Pfenex receives FDA approval for PF 708, teriparatide injection biosimilar, to treat osteoporosis.

Pfenex Inc. has announced that the FDA has approved the new drug application (�NDA�) for PF 708 submitted under the 505(b)(2) regulatory pathway, with Forteo (teriparatide injection) as the reference drug. Like Forteo, the FDA-approved PF 708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture.

�The FDA�s approval of PF 708 marks a major milestone in Pfenex�s history as our first approved commercial product and further validates our Pf?nex Expression Technology platform. We look forward to continuing to work with our commercialization partner Alvogen to launch PF 708 in the U.S. We believe PF 708 has the potential to significantly enhance patient access to an important therapy as a cost-effective alternative to Forteo, which had $1.6 billion in global sales in 2018,� said Eef Schimmelpennink, Chief Executive Officer of Pfenex.

Pfenex is also asking the FDA to designate PF 708 as therapeutically equivalent (�A� rated) to Forteo, which would permit PF 708 to be automatically substituted for Forteo in many states. To further support an �A� rating, Pfenex is conducting a comparative human factors study between PF 708 and Forteo as requested by FDA. Pfenex anticipates submitting the final study report to the FDA as early as the second half of October 2019 and believes that this completes the information package required by the FDA to evaluate the therapeutic equivalence of PF 708.

In May, the European Medicines Agency (EMA) accepted the Marketing Authorization Application for PF708, which was submitted by Pfenex's partner Alvogen as a biosimilar to Forsteo(R) in the treatment of osteoporosis. Alvogen expects to receive initial comments on the application in the third quarter of 2019. If EMA approval is received, PF708 will be authorized for marketing in all 28 member states of the EU. Under the licensing agreement with Pfenex and Alvogen, Alvogen's European distribution partner, Theramex, a leading global specialty pharmaceutical company dedicated to women's health, will initiate sales of PF708, if the EMA approval is received.

Pursuant to the Development and License Agreement with Alvogen, Alvogen is responsible for commercializing and manufacturing PF 708 in the U.S. and for fulfilling all regulatory requirements associated with maintaining the PF 708 NDA. Alvogen also has exclusive rights to commercialize and manufacture PF 708 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). PF708 has been filed and accepted with the EMA using the biosimilar pathway with Forsteo as the reference medicinal product. 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 achieved $1.6 billion in global product sales in 2018.