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):
- 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).
Dr Patrik 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 at http://www.thrombogenics.com
ThromboGenics is a biopharmaceutical company focused on developing innovative ophthalmic medicines. The Company's lead product ocriplasmin has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic vitreomacular adhesion (VMA). The MAA for ocriplasmin has been accepted for review in Europe and the BLA will be re-submitted in the U.S. by April 2012. Ocriplasmin is in Phase II clinical development for additional vitreoretinal conditions.
ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International. These include TB-402 (anti-Factor VIII), a long-acting anticoagulant in Phase II, and TB-403 (anti-PlGF), in Phase Ib/II for cancer in partnership with Roche.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at http://www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
For further information please contact:
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Tel: + 32-16-75-13-10
Tel: + 32-16-75-13-10
SOURCE ThromboGenics NV