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March 8, 2012 /PRNewswire/ --
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today issued a business update and its financial results for the full year ending
December 31, 2011.
Over the past 12 months, ThromboGenics has built its capabilities in anticipation of the launch of its lead product, ocriplasmin. It has filed a regulatory submission in
Europe for ocriplasmin for symptomatic vitreomacular adhesion (VMA) including macular hole and plans to resubmit the Biologics License Application (BLA) filing for ocriplasmin in the U.S. in
April 2012 for the same indication. The US Food and Drug Administration has advised that it will give Priority Review to the BLA filing.
During 2012, ThromboGenics is confident of delivering a number of further significant milestones as it remains on track to achieve its goal of becoming a successful and profitable biopharmaceutical company developing and commercializing innovative ophthalmic medicines.
2011 Highlights (including post-period events):
European Medicines Agency (EMA) accepts for review the Marketing Authorisation Application (MAA) for ocriplasmin for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.
ThromboGenics submitted the BLA for ocriplasmin with the FDA in December 2011. Following discussions with the FDA, ThromboGenics will resubmit the BLA in April 2012 in order to meet the Agency's timelines for Priority Review.
Continued expansion of the commercial organization ahead of the anticipated launch of ocriplasmin.
Presentation of ocriplasmin clinical trial data by leading retina specialists at major international ophthalmology congresses.
Other clinical programs
ThromboGenics initiates Phase IIb trial with TB-402 (anti-factor VIII), its novel long-acting anticoagulant, for the prophylaxis of venous thromboembolism (VTE) after total hip replacement.
Partner Roche starts Phase Ib/II trial with TB-403, a novel anticancer (anti-PIGF), in combination with Avastin for glioblastoma multiforme (brain tumor).
Recruitment of two Chief Scientific Officers to develop the Company's preclinical ophthalmology and cancer pipelines.
€80.4 million in cash and cash investments as of 31 December 2011, compared with €109.2 million at the end of December 2010.
€ 2.5 million in total revenue in 2011, compared with €6.2 million in 2010.
Net loss of €21.6 million in 2011, compared with €13.9 million in 2010, equivalent to diluted loss per share of €0.67 (€0.47 in 2010).
DrPatrik De Haes, CEO of ThromboGenics, commenting on today's announcement, said: "We have made very good progress over the last year towards our goal of becoming a successful and profitable biopharmaceutical company developing and commercializing innovative ophthalmic medicines. We have filed ocriplasmin with the EMA. In the U.S., following discussions with the FDA, we plan to resubmit our BLA in order for ThromboGenics to meet the expedited timelines for Priority Review. We are encouraged that the FDA has indicated that ocriplasmin could be subject to Priority Review, as this designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.
"Over the coming months we will be working with the regulatory agencies in
Europe and the US to gain approval for ocriplasmin. If approved, ocriplasmin could be the first pharmacological treatment for symptomatic VMA including macular hole. I look forward to the next 12 months and I am confident that we will deliver a number of very significant milestones that will create significant value for our shareholders."
The full report can be accessed athttp://www.thrombogenics.com