Ionis Pharmaceuticals’ (IONS) Spinraza (nusinersen) is a drug designed for the treatment of spinal muscular atrophy (or SMA), a type of severe motor-neuron disease.
Biogen (BIIB) has held the worldwide development and commercialization rights for nusinersen since January 2012, and Ionis receives royalties for Spinraza sales from Biogen.
The chart above shows recent developments for Spinraza. The company has classified nusinersen under the severe and rare therapeutic areas. For US markets, the FDA has approved Spinraza for the treatment of both pediatric and adult patients with spinal muscular atrophy.
Biogen holds the future developing, manufacturing, and commercialization rights for nusinersen.
Recent developments for Spinraza
Let’s take a look at a few recent developments for Spinraza:
- In 3Q17, Ionis received $32.9 million from Biogen toward Spinraza royalties.
- On November 1, 2017, Ionis and Biogen announced the end-of-study results for the ENDEAR study, which were published in The New England Journal of Medicine.
- On October 27, 2017, Ionis announced that Spinraza had been awarded the Prix Galien USA Award for the Best Biotechnology Product in 2017.
- On October 5, 2017, Biogen released new data from its ENDEAR study, a Phase III study. The new data showed that infants with SMA who’d initiated treatment with Spinraza earlier had shown greater benefits and improvements in their motor function outcomes.
- Biogen also released data from its EMBRACE study, a Phase II study, and the interim analysis showed greater motor milestone achievements in children with SMA who’d been treated with Spinraza.