Biotech Values

[DewDiligence]

PFNX reports PF708 bioequivalence to Forteo:

http://finance.yahoo.com/news/pfenex-reports-positive-top-line-200500358.html

"Today we are excited to announce the positive top-line data from our initial bioequivalence study in healthy subjects for PF708. As we disclosed previously, we are developing PF708 as a therapeutic equivalent to Forteo, through the 505(b)(2) regulatory path in the US. Based on the feedback we have received from FDA, and the positive data announced today, we expect to satisfy the 505(b)(2) filing requirements with an additional immunogenicity/pharmacokinetic study in subjects with osteoporosis," stated Bertrand C. Liang, chief executive officer of Pfenex. "The clinical program is anticipated to initiate by year-end."

Forteo is regulated by the FDA as a small-molecule drug; hence, the 505b2 pathway applies (rather than the 351(k) pathway for FoBs).