Originally posted by pmpack
From the Announcement can somebody please tell what this actually means in terms going forward.
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The company says the licensing agreement remains in place, requiring Mylan to continue to take “commercially reasonable efforts to develop TPM-daptomycin, not to sell a generic daptomycin and to pay royalties to Phosphagencis on commercial sales.
“Phosphagenics may be required to enforce its remaining rights to require Mylan to act in line with requirements of the licencing agreement,” the company says.
PM
Could have something to do with this approval this year for Mylan Dapto and being placed under their label as per a prev recent POH Ann.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205037
I am assuming if our agreement has strict requirements re a generic Dapto being approved and sold then it could imply that mylan have not adhered to developing a TPM Dapto as per agreement opting to produce generic first against terms of agreement.
Hence why POH indicate they have to weigh up their options on that as a breach maybe.