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Pfenex Receives General Advice Letter for PF708
Pfenex Inc. (PFNX) reported that its commercialization partner for PF708, Alvogen Malta Operations Ltd., has received a General Advice Letter from the FDA for the submission of additional comparative use human factors data. The letter also emphasized that the data specifically from Forteo experienced users would be required before the determination of PF708 Therapeutic Equivalence. The application was already accompanied by comparative use human factors (CUHF) data from Forteo-experienced patients and caregivers.
Pfenex is working on PF708 in collaboration with Alvogen Malta Operations Ltd. The company stated that the FDA now requires the data from larger number of experienced subjects. However, the FDA has stated that it will continue with the assessment of data already provided with the application. The regulatory body also offered guidance to the company with regard to study methodology to be employed for generating additional data.
Eef Schimmelpennink, Chief Executive Officer of Pfenex, said, “We intend to work closely with Alvogen and the FDA to expeditiously move toward a solution addressing the Agency’s expressed views, so that we can submit additional data as soon as possible. Additionally, we will continue to support Alvogen with its commercial strategy planning in the U.S. while continuing to seek “A” therapeutic equivalence designation.”
Pfenex is a biotechnology firm which mainly focuses on leveraging the use of its proprietary protein production platform, Pfenex Expression Technology, for developing novel protein therapeutics. The company has a strong development pipeline, including drug candidates such as PF745 which is a half-life extended recombinant Erwinia asparaginase and PF743 which is a recombinant Erwinia asparaginase.
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