A leap in sales driven by spinal muscular atrophy drug Spinraza sent Biogen shares upwards yesterday, but those gains could be reversed or boosted by much-anticipated Alzheimer’s data due later today.
Biogen’s top-line rose 9% to $3.4bn in the second quarter, with its maturing multiple sclerosis franchise staying relatively stable at $2.3bn – despite tough competition from Roche’s fast-growing new MS drug Ocrevus (ocrelizumab).
Spinraza (nusinersen) led the charge, with sales more than doubling to $423m after 18 months on the market – thanks to a $750,000 first-year list price in the US that halves in year two. There was some deceleration in new patients starting treatment with the drug, but Biogen maintains that expanding use in adult SMA patients as well as children will unlock a “large underserved patient pool” – and of course the drug is still rolling out internationally.
On the company’s results call, analysts asked about potential competition to Spinraza from rival therapies such as oral liquid drug risdiplam (RG7916) developed by Roche and PTC Therapeutics and a one-off gene therapy in testing by Novartis/Avexis. Biogen chief executive Michel Vounatsos responded by saying “we think there is going to be [a] future where there are multiple options for patients with SMA” and there may well be “combinatorial…or complementary effects” for drugs with different mechanisms.
In the meantime, the company isn’t resting on its laurels in the SMA category, licensing two new myostatin-targeting drugs from AliveGen with potential in that indication in a $535m deal yesterday. It’s also working on a follow-up to Spinraza with partner Ionis – which originated the drug.
Another candidate for SMA has hit a snag, however, with the FDA applying a clinical hold on a gene therapy candidate developed in partnership with the University of Pennsylvania, just ahead of the start of a phase I/II trial.
“We believe we have a path forward and we are working to lift the hold as quickly as possible,” said Biogen’s head of R&D Michael Ehlers on the call.
There’s no denying that the main focus of analysts’ interest on the update was Biogen’s Alzheimer’s programmes, and particularly BAN2401, which has data scheduled for presentation today at the Alzheimer’s Association International Conference in Chicago by partner Eisai.
After a lacklustre showing at 12 months in a phase 2 trial, BAN2401 did better at the 18-month timepoint, with Biogen and Eisai reporting an impact on Alzheimer’s symptom progression earlier this month. Biogen is holding a conference call later today to discuss the data when it comes out.
BAN2401 and Biogen’s second Alzheimer’s play aducanumab (in a phase Ib trial due to generate results in 2020) both target soluble beta amyloid fibrils. Earlier this week another drug in that category, Alzheon’s tramiprosate, also reported some encouraging data in a mid-stage trial, although that involved a subgroup of patients with a genetic predisposition to developing the disease early.
The company also said it has started dosing patents in a phase 2 trial of its tau protein-targeting Alzheimer’s drug BIIB092, licensed from Bristol-Myers Squibb last year.