Pfenex Submits New Drug Application To U.S. FDA Seeking Approval Of PF708 For The Treatment Of Osteoporosis

Submitted as a 505(b)(2) NDA with an Expected Ten-Month Review

Pfenex Inc. recently announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of PF708 for the treatment of osteoporosis. The application is submitted as a 505(b)(2) NDA and references Eli Lilly and Company’s Forteo (teriparatide) as the Reference Listed Drug.

“We are pleased to submit to the FDA an NDA for PF708 as a proposed therapeutic equivalent to Forteo, which achieved $1.7B in global sales in 2017,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “We believe the timing of the NDA submission for PF708 could allow for a potential commercial launch as early as the fourth quarter of 2019 in the U.S., subject to FDA acceptance, approval and other factors. We continue to work closely with Alvogen to support the overall plans for commercialization of PF708 in the U.S.”

The NDA submission for PF708 is based on positive data from the PF708-301 Phase III clinical study announced earlier this year, which showed comparable overall profiles between PF708 and Forteo after 24 weeks of daily injection in osteoporosis patients. In addition, the NDA includes data from the PF708-101 study, a single-dose, 2-way crossover study comparing the pharmacokinetics of PF708 and Forteo in healthy subjects.

About PF708
PF708 is being developed as a therapeutic equivalent candidate to Forteo, which is approved and marketed by Eli Lilly and Company for the treatment of osteoporosis in certain patients with a high risk of fracture. Forteo achieved $1.7B in global product sales in 2017. PF708 is being developed pursuant to the 505(b)(2) regulatory pathway in the U.S. and references Forteo as the Reference Listed Drug.

About Pfenex Inc.
We are a clinical-stage development and licensing biotechnology company focused on leveraging our Pfēnex Expression Technology to develop and improve protein therapies for unmet patient needs. Using the patented Pfēnex Expression Technology platform, we have created an advanced pipeline of therapeutic equivalents, vaccines, biologics and biosimilars. The Company also uses its Pfenex Expression Technology platform to produce CRM197, a diphtheria toxoid carrier protein used in prophylactic and therapeutic vaccines. Our lead product candidates are PF708, a therapeutic equivalent candidate to Forteo (teriparatide) for the treatment of osteoporosis, and our novel anthrax vaccine candidates, Px563L and RPA563, funded through an advanced development contract with the U.S. government. In addition, we are developing hematology/oncology products, including PF743, a recombinant crisantaspase, and PF745, a recombinant crisantaspase with half-life extension technology, in collaboration with Jazz Pharmaceuticals. Furthermore, our pipeline includes biosimilar candidates to Lucentis and Neulasta. For more information, visit http://www.pfenex.com/.