|By Marketwired .||
|November 8, 2012 02:00 AM EST||
LEUVEN, BELGIUM -- (Marketwire) -- 11/08/12 -- TiGenix NV (EURONEXT BRUSSELS: TIG)
- ChondroCelect Sales EUR 3.2 Million for First Nine Months
- Cx611 RA Program on Track to Report Preliminary Results in Q4
- Cx601 Partnering Discussions On-going
- Company Sufficiently Financed to Keep Executing on Plan
TiGenix NV (EURONEXT BRUSSELS: TIG), the European leader in cell therapy, gives an update of its business activities and provides the financial highlights for the third quarter ending September 30, 2012.
- ChondroCelect sales benefit from continued uptake in Belgium and in the Netherlands
- Progress development pipeline
- ADMIRE-CD Phase III trial (Cx601) enrollment on-going
- Cx601 Phase II study published in international peer-reviewed journal
- Cx611 Phase IIa in rheumatoid arthritis (RA) to report preliminary results in Q4
- Jean Stéphenne appointed chairman & Russell Greig appointed member of the board of directors
- European central facility obtains EMA approval for commercial production of ChondroCelect
- Partnering discussion for lead program Cx601 on-going
- ChondroCelect sales for the first nine months of 2012 amounted to EUR 3.2 million, comprising of EUR 2.5 million from 2012 sales, up 130% compared to same period of last year, and EUR 0.7 million of deferred sales from 2011
- ChondroCelect sales of the third quarter amounted to EUR 1.1 million, a 152% increase compared to the same period of 2011
- EUR 8 million cash on hand
"We are very pleased with our continued progress on all fronts," says Eduardo Bravo, CEO of TiGenix. "We anticipate delivering on a number of key milestones in the months ahead, such as reimbursement of ChondroCelect in at least one major market, partnering of Cx601, and preliminary and final results of our state-of-the-art Cx611 Phase II trial in RA. Based on our current cash position, and achieving our short-term milestones we are sufficiently financed to reach the end of 2013"
ChondroCelect sales up substantially
ChondroCelect sales for the third quarter of 2012 amounted to EUR 1.1 million, compared to sales of EUR 0.4 million in the same period of last year, reflecting the continued uptake in Belgium and the Netherlands. For the nine months ended September 30, ChondroCelect sales have grown 130% to EUR 2.5 million, compared to EUR 1.1 million in the same period of last year, excluding deferred sales of 2011.
Discussions to obtain national reimbursement keep advancing in Spain, France, and Germany, and the company expects a positive decision in at least one of these countries in the months ahead.
Patient enrollment on plan in ADMIRE-CD Phase III trial (Cx601) in complex perianal fistulas
Since July, after enrolling the first patient in the ADMIRE-CD trial, its pivotal Phase III clinical trial with Cx601, enrollment is progressing on plan. Cx601 is an adipose derived allogeneic stem cell suspension for the treatment of complex perianal fistulas in Crohn's disease patients. ADMIRE-CD is a multicenter, randomized, double-blind, placebo-controlled Phase III trial that will enroll approximately 278 patients at 46 centers across 7 European countries and Israel. The main objectives of the study are to demonstrate safety and superior efficacy over placebo in perianal fistulas in Crohn's disease patients who failed to respond to previous treatment(s), in most cases biologicals, and to confirm the strong safety and efficacy results from the Phase II trial completed in 2011. Final results of the trial are expected in H2 2014, and, if positive, will allow the Company to file for marketing authorization with the European Medicines Agency.
In early October, the study results of the Phase II trial of Cx601 were published online ahead of print in the peer-reviewed International Journal of Colorectal Disease.
Cx611 Phase IIa in rheumatoid arthritis to report preliminary safety results in Q4
On August 8, the Company completed enrollment in its Phase IIa trial of Cx611 in rheumatoid arthritis (RA). This is the most advanced clinical trial in the world with stem cells in RA and the Company expects to report preliminary results in Q4 and final results no later than April 2013. Although the primary objective is to demonstrate safety, feasibility, tolerance and optimal dosing, this 53-subject, randomized, placebo controlled, multicenter study will follow patients for 6 months after three injections of Cx611. It will therefore provide a strong first indication of the duration of the efficacy of Cx611 in this very difficult patient population -- enrolled patients have previously failed to respond to at least one biological -- and will set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders.
Jean Stéphenne appointed chairman & Russell Greig appointed member of the board of directors
On September 20, TiGenix appointed Jean Stéphenne chairman and Russell Greig member of the board of directors. Both are former members of the Corporate Executive Team of GlaxoSmithKline (GSK), and have a sterling track record that will be of immense value as TiGenix enters into a pivotal phase of its growth with the commercial roll-out of ChondroCelect and the advanced clinical development of its cell therapy programs.
