Alvogen and Pfenex (NYSE American: PFNX) have entered into an agreement granting Alvogen exclusive rights to commercialize Pfenex’s lead drug candidate, PF708, a teriparatide therapeutic equivalent candidate to Eli Lilly & Company’s Forteo®, in the United States.
This collaboration aligns the interests and strengths of Pfenex and Alvogen in actions designed to secure regulatory approval and commercializing PF708 in the United States. Pfenex will continue to be responsible for development and registration of PF708, while Alvogen will provide additional regulatory and development expertise.
PF708 is being developed through the 505(b)(2) regulatory pathway in the United States and references Forteo® which achieved $1.7 billion in global sales in 2017. Following the positive top-line PF708-301 study results as announced last month, Pfenex expects to submit a new drug application for PF708 to the U.S. Food and Drug Administration (FDA) in the third quarter of 2018 leading to potential launch in the US, if approved by regulators, as early as the third quarter of 2019.
Robert Wessman, Chairman and CEO commented: “We are excited by the market opportunity that PF708 offers as a therapeutic equivalent candidate to Forteo® for the U.S. market. We look forward to working with the Pfenex team in preparing the PF708 program for the NDA submission to the FDA, and setting up a robust commercial manufacturing and supply chain.
“Once PF708 receives market approval, we expect to quickly leverage our commercial operations in the U.S. in bringing the product to market. PF708 is highly complementary to our product portfolio in the U.S., which is focused on complex high value generics and brands, including niche generics, patches, semi-solids, controlled release oral drugs and injectables.”
Eef Schimmelpennink, Chief Executive Officer of Pfenex commented: “We are excited to partner with Alvogen and believe that, given their proven success in the US market, it will maximize the value of PF708. Alvogen’s established commercial business with vast resources and experience will support us through the NDA submission process, product launch and commercialization. When these operational benefits are combined with the favorable financial terms of the agreement, we see this collaboration as a significant step towards building long-term value for Pfenex stockholders.
“We have structured the agreement with Alvogen in a way that offers Pfenex experienced guidance and financial support as the PF708 commercialization program advances. By leading the PF708 program up to potential approval, the Pfenex team will be building additional experience for the development of future programs, while also maintaining the potential for long term value capture through a significant share of gross profits.”
About Pfenex Inc. Pfenex Inc. is a clinical-stage development and licensing biotechnology company focused on leveraging our Pfēnex Expression Technology® to improve protein therapies for unmet patient needs. Using the patented Pfēnex Expression Technology platform, the company has created an advanced pipeline of therapeutic equivalents, vaccines, biologics and biosimilars. The company's 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, Pfenex is 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, the company's pipeline includes biosimilar candidates to Lucentis® and Neulasta®.