Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
Become a Member | Sign in
Home>News>This Article

ThromboGenics NV - Business Update

Published: Friday, November 09, 2012
Last Updated: Friday, November 09, 2012
Bookmark and Share
Company to build a first-class US commercial organization to launch JETREA in January 2013.

ThromboGenics NV has issued a business update and its nine-month financial results for the period ending 30 September, 2012.

Highlights (including post-period events)

JETREA® (ocriplasmin)
• JETREA® (ocriplasmin) was approved by the U.S. Food and Drugs Administration (FDA) for the treatment of symptomatic Vitreomacular Adhesion (VMA) on the PDUFA date of 17 October.
• In August, the prestigious medical journal the New England Journal of Medicine (NEJM) published the results from the JETREA® (ocriplasmin) Phase III clinical trial program. The publication (“Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes”) highlighted that JETREA® is superior to placebo in resolving VMA and related vitreomacular traction (VMT).
• ThromboGenics is on target to build a first-class US commercial organization to launch JETREA in January 2013.
• The JETREA® Marketing Authorization Application (MAA) is under review in Europe by the EMA; a CHMP opinion is expected in January 2013. A positive opinion would pave the way for EU approval in March 2013.

• In March, ThromboGenics signed an important strategic deal with Alcon, the global leader in eye care, for the commercialization of JETREA® outside the U.S. ThromboGenics will receive up to €375 million in upfront and milestone payments plus royalties that will give it an important share of the economics from JETREA’s sales outside the U.S.
• On October 30, ThromboGenics hosted a Capital Markets Day in Brussels for investors and analysts.

• In March, ThromboGenics raised €77.8 million in a private placement.
• In June, the Belgian tax authorities granted the Company a positive ruling enabling it to benefit from the application of the Belgian patent income deduction regime in conjunction with the existing deduction carry forwards of ThromboGenics NV.
• ThromboGenics had €168.6 million in cash and cash investments as of 30 September 2012, compared with €88.3 million at the end of September 2011.
• The Company reported revenues of €75.1 million in the first nine months of 2012 versus €2.5 million in the first nine months of 2011. The revenues in 2012 are almost entirely due to the upfront payment from Alcon.

Dr. Patrik De Haes, CEO of ThromboGenics, said: “The FDA’s approval of JETREA®, the first pharmacological treatment for symptomatic Vitreomacular Adhesion (VMA) in the U.S., is a transformational event for ThromboGenics and our shareholders.

“We are making excellent progress in building our U.S. commercial organization and I am sure that we will have a first-class team in place to launch JETREA® in January 2013. We are also encouraged by the high level of awareness of symptomatic VMA and the clinical data that we have generated with JETREA®.

“We are confident that the launch of JETREA® will be successful in the US. I believe the U.S. retina community and thousands of patients suffering with symptomatic VMA will welcome JETREA® as the first pharmacological treatment option for this progressive sight threatening condition whose only current treatment option is surgery.”

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

ThromboGenics Announces FDA Acceptance of IND Application
FDA acceptance for Phase II study with JETREA® for the treatment of non-proliferative diabetic retinopathy (CIRCLE).
Tuesday, November 24, 2015
ThromboGenics and VIB Launch New Oncology Company
Oncurious NV to develop TB-403 for pediatric brain tumors.
Tuesday, April 14, 2015
ThromboGenics Initiates Major Post-Marketing Patient Trial with JETREA® in the US
ORBIT study designed to generate further data on the “real world” use of JETREA®.
Thursday, March 06, 2014
ThromboGenics Appoints Dr David Guyer to its Board of Directors
Dr Guyer is currently the Co-Founder and Chief Executive Officer of Ophthotech Corporation.
Monday, December 23, 2013
ThromboGenics Business Update
US sales through end of April 2013 have exceeded $10 million.
Monday, May 27, 2013
ThromboGenics Receives Positive CHMP Opinion for JETREA®
Positive opinion clears the way for the potential EMA approval of JETREA® as the first pharmacological option for the treatment of VMT, including when associated with macular hole of diameter less than or equal to 400 microns.
Wednesday, April 24, 2013
ThromboGenics NV - Business Update
ThromboGenics sign an important strategic deal with Alcon.
Monday, October 22, 2012
U.S. FDA Approves ThromboGenics’ JETREA® (Ocriplasmin)
JETREA® is the first pharmacological agent approved for the treatment of symptomatic VMA.
Thursday, October 18, 2012
ThromboGenics Announces Publication of New England Journal of Medicine Paper
Paper highlights that ocriplasmin is superior to placebo in resolving VMT and closing macular holes in patients with VMA.
Saturday, September 15, 2012
ThromboGenics and BioInvent Announce Results from Phase IIb VTE Prevention Study with TB-402
All further development of TB-402 will be stopped.
Thursday, July 05, 2012
ThromboGenics and BioInvent Complete Enrolment of Phase IIb Trial with TB-402 Ahead of Schedule
The companies announced they have completed the enrolment of a 632-patient Phase IIb trial with their long-acting anticoagulant TB-402 (factor VIII inhibitor).
Friday, December 16, 2011
ThromboGenics Announces that Microplasmin Meets Primary Endpoint in Phase III Trial for VMA
Highly significant trial result demonstrates the potential of microplasmin in the treatment of retinal disease.
Monday, April 26, 2010
ThromboGenics Announces Results From a Phase IIa Trial Evaluating Microplasmin for the Treatment of Diabetic Macular Edema (MIVI II DME)
ThromboGenics NV announces results of a Phase IIa trial evaluating microplasmin intravitreal injection for the treatment of Diabetic Macular Edema (MIVI II DME). The data from this trial were presented at the ASRS (American Society of Retina Specialists) Conference in New York on 3 October, 2009 by Professor Peter Stalmans, University Hospitals Leuven, Belgium.
Friday, October 09, 2009
ThromboGenics Completes Patient Enrolment for Phase II Trial of Microplasmin for the Treatment of DME
The MIVI II DME trial is a Phase II clinical trial evaluating the safety and initial efficacy of intravitreal microplasmin for the treatment of DME patients.
Monday, March 09, 2009
Scientific News
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
Scroll Up
Scroll Down

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos