Monthly Archives: February 2008

Guest content from John Avellanet, managing director and principal of Cerulean Associates:

John Avellanet

Follow-on biologics are a foregone conclusion in the US. Too much money is at stake. The more difficult discussion starts with how to prepare your company to compete.

Science Succumbs to Dollars
The financial pull on reimbursement organizations and the constituent push on Congress for less expensive biotechnology treatments will inevitably lead to a regulatory approval pathway for so-called follow-on or generic biologics.

I’ll be at Rutgers on February 29th, giving a talk on biotechnology entrepreneurship. My objective is to dispel the popular notions about how biotechnology entrepreneurship occurs, and to provide case studies demonstrating the diversity of methods by which biotechnology entrepreneurs start and build their businesses. I’ll also provide some case studies of significant mis-steps, with the intention of demonstrating that risks can come from many sources.

For more information, visit http://aesop.rutgers.edu/~dgenes/events.html or contact the organizers at dgenes@eden.rutgers.edu

The following appeal for generic biologic legislation was sent in from Insmed via youtube.

I’ve posted previously on the challenges of developing a framework for generic biologic approvals and questioned how much we can really expect to save. In the editorial for the upcoming issue of the Journal of Commercial Biotechnology, I argue that the United States is unlikely to lead in generic biologic regulation.

Got any ideas to overcome the challenges? I’d love to post them here or at the Journal of Commercial Biotechnology.

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in February 2008
*Drugs may be
covered by multiple patents

Tradename Applicant Generic Name Patent Number Patent Expiration
CAMPTOSAR Pfizer Inc irinotecan hydrochloride 4,604,463 FEB 20,2008
CIPRO HC Alcon ciprofloxacin hydrochloride; hydrocortisone 4,844,902 FEB 11,2008
CIPRODEX Alcon ciprofloxacin; dexamethasone 4,844,902 FEB 11,2008
DEPOCYT Pacira Pharms Inc cytarabine 6,071,534 FEB 18,2008
DEPODUR Pacira Pharms Inc morphine sulfate 6,071,534 FEB 18,2008
FOSAMAX Merck alendronateLe but de poker pacific. sodium 4,621,077 FEB 06,2008
FOSAMAX PLUS D Merck alendronate sodium; cholecalciferol 4,621,077 FEB 06,2008
INSPRA Gd Searle Llc eplerenone 4,559,332 FEB 11,2008
LOTEMAX Pharmos loteprednol etabonate 4,996,335 FEB 26,2008
TESLASCAN Ge Healthcare mangafodipir trisodium 4,992,554 FEB 12,2008

Courtesy of DrugPatentWatch.com