ThromboGenics Announces Business Update and 2011 Full-Year Results
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
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.
- EUR80.4 million in cash and cash investments as of 31 December 2011, compared with EUR109.2 million at the end of December 2010. - EUR 2.5 million in total revenue in 2011, compared with EUR6.2 million in 2010. - Net loss of EUR21.6 million in 2011, compared with EUR13.9 million in 2010, equivalent to diluted loss per share of EUR0.67 (EUR0.47 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
“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
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
For further information please contact:
ThromboGenics Dr. Patrik De Haes, CEO Chris Buyse, CFO Tel: + 32-16-75-13-10 email@example.com Tel: + 32-16-75-13-10 firstname.lastname@example.org Tel: +44(0)207-638-9571 email@example.com
SOURCE ThromboGenics NV