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DewDiligence

04/14/22 9:59 AM

#821 RE: DewDiligence #820

MRK’s V116—(follow-on_to Vaxneuvance)—receives FDA BTD for prevention of pneumococcal disease in adults:

https://finance.yahoo.com/news/merck-announces-u-fda-granted-104500278.html

The phase-3 trial is expected to start during 2022.

V116 is a 21-valent vaccine; the 21 strains are: 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B.
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DewDiligence

06/22/22 7:22 AM

#829 RE: DewDiligence #820

FDA approves MRK’s pneumococcal vaccine, Vaxneuvance for infants/children:

https://finance.yahoo.com/news/u-fda-approves-merck-vaxneuvance-104500312.html

Vaxneuvance was already FDA-approved for adults (#msg-164961310), but I don’t think Vaxneuvance will compete effectively with PFE’s Prevnar-20, which has broader coverage of pneumococcal serotypes and a simpler (one-shot) treatment course (#msg-166441188).

PFE's Prevnar-20 is FDA approved for adults, but is not yet approved for infants/children, so MRK does have a head start in the pediatric market.

MRK pays PFE a royalty of 7.25% on worldwide Vaxneuvance sales during 2022-2026 and a 2.5% royalty during 2027-2035 (#msg-166075692).