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DewDiligence

08/25/21 10:56 AM

#239297 RE: DewDiligence #238735

MRK’s Vaxneuvance—(f/k/a V114)—meets_immunogenicity_NI_endpoint_in all_but_one_serotype in_infants_<3mo:

https://www.businesswire.com/news/home/20210825005054/en

The comparator was PFE’s Prevnar-13, which is effectively an obsolete product now that PFE has Prevnar-20, which has protection for seven additional serotypes.

Vaxneuvance narrowly missed non-inferiority to Prevnar-13 on serotype 6A; it’s unlikely, IMO, that this one miss will prevent regulatory approval. (Non-inferiority in this trial was predefined as the lower bound of the 2-sided 95% CI on effect size being >0.50.)

The real issue for MRK’s Vaxneuvance is that PFE’s new Prevnar-20 looks set to capture the lion’s share of the market for next-generation pneumococcal vaccines.

DewDiligence

09/24/21 3:57 PM

#239667 RE: DewDiligence #238735

PFE gains royalty on MRK’s Vaxneuvance/V114 pneumococcal vaccine:

https://www.fiercepharma.com/vaccines/pfizer-merck-settle-patent-dispute-next-gen-pneumococcal-shots

In a settlement this week in the U.S. federal court in Delaware, Merck and Pfizer agreed to dismiss patent claims against one another. Under the deal, Merck will pay Pfizer 7.25% of its net sales from pneumococcal conjugate shots worldwide through the end of 2026… After that, the company will owe a 2.5% royalty to its New York rival through the end of 2035…

The royalty is based on the settlement of patent litigation pertaining to conjugated vaccines.

DewDiligence

04/01/22 10:27 AM

#241868 RE: DewDiligence #238735

MRK—Vaxneuvance sBLA for pediatrics gets 3-month extension to 7/1/22:

https://finance.yahoo.com/news/merck-provides-fda-review-supplemental-104500754.html

Vaxneuvance is 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).

p.s. 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).

DewDiligence

06/22/22 7:19 AM

#242911 RE: DewDiligence #238735

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).