Novartis targets 60 marketing submissions through 2021 in EU, Japan, US

Novartis on Monday issued an update on its drug pipeline, noting that it hopes to file 60 marketing applications in Europe, Japan and the US from 2019 to 2021. The company said that it has 26 "potential blockbusters" in confirmatory development, with 13 projects in clinical development across cell, gene and radioligand therapies.

The update comes after remarks were reported last week from Jay Bradner, president of the Novartis Institutes for Biomedical Research, suggesting that the company has reduced its drug research programmes from 430 to 340, including exiting infectious diseases, after completing a review of its portfolio. Earlier this year, Novartis shuttered its antibacterial and antiviral research operations as part of plans to narrow its R&D focus.

Novartis is also increasing its focus in areas such as cell and gene therapies following its purchase of gene therapy company AveXis for $8.7 billion in April. The Swiss drugmaker gained the spinal muscular atrophy (SMA) type 1 treatment AVXS101 through the acquisition, with the company noting Monday that it is on track to be launched in the first half of 2019, while clinical development is under way in all other SMA subtypes.

Commenting on potential pricing of AVXS101, Novartis suggested that the gene therapy could be cost-effective to healthcare systems at $4 million to $5 million per patient. "$4 million is a significant amount of money, but we believe this is a cost-effective point," said Dave Lennon, president of AveXis. "We've shown through other studies we are cost effective in [that] range," Lennon remarked, adding "and ultimately, this is important context as we consider how we're going to evaluate value for AVXS101."

According to Novartis, Mayzent (siponimod) is expected to launch in the US in the first quarter of next year for the treatment of patients living with secondary progressive multiple sclerosis. The drug, previously known as BAF312, is also under review in Europe, where a decision on approval is anticipated by the end of 2019. Meanwhile, the company is also developing the next- generation B-cell depletor OMB157 (ofatumumab) in MS.

Novartis added that it is also seeking line extensions for existing products, including Cosentyx (secukinumab), which is expected to be the company's largest drug next year. The therapy is currently authorised for the treatment of psoriasis, psoriatric arthritis and ankylosing spondylitis, with the company targeting expansion in non-radiographic axial spondyloarthritis, hidradenitis suppuravita and a number of paediatric indications.

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