Radius's Tymlos Dawdles At CHMP, No EU Opinion Yet
Executive Summary
Radius Health has a new CEO, but the company's path to the EU market for its novel osteoporosis therapy Tymlos looks still subject to questions at this week's meeting of the European Medicines Agency’s CHMP.
Radius Health Inc.'s osteoporosis therapy Tymlos (abaloparatide) is enjoying a free run at the US market with the recent delay to its rival Evenity (romosozumab) in the novel anabolic therapy space, but there still seem to be some blocks on its path to the EU market.
Radius highlighted a positive opinion from the European Medicines Agency’s main scientific committee, the CHMP, for abaloparatide-SC in July as one of its key upcoming milestones during its first quarter earnings call on May 1, just after the drug received its US approval. The company decided to price Tymlos competitively with Eli Lilly & Co.'s similar but firmly established product Forteo (teriparatide) in a bid to reach blockbuster status.
However, in the agenda for this week's meeting of the CHMP (July 17-20), the drug was notable by its absence from the list of products which are due to receive an opinion on their initial applications. Instead, abaloparatide tops the list of products for which there are still "Outstanding issues at Day 180".
The setback comes just as the company has appointed a new CEO, the Novo Nordisk veteran Jesper Høiland, to succeed Robert Ward, who had been at the helm since 2013. Before joining Radius, Høiland was president of Novo Nordisk’s US operations.
Radius's confident prediction of a positive opinion in July came after the application was discussed during the March CHMP meeting, concerning an extension to a clock stop to respond to "the List of Outstanding Issues adopted on 15 December 2016" (this is according to the meeting's agenda, listed under the heading, "Update on on-going initial applications for Centralised procedure").
The minutes of the March CHMP meeting state that the committee noted the request by the applicant for a clock stop extension to respond to the List of Outstanding Issues adopted on 15 December 2016 and adopted " a revised list of outstanding issues with a specific timetable". It appears some issues are still outstanding.
All this amounts to a further delay for the product in the EU. Radius submitted a centralized marketing authorization application (MAA) for abaloparatide-SC in November 2015, which was validated by the EMA the following month. In May last year, Radius said the EMA had granted it an additional three-month extension to the procedural timetable for it to respond in the assessment. At that point, Radius still anticipated that "the CHMP may adopt an Opinion regarding the MAA in late 2016 or in 2017".
Radius is no stranger to regulatory twists and turns for abaloparatide – the US application was also subject to a three-month delay in March pushing back the PDUFA date to June 30 "to allow time to review information submitted by Radius Health in response to the FDA's Information Requests". In the end, the actual approval came two months earlier than this, at the end of April.
Partner Sought
There is another outstanding issue for Radius in the EU: the matter of a commercial partner for the product. Having on board an Ex-US/ROW partnership for it by the time of EU launch was also stated as an ambition in the Q1 results presentation. There is no news on this yet from the company although arguably a delay to the approval buys it more time here.
In any case, Radius still has the upper hand over Evenity in the EU as well as the US. The Amgen Inc./UCB SA product is yet to be filed there, but has a submission slated by year end. (Also see "US FDA Sends Amgen/UCB Evenity Back With BRIDGE Request" - Scrip, 17 Jul, 2017.)