Investing.com -- Shares of Swedish Orphan Biovitrum (STO:SOBI) fell by 4% today after the FDA approved Merck (NSE:PROR)’s respiratory syncytial virus (RSV) vaccine Enflonsia (clesrovimab), which will compete with Beyfortus, a product that generates significant royalties for Sobi.

The approval of Enflonsia was anticipated but is perceived as a potential threat to Beyfortus’ market share, and consequently, to Sobi’s royalty revenue.

The approval of Enflonsia came last night and is expected to directly compete with Beyfortus. Analysts had already predicted a decline in Beyfortus sales by 10% in the US this year, factoring in the impact of Enflonsia’s entry into the market.

Despite Sanofi (EPA:SASY) (NASDAQ:SNY)’s optimism about the growth potential in the RSV vaccine market, the presence of a new competitor could alter the landscape.

RBC analysts commented on the situation, stating, "We assume Beyfortus sales fall 10% in the US this year, despite Sanofi’s confidence that the market has clear room for growth, thus we already assume Enflonsia will impact Beyfortus’ share.

We also note Sanofi has committed to ship Beyfortus early, to reassure physicians that it has ample capacity to fully supply the market.

While Enflosia has now gained approval, it will need a positive ACIP recommendation. This now has a degree of uncertainty given that the Secretary of State for Health, Robert F. Kennedy, has removed all 17 members of the ACIP panel in the last few days.

He has promised to replace the ACIP panel and the next meeting, due on 25-27 June, should still go ahead. However, there’s now a possibility that the ACIP meeting could slip."

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Source:Investing