Click here to close now.


News Feed Item

Optimer Pharmaceuticals and AstraZeneca Collaborate to Commercialize Fidaxomicin for Clostridium Difficile Infection in Latin America

JERSEY CITY, N.J., Dec. 3, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today the execution of an exclusive agreement with AstraZeneca to commercialize fidaxomicin tablets for the treatment of Clostridium difficile Infection (CDI) in South America, including Brazil, Central America, Mexico and the Caribbean.


Under the terms of the agreement AstraZeneca is responsible for the commercialization of fidaxomicin in the territory covered by the collaboration and Optimer is entitled to receive an up-front payment of $1 million, up to $3 million in milestone payments upon first commercial sale in certain countries, and up to $19 million in other milestone payments contingent on the achievement of sales-related targets for fidaxomicin in the territory. Optimer is further entitled to receive payments from AstraZeneca that provide a return resulting in a double digit percent of net sales in the territory under a fidaxomicin supply agreement.

"C. difficile infection is a global problem and this collaboration further advances our plans to make fidaxomicin available to patients in need globally," said Pedro Lichtinger, President and Chief Executive Officer of Optimer. "AstraZeneca has the infrastructure and expertise to commercialize fidaxomicin in the diverse range of countries that make up Central and South America, and they will be a strong partner moving forward."

Rich Fante, President, AstraZeneca US and Regional Vice President, Americas, commented on the deal: "We are pleased to partner with Optimer to pursue the regulatory approval and commercialization of fidaxomicin in Latin America.  This product is a good fit with our hospital portfolio and we look forward to the opportunity to provide a new treatment option to patients suffering from this debilitating and sometimes fatal infection."

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®.  It is also approved and marketed in Canada by Optimer for the treatment of Clostridium difficile infection. In addition, the European Commission granted Marketing Authorization to fidaxomicin for the treatment of adults with Clostridium difficile infection under the trade name DIFICLIR™.

About CDI
CDI is 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.

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 in the U.S. for the treatment of CDAD in adults 18 years of age or older. DIFICID is administered in 200 milligram tablets given orally twice daily.

Important Safety Information for DIFICID
DIFICID is contraindicated in patients with hypersensitivity to fidaxomicin or to any of the excipients in the formulation. 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%).

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 U.S. 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

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit:

Forward-Looking Statements
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 AstraZeneca, Optimer's potential receipt of milestone and other payments under the agreement with AstraZeneca, 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 AstraZeneca and Optimer's businesses including, without limitation, risks relating to: whether regulatory authorities will review or approve applications to market fidaxomicin, the implementation and continuation of the AstraZeneca license agreement, each party's performance of its respective obligations under the license agreement, AstraZeneca'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
(858) 964-3418

Canale Communications, Inc.
Jason I. Spark, Senior Vice President
(619) 849-6005

OPTIMER and DIFICID are trademarks of Optimer Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.

SOURCE Optimer Pharmaceuticals, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Through WebRTC, audio and video communications are being embedded more easily than ever into applications, helping carriers, enterprises and independent software vendors deliver greater functionality to their end users. With today’s business world increasingly focused on outcomes, users’ growing calls for ease of use, and businesses craving smarter, tighter integration, what’s the next step in delivering a richer, more immersive experience? That richer, more fully integrated experience comes ab...
For almost two decades, businesses have discovered great opportunities to engage with customers and even expand revenue through digital systems, including web and mobile applications. Yet, even now, the conversation between the business and the technologists that deliver these systems is strained, in large part due to misaligned objectives. In his session at DevOps Summit, James Urquhart, Senior Vice President of Performance Analytics at SOASTA, Inc., will discuss how measuring user outcomes –...
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in high-performance, high-efficiency server, storage technology and green computing, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology is a premier provider of advanced server Building Block Solutions® for Data ...
SYS-CON Events announced today the Containers & Microservices Bootcamp, being held November 3-4, 2015, in conjunction with 17th Cloud Expo, @ThingsExpo, and @DevOpsSummit at the Santa Clara Convention Center in Santa Clara, CA. This is your chance to get started with the latest technology in the industry. Combined with real-world scenarios and use cases, the Containers and Microservices Bootcamp, led by Janakiram MSV, a Microsoft Regional Director, will include presentations as well as hands-on...
This week, the team assembled in NYC for @Cloud Expo 2015 and @ThingsExpo 2015. For the past four years, this has been a must-attend event for MetraTech. We were happy to once again join industry visionaries, colleagues, customers and even competitors to share and explore the ways in which the Internet of Things (IoT) will impact our industry. Over the course of the show, we discussed the types of challenges we will collectively need to solve to capitalize on the opportunity IoT presents.
As more intelligent IoT applications shift into gear, they’re merging into the ever-increasing traffic flow of the Internet. It won’t be long before we experience bottlenecks, as IoT traffic peaks during rush hours. Organizations that are unprepared will find themselves by the side of the road unable to cross back into the fast lane. As billions of new devices begin to communicate and exchange data – will your infrastructure be scalable enough to handle this new interconnected world?
Containers are all the rage among developers and web companies, but they also represent two very substantial benefits to larger organizations. First, they have the potential to dramatically accelerate the application lifecycle from software builds and testing to deployment and upgrades. Second they represent the first truly hybrid-approach to consuming infrastructure, allowing organizations to run the same workloads on any cloud, virtual machine or physical server. Together, they represent a ver...
As operational failure becomes more acceptable to discuss within the software industry, the necessity for holding constructive, actionable postmortems increases. But most of what we know about postmortems from "pop culture" isn't actually relevant for the software systems we work on and within. In his session at DevOps Summit, J. Paul Reed will look at postmortem pitfalls, techniques, and tools you'll be able to take back to your own environment so they will be able to lay the foundations for h...
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet condit...
SYS-CON Events announced today that Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, will keynote at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Saviynt Inc. has announced the availability of the next release of Saviynt for AWS. The comprehensive security and compliance solution provides a Command-and-Control center to gain visibility into risks in AWS, enforce real-time protection of critical workloads as well as data and automate access life-cycle governance. The solution enables AWS customers to meet their compliance mandates such as ITAR, SOX, PCI, etc. by including an extensive risk and controls library to detect known threats and b...
DevOps Summit, taking place at the Santa Clara Convention Center in Santa Clara, CA, and Javits Center in New York City, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait...
Overgrown applications have given way to modular applications, driven by the need to break larger problems into smaller problems. Similarly large monolithic development processes have been forced to be broken into smaller agile development cycles. Looking at trends in software development, microservices architectures meet the same demands. Additional benefits of microservices architectures are compartmentalization and a limited impact of service failure versus a complete software malfunction....
DevOps and Continuous Delivery software provider XebiaLabs has announced it has been selected to join the Amazon Web Services (AWS) DevOps Competency partner program. The program is designed to highlight software vendors like XebiaLabs who have demonstrated technical expertise and proven customer success in DevOps and specialized solution areas like Continuous Delivery. DevOps Competency Partners provide solutions to, or have deep experience working with AWS users and other businesses to help t...
The last decade was about virtual machines, but the next one is about containers. Containers enable a service to run on any host at any time. Traditional tools are starting to show cracks because they were not designed for this level of application portability. Now is the time to look at new ways to deploy and manage applications at scale. In his session at @DevOpsSummit, Brian “Redbeard” Harrington, a principal architect at CoreOS, will examine how CoreOS helps teams run in production. Attende...