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ThromboGenics NV (TBGNF) - Business Update



8/30/2012 10:34:20 AM

LEUVEN, Belgium, 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.

Highlights (including post-period events)

Ocriplasmin

  • 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.

Financial Highlights

  • 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.

We are also in an on-going dialogue with the EMA as it reviews the European filing for ocriplasmin. Our partnership with Alcon is going well, as we leverage the strengths of both organizations, and we are convinced that it is the ideal partner to commercialize ocriplasmin outside the U.S.. ThromboGenics is now well placed to generate significant value for both shareholders and patients given the important ocriplasmin milestones we have delivered in 1H 2012."

For full report, please go tohttp://www.thrombogenics.com

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on developing and commercializing 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), otherwise termed vitreomacular traction (VMT). The Marketing Authorisation Application (MAA) for ocriplasmin has been accepted for review in Europe and in the U.S. the FDA has accepted the Biologics License Application (BLA) filing and granted it Priority Review. In July 2012, a FDA Advisory Committee issued a positive recommendation supporting the approval of ocriplasmin for the treatment of symptomatic VMA.

In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States. Under this agreement, ThromboGenics could receive up to a total of 375 million in up-front and milestone payments, plus an attractive level of royalties on Alcon's net sales of ocriplasmin. ThromboGenics and Alcon intend to share the costs equally of developing ocriplasmin for a number of new vitreoretinal indications.

ThromboGenics is also developing TB-403, a novel antibody therapeutic, in collaboration with BioInvent International, for cancer and non-cancer, including ophthalmic indications.

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:

ThromboGenics

Wouter Piepers, Global Head of Corporate Communications
Tel: +32-16-75-13-10 / +32(0)478-33-56-32
wouter.piepers@thrombogenics.com

Dr. Patrik De Haes, CEO
Tel: +32-16-75-13-10
patrik.dehaes@thrombogenics.com

Chris Buyse, CFO
Tel: +32-16-75-13-10
chris.buyse@thrombogenics.com


Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
Tel: +44 20-7638-9571
sita.shah@citigatedr.co.uk


The Trout Group
Todd James/ Simon Harnest
Tel: +1-646-378-2926
tjames@troutgroup.com


SOURCE ThromboGenics NV


Read at BioSpace.com


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