|By PR Newswire||
|February 24, 2013 01:18 PM EST||
EAST HANOVER, N.J., Feb. 24, 2013 /PRNewswire/ -- Late-breaking results from ASTERIA II, a Phase III placebo-controlled study, showed positive results in patients with moderate to severe chronic idiopathic urticaria (CIU), referred to as chronic spontaneous urticaria (CSU) outside the United States, who remained symptomatic despite treatment with approved antihistamine doses. The data were published today in the New England Journal of Medicine and will be presented tomorrow at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in San Antonio, Texas. Omalizumab is not indicated for CIU.
The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score (ISS). The study met its primary endpoint, showing that omalizumab given at doses of 150 mg and 300 mg every four weeks led to significant improvement from baseline at Week 12 in the mean weekly ISS from baseline (approximately 14 in all treatment groups) by 8.1 (p=0.001) and 9.8 (p<0.001), respectively, compared to a 5.1 improvement in patients on placebo. The omalizumab 75 mg dose group did not demonstrate statistical significance compared to placebo for the primary endpoint. All eight pre-specified secondary endpoints in the ASTERIA II trial were met for the 150 mg and 300 mg doses, except for the 150 mg dose that did not show a significant difference from placebo in the proportion of angioedema-free days from Week 4 to Week 12 of therapy.
CIU is a distressing skin condition characterized by red, swollen, itchy and sometimes painful hives on the skin, spontaneously presenting and reoccurring for more than six weeks. At any given time, the prevalence of CIU is 0.5% to 1% worldwide. While antihistamines are used first to treat CIU, more than 50% of patients are unable to achieve symptom relief with approved doses.
"These results indicate that omalizumab could potentially be an important addition in the treatment of chronic idiopathic urticaria, a disease that can have a significant impact on patients and can be challenging to manage," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "We are committed to helping patients with this disease and look forward to receiving further results from ongoing longer-term clinical trials."
ASTERIA II is the first Phase III data to be presented from a clinical trial program in CIU, which also includes two additional studies investigating the efficacy and safety profile of omalizumab over 24 weeks treatment duration. Novartis regulatory submissions are on track for 2013.
"These results are encouraging news for appropriate patients whose CIU is unresponsive to antihistamines," said study co-lead investigator, Thomas Casale, MD, Chief of Allergy & Immunology at Creighton University Medical Center and Professor of Medicine and Medical Microbiology at Creighton University, Omaha, NE. "New and effective therapeutic strategies for CIU are necessary as treatment options are limited for these patients."
ASTERIA II was a global, multi-center, randomized, double-blind study that evaluated the efficacy and safety profile of omalizumab compared to placebo and involved 323 patients aged between 12 and 75 with a diagnosis of moderate to severe CIU for at least six months. Patients were required to have the presence of itch and hives for at least eight consecutive weeks at any time prior to enrollment despite use of approved doses of H1 antihistamine treatment. Patients were randomized to omalizumab 75 mg, 150 mg or 300 mg or placebo, given subcutaneously every four weeks, for a total of three doses within a 12-week treatment period, with a 16-week follow-up period. Patients continued to receive stable doses of their pre-randomization H1 antihistamine. For the primary endpoint, the omalizumab 75 mg dose group did not demonstrate statistical significance compared to placebo. However, omalizumab 150 mg and 300 mg dose groups met the pre-specified primary endpoint and all eight pre-specified secondary endpoints in the ASTERIA II trial, except for the 150 mg dose that did not show a significant difference from placebo in the proportion of angioedema-free days from Week 4 to Week 12 of therapy. Patient response, as measured by the median time to Minimally Important Difference (MID) in itch severity score, a secondary endpoint, occurred at Week 1 (300 mg dose) and Week 2 (150 mg dose), compared to Week 4 in the placebo group.
