|By PR Newswire||
|January 4, 2013 01:31 AM EST||
LEUVEN, Belgium, January 4, 2013 /PRNewswire/ --
JETREA® US Price Set at USD 3,950 per Vial
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, confirms its JETREA®US launch date of Monday January 14th, 2013.
JETREA® (ocriplasmin) Intravitreal Injection is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion (VMA). The US price for a single-use glass vial of JETREA® is set at USD 3,950.
Next week, Dr. Patrik De Haes, Chief Executive Officer of ThromboGenics, will present during the 31st Annual J.P. Morgan Healthcare Conference from January 7th to 9th, 2013 in San Francisco, USA.
The ThromboGenics presentation will be held on Wednesday, January 9th at 11.00 am PST (20.00 CET) at the Westin St. Francis Hotel in San Francisco. It will include the Company's plans for launching JETREA® (ocriplasmin) in January through its own U.S. commercial organization, which will mark a major milestone for transforming ThromboGenics into a fully operational biopharmaceutical company that provides innovative ophthalmic medicines.
JETREA® represents a paradigm shift and for the first time offers a pharmacological treatment option to patients suffering with symptomatic VMA. The U.S. Food and Drug Administration (FDA) approved JETREA® in October 2012 as the first pharmacological agent for the treatment of symptomatic VMA. Symptomatic VMA is a progressive, sight-threatening condition that, when left untreated, frequently leads to retinal distortion, further deterioration in vision, and irreversible damage to eyesight. The recommended dose of JETREA® is 0.125 mg (0.1 mL) of the diluted solution administered by intravitreal injection to the affected eye once as a single injection.
The approval was based on the data from ThromboGenics' Phase III program where JETREA® was shown to be superior to placebo for the treatment of symptomatic VMA (26.5% versus 10.1%; p<0.01). Treatment with JETREA® was associated with some, mainly transient, ocular adverse events.
Important safety and prescribing information about JETREA® is available at http://www.jetrea.com.
About JETREA® (ocriplasmin)
JETREA®(ocriplasmin) is a truncated form of human plasmin that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of symptomatic VMA. 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 FDA for the treatment of symptomatic VMA. The Marketing Authorisation Application (MAA) for ocriplasmin is under review in Europe.
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.
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
SOURCE ThromboGenics NV
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...
Dec. 10, 2016 07:30 PM EST Reads: 1,784
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. 10, 2016 07:00 PM EST Reads: 4,121
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
Dec. 10, 2016 06:45 PM EST Reads: 1,076
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Dec. 10, 2016 06:30 PM EST Reads: 1,939
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. 10, 2016 06:30 PM EST Reads: 1,518
SYS-CON Events has announced today that Roger Strukhoff has been named conference chair of Cloud Expo and @ThingsExpo 2017 New York. The 20th Cloud Expo and 7th @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "The Internet of Things brings trillions of dollars of opportunity to developers and enterprise IT, no matter how you measure it," stated Roger Strukhoff. "More importantly, it leverages the power of devices and the Internet to enable us all to im...
Dec. 10, 2016 06:30 PM EST Reads: 998
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Dec. 10, 2016 06:15 PM EST Reads: 1,047
"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. 10, 2016 05:30 PM EST Reads: 975
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. 10, 2016 05:15 PM EST Reads: 2,355
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
Dec. 10, 2016 05:15 PM EST Reads: 1,395
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. 10, 2016 04:30 PM EST Reads: 1,812
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
Dec. 10, 2016 04:30 PM EST Reads: 1,903
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Phil Hombledal, Solution Architect at CollabNet, discussed how customers are able to achieve a level of transparency that e...
Dec. 10, 2016 04:30 PM EST Reads: 1,347
Rapid innovation, changing business landscapes, and new IT demands force businesses to make changes quickly. In the eyes of many, containers are at the brink of becoming a pervasive technology in enterprise IT to accelerate application delivery. In this presentation, attendees learned about the: The transformation of IT to a DevOps, microservices, and container-based architecture What are containers and how DevOps practices can operate in a container-based environment A demonstration of how ...
Dec. 10, 2016 03:45 PM EST Reads: 1,318
Cloud Expo, Inc. has announced today that Andi Mann returns to 'DevOps at Cloud Expo 2017' as Conference Chair The @DevOpsSummit at Cloud Expo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "DevOps is set to be one of the most profound disruptions to hit IT in decades," said Andi Mann. "It is a natural extension of cloud computing, and I have seen both firsthand and in independent research the fantastic results DevOps delivers. So I am excited to help the great t...
Dec. 10, 2016 03:45 PM EST Reads: 903