ThromboGenics: business update

Leuven, Belgium, November 3, 2011 – ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today issued a business update and its nine-month financial results ending 30 September, 2011.

Highlights (including post-period events)

Ocriplasmin

  • European Medicines Agency (EMA) accepts for review the ocriplasmin Marketing Authorisation Application (MAA) for treatment of symptomatic vitreomacular adhesion (VMA) including macular hole
  • Preparation of U.S. ocriplasmin filing with the FDA is on target and submission is planned before the end of 2011
  • Leading retina specialists present ocriplasmin Phase III data, including responder analysis, at the American Academy of Ophthalmology (AAO), the world’s largest ophthalmology conference. Ocriplasmin featured as the opening talk in the first scientific session of the Retina Subspecialty Day and also in Best of the Posterior Segment Specialty Meetings

Antibody candidates

  • Recruitment progressing well in a 600-patient Phase IIb trial with TB-402 (anti-Factor VIII antibody) for the prevention of venous thromboembolism (VTE) after total hip replacement surgery
  • Our partner Roche has started patient recruitment into two Phase Ib/II trials with the novel human anticancer antibody TB-403 (anti-PIGF)

Financial

  • €88.3 million in cash and cash investments as of 30 September 2011, compared with €59.1 million at the end of September 2010
  • Reported revenues of €2.5 million in the first nine months of 2011 versus €6.1 million in the first nine months of 2010

Dr Patrik De Haes, CEO of ThromboGenics, commenting on today’s update said: “We are delighted that the EMA has accepted the European Marketing Authorisation Application for ocriplasmin for review. We are now focused on filing the Biologics License Application (BLA) with the FDA before the end of the year. If approved, ocriplasmin would be the first pharmacological treatment for symptomatic VMA including macular hole. This would be a major advance in treating a condition that can only currently be treated with surgery, usually after the patient’s sight has deteriorated significantly.”

“We are extremely encouraged by the growing interest in ocriplasmin among the retina community in the USA and Europe, as physicians recognize the advantages of having a pharmacological option to treat this progressive retinal condition earlier. The growing advocacy, combined with the growing momentum of our commercial activities, gives me confidence that our ocriplasmin-based ophthalmic strategy will deliver value for the company and its shareholders, as well as important clinical benefits for retina specialists and patients.”

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