David's New Book

Monday, March 1, 2010

Innovation in Biotech?

In examining the late stage pipeline for antibiotics in biotech, I have been disappointed.

Antimicrobial Compounds in Development by Biotech.
Compound Manufacturer Company of origin Status
Dalbavancin Pfizer from Vicuron Merrell Marion Dow Unknown
Iclaprim Arpida Roche Failed in US
Oritavancin Targanta Lilly Failed in US
Telavancin Theravance Theravance Approved
Ceftibiprole Basilea-Johnson&Johnson (J&J) Roche Delayed in US
Cethromycin Advanced Life Sciences Abbott Failed in US
Doripenem Peninsula J&J Shionogi Approved
EDP-420 Enanta Enanta Ph. II
Faropenem Replidyne Daiichi Suntory Failed in US
Ceftaroline Cerexa/Forest Takeda Submitted for approval
NXL-104 Novexel Aventis Phase II
NXL-103 Novexel Aventis Phase II
PTK-0796 Paratek - Novartis Paratek Phase III
Torezolid Trius Dong-A Ph. II
Radezolid Rib-X Rib-X Ph II


In this table, the Ph. II or later stage systemic antibacterial compounds in bold are those that were actually discovered in biotech and not in large Pharma. I only count four out of the 15 total, from Theravance (now approved in the US), Enanta, Rib-X and Paratek. (I have not included Optimer whose OPT-80 for CDAD is apparently home grown. Nor have I included several quinolones being developed in biotech – all licensed from larger pharmaceutical companies).

But – I finally have something to be optimistic about. Several biotechs are nearing Ph. II development with compounds actually innovated within their biotechs. Nabriva has a series of pleuromutilins ready for Ph. II trials. They are active against Gram-positive skin pathogens and both typical and atypical respiratory pathogens. Tetraphase has a lead molecule with broad-spectrum activity that comes out of a novel and exciting method of synthesis of tetracyclines also poised for Ph. II trials. Achaogen has a lead aminoglycoside that they discovered which is ready for Ph. II. Maybe innovation in biotech is going to actually produce some new antibiotics active against resistant pathogens. This would be welcome news for us all. I just hope that when these companies are ready, there will still be a few large pharmas around as potential partners.