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New Meds Set to Reshape US CNS and oncology Markets

CNS and cancer will be biopharma battlegrounds this year according to Clarivate Analytics, which says new meds will reshape the US market.

The US Food and Drug Administration (FDA) looks set to approve several innovative therapies for central nervous system (CNS) disorders and cancer in 2020 according to Clarivate.

The firm cited Biohaven’s rimegepant—which treats migraine—as well as Novartis’ OMB-157 and Celgene/B-MS’ ozanimod—which treat multiple sclerosis—as examples of drugs they expect to win approval this year.

In contrast, in oncology, Clarivate expects products approved in the past few years to have the most significant impact on the market.

A spokesman told us “A number of already approved and about-to-be approved therapies will battle for market share, particularly in cancer and multiple sclerosis.

He cited products approved to treat cancers of the bladder, prostate, breast, and lung—all of which were cleared last year—as examples.

Most of the biopharmaceutical products set to launch this year are monoclonal antibodies (mAbs). However, several cell and gene therapies are also poised to reach the market.

“MAbs will continue to dominate the market but ramping up will be cell and gene therapies—several, of which are expected to reach the US market this year to treat blood disorders and capture market share over the next couple of years,” the spokesman told us.

The spokesman cited Biomarin’s gene therapy valoctocogene roxaparvove (Valrox) as one such product.

Valrox—which is designed to treat hemophilia A—was filed for FDA review in December based on interim data from a Phase III study as well as three-year data from Phase I/II studies.

At the time Biomarin predicted that regulatory assessment would begin this month.

Clarivate shared its thoughts on the market to coincide with the publication of its “Drugs to Watch” report. It also looked at various US Government efforts to reduce pharmaceutical prices.

The spokesman told us “Whether Congress manages to send any substantial legislation to the president depends on whether each party, in both houses, is truly interested in reaching a bipartisan solution.

“While most drug manufacturers are keeping their price increases in the single-digit range, the number of price increases that greeted the new year would suggest the legislative proposals and campaign talking points are not resonating with many brand companies.

“The savings that have been seen are mostly due to new generic and biosimilar competition,” he added.

Written by: Gareth Macdonald

Published on: February 18th, 2020

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