European production facility obtains EMA approval
On October 9, TiGenix obtained approval from the European Medicines Agency to manufacture ChondroCelect at its European manufacturing plant in Sittard-Geleen in the Netherlands. The state-of-the-art manufacturing site is unique in Europe as it is 100% geared towards the production of innovative cell therapy products. The plant provides TiGenix with manufacturing capabilities to support the anticipated growth in demand for ChondroCelect.
Partnering discussion for lead program Cx601 on-going
TiGenix keeps advancing its discussions with a number of parties regarding the commercial rights to Cx601 to maximize the value of its lead program.
Financial results for the first nine months of 2012
ChondroCelect sales for the first 9 months of EUR 3.2 million
ChondroCelect sales for the first nine months of 2012 amounted to EUR 3.2 million, comprising of EUR 2.5 million of sales from 2012, and EUR 0.7 million in deferred sales from 2011. Sales for Q3 2012 were EUR 1.1 million, representing a 152% increase compared to Q3 2011.
Cash position of EUR 8 million on September 30, 2012
On September 30, the Company had a cash position of EUR 8 million. Net cash used during the first nine months of 2012 was EUR 11.7 million, in line with management's guidance. Based on its current cash position, anticipated commercial revenues from ChondroCelect sales, partnering of Cx601, already allocated grants, and new grants, the company believes it is sufficiently financed to keep executing on its business plan.
Outlook next 12 months
- National reimbursement decisions in major European countries for ChondroCelect
- ChondroCelect distribution agreements in selected countries
- First commercial batches of ChondroCelect produced at Sittard-Geleen manufacturing facility
- Preliminary results of Cx611 in Rheumatoid Arthritis in Q4, 2012
- Partnering agreement for Cx601
- Final results of Cx611 in RA in April, 2013
TiGenix NV (EURONEXT BRUSSELS: TIG) is a leading European cell therapy company with a marketed cell therapy product for cartilage repair, ChondroCelect®, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.
This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix' control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix' expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.
The world's leading Cloud event, Cloud Expo has launched Microservices Journal on the SYS-CON.com portal, featuring over 19,000 original articles, news stories, features, and blog entries. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. Microservices Journal offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Follow new article posts on Twitter at @MicroservicesE
Mar. 30, 2015 12:00 PM EDT Reads: 1,483
SYS-CON Events announced today the IoT Bootcamp – Jumpstart Your IoT Strategy, being held June 9–10, 2015, in conjunction with 16th Cloud Expo and Internet of @ThingsExpo at the Javits Center in New York City. This is your chance to jumpstart your IoT strategy. Combined with real-world scenarios and use cases, the IoT Bootcamp is not just based on presentations but includes hands-on demos and walkthroughs. We will introduce you to a variety of Do-It-Yourself IoT platforms including Arduino, Raspberry Pi, BeagleBone, Spark and Intel Edison. You will also get an overview of cloud technologies s...
Mar. 30, 2015 11:00 AM EDT Reads: 2,136
SYS-CON Events announced today that SafeLogic has been named “Bag Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SafeLogic provides security products for applications in mobile and server/appliance environments. SafeLogic’s flagship product CryptoComply is a FIPS 140-2 validated cryptographic engine designed to secure data on servers, workstations, appliances, mobile devices, and in the Cloud.
Mar. 30, 2015 11:00 AM EDT Reads: 1,485
After making a doctor’s appointment via your mobile device, you receive a calendar invite. The day of your appointment, you get a reminder with the doctor’s location and contact information. As you enter the doctor’s exam room, the medical team is equipped with the latest tablet containing your medical history – he or she makes real time updates to your medical file. At the end of your visit, you receive an electronic prescription to your preferred pharmacy and can schedule your next appointment.
Mar. 30, 2015 10:00 AM EDT Reads: 869
Wearable technology was dominant at this year’s International Consumer Electronics Show (CES) , and MWC was no exception to this trend. New versions of favorites, such as the Samsung Gear (three new products were released: the Gear 2, the Gear 2 Neo and the Gear Fit), shared the limelight with new wearables like Pebble Time Steel (the new premium version of the company’s previously released smartwatch) and the LG Watch Urbane. The most dramatic difference at MWC was an emphasis on presenting wearables as fashion accessories and moving away from the original clunky technology associated with t...
Mar. 30, 2015 10:00 AM EDT Reads: 1,453
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch of Docker's initial release in March of 2013, interest was revved up several notches. Then late last...
Mar. 30, 2015 09:15 AM EDT Reads: 2,245
The WebRTC Summit 2014 New York, to be held June 9-11, 2015, at the Javits Center in New York, NY, announces that its Call for Papers is 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 16th International Cloud Expo, @ThingsExpo, Big Data Expo, and DevOps Summit.
