Pfenex Inc (NYSE:PFNX) rose Monday after receiving U.S. Food and Drug Administration approval for PF708 to treat osteoporosis.
The company, based in San Diego, announced Monday it is also asking the FDA to designate PF708 as therapeutically equivalent ("A" rated) to Forteo, which would permit PF708 to be automatically substituted for Forteo in many states. To further support an “A” rating, Pfenex is conducting a comparative human factors study between PF708 and Forteo as requested by FDA.
According to CEO Eef Schimmelpennink, "The FDA’s approval of PF708 marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our Pfēnex Expression Technology platform. We look forward to continuing to work with our commercialization partner
"Alvogen to launch PF708 in the U.S. We believe PF708 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"
Pfenex anticipates submitting the final study report to the FDA as early as the second half of October and believes that this completes the information package required by the FDA to evaluate the therapeutic equivalence of PF708.
PF708 is approved in the U.S. under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug. The U.S. approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture.
Pfenex shares began Monday up 54 cents, or 10.3%, to $8.23