The incidence and severity of adverse events (AEs) was similar across treatment groups. The most frequently reported treatment-emergent adverse events in patients taking omalizumab (>10% in any omalizumab treatment arm) in the study (including treatment period and follow-up period) were nasopharyngitis (nasal and throat infection or common cold), idiopathic urticaria (hives and itching, trigger unknown) and headache. Five (6.3%) patients experienced serious adverse events (SAEs) in the omalizumab 300 mg dose group, compared to two (2.5%) in the placebo group. In the 150 mg and 75 mg dose groups, one patient experienced SAEs in each group (1.1% and 1.3%, respectively). No deaths were reported during this study.
Omalizumab is not indicated for CIU.
Omalizumab is a biologic therapy unique in targeting immunoglobulin E (IgE). Research is ongoing to understand the mechanism of action of omalizumab in CIU and to investigate its potential impact on the drivers of CIU. Omalizumab is approved for the treatment of moderate to severe allergic asthma under the brand-name Xolair® in more than 90 countries, including the US since 2003 and the EU since 2005. In the US, Xolair is indicated for appropriate people who are 12 years of age and older who have moderate to severe persistent allergic asthma caused by year-round allergens in the air and are uncontrolled on inhaled corticosteroids. Xolair helps reduce the number of asthma attacks in people with allergic asthma who still have asthma symptoms even though they are taking inhaled steroids. Xolair should not be used to treat other allergic conditions. Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks. Xolair should not be used in children under 12 years of age.
Omalizumab is being jointly developed by Novartis and Genentech. In the US, Xolair® (omalizumab) for subcutaneous use in appropriate allergic asthma patients is co-promoted by Novartis Pharmaceuticals Corporation and Genentech.
About Xolair® (omalizumab) for subcutaneous use
Important Safety Information: Appropriate Moderate-Severe Allergic Asthma Patients
Xolair should always be injected in a doctor's office. Patients should read the Medication Guide before starting Xolair treatment and before each and every treatment.
A severe allergic reaction called anaphylaxis has happened in some patients after they received Xolair. Anaphylaxis is a life-threatening condition and can lead to death. Patients must seek emergency medical treatment right away if symptoms occur.
Signs and symptoms of anaphylaxis include:
- wheezing, shortness of breath, cough, chest tightness, or trouble breathing
- low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom"
- flushing, itching, hives, or feeling warm
- swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
Anaphylaxis from Xolair can happen:
- right after receiving a Xolair injection or hours later
- after any Xolair injection. Anaphylaxis has occurred after the first Xolair injection or after many Xolair injections.
A patient's healthcare provider should watch the patient for some time in the office for signs or symptoms of anaphylaxis after injecting Xolair. If patients have signs or symptoms of anaphylaxis, they must tell their healthcare provider right away.
Patients must not receive Xolair if they have ever had an allergic reaction to a Xolair injection. Patients should not use Xolair if they are allergic to any of its ingredients.
In clinical studies, a variety of cancer types, including breast, skin, prostate, and parotid (a type of salivary gland), were reported in more patients who received Xolair than in patients who did not receive Xolair.
Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks.
Xolair is not a substitute for the medicines patients are already taking. Patients must not change or stop taking any of their other asthma medicines unless their doctor tells them to do so.
Some patients on Xolair may have an abnormal increase in eosinophils (a type of white blood cell) in the blood or tissues, sometimes causing an inflammation of blood vessels which can lead to rash, worsening of respiratory symptoms, heart trouble, and/or nerve pain and weakness.
Joint inflammation or pain, rash, fever, and swollen lymph nodes have been seen in some patients taking Xolair after the first or subsequent injections. Patients should talk to their doctor if they have experienced any of these signs and symptoms.
In allergic asthma studies, the most commonly seen side effects occurring more frequently in patients receiving Xolair than in patients who received placebo (an injection with no active medicine) were joint pain, pain (general), leg pain, tiredness (fatigue), dizziness, fracture, arm pain, itching, inflammation of the skin, and earache.
In allergic asthma studies, the most common side effects in patients, who either needed to stop Xolair or needed medical attention, were injection site reaction, viral infections, upper respiratory tract infection, sinusitis, headache, and sore throat. These side effects were seen at similar rates in Xolair-treated patients as in patients that did not receive Xolair.
There are other possible side effects with Xolair. Patients should talk to their doctor for more information and if they have any questions about their treatment.