Mar. 30, 2015 09:00 AM EDT Reads: 1,635
SOA Software has changed its name to Akana. With roots in Web Services and SOA Governance, Akana has established itself as a leader in API Management and is expanding into cloud integration as an alternative to the traditional heavyweight enterprise service bus (ESB). The company recently announced that it achieved more than 90% year-over-year growth. As Akana, the company now addresses the evolution and diversification of SOA, unifying security, management, and DevOps across SOA, APIs, microservices, and more.
Mar. 30, 2015 08:30 AM EDT Reads: 2,073
GENBAND has announced that SageNet is leveraging the Nuvia platform to deliver Unified Communications as a Service (UCaaS) to its large base of retail and enterprise customers. Nuvia’s cloud-based solution provides SageNet’s customers with a full suite of business communications and collaboration tools. Two large national SageNet retail customers have recently signed up to deploy the Nuvia platform and the company will continue to sell the service to new and existing customers. Nuvia’s capabilities include HD voice, video, multimedia messaging, mobility, conferencing, Web collaboration, deskt...
Mar. 30, 2015 01:00 AM EDT Reads: 1,489
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
Mar. 29, 2015 10:00 PM EDT Reads: 1,835
SYS-CON Events announced today that Cisco, the worldwide leader in IT that transforms how people connect, communicate and collaborate, has been named “Gold 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 City, NY. Cisco makes amazing things happen by connecting the unconnected. Cisco has shaped the future of the Internet by becoming the worldwide leader in transforming how people connect, communicate and collaborate. Cisco and our partners are building the platform for the Internet of Everything by connecting the...
Mar. 29, 2015 07:00 PM EDT Reads: 5,259
Temasys has announced senior management additions to its team. Joining are David Holloway as Vice President of Commercial and Nadine Yap as Vice President of Product. Over the past 12 months Temasys has doubled in size as it adds new customers and expands the development of its Skylink platform. Skylink leads the charge to move WebRTC, traditionally seen as a desktop, browser based technology, to become a ubiquitous web communications technology on web and mobile, as well as Internet of Things compatible devices.
Mar. 29, 2015 06:00 PM EDT Reads: 1,871
SYS-CON Events announced today that robomq.io will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. robomq.io is an interoperable and composable platform that connects any device to any application. It helps systems integrators and the solution providers build new and innovative products and service for industries requiring monitoring or intelligence from devices and sensors.
Mar. 29, 2015 06:00 PM EDT Reads: 1,500
Docker is an excellent platform for organizations interested in running microservices. It offers portability and consistency between development and production environments, quick provisioning times, and a simple way to isolate services. In his session at DevOps Summit at 16th Cloud Expo, Shannon Williams, co-founder of Rancher Labs, will walk through these and other benefits of using Docker to run microservices, and provide an overview of RancherOS, a minimalist distribution of Linux designed expressly to run Docker. He will also discuss Rancher, an orchestration and service discovery platf...
Mar. 29, 2015 04:15 PM EDT Reads: 2,449
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes for use cases across the industrial, enterprise, and consumer segments.
Mar. 29, 2015 03:30 PM EDT Reads: 2,197
SYS-CON Events announced today that Solgenia 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, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Solgenia is the global market leader in Cloud Collaboration and Cloud Infrastructure software solutions. Designed to “Bridge the Gap” between Personal and Professional Social, Mobile and Cloud user experiences, our solutions help large and medium-sized organizations dr...
Mar. 29, 2015 03:00 PM EDT Reads: 2,877
SYS-CON Events announced today that Liaison Technologies, a leading provider of data management and integration cloud services and solutions, 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. Liaison Technologies is a recognized market leader in providing cloud-enabled data integration and data management solutions to break down complex information barriers, enabling enterprises to make smarter decisions, faster.
Mar. 29, 2015 03:00 PM EDT Reads: 3,490
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the M2M space. This really allows some room for influential individuals to create more high value inter...
Mar. 29, 2015 01:45 PM EDT Reads: 4,684
The list of ‘new paradigm’ technologies that now surrounds us appears to be at an all time high. From cloud computing and Big Data analytics to Bring Your Own Device (BYOD) and the Internet of Things (IoT), today we have to deal with what the industry likes to call ‘paradigm shifts’ at every level of IT. This is disruption; of course, we understand that – change is almost always disruptive.
Mar. 29, 2015 11:45 AM EDT Reads: 1,143
SYS-CON Events announced today that Akana, formerly SOA Software, has been named “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Akana’s comprehensive suite of API Management, API Security, Integrated SOA Governance, and Cloud Integration solutions helps businesses accelerate digital transformation by securely extending their reach across multiple channels – mobile, cloud and Internet of Things. Akana enables enterprises to share data as APIs, connect and integrate applications, drive part...
Mar. 28, 2015 04:15 PM EDT Reads: 1,571