JERSEY CITY, N.J.—Optimer Pharmaceuticals Inc. announced Dec. 3 that it had inked an exclusive agreement with AstraZeneca PLC tocommercialize fidaxomicin tablets for the treatment of Clostridium difficile infection (CDI) in South America, including Brazil, Central America, Mexico and the Caribbean.

 

Underthe terms of the agreement AstraZeneca is responsible for thecommercialization of fidaxomicin in the territory covered by thecollaboration and Optimer is entitled to receive an upfront payment of $1 million, as much as $3 million in milestone payments upon first commercial sale in certain countries and potentially $19 millionin other milestone payments contingent on the achievement ofsales-related targets for fidaxomicin in the territory. Optimer isfurther entitled to receive payments from AstraZeneca that provide areturn resulting in a double-digit percent of net sales in the territoryunder a fidaxomicin supply agreement.

 

"C. difficile infection is a global problem and this collaboration further advancesour plans to make fidaxomicin available to patients in need globally,"said Pedro Lichtinger, president andCEO of Optimer. "AstraZeneca has the infrastructureand expertise to commercialize fidaxomicin in the diverse range ofcountries that make up Central and South America, and they will be a strong partner moving forward."

 

"This product is a good fit with our hospital portfolio and we lookforward to the opportunity to provide a new treatment option to patientssuffering from this debilitating and sometimes fatal infection," added Rich Fante, president of AstraZeneca US and regional vice president for the Americas.

 

Fidaxomicin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of C. 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 C. difficile infection. In addition, the European Commission granted marketing authorization to fidaxomicin for the treatment of adults with C. difficile infection under the trade name Dificlir.

 

CDI is a serious illness resulting frominfection of the inner lining of the colon by C. difficile bacteria and can lead to inflammation of the colon, severe diarrhea and sometimes death. CDAD is the most common symptom of CDI.

SOURCE: Optimer news release