First sales of Dificlir by Astellas Pharma Europe triggers 10 Million Euro Milestone Payment to Optimer Pharmaceuticals
SAN DIEGO, June 7, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced that Astellas Pharma Europe achieved the first sales of DIFICLIR (fidaxomicin) tablets, triggering a 10 million Euro milestone payment from Astellas to Optimer. Under the 2011 collaboration and license agreement, Optimer granted to Astellas development and commercialization rights in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States (CIS). The European Commission granted Marketing Authorization for DIFICLIR tablets for the treatment of adults with Clostridium difficile infections (CDI) in December, 2011.
"We are truly excited about the potential of DIFICLIR™ to achieve better clinical outcomes for patients with CDI, as Astellas sequentially launches this important new medicine across Europe," said Pedro Lichtinger, President and Chief Executive Officer of Optimer. "We believe DIFICLIR will achieve rapid adoption in markets across Europe because of the high unmet medical need. Additionally, the Astellas strategic focus on anti-infectives combined with their significant commercial and medical programs in this therapy area will be truly impactful."
The Summary of Product Characteristics, including the DIFICLIR product label, can be accessed directly from the EMA website at http://www.ema.europa.eu .
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. 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 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 seeking marketing authorization for fidaxomicin in Canada and 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 press release that are not a description of historical facts are forward-looking statements, including without limitation statements related to the future commercialization of DIFICLIR in Europe, and Optimer's expectations regarding the impact of the commercial launch of DIFICLIR. 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. These forward-looking statements are based on management's expectations on the date of this release. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the implementation and continuation of Optimer's collaboration and supply agreements with Astellas, Astellas' ability to commercialize DIFICLIR in its licensed territory and expand sales into additional countries, Astellas' ability to obtain pricing and reimbursement approvals in countries within its licensed territory, the ability of Optimer and its third party contractors to manufacture and supply sufficient quantities of DIFICLIR for sale by Astellas, whether healthcare professionals will prescribe DIFICLIR, and other risks detailed in Optimer's filings with the 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
SOURCE Optimer Pharmaceuticals, Inc.
Web Site: http://www.optimerpharma.com
Posted: June 2012
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