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The company plans to move PRA023 forward into Phase III studies based on positive Phase II safety and efficacy data in UC and Crohn's disease, positioning Prometheus in a race with Roivant.
Roivant will form a new "vant" company to develop and commercialize Pfizer's TL1A inhibitor for ulcerative colitis.
Based on promising Phase II data, two companies in South Korea are moving ahead with late-stage development in the gout space, with JW Pharmaceutical getting approvals to begin a multinational Phase III trial for epaminurad, while LG Chem has recently submitted an application for a Phase III program with its contender tigulixostat.
Skyrizi is the first specific IL-23 inhibitor for the treatment of Crohn's disease in Europe, though the drug was approved with a broader label in the US.
The Belgian group was stunned by an FDA rejection in May for its dual IL-17A and IL-17F inhibitor and although the refiling is complete, UCB may still have to wait six months to get Bimzelx into the all-important US psoriasis market.
Multi-product players may be able to use bundled rebates for preferred formulary status and biosimilars offer a new competitive dynamic, but there is hope for novel therapies.
Remission rates with existing therapies leave much room for improvement, so a variety of treatments are needed – leaving major players attempting to carve unique paths in a crowded market.
The ulcerative colitis and Crohn’s disease landscapes may shift soon but new drugs will compete with entrenched blockbusters, including Humira, Stelara and Entyvio, with biosimilars on the way.
The company has admitted making mistakes in its R&D, but must now convince investors that its new multi-modality approach will pay off.
Amgen will be first to launch a Humira biosimilar in the US with its Amgevita, but it and other adalimumab copies may add pressure to the company’s already declining top-seller Enbrel.
Human Immunology Biosciences (HI-Bio) launched with $120m and two candidates from MorphoSys, including the CD38 inhibitor felzartamab already in the clinic for immune-mediated kidney diseases.
GSK’s new R&D leader, Tony Wood, has promised a more hard-nosed attitude to picking winners – including a ‘pragmatic’ approach to the hyper-competitive field of oncology.
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