| HBS Case Collection
(Revised from original 2009 version)
Targanta Therapeutics: Hitting a Moving Target
This case explores regulatory, product testing, and business strategy at Targanta Therapeutics, a biotech company preparing its first new drug application to the FDA. In October 2007, Mark Leuchtenberger, president and CEO of Targanta—which has just held a successful IPO—weighs options for the approximately ten-month review period after the company submits to the Food and Drug Administration. The case reviews Targanta's origins and "de-risking" of oritavancin, an antibiotic therapy for drug-resistant infections that was first invented at Eli Lilly and then spun out to InterMune before Targanta acquired it in late 2005. To highlight the impact of regulatory policy on business strategy, the case then describes a set of choices facing the firm, including staffing a marketing and sales group, carrying out additional clinical testing to expand the approved indications, applying for European market approval, or keeping funds in reserve in the event that the FDA requests further data.
Keywords: Decision Choices and Conditions;
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Business and Government Relations;