary objective of reducing symptoms of myelofibrosis, a rare type of blood cancer that causes scar tissue to form in the bone marrow and leads to anaemia, fatigue, itching, weight loss, and other symptoms.

Despite the mixed results, Novartis said pelabresib had the potential to be "practice-changing" when it revealed its MorphoSys takeover bid.