Pfenex: The First U.S. Forteo Biosim And A Host Of Other Biosims In Pipeline [Seeking Alpha]
PFENEX INC (PFNX)
NASDAQ:AMEX Investor Relations:
pfenex.com
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Source: Seeking Alpha
Pfenex: The First U.S. Forteo Biosim And A Host Of Other Biosims In Pipeline Summary PFNX develops biosimilars to major drugs approaching patent expiry. Its lead drug is a Forteo biosimilar targeting a $1.7bn market in osteoporosis. Other pipeline drugs, a record of strong partnerships, etc. make this a derisked investment before PDUFA. Using the 351(k) and the 505(b)(2) pathways, Pfenex (NYSEMKT: The company has filed for regulatory approval in osteoporosis for a Forteo biosim, approval should be before year-end. Forteo has major patent expiry issues this year; however, PFNX will also face regulatory hurdles. PFNX also has a US govt-funded anthrax vaccine program. It has a solid collaboration with Jazz Pharma (NASDAQ: JAZZ MRK Catalyst PF708, PFNX's lead drug and Forteo biosim, is targeting osteoporosis as a biosimilar of Forteo from Eli Lilly (NYSE: LLY The company has also completed a Phase 3 trial for CRM197 as a pneumococcal conjugate vaccine and has entered registration phase. S
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