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.
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"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 .
About CDI
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.
Forward-Looking Statements
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.
Contacts
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor Relations and Corporate
Communications
858-964-3418
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
619-849-6005
SOURCE Optimer Pharmaceuticals, Inc.
Web Site: http://www.optimerpharma.com
Posted: June 2012
