LEUVEN, Belgium, 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): Ocriplasmin
- 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.
- 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).