Optimer® was founded in 1998. In 1999, we acquired worldwide rights to the technology behind the Optimer one pot Synthesis (OPopS) drug discovery platform, which enables the rapid synthesis of a wide array of carbohydrate based compounds. This technology enabled the launch of our drug discovery programs which produced proprietary breakthroughs including OP-1068 (solithromycin), a new class of fluoroketolide antibiotic currently in development at Cempra, and fidaxomicin, a novel 18-membered macrolide antibiotic for the treatment of Clostridium difficile-associated diarrhea (CDAD).
In 2010, Optimer completed a large, multinational, clinical development program for DIFICID® (fidaxomicin) tablets, including two large Phase 3 clinical studies that met the primary endpoint of non-inferiority in clinical response compared to oral vancomycin. The two Phase 3 studies further established the superiority of DIFICID in sustaining a clinical response for 25 days beyond the end of treatment compared to oral vancomycin.
The Optimer development team was the first to design Phase 3 clinical trials to evaluate sustained clinical response, defined as clinical response at the end of treatment without proven or suspected CDAD recurrence through 25 days beyond the end of treatment. Sustained clinical response is now accepted as an important clinical endpoint in the management of CDAD.
On May 27, 2011, the US Food and Drug Administration approved DIFICID tablets for the treatment of adult patients with CDAD. DIFICID became available in the U.S. in July 2011 and is also available in Canada. Additionally, it is available in the European Union under the trade name DIFICLIR™. DIFICID is the first drug indicated for CDAD to be approved in over 25 years in the US.
Optimer has established a premier hospital based sales team to commercialize DIFICID. DIFICID experienced one of the most successful launches for a hospital based antibiotic in recent history, driven by expertise in access, reimbursement, health economics and medical education.
Our history has shaped our culture. We are transformative. We are passionate about developing and commercializing medicines that have a positive impact on society and provide value to the healthcare system.
DIFICID started with a great idea and from excellence in biochemistry, manufacturing and clinical R&D, it has resulted in an innovative product aimed at improving the health of the lives we touch.