Optimer Pharmaceuticals executed an agreement with AstraZeneca to commercialize fidaxomicin tablets for the treatment of Clostridium difficile infection (CDI) in South America including Brazil, Central America, Mexico, and the Caribbean.
AstraZeneca will be responsible for the commercialization of fidaxomicin in the territory covered by the collaboration, and Optimer is entitled to receive an upfront payment of $1 million, up to $3 million in milestone payments upon first commercial sale in certain countries, and up to $19 million in other milestone payments contingent on the achievement of sales-related targets for fidaxomicin in the territory; this would make the agreement potentially worth $23 million.
"C. difficile infection is a global problem, and this collaboration further advances our plans to make fidaxomicin available to patients in need globally," said Pedro Lichtinger, president and CEO of Optimer. "AstraZeneca has the infrastructure and expertise to commercialize fidaxomicin in the diverse range of countries that make up Central and South America, and they will be a strong partner moving forward."
Fidaxomicin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Clostridium difficile-associated diarrhea in adults 18 years of age or older in the United States under the trade name DIFICID®. It is also approved and marketed in Canada by Optimer for the treatment of Clostridium difficile infection. In addition, the European Commission granted marketing authorization to fidaxomicin for the treatment of adults with Clostridium difficile infection under the trade name DIFICLIR™.
Optimer also entered an exclusive collaboration and license agreement with Astellas Pharma in March of this year to develop and commercialize fidaxomicin tablets in Japan. Plus, in April of 2011, Cubist Pharmaceuticals negotiated an exclusive two-year agreement to co-promote DIFICID in the U.S.
2011 was a good year for Optimer as its total revenues that year were $145 million, compared to $1.5 million in 2010, according to financial results reported for the fourth quarter and fiscal year that ended December 31, 2011. According to Optimer, the increases in revenues were primarily due to an upfront payment received from Astellas Pharma Europe in the first quarter and an EMA approval milestone earned in the fourth quarter in connection with the DIFICID license agreement in Europe, as well as the July 18, 2011 commercial launch of DIFICID in the United States.