Pfenex Reports Positive Results for PF708 Comparative Use Human Factors Study
GlobeNewswire•October 14, 2019
Study results found that the FDA-approved PF708 product is noninferior to Forteo® based on a pre-specified statistical analysis of critical patient and caregiver tasks
Pfenex believes the study report completes the information package required by the FDA to evaluate the FDA-approved PF708 product for therapeutic equivalence
SAN DIEGO, Oct. 14, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today it has successfully completed the PF708 comparative use human factors (HF) study and submitted the final study report to the FDA. The study found that the user interface of the FDA-approved PF708 product was noninferior to that of Forteo® for each critical user task evaluated in the study. Pfenex believes this submission completes the information package required by the FDA to evaluate the therapeutic equivalence of the PF708 product. Pfenex is seeking FDA designation of the recently-approved product as therapeutically equivalent (“A” rated) to Forteo, which would permit PF708 to be automatically substituted for Forteo in many states.
“We are very pleased with the outcome of the human factors study, which we believe demonstrates noninferiority between the user interfaces of our product and Forteo,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “We look forward to the FDA’s review of the study report, along with the bioequivalence and pharmaceutical equivalence data in our recently approved NDA. We believe these results complete the information package required by the FDA to evaluate therapeutic equivalence of our PF708 product,” commented Mr. Schimmelpennink.
The comparative use HF study was a simulated use study intended to evaluate the effect of each product’s delivery device and user interface on critical task performance by untrained osteoporosis patients and caregivers. The study used a paired design of the FDA-approved PF708 and the Forteo products.
A total of 102 untrained participants, 52 osteoporosis patients and 50 caregivers, completed the study. For 67% (12 of 18) of critical tasks performed in the patient user group, and 83% (15 of 18) performed in the caregiver group, PF708 had fewer or equal user errors when compared to Forteo. Importantly, in each of the instances where PF708 had marginally higher user error rates (33% and 17 % of critical tasks among patients and caregivers, respectively), the magnitude of the differences was such that no error difference in either user group exceeded the predetermined maximum allowable difference. For these reasons, Pfenex believes the study data demonstrate that the user interface of the FDA-approved PF708 product is noninferior to that of Forteo. With submission of the final study report to FDA, the agency can begin its review of the relevant data to make a therapeutic equivalence determination.
PF708 was approved in the U.S. under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug. The FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk of fracture. Pursuant to the Development and License Agreement with Alvogen, Alvogen is responsible for commercializing and manufacturing PF708 in the U.S. and for fulfilling all regulatory requirements associated with maintaining the PF708 NDA. Alvogen also has exclusive rights to commercialize and manufacture PF708 in the EU, certain countries in the Middle East and North Africa (MENA), and the Rest of World (ROW) territories (the latter defined as all countries outside of the EU, U.S. and MENA, excluding Mainland China, Hong Kong, Singapore, Malaysia and Thailand). A marketing authorization application for PF708 has been filed and accepted with the EMA using the biosimilar pathway with Forsteo® as the reference medicinal product and has been filed with the Kingdom of Saudi Arabia's Saudi Food and Drug Authority (SFDA). Pursuant to the Development and License Agreement with NT Pharma Group Company Ltd. (NT Pharma) we granted an exclusive license to NT Pharma to commercialize PF708 in Mainland China, Hong Kong, Singapore, Malaysia and Thailand and a non-exclusive license to conduct development activities in such territories with respect to PF708. Forteo® and Forsteo® are approved and marketed by Eli Lilly companies for the treatment of osteoporosis in certain patients with a high risk of fracture. Forteo® and Forsteo® achieved $1.6 billion in global product sales in 2018.
About Pfenex Inc.
Pfenex is a development and licensing biotechnology company focused on leveraging its Pfenex Expression Technology® to develop and improve protein therapies for unmet patient needs. Using the patented Pfenex Expression Technology platform, Pfenex has created an advanced pipeline of potential therapeutic equivalents, vaccines, biologics and biosimilars. Pfenex’s lead product candidate is PF708, a therapeutic equivalent candidate to Forteo® (teriparatide injection). PF708 has been approved in the U.S. for the treatment of osteoporosis in certain patients at high risk of fracture, and marketing authorization applications are pending in other jurisdictions. In addition, Pfenex is developing hematology/oncology products in collaboration with Jazz Pharmaceuticals, including PF743, a recombinant crisantaspase, and PF745, a recombinant crisantaspase with half-life extension technology. Pfenex also uses its Pfenex Expression Technology platform to produce CRM197, a diphtheria toxoid carrier protein used in prophylactic and therapeutic vaccines.