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August 30, 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 six-month period ending
30 June 2012.
In July, the US Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee recommended ocriplasmin for the treatment of symptomatic vitreomacular adhesion (VMA). The Committee voted 10 to 0 that the benefits of administering ocriplasmin for the treatment of vitreomacular adhesions outweighed the potential risks;
In August, the prestigious medical journal the New England Journal of Medicine ( NEJM) published the results from the ocriplasmin Phase III clinical trial program. The publication highlighted that ocriplasmin is superior to placebo in resolving vitreomacular adhesion (VMA), related vitreomacular traction (VMT) and macular holes;
In March, ThromboGenics signed an important strategic deal with Alcon, the global leader in eye care. Upon approval, Alcon will commercialize the ThromboGenics developed drug ocriplasmin outside the U.S. ThromboGenics will receive up to €375 million in upfront and milestone payments plus royalties that will give it a significant share of the economics from ocriplasmin's sale outside the U.S. ThromboGenics plans to commercialize ocriplasmin in the U.S. through its own commercial organization.
In March, ThromboGenics raised €77.8 million through a private placement with a range of domestic and international investors at a price of €24 per share;
In June, the Belgian tax authorities granted the Company a positive ruling enabling it to benefit from the "patent income deduction regime". This will result in a reduced tax rate for all patent related ocriplasmin income;
The Company had €186.1 million in cash and cash investments as of 30 June 2012 compared with €96.4 million at the end of June 2011;
Reported revenues of €75.1 million in the first six months of 2012 versus €2.4 million in the same period in 2011;
The Company achieved a net profit of €56.2 million in the first half of 2012 against a net loss of €10.2 million in the corresponding period in 2011.
Patrik De Haes, CEO of ThromboGenics, said: "In 2012, we have made significant progress towards our goal of commercializing ocriplasmin for the treatment of symptomatic VMA.
The FDA Advisory Committee's recent recommendation for ocriplasmin is a key milestone in allowing us to potentially make this first pharmacological treatment option available to the patients in the U.S. with this sight threatening disorder. We are continuing to work with the FDA as it completes the review of the ocriplasmin biologics licensing application. In parallel with our regulatory activities, we are investing in the resources needed to successfully launch ocriplasmin in the U.S.