Welcome!

News Feed Item

Horizon Pharma Announces Receipt of Additional U.S. Patent Allowance for DUEXIS(R)

DEERFIELD, IL -- (Marketwire) -- 02/05/13 -- Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application Serial No. 13/620,150 entitled "Stable Compositions of Famotidine and Ibuprofen" with claims that cover DUEXIS® (ibuprofen and famotidine) tablets. DUEXIS is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers.

"This additional Notice of Allowance for DUEXIS, our fourth in the U.S., continues to validate the strength of our intellectual property for DUEXIS," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. "Horizon will continue to vigorously expand and protect the innovation and intellectual property of DUEXIS, with protection currently out to 2028."

The Notice of Allowance concludes the substantive examination of this U.S. patent application and will result in the issuance of the U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire in 2028. After issuance, Horizon plans to list the U.S. patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. Horizon has now been granted four patents covering DUEXIS in the U.S. since October 2011.

About DUEXIS
DUEXIS, a proprietary single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months. For more information, please visit www.DUEXIS.com.

Important Safety Information About DUEXIS
DUEXIS is not right for everyone. People who have had asthma, hives, or an allergic reaction to aspirin or other NSAIDs should not take DUEXIS. Women in the late stages of pregnancy should not take DUEXIS. People who have had allergic reactions to medications like famotidine (histamine H2-receptor antagonists) should not take DUEXIS.

Tell your health care provider right away if you have signs of active bleeding (persistent and unexplained) while you are taking DUEXIS.

NSAID-containing medications like DUEXIS can cause high blood pressure or make existing high blood pressure worse, either of which can increase the chance of a heart attack or stroke. Your health care provider should check your blood pressure while you are taking DUEXIS.

Before you start taking DUEXIS, tell your health care provider if you have heart problems, kidney problems, or liver problems, or if you are taking medications for high blood pressure. DUEXIS can increase the chance of potentially significant liver injury and/or kidney injury, which may be fatal. Stop taking DUEXIS immediately and contact your health care provider if you experience any signs and/or symptoms of liver or kidney injury.

Serious allergic reactions, including skin reactions, can happen without warning and can be life threatening. Stop taking DUEXIS and consult your doctor immediately if you get a skin rash or if you start to have problems breathing or swallowing or if you develop swelling of your face or throat.

The most common side effects of DUEXIS include nausea, diarrhea, constipation, upper abdominal pain and headache.

Please see Medication Guide and full Prescribing Information, available at www.DUEXIS.com.

About Horizon Pharma
Horizon Pharma, Inc. is a specialty pharmaceutical company that has developed and is commercializing DUEXIS and RAYOS/LODOTRA, both of which target unmet therapeutic needs in arthritis, pain and inflammatory diseases. The Company's strategy is to develop, acquire, in-license and/or co-promote additional innovative medicines where it can execute a targeted commercial approach in specific therapeutic areas while taking advantage of its commercial strengths and the infrastructure the Company has put in place.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the issuance of a patent based on the notice of allowance from the U.S. Patent and Trademark Office and the ability to protect the commercial potential of DUEXIS to 2028. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include risks regarding whether the administrative processes required for the issuance of a patent as indicated in the notice of allowance will be completed in a timely matter or at all, whether the patent, if issued as indicated in the notice of allowance, will provide sufficient protection and market exclusivity for DUEXIS, whether any patents issued to Horizon may be challenged, invalidated, infringed or circumvented by third parties and other factors described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release, and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.

Contacts
Robert J. De Vaere
Executive Vice President, Chief Financial Officer
Email Contact

Investors
Kathy Galante
Burns McClellan, Inc.
212-213-0006
Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
Recognizing the need to identify and validate information security professionals’ competency in securing cloud services, the two leading membership organizations focused on cloud and information security, the Cloud Security Alliance (CSA) and (ISC)^2, joined together to develop an international cloud security credential that reflects the most current and comprehensive best practices for securing and optimizing cloud computing environments.
SYS-CON Events announced today that (ISC)²® (“ISC-squared”) will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Two leading non-profits focused on cloud and information security, (ISC)² and Cloud Security Alliance (CSA), developed the Certified Cloud Security Professional (CCSP) certification to address the increased demand for cloud security expertise due to rapid growth in cloud. Recently named “The Next...
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
DevOps is not just last year’s buzzword. Companies with DevOps practices are 2.5x more likely to exceed profitability, market share, and productivity goals. But how do you enable high performance? What can you do right now to start? Find out from DevOps experts including Gene Kim, co-author of "The Phoenix Project," and the Dynatrace Center of Excellence.
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, will give users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion w...
SYS-CON Events announced today that iDevices®, the preeminent brand in the connected home industry, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. iDevices, the preeminent brand in the connected home industry, has a growing line of HomeKit-enabled products available at the largest retailers worldwide. Through the “Designed with iDevices” co-development program and its custom-built IoT Cloud Infrastruc...
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...