Privately-held generics firm Alvogen has paid to market Pfenex’s (NYSE: PFNX) copy of Forteo (teriparatide), an osteoporosis drug marketed by US pharma major Eli Lilly (NYSE: LLY), in the USA.
Pfenex’s PF708 is being developed through the 505(b)(2) regulatory pathway in the USA and based on positive trial results, the company plans to submit a New Drug Application (NDA) to the US Food and Drug Administration in the third quarter of 2018, leading to potential launch, if approved by regulators, as early as the third quarter of 2019.
"Alvogen's established commercial business with vast resources and experience will support us through the NDA submission, launch and commercialization"
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