Biogen Inc’s TECFIDERA has received approval from the National Medical Products Administration (NMPA) in China for treating relapsing multiple sclerosis (MS).
This approval expands Biogen’s (BIIB) footprint in China. TECFIDERA has been on the market since 2013. It has been approved in 69 countries and more than 500 thousand people have been treated with the drug across the globe.
Rachid Izzar, President, Intercontinental Region at Biogen said, “It is truly a milestone to bring this well-established treatment to China and be able to help people living with relapsing multiple sclerosis.”
Izzar added, “We thank the NMPA for undertaking priority review to approve TECFIDERA. We are committed to expanding our presence in China and working with the MS community to address unmet medical needs through innovative therapies and solutions.” (See Biogen stock analysis on TipRanks)
The approval is based on two Phase 3 studies, DEFINE and CONFIRM. In DEFINE the drug was given to patients twice a day and reduced the annualized relapse rate by 53% versus placebo. In CONFIRM, a similar dosage reduced the proportion of patients who relapsed by 34% versus placebo.
Multiple sclerosis is an autoimmune neurologic disease affecting the central nervous system. It is a lifelong, progressive disease affecting movement, vision, and cognition.
On April 14, Mizuho Securities analyst Salim Syed reiterated a Hold rating on the stock and maintained a $244 price target (9.8% downside potential).
Commenting on the forthcoming 1Q earnings on April 22, Syed said, “With aducanumab’s PDUFA now less than two months away (PDUFA is June 7), any commentary from management on its regulatory, pricing or launch prospects and plans will likely be the number one investor issue.”
Consensus among analysts is that Biogen is a Moderate Buy based on 10 Buys, 9 Holds, and 3 Sells. The average analyst price target of $308.21 implies upside potential of 14%. Shares have dropped about 17.3% over the past year.
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