|By PR Newswire||
|January 8, 2014 07:01 PM EST||
MARLOW, England, January 9, 2014 /PRNewswire/ --
New aesthetic indication for market-leading neuromodulator which can now help improve appearance of lines around the eyes, as well as treating glabellar frown lines
Today, Allergan, Inc. announced that BOTOX® has received the licence from the Medicines and Healthcare products Regulatory Agency (MHRA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet lines) seen at maximum smile, either alone or when treated at the same time as glabellar (or frown) lines seen at maximum frown, in adult patients where these facial lines have an important psychological impact. This marketing authorisation is specific to Allergan's botulinum toxin type A product and is based on Allergan's successful global Phase III clinical trial programme in Crow's Feet Lines.
"This latest approval for BOTOX® demonstrates Allergan's continued commitment to excellence in neuromodulator innovation and our long-term leadership in medical aesthetics," said Paul Navarre, President of Allergan Europe, Africa & Middle East. "We are proud to deliver this important innovation to medical aesthetics practitioners in the UK, allowing them for the first time to treat the glabellar and crow's feet areas either alone or simultaneously."
The MHRA licence for the use of BOTOX® to treat crow's feet lines is based on the results of two randomised, multi-centre, placebo-controlled clinical studies involving more than 1,350 patients. These studies met their primary endpoint, demonstrating that patients who received treatment with BOTOX® achieved none or mild lines according to investigator assessment at day 30, compared to those patients who did not receive botulinum toxin type A treatment and this significant reduction in the appearance of crow's feet lines lasted an average of four months post-treatment. In general, patients treated with BOTOX® reported that they looked younger and more attractive. In these studies, Allergan's botulinum toxin type A product was generally well tolerated. Like all medicines, Allergan's botulinum toxin type A product may cause side effects, although the incidence rate is variable. In general, adverse reactions occurred within the first few days following injection and were temporary.
"Crow's Feet Lines are amongst the top ageing concerns for people in the UK and Europe. Whilst these lines form a natural part of our eye expressions, over time they can become fixed or elongated even when our faces are relaxed, which can make us look tired or stressed," said David Eccleston, Clinical Director, MediZen Clinic. "Softening the appearance of Crow's Feet Lines as well as the glabellar lines with BOTOX® can deliver a refreshed and natural look, helping patients to look like themselves again and improve their self-confidence."
Notes to Editor
BOTOX® (botulinum toxin type A) is a prescription medication that works by relaxing the specific muscles that cause crow's feet lines or frown lines to form. By decreasing muscle activity, it's possible to soften the appearance of these lines and wrinkles without radically changing facial appearance or making a patient look as if they have had "work done". The temporary effect lasts for up to four months. Patient satisfaction data shows that following treatment with BOTOX®, patients reported looking more relaxed and confident, as well as looking as young as they feel. BOTOX® should only be administered in a clinical setting by an appropriately trained physician.
About Allergan's botulinum toxin type A
Worldwide, approximately 35 million vials of Allergan's botulinum toxin type A products have been distributed over the past 21 years (1990-2012). The safety and efficacy of Allergan's botulinum toxin type A product has been well-established with approximately 65 randomised, placebo-controlled clinical trials involving approximately 15,000 patients and, with more than 2,500 articles in scientific and medical journals, Allergan's neurotoxin is one of the most widely researched medicines in the world.
Allergan is a multi‐specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have approximately 11,100 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever‐evolving portfolio of pharmaceuticals, biologics, medical devices and over‐the‐counter consumer products, and state‐of‐the‐art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
This press release contains "forward‐looking statements", including but not limited to the statements by Mr Paul Navarre and Mr David Eccleston and other statements regarding the use of BOTOX® to treat Crow's Feet Lines. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2012 Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.
© Allergan, Ltd. BOTOX® is a registered trademark owned by Allergan Inc.
