AbbVie ($ABBV) and partner Biogen ($BIIB) are just months away from a European approval for their new multiple sclerosis mAb after the CHMP gave the drug a green light today.
Zinbryta (aka daclizumab) has been recommended by the EMA’s drug safety and efficacy arm for relapsing forms of multiple sclerosis. This recommendation will be sent to the European Commission, which will typically make a final approval within three months; it can then be launched across the EU.
The drug is a new form of a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 receptor subunit (CD25), which is expressed at high levels on T-cells that become activated in people with MS.
The CHMP said its decision to recommend the drug comes from the drug’s ability to reduce the annualised relapse rate in RMS patients as well as the risk of 24-week confirmed disability progression.
This is based on results from two clinical trials, Decide and Select, in which the drug, when injected every four weeks, improved results on key measures of MS disease activity in patients with RMS compared to Biogen’s aging blockbuster MS treatment Avonex, and placebo, respectively.
There were however more safety issues with Zinbryta compared to Avonex, which included elevations in liver toxicities and an increased number of injection-related problems.
The MS space is already packed with players and further crowding, thanks largely to Biogen. Tecfidera, the company's oral treatment, debuted in April 2013 and minted more than $3.6 billion in sales last year, shifting a landscape that was once dominated by Teva’s ($TEVA) Copaxone--before the Israeli generics giant began losing its patents for the drug last year.
There are also therapies from Novartis ($NVS) in the form of Gilenya, Sanofi-Genzyme's ($SNY) Lemtrada and Aubagio, and Biogen’s other mAb MS drug Tysabri. On top of this, there are experimental therapies from Roche ($RHHBY) and French biotech MedDay in late-stage studies for progressive forms of MS--which currently have no treatments available.
But things have in recent months not been going well for Biogen's MS franchise as Tecfidera, despite its impressive sales, has seen its growth rate slow. Coupled with this, earlier this year Europe revoked one of its key patents; Biogen is appealing the decision, but if it fails, this could wipe off $1 billion from its balance sheet for the drug.
And while Zinbryta’s monthly schedule and self-administered dosing system could score points among physicians and patients--Biogen already markets its every-two-weeks MS treatment in Plegridy, approved in 2014.
Analysts say that this drug should bring blockbuster sales at its peak, but it'll likely cannibalize Avonex sales on the way there. Same goes for Zinbryta, which some analysts expect to top out at around $500 million.
Plegridy, alongside Avonex and Tysabri have in fact all seen sales slow or disappoint analysts over the past three quarters--meaning a new MS drug could help boost its slightly flagging franchise, should its uptake prove strong in Europe.
For AbbVie, however, elbowing into the MS market is less of a zero-sum game. The company bought into the treatment through its $700 million deal for Facet Biotech back in 2010, and the drug has long been one of its top late-stage prospects.
Zinbryta is currently being reviewed by the FDA.
“For people with relapsing forms of MS and active disease, Zinbryta has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Alfred Sandrock, EVP and chief medical officer at Biogen.
“Zinbryta may offer another option for people with multiple sclerosis with its targeted mechanism of action which did not cause broad and prolonged immune cell depletion.”
-check out the joint release