|By PR Newswire||
|January 18, 2013 07:00 AM EST||
LEUVEN, Belgium, January 18, 2013 /PRNewswire/ --
Positive opinion clears the way for the potential EMA approval of JETREA® as the first pharmacological option for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for JETREA® (ocriplasmin), recommending JETREA® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
VMT, in the US referred to as symptomatic VMA, is an age-related progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness. It is estimated that 250,000 to 300,000 patients in Europe alone suffer from this condition.
JETREA®, a recombinant form of a human protein (plasmin), is administered through a one-time, single intravitreal injection. It targets the protein fibers which cause the abnormal pulling between vitreous and macula that causes VMT. By dissolving these proteins, JETREA® releases the traction, and helps to complete the detachment of the vitreous from the macula.
Alcon, a division of Novartis, acquired the rights to commercialize JETREA® outside the United States in March 2012. ThromboGenics retains the rights to commercialize the drug in the US. In the US, JETREA® has received FDA approval for the treatment of patients with symptomatic vitreomacular adhesion (VMA). Earlier this week, ThromboGenics introduced JETREA® in the US. The first patients have already received this novel treatment in multiple locations across the country.
"We are very pleased that the CHMP has provided a positive recommendation for JETREA® for the treatment of VMT, including when associated with macular holes," says Dr Patrik De Haes, CEO of ThromboGenics. "With our partner Alcon, ThromboGenics, as the marketing authorization holder, will continue to work with the European Medicines Agency and the European Commission as it finalizes the JETREA® European Marketing Authorization Application. Today, more than ever, we are convinced that VMT is an area of unmet medical need. With today's positive CHMP opinion, we anticipate a final decision by the European Commission within the next 2 to 3 months. The decision will be applicable to all 27 European Union Member states plus Iceland and Norway. Upon the Commission's final approval and completion of pricing and reimbursement, we intend to support our partner Alcon in making this novel treatment option available to patients in the EU as soon as possible," De Haes concludes.
JETREA® is used to treat adults with an eye disease called vitreomacular traction (VMT), including when it is associated with a small hole in the macula (central part of the light-sensitive layer at the back of the eye).
VMT is caused by traction resulting from a persistent attachment of the vitreous (jelly-like material in the center of the eye) to the macula at the back of the eye. The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces. VMT can cause symptoms such as distorted or decreased vision. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).
JETREA® works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present which may decrease the symptoms caused by VMT.
Currently the only available treatment in the EU is "observation" or "watchful waiting" until a patient becomes a surgical candidate, usually at a very late stage of the disease., A patient would then receive a surgical procedure and repair of the retina. However, for many patients this is not a suitable option, as irreversible damage to the retina may have already occurred.,
"Vitreomacular traction and macular hole formation are disabling eye diseases that influence visual function, and affect activities of patients in their daily life," said Prof. Dr. Peter Stalmans, Department of Ophthalmology, University Hospitals, Leuven, Belgium. "When the disease worsens, vitrectomy surgery is the only available treatment option. Release of the vitreous traction by pharmacologic vitreolysis can omit the need for vitrectomy. Upon approval, JETREA® will be the first available product with proven clinical efficacy to release vitreous traction, hence provides a paradigm-shifting treatment option for these eye diseases," he concludes.
Dr. Albert Augustin, Professor of Ophthalmology and Chairman of the Department of Ophthalmology at the Klinikum Karlsruhe, Germany, said: "JETREA® represents an important breakthrough for both physicians and patients and is expected to establish a new standard of care for patients with VMT and small macular holes. If approved, a single injection of JETREA® in the affected eye could help to prevent disease progression and/or vision loss."
For patients with VMT and macular holes, everyday activities, such as reading, driving, the ability to work, use computer screens and overall quality of life are significantly affected," said Professor Yit Yang, Consultant Ophthalmologist, Wolverhampton Eye Hospital, and Visiting Professor, Aston University, UK. "I am looking forward to administering JETREA® to patients who I would normally observe till worsening or progression of the disease, as we seek to improve their quality of life."
The EU MAA submission was based on data from two pivotal Phase III clinical trials that evaluated the safety and efficacy of a single administration of JETREA®. Both studies met their primary endpoint and demonstrated that JETREA® successfully resolved VMT and macular holes compared to placebo.
At day 28, 26.5% Jetrea-treated patients achieved resolution (versus 10.1% with placebo [P<0.001]). 72% of JETREA® patients who achieved resolution of VMT and macular holes by Day 28, did so within seven days.
All adverse reactions were ocular. The most commonly reported were vitreous floaters, eye pain and photopsia, as well as conjunctival haemorrhage resulting from the injection procedure. Most of the adverse reactions occurred within the first week after the injection. The majority of these reactions were non-serious, mild in intensity and resolved within 2 to 3 weeks.
