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ThromboGenics NV - Business Update

LEUVEN, Belgium, November 8, 2012 /PRNewswire/ --

Regulated Information

Disclosure in accordance with the law of May 2, 2007

ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, has today issued a business update and its nine-month financial results for the period ending 30 September, 2012.  

Highlights (including post-period events)

JETREA ® (ocriplasmin)

  • JETREA ® (ocriplasmin) was approved by the U.S. Food and Drugs Administration (FDA) for the treatment of symptomatic Vitreomacular Adhesion (VMA) on the PDUFA date of 17 October
  • In August, the prestigious medical journal the New England Journal of Medicine ( NEJM) published the results from the JETREA ® (ocriplasmin) Phase III clinical trial program. The publication ( " Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes " ) highlighted that JETREA ® is superior to placebo in resolving VMA and related vitreomacular traction (VMT)
  • ThromboGenics is on target to build a first-class US commercial organization to launch JETREA in January 2013
  • The JETREA ® Marketing Authorisation Application (MAA) is under review in Europe by the EMA; a CHMP opinion is expected in January 2013. A positive opinion would pave the way for EU approval in March 2013

Corporate

  • In March, ThromboGenics signed an important strategic deal with Alcon, the global leader in eye care, for the commercialization of JETREA ® outside the U.S. ThromboGenics will receive up to €375 million in upfront and milestone payments plus royalties that will give it an important share of the economics from JETREA's sales outside the U.S.
  • On October 30, ThromboGenics hosted a Capital Markets Day in Brussels for investors and analysts

Financial

  • In March, ThromboGenics raised €77.8 million in a private placement
  • In June, the Belgian tax authorities granted the Company a positive ruling enabling it to benefit from the application of the Belgian patent income deduction regime in conjunction with the existing deduction carry forwards of ThromboGenics NV
  • ThromboGenics had €168.6 million in cash and cash investments as of 30 September 2012, compared with €88.3 million at the end of September 2011
  • The Company reported revenues of €75.1 million in the first nine months of 2012 versus €2.5 million in the first nine months of 2011. The revenues in 2012 are almost entirely due to the upfront payment from Alcon

Dr. Patrik De Haes, CEO of ThromboGenics, said: "The FDA's approval of JETREA ®, the first pharmacological treatment for symptomatic Vitreomacular Adhesion (VMA) in the U.S., is a transformational event for ThromboGenics and our shareholders.

"We are making excellent progress in building our U.S. commercial organization and I am sure that we will have a first-class team in place to launch JETREA ® in January 2013. We are also encouraged by the high level of awareness of symptomatic VMA and the clinical data that we have generated with JETREA ®.

"We are confident that the launch of JETREA ® will be successful in the US. I believe the U.S. retina community and thousands of patients suffering with symptomatic VMA will welcome JETREA ® as the first pharmacological treatment option for this progressive sight threatening condition whose only current treatment option is surgery."

For the full report, please go to  http://www.thrombogenics.com .

About  JETREA ®   (ocriplasmin)

JETREA ® is a truncated form of human plasmin that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of symptomatic VMA. JETREA ® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.

JETREA ® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.

JETREA ® 's Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA ® was generally well tolerated with most adverse events being transient and mild in severity.

About ThromboGenics

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