Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, December 11-15, 2017, we had thoughts on the following: Galapagos pleases investors by grabbing co-pro rights to filgotinib; Boston aims to challenge Medtronic and Abbott in DBS; The FDA considers loosening device rules further; Erytech spoils US debut with AML trial failure; Roche picks up Ionis’s Huntington’s drug .
These snippets were previously published daily via twitter.
Galapagos pleases investors by grabbing co-pro rights to filgotinib
December 15, 2017
Galapagos’s decision to grab the co-promotion rights to filgotinib for eight European countries under its agreement with Gilead Sciences is arguably a sign of the easy availability of financing for smallish biotechs. Where once a company like Galapagos would hope to be bought by its larger partner it now has the wherewithal to go to market with the anti-rheumatic, which will be its first commercial product if approved. Under the deal, struck an eyeblink ahead of the expiry of the lock-up and standstill arrangement between the two groups, Galapagos will assume 35% of the co-promotion efforts in Germany, France, Italy, Spain, the UK, the Netherlands, Belgium, and Luxembourg and reap an equal share of the profits in these countries. Outside these eight territories, Galapagos will be eligible to receive tiered royalty percentages ranging from 20-30% on global net sales of filgotinib. Rather than showing their displeasure over the lack of a takeout, as investors in Loxo Oncology did last month when that group licensed two cancer drugs to Bayer, Galapagos’s shareholders have boosted its stock 7% so far today.
Boston aims to challenge Medtronic and Abbott in DBS
December 12, 2017
It won’t compensate for the disappointment of the delayed launch of the Lotus valve, but the approval of Boston Scientific’s Vercise deep brain stimulation device is still some much-needed good news for the group. The premarket approval, granted for the treatment of symptoms of Parkinson’s disease, has been some time coming: Boston submitted the device to the FDA in August 2015 and it was approved in Europe in 2012. Vercise has two leads which can deliver different amounts of current and can be used to target different regions of the subthalamic nucleus, which Boston believes will improve outcomes while reducing side effects. The US deep brain stimulation market, estimated to be worth around $400m by Wells Fargo analysts, is dominated by Medtronic and Abbott and Boston could have an uphill fight for share despite this approval. Wells Fargo analysts put sales of Boston’s neuromodulation business, which includes Vercise, at $621m in 2017, rising to $694m next year.
The FDA considers loosening device rules further
December 12, 2017
The FDA’s ongoing efforts to be business-friendly have resulted in a new proposal intended to get medical devices to market faster. In future, if the plans are adopted, some lower-risk medical devices could gain clearance from the regulator without the application having to identify a predicate. Instead of proving noinferiority to a device already approved, a developer could benchmark its product against a set of safety and performance criteria or guidance documents. This idea might not necessarily be a bad one, provided safety is prioritised – it is not too dissimilar to the way devices gain EU approval under current rules. But the agency’s commissioner, Scott Gottlieb, also said that the agency would consider shifting some of the burden of proving a device’s safety and efficacy from pre-market trials to post-market registries – even for high-risk products. Doubtless medtech groups would jump at the chance to avoid the costly studies currently necessary to win premarket approval (PMA), but this could potentially pose a risk to patients. Draft guidance on the proposals is due early next year, and will be examined minutely to ensure that business-friendly does not mean patient-unfriendly.
Erytech spoils US debut with AML trial failure
December 11, 2017
With its latest clinical setback Erytech has not only seen more than 30% of its value evaporate in one day, but even more pressure heaped on its only late-stage asset Graspa. After a surprise clinical triumph earlier this year in another indication there were hopes Graspa could continue its winning streak with positive AML data. Instead, on Friday the product failed to show any overall survival benefit in a phase IIb AML study. AML has traditionally been one of the industry’s most notoriously difficult disorders, with only Novartis’ Rydapt offering any new advances, albeit for only a specific group of AML sufferers. As such, Erytech’s chances of success were slim; the steep fall in the share price, however, might have been due to investors hoping for a replica of the March success in pancreatic cancer. The news in AML also comes less than a month after the French biotech company raised $144m by floating shares on the US market, something that will not have helped shareholder reaction.
Roche picks up Ionis’s Huntington’s drug
December 11, 2017
In exercising its licence option for IONIS-HTTRx Roche has shown its confidence in Ionis’s antisense approach to Huntington’s disease. But if the size of the licence fee is any indication, it might not be that confident after all: Roche has signed over just $45m, reflecting the drug’s status as an early-stage CNS asset. There are signs of IONIS-HTTRx’s efficacy, with Ionis saying the drug caused dose-dependent reductions of mutant huntingtin protein in its phase I/II trial, and it was sufficiently safe and tolerable for development to continue. But this is hardly conclusive, and while it is true that malformed huntingtin causes Huntington’s disease, so far the theory that reducing levels of huntingtin will slow the progression of the condition remains unproven. Hard data on outcomes will be needed, and that is now Roche’s responsibility, with the Swiss group taking over all development and commercial activities under the deal.