. ThromboGenics and Alcon internal estimates
. Idiopathic macular hole. American Academy of Ophthalmology; 2008
. Stalmans P. Management and intervention strategies for symptomatic vitreomacular adhesions. Retinal Physician 2011
. Koerner F & Garweg J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc Ophthalmol 1999;97:449-458
. Dugel PU, Brown DM, Humayun MS et al. Symptomatic vitreomacular adhesion: diagnosis, pathologic implications, and management. Retina Today 2011;(Suppl):1-14
. Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med 2012;367:606-615
About JETREA® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin. In the US, JETREA® is indicated for the treatment of symptomatic VMA. In Europe, JETREA® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter ≤ 400 microns. JETREA® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
JETREA® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
JETREA's Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA was generally well tolerated with most adverse events being transient and mild in severity.
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company's lead product, JETREA® (ocriplasmin), has been approved by the US FDA for the treatment of symptomatic VMA and was launched in January 2013.
In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of JETREA® outside the United States. Under this agreement, ThromboGenics could receive up to a total of €375 million in up-front and milestone payments. It will receive significant royalties from Alcon's net sales of JETREA®. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.
The JETREAEuropean Marketing Authorisation Application is currently under review by the European Medicines Agency. Following the positive CHMP recommendation, a final decision by the European Commission on European approval is expected in the first half of 2013.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), formerly referred to as TB-403, for the treatment of ophthalmic indications.
ThromboGenics is headquartered in Leuven, Belgium, and has-offices in Iselin, NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at http://www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.
For further information please contact:
Wouter Piepers, Global Head of Corporate Communications
+32-16-75-13-10 / +32-478-33-56-32
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Citigate Dewe Rogerson
David Dible / Nina Enegren / Sita Shah
The Trout Group (US investor relations)
Todd James / Simon Harnest
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 6, 2016 10:15 AM EST Reads: 521
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
Dec. 6, 2016 09:15 AM EST Reads: 2,141
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 6, 2016 09:00 AM EST Reads: 3,963
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Dec. 6, 2016 08:45 AM EST Reads: 7,124
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, drew together recent research and lessons learned from emerging and established compa...
Dec. 6, 2016 08:30 AM EST Reads: 879
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web co...
Dec. 6, 2016 08:30 AM EST Reads: 1,335
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
Dec. 6, 2016 08:15 AM EST Reads: 1,671
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Dec. 6, 2016 07:15 AM EST Reads: 1,837
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Dec. 6, 2016 07:15 AM EST Reads: 740
Businesses and business units of all sizes can benefit from cloud computing, but many don't want the cost, performance and security concerns of public cloud nor the complexity of building their own private clouds. Today, some cloud vendors are using artificial intelligence (AI) to simplify cloud deployment and management. In his session at 20th Cloud Expo, Ajay Gulati, Co-founder and CEO of ZeroStack, will discuss how AI can simplify cloud operations. He will cover the following topics: why clou...
Dec. 6, 2016 07:00 AM EST Reads: 836
The Internet of Things (IoT) promises to simplify and streamline our lives by automating routine tasks that distract us from our goals. This promise is based on the ubiquitous deployment of smart, connected devices that link everything from industrial control systems to automobiles to refrigerators. Unfortunately, comparatively few of the devices currently deployed have been developed with an eye toward security, and as the DDoS attacks of late October 2016 have demonstrated, this oversight can ...
Dec. 6, 2016 06:30 AM EST Reads: 1,131
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Dec. 6, 2016 06:00 AM EST Reads: 526
Internet-of-Things discussions can end up either going down the consumer gadget rabbit hole or focused on the sort of data logging that industrial manufacturers have been doing forever. However, in fact, companies today are already using IoT data both to optimize their operational technology and to improve the experience of customer interactions in novel ways. In his session at @ThingsExpo, Gordon Haff, Red Hat Technology Evangelist, will share examples from a wide range of industries – includin...
Dec. 6, 2016 05:00 AM EST Reads: 1,656
"We build IoT infrastructure products - when you have to integrate different devices, different systems and cloud you have to build an application to do that but we eliminate the need to build an application. Our products can integrate any device, any system, any cloud regardless of protocol," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 6, 2016 04:45 AM EST Reads: 1,002
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Dec. 6, 2016 04:30 AM EST Reads: 1,936
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 6, 2016 12:45 AM EST Reads: 870
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Dec. 6, 2016 12:30 AM EST Reads: 1,201
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discussed how businesses can gain an edge over competitors by empowering consumers to take control through IoT. He cited examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He also highlighted how IoT can revitalize and restore outdated business models, making them profitable ...
Dec. 6, 2016 12:30 AM EST Reads: 4,593
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Dec. 6, 2016 12:00 AM EST Reads: 920
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 10:30 PM EST Reads: 1,072