Of je het nu echt een rapport mag noemen weet ik niet. Maar is toch een duidelijke bevestiging van wat we al weten. Die pb's komen er aan in de komende days/weeks.
Kempen 6 april 2018
From the road: Galapagos
European Life Sciences
Last week we roadshowed Galapagos CFO Bart Filius and Chief Commercial Officer Michele Manto (ex-global head of rheumatology at AbbVie, responsible for Humira and upadacitinib, launching Humira in Crohn’s, PsA, Asp) in London. Given the opportunity to have a glimpse on filgotinib's commercialization strategy, the discussion largely focused on the place for filgotinib in a crowded market and the ways around seemingly impenetrable rebates on Humira, as well as plans for GLPG1690 in IPF and a status update on cystic fibrosis. With multiple read-outs across the pipeline, Galapagos is all set to deliver.
Why Galapagos? The CCO joined Galapagos as he believed in filgotinib and the strength of the phase II data, especially in Crohn’s, as well as the pipeline that should follow to the market after filgotinib and leverage on established infrastructure.
Planning for launch. Although investors wanted more granularity on the commercialization strategy, already the initial blueprints were appreciated. While Gilead will ultimately set the strategy, in light of the anticipated launch in 2020, Galapagos is starting to build a 300 people sales force to cover 8 co-promotion countries.
Value over rebates. It is a widely-held view that with PBMs profiting from Humira rebates in the US and secret discounts across Europe, it would be challenging to advance a new class/or a new drug to first-line. However, the inflammation market is changing with biosimilars and new therapeutic classes, exemplified by baricitinib and tofacitinib taking the major share in biologic-naïve RA patients in Germany and in the US respectively. While the price is an important part of the market access negotiations and Gilead is a great partner to lead that discussion, Galapagos sees more ways to differentiate than plain price discounts. Biologics in RA have apparent limitations such as speed and persistence of response in addition to a worse side effect profile compared to JAKs, which give an opportunity for filgotinib to demonstrate value (incl. monetary) to patients and payers beyond ACR scores at 10 weeks. Meanwhile, within the JAK class, cleaner safety and a potentially broader label should allow filgotinib to stand out of the class.
IPF is ready to get out of the blocks. The phase III trial is ready to start very soon, awaiting the minutes from the EMA and feedback from KOLs. The general thinking is an all-comers study of ~1000 patients allowing to evaluate 1690 in combination with SOC as well as monotherapy and potentially leading to a broad label “for the treatment of IPF” and a much larger market opportunity than €2b with nintedanib and pirfenidone combined as 20-50% of patients just aren’t treated.
CF in short. FALCON (2451-based triple) is to start in the coming days/weeks, but clearly, 3067 is a favorite potentiator (a large phase II reading out in H1’19). PELICAN (2222+Orkambi) reads out in Q2, but don’t get expectation up too much as Orkambi is not the best background therapy to work with. The aim is to have phase II triple and move to phase III in H2’19, Vertex triple approval before that will make life more complicated (active control?), but not impossible to bring a Galapagos triple to market. In regards to the price, nothing is set, but the company would expect AbbVie to be reasonable and play the payers' desire for competition in their favor.
What’s next? Q2'18: UC interim, PSA phase II, PELICAN in CF; Q3'18: FINCH 2 in RA, phase II Asp; start phase II with MOR106 in AtD and phase IIb with 1972 in OA, start pivotal phase III with 1690 in IPF.
Today's notes from the road contributor: Anastasia Karpova.