Xolair has not been studied in pregnant women. Pregnant women exposed to Xolair are encouraged to enroll in the Xolair Pregnancy Exposure Registry. Patients can get more information by calling 1-866-4XOLAIR (1-866-496-5247) or by speaking with their doctor.
For the full Prescribing Information, including Boxed WARNINGS and Medication Guide for additional important safety information please log onto http://www.pharma.us.novartis.com/cs/www.pharma.us.novartis.com/product/pi/pdf/Xolair.pdf or contact Christine Cascio at 862-778-8026.
The foregoing release contains forward-looking statements that can be identified by terminology such as "to be," "will be," "to investigate," "potentially," "could," "committed," "look forward to," "on track," "potential," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for omalizumab or regarding potential future revenues from omalizumab. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with omalizumab to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that omalizumab will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that omalizumab will achieve any particular levels of revenue in the future. In particular, management's expectations regarding omalizumab could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; government, industry and general public pricing pressures; competition in general; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative prescription drugs used to treat a number of diseases and conditions, including cardiovascular, dermatological, central nervous system, bone disease, cancer, organ transplantation, psychiatry, infectious disease and respiratory. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
Novartis Media Relations
+1 212 830 2465 (direct)
+1 862 579 8456 (mobile)
Novartis Pharmaceuticals Corporation
+1 862 778 8026 (direct)
+1 862 926 7992 (mobile)
e-mail: [email protected]
SOURCE Novartis Pharmaceuticals Corporation
“In the past year we've seen a lot of stabilization of WebRTC. You can now use it in production with a far greater degree of certainty. A lot of the real developments in the past year have been in things like the data channel, which will enable a whole new type of application," explained Peter Dunkley, Technical Director at Acision, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 19, 2014 06:00 PM EST Reads: 1,154
The BPM world is going through some evolution or changes where traditional business process management solutions really have nowhere to go in terms of development of the road map. In this demo at 15th Cloud Expo, Kyle Hansen, Director of Professional Services at AgilePoint, shows AgilePoint’s unique approach to dealing with this market circumstance by developing a rapid application composition or development framework.
Dec. 19, 2014 04:45 PM EST Reads: 800
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud strategy and programs. In this Power Panel at 15th Cloud Expo (http://www.CloudComputingExpo.com), moderated by Ashar Baig, Research Director, Cloud, at Gigaom Research, Nate Gordon, Director of T...
Dec. 19, 2014 11:30 AM EST Reads: 2,295
"BSQUARE is in the business of selling software solutions for smart connected devices. It's obvious that IoT has moved from being a technology to being a fundamental part of business, and in the last 18 months people have said let's figure out how to do it and let's put some focus on it, " explained Dave Wagstaff, VP & Chief Architect, at BSQUARE Corporation, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 19, 2014 11:00 AM EST Reads: 1,851
SYS-CON Events announced today that Windstream, a leading provider of advanced network and cloud communications, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Windstream (Nasdaq: WIN), a FORTUNE 500 and S&P 500 company, is a leading provider of advanced network communications, including cloud computing and managed services, to businesses nationwide. The company also offers broadband, phone and digital TV services to consumers primarily in rural areas.
Dec. 19, 2014 07:00 AM EST Reads: 2,163
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things one of the hottest topics in tech? In his session at @ThingsExpo, Chris Gray, Director, Embedded and Internet of Things, discussed the underlying factors that are driving the economics of intelligent systems. Discover how hardware commoditization, the ubiquitous nature of connectivity, and the emergence of Big Data a...
Dec. 19, 2014 06:30 AM EST Reads: 2,157
ARMONK, N.Y., Nov. 20, 2014 /PRNewswire/ -- IBM (NYSE: IBM) today announced that it is bringing a greater level of control, security and flexibility to cloud-based application development and delivery with a single-tenant version of Bluemix, IBM's platform-as-a-service. The new platform enables developers to build ap...
