Optimer Pharmaceuticals, Inc. and Specialised Therapeutics Australia Collaborate to Commercialize Fidaxomicin for Clostridium difficile Infection in Australia and New Zealand
Published: Jun 19, 2012
SAN DIEGO, June 19, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) and Specialised Therapeutics Australia Pty, Ltd. (STA) announced today the execution of an exclusive agreement to register and commercialize fidaxomicin tablets in Australia and New Zealand for the treatment of Clostridium difficile Infection (CDI).
"CDI presents a serious bacterial health threat and current CDI treatment options are limited. Our license of fidaxomicin gives us a great opportunity to bring a highly differentiated and much-needed new therapy to patients in Australia and New Zealand," said Carlo Montagner, Chief Executive Officer of STA. "An application has already been filed with the Australian Therapeutic Goods Administration and pending approval, we are planning to launch fidaxomicin in mid 2013."
Under the agreement Optimer is entitled to receive commercial milestone payments upon the achievement of cumulative net sales targets. In addition, Optimer will also receive payments for the supply of fidaxomicin tablets to STA for a return equivalent to approximately 30% of expected fidaxomicin sales in Australia and New Zealand. STA is responsible for all costs associated with the registration and commercialization of fidaxomicin tablets in Australia and New Zealand.
"We are systematically executing on our plans to bring fidaxomicin to patients in need across the globe," said Pedro Lichtinger, President and Chief Executive Officer of Optimer. "Agreements such as this one with STA will support our plans to commercialize fidaxomicin globally, and we will ensure that we are engaged with the companies best able to bring fidaxomicin to patients in their specific territories."
Fidaxomicin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age or older in the United States under the trade name DIFICID®. In addition, the European Commission granted Marketing Authorization to fidaxomicin for the treatment of adults with Clostridium difficile infection under the trade name DIFICLIR.
Clostridium difficile infection (CDI) has become a significant medical problem in hospitals, long-term care facilities and in the community. CDI is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Clostridium difficile-associated diarrhea (CDAD) is the most common symptom of CDI. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, possibly allowing C. difficile bacteria to flourish. Older patients in particular are at risk for CDI, potentially because of a weakened immune system or the presence of underlying disease. Approximately two-thirds of CDI patients are 65 years of age or older. Historically, approximately 20% to 30% of CDI patients who initially respond to treatment experience a clinical recurrence.
About Specialised Therapeutics Australia
Specialised Therapeutics Australia (STA), a bio-pharmaceutical company dedicated to working with leading pharmaceutical companies worldwide to make acute care therapies for high unmet medical needs available to people living in Australia and New Zealand. Our therapeutic portfolio and pipeline encompasses oncology, infectious disease, respiratory, dermatology, endocrinology and central nervous system (CNS). Additional information can be found at www.specialisedtherapeutics.com.au.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer developed and commercialized DIFICID® (fidaxomicin) tablets, an FDA-approved antibacterial drug for the treatment of adult patients with Clostridium difficile-associated diarrhea (CDAD). Optimer has also received Marketing Authorization for fidaxomicin tablets in the European Union under the trade name DIFICLIR. The company is exploring marketing authorization in other parts of the world where C. difficile has emerged as a serious health problem, including Asia. Additional information can be found at http://www.optimerpharma.com.
Statements included in this release that are not a description of historical facts are forward-looking statements, including without limitation statements related to the potential availability of fidaxomicin to patients, the potential benefits of the agreement with STA, Optimer's potential receipt of milestone and other payments under the agreement with STA, and plans to commercialize fidaxomicin globally. Words such as "believes," "would," "anticipates," "plans," "expects," "may," "intend," "will," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in STA's and Optimer's businesses including, without limitation, risks relating to: whether regulatory authorities will review or approve the application to market fidaxomicin, the implementation and continuation of the STA license agreement, each party's performance of its respective obligations under the license agreement, STA's ability to successfully commercialize fidaxomicin in the licensed territory, whether fidaxomicin will receive reimbursement from government authorities and other healthcare payors, whether healthcare professionals will prescribe fidaxomicin, the development of alternative treatments for or means of preventing CDI and other risks detailed in Optimer's filings with the U.S. Securities and Exchange Commission.
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor Relations and Corporate Communications
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
OPTIMER and DIFICID are trademarks of Optimer Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.
SOURCE Optimer Pharmaceuticals, Inc.