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DewDiligence

06/28/23 1:37 PM

#247779 RE: DewDiligence #184709

PFE/OPK—FDA approves Ngenla weekly treatment_for growth-hormone deficiency in children:

https://finance.yahoo.com/news/fda-approves-pfizer-ngenla-long-104500067.html

The approval is based on Ngenla’s showing non-inferiority to PFE’s daily Genotropin. Genotropin had annualized worldwide sales of ~$600M in 1Q23, despite competition from ASND’s Skytrofa (#msg-165622237).

The Ngenla BLA received a CRL in Jan 2022 for undisclosed reasons (#msg-167595039). PFE and OPK inked a partnership deal for commercial development of hGH in 2014 (#msg-109075402).