Dec. 19, 2014 05:00 AM EST Reads: 1,974
SYS-CON Events announced today that IDenticard will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. IDenticard™ is the security division of Brady Corp (NYSE: BRC), a $1.5 billion manufacturer of identification products. We have small-company values with the strength and stability of a major corporation. IDenticard offers local sales, support and service to our customers across the United States and Canada. Our partner network encompasses some 300 of the world's leading systems integrators and security s...
Dec. 19, 2014 04:00 AM EST Reads: 1,978
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. 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 for long development cycles that produce software that is obsolete at launch. DevOps may be disruptive, but it is essential.
Dec. 18, 2014 09:45 PM EST Reads: 1,005
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 18, 2014 09:00 AM EST Reads: 1,284
Nigeria has the largest economy in Africa, at more than US$500 billion, and ranks 23rd in the world. A recent re-evaluation of Nigeria's true economic size doubled the previous estimate, and brought it well ahead of South Africa, which is a member (unlike Nigeria) of the G20 club for political as well as economic reasons. Nigeria's economy can be said to be quite diverse from one point of view, but heavily dependent on oil and gas at the same time. Oil and natural gas account for about 15% of Nigera's overall economy, but traditionally represent more than 90% of the country's exports and as...
Dec. 18, 2014 06:00 AM EST Reads: 811
The Internet of Things is a misnomer. That implies that everything is on the Internet, and that simply should not be - especially for things that are blurring the line between medical devices that stimulate like a pacemaker and quantified self-sensors like a pedometer or pulse tracker. The mesh of things that we manage must be segmented into zones of trust for sensing data, transmitting data, receiving command and control administrative changes, and peer-to-peer mesh messaging. In his session at @ThingsExpo, Ryan Bagnulo, Solution Architect / Software Engineer at SOA Software, focused on desi...
Dec. 17, 2014 11:15 PM EST Reads: 1,319
"At our booth we are showing how to provide trust in the Internet of Things. Trust is where everything starts to become secure and trustworthy. Now with the scaling of the Internet of Things it becomes an interesting question – I've heard numbers from 200 billion devices next year up to a trillion in the next 10 to 15 years," explained Johannes Lintzen, Vice President of Sales at Utimaco, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 11:00 PM EST Reads: 1,376
"For over 25 years we have been working with a lot of enterprise customers and we have seen how companies create applications. And now that we have moved to cloud computing, mobile, social and the Internet of Things, we see that the market needs a new way of creating applications," stated Jesse Shiah, CEO, President and Co-Founder of AgilePoint Inc., in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 08:00 PM EST Reads: 1,353
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the industry’s first all flash version of HyperConverged Appliances that include both compute and storag...
Dec. 17, 2014 06:30 PM EST Reads: 1,258
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile devices as well as laptops and desktops using a visual drag-and-drop application – and eForms-buildi...
Dec. 17, 2014 11:45 AM EST Reads: 1,482
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core of our infrastructures. At the same time, we have old approaches made new again like micro-services...
Dec. 16, 2014 11:45 PM EST Reads: 1,316
Code Halos - aka "digital fingerprints" - are the key organizing principle to understand a) how dumb things become smart and b) how to monetize this dynamic. In his session at @ThingsExpo, Robert Brown, AVP, Center for the Future of Work at Cognizant Technology Solutions, outlined research, analysis and recommendations from his recently published book on this phenomena on the way leading edge organizations like GE and Disney are unlocking the Internet of Things opportunity and what steps your organization should be taking to position itself for the next platform of digital competition.
Dec. 15, 2014 11:45 PM EST Reads: 1,678
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Dec. 15, 2014 10:30 AM EST Reads: 6,878
As the Internet of Things unfolds, mobile and wearable devices are blurring the line between physical and digital, integrating ever more closely with our interests, our routines, our daily lives. Contextual computing and smart, sensor-equipped spaces bring the potential to walk through a world that recognizes us and responds accordingly. We become continuous transmitters and receivers of data. In his session at @ThingsExpo, Andrew Bolwell, Director of Innovation for HP's Printing and Personal Systems Group, discussed how key attributes of mobile technology – touch input, sensors, social, and ...
Dec. 15, 2014 10:00 AM EST Reads: 1,958