1. UK SmPC for BOTOX® 50 Units
2. Stotland MA et al. J Plas Recons Surg: 2007; 120(5):1386-1393
3. Allergan Data On File
“DevOps is really about the business. The business is under pressure today, competitively in the marketplace to respond to the expectations of the customer. The business is driving IT and the problem is that IT isn't responding fast enough," explained Mark Levy, Senior Product Marketing Manager at Serena Software, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 18, 2014 04:00 AM EST Reads: 747
Mobile commerce traffic is surpassing desktop, yet less than 20% of sales in the U.S. are mobile commerce sales. In his session at 15th Cloud Expo, Dan Franklin, Segment Manager, Commerce, at Verizon Digital Media Services, defined mobile devices and discussed how next generation means simplification. It means taking your digital content and turning it into instantly gratifying experiences.
Dec. 18, 2014 03:00 AM EST Reads: 753
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 a...
Dec. 17, 2014 11:15 PM EST Reads: 1,208
"Ulunsoft is a start-up that focuses on how enterprises build cloud-based IT infrastructure for business," explained Haibo Zhu, President of Ulunsoft Corp, 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. 17, 2014 11:00 PM EST Reads: 1,058
"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 San...
Dec. 17, 2014 11:00 PM EST Reads: 1,283
As enterprises engage with Big Data technologies to develop applications needed to meet operational demands, new computation fabrics are continually being introduced. To leverage these new innovations, organizations are sacrificing market opportunities to gain expertise in learning new systems. In his session at Big Data Expo, Supreet Oberoi, Vice President of Field Engineering at Concurrent, Inc., discussed how to leverage existing infrastructure and investments and future-proof them against e...
Dec. 17, 2014 10:00 PM EST Reads: 1,314
“The year of the cloud – we have no idea when it's really happening but we think it's happening now. For those technology providers like Zentera that are helping enterprises move to the cloud - it's been fun to watch," noted Mike Loftus, VP Product Management and Marketing at Zentera Systems, 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. 17, 2014 09:00 PM EST Reads: 728
"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: 1,250
"Desktop as a Service is emerging as a very big trend. One of the big influencers of this – for Esri – is that we have a large user base that uses virtualization and they are looking at Desktop as a Service right now," explained John Meza, Product Engineer at Esri, 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. 17, 2014 07:00 PM EST Reads: 1,431
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 ...
Dec. 17, 2014 06:30 PM EST Reads: 1,137
"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. 17, 2014 06:00 PM EST Reads: 1,106
"Application monitoring and intelligence can smooth the path in a DevOps environment. In a DevOps environment you see constant change. If you are trying to monitor things in a constantly changing environment, you're going to spend a lot of your job fixing your monitoring," explained Todd Rader, Solutions Architect at AppDynamics, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 04:00 PM EST Reads: 1,483
AppDynamics, the application intelligence leader for software-defined businesses, announced the general availability of the AppDynamics Fall '14 Release. Serving the combined needs of IT and business teams across the enterprise, the latest release provides a comprehensive view across all aspects of digital performance in ultra large scale deployments. AppDynamics delivers Application Intelligence by building out advanced capabilities across the key areas of analytics, unified monitoring and D...
Dec. 17, 2014 01:30 PM EST Reads: 653
In addition, Tesora adds the popular enterprise distribution from Mirantis to the Tesora OpenStack Database Certification Program ensuring compatibility with both NoSQL and SQL database management systems on Trove and eliminating the headache of enterprises having to test integration on their own. "We're providing Mirantis customers with the most production-ready OpenStack Trove implementation, saving the work and time necessary to ensure compatibility," said Ken Rugg, CEO of Tesora. "Working...
Dec. 17, 2014 12:30 PM EST Reads: 623
Docker containerization is gaining rapid popularity with Software-as-a-Service (SaaS) developers because of clear benefits such as simplified and continuous app delivery. Enterprise developers also want to leverage Docker for easy provisioning and efficient testing, but IT has unique needs that Docker does not solve out-of-the-box, such as security and access control, supporting heterogeneous infrastructure, apps and app stacks, backup and recovery, visibility and monitoring, and integration. Ho...
Dec. 17, 2014 12:15 PM EST Reads: 672