SAN DIEGO, Oct. 2, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced today the implementation of an initiative designed to accelerate and expand patient access to DIFICID® (fidaxomicin) tablets. Separately, and consistent with its goal of improving awareness and understanding of the disease, Optimer is also announcing a new project analyzing the burden of Clostridium difficile infection (CDI).
DIFICID, the only treatment approved by the FDA for Clostridium difficile-associated diarrhea (CDAD) in over 25 years, generated $51.1 million in net sales in its first year on the market. Optimer has been successful in generating significant brand recognition for DIFICID among physicians and in communicating that DIFICID has a comparable rate of clinical response at the end of ten day treatment versus oral vancomycin, and a superior rate of sustained clinical response through 25 days beyond the end of treatment. Optimer intends to build upon its successful launch with initiatives that it believes will significantly expand and accelerate patient access to DIFICID.
Today Optimer announced that it is implementing a hospital contracting initiative designed to address cost as the barrier to prescribing DIFICID for hospital inpatients. This program reduces the acquisition cost of DIFICID to acute care hospitals for all inpatients, which Optimer believes will significantly expand adoption of DIFICID in acute care hospitals. Expansion of DIFICID use in acute care hospitals may also have the effect of enhancing DIFICID's retail market, as hospitals' use of generic vancomycin slurry preceded increased retail prescriptions of branded Vancocin® capsules following patient discharge.
Optimer recognizes that continuity of care from the inpatient setting through the post-discharge setting is important. Optimer's RxAssist program provides resources to facilitate continuity of care, including information regarding coverage determination and benefits, priorauthorizations, coverage appeals, and information about options for out of pocket assistance. Optimer has seen utilization of RxAssist steadily increase since its launch in August.
"At just over one year post launch of DIFICID, we continue to be focused on greater patient access to DIFICID, which goes beyond initial response in the treatment of CDAD with superior sustained efficacy that extends through 25 days post treatment versus vancomycin," said Pedro Lichtinger, President and CEO of Optimer Pharmaceuticals. "We believe that greater patient access to DIFICID is beneficial to patients, and will result in increased DIFICID utilization."
Optimer also announce that it has new data regarding the burden of disease in the hospital setting. Consistent with its goal of increasing disease state awareness, Optimer commissioned an analysis of Medicare data, intended for publication, which evidences the incidence of Medicare inpatients' CDI readmissions and suggests a link between CDI, hospital readmissions, and increased hospital costs. These data help address gaps in evidence regarding the burden of CDI.
Investor and Analyst Reception on October 8, 2012
Optimer will host an investor and analyst reception on October 8, 2012 at 9:00 a.m. Eastern time in New York City to expand on the strategy described above, provide a long-term outlook for DIFICID market penetration, and review third quarter 2012 top-line revenues. A live audio webcast of the event will be accessible on the Investors page of the Company's website at www.optimerpharma.com and may also be accessed via listen-only dial in at (877) 442-2965 for U.S. callers and +1- (760) 298-5087 for international dialers. The access code for the call is 37429762. Presentation replays will be available at the same location for 90 days following the presentation.
About Clostridium difficile-associated Diarrhea (CDAD)
Clostridium difficile infection (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 is the most common symptom of CDI. In recent years, C. difficile has surpassed methicillin-resistant Staphylococcus aureus (MRSA) as the leading cause of healthcare-acquired infections in community hospitals. Patients typically develop CDAD from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, possibly allowing C. difficile bacteria to flourish.
About DIFICID® (fidaxomicin) Tablets
DIFICID is the first macrolide antibacterial drug indicated for Clostridium difficile-associated diarrhea (CDAD) to be approved in over 25 years in the U.S. It is indicated for the treatment of CDAD in adults 18 years of age or older. DIFICID is administered in 200 mg tablets given orally twice daily.
Important Safety Information for DIFICID
DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%) and neutropenia (2%).
Please visit www.DIFICID.com or call 855-DIFICID (343-4243) for full prescribing information for DIFICID.
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 DIFICID® (fidaxomicin) tablets, an FDA-approved macrolide antibacterial drug for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and older and is commercializing DIFICID in the US and Canada. Optimer also received marketing authorization for fidaxomicin tablets in the European Union where its partner, Astellas Pharma Europe, is commercializing fidaxomicin 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 press release that are not a description of historical facts are forward-looking statements, including without limitation statements related to Optimer's plans to launch a hospital contracting initiative to lower the acquisition cost of DIFICID to acute care hospitals, any anticipated increase in hospital utilization of DIFICID as a result of that initiative, the potential increase in retail utilization of DIFICID if hospital utilization increases, Optimer's plans to implement other initiatives to increase patient access to DIFICID and Optimer's belief that greater patient access will result in greater DIFICID utilization, Optimer's expectation that utilization of its Rx Assist program will continue to increase, and expectations of future publication of research and analyses. 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 and Optimer undertakes no obligation to update or revise these statements, except as may be required by law. 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: Optimer's ability to continue driving adoption and use of DIFICID, DIFICID's ability to compete with cheaper generic competition, whether healthcare professionals will prescribe DIFICID, the extent to which DIFICID will be accepted on additional hospital formularies and the timing of hospital formulary decisions, whether Optimer's hospital contracting strategy will result in additional DIFICID prescriptions in the hospital or retail markets, whether Rx Assist is utilized and whether it will facilitate access to DIFICID and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
Optimer Pharmaceuticals, Inc.
David Walsey, VP of Investor Relations and Corporate Communications
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.