ThromboGenics NV - Business Update
News Nov 09, 2012
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) 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.”
Arsenic Trioxide Could Extend Lives of Patients with Aggressive Brain CancerNews
Arsenic trioxide could be a powerful therapy that could extend the lives of certain glioblastoma patients by as much as three to four times the median expectation.READ MORE
XenoGesis and Juniper Pharma Services Strengthen AllianceNews
Campanies extend strategic alliance in early drug development services.READ MORE
Quotient Clinical Signs Cocrystal Agreement with NuformixNews
Partnership to evaluate cocrystal formulations using translational pharmaceutics.READ MORE
Comments | 0 ADD COMMENT
Annual Conference on Antimicrobials and Drug Resistance
Sep 24 - Sep 25, 2018
1st Alpine Winter Conference on Medicinal and Synthetic Chemistry
Jan 28 - Feb 01, 2018