© AVARAND/SHUTTERSTOCKThis past August, the US Food and Drug Administration (FDA) approved an intravenous antibiotic called oritavancin (Orbactiv) to treat skin infections, some 20 years after the pharmaceutical company Eli Lilly began developing it. The drug candidate had completed Phase 1 and was in Phase 2 and 3 clinical trials when, in 2001, the company discontinued its antibiotic program and sold oritavancin to the biotech InterMune for a base payment of $50 million, with an additional $15 million paid out in 2003. InterMune conducted more Phase 1 trials to clarify details of the drug’s safety and dosing. They also worked with Eli Lilly to complete a second major Phase 3 trial that the pharma giant had begun. But then, citing a desire to focus more narrowly on liver and lung drugs, InterMune sold the drug to
Targanta Therapeutics in 2005. By 2007, the company had paid InterMune $4 million and Eli Lilly $1 million, as well as given InterMune shares of Targanta stock.
Targanta was the first company to submit a new drug application (NDA) for oritavancin. After completing additional Phase 1 and Phase 2 trials, company executives filed the NDA in February 2008. Ten months later, the FDA rejected the drug, claiming it had failed to demonstrate sufficient proof of efficacy and safety.
Oritavancin again changed hands in 2009, when The Medicines Company, a biotech focused on providing drugs to acute or intensive-care hospitals, acquired Targanta for a base $42 million paid to shareholders. Five years of supplemental clinical trials and FDA consults later, oritavancin was resurrected as an FDA-approved ...
