22 May 2014 ThromboGenics Business Update
Corporate
• In February, the Board of Directors of ThromboGenics decided to explore strategic options for the Company. This decision is intended to increase the Company’s ability to realize the significant commercial potential of JETREA® (ocriplasmin) in the US, and to fully capitalize on the Company’s proven product development capabilities
• The strategic review is ongoing. An update will be provided in due course
Financial
• Cash of €156.9 million on hand at the end of March 2014, compared to €172.4 million at the end of December 2013
JETREA® in the US
• The Company’s US organization continues to focus on establishing JETREA® as an earlier treatment for patients with symptomatic vitreomacular adhesion (VMA)
• New efficacy and safety data presented at The Association for Research in Vision and Ophthalmology (ARVO) in May 2014 highlighted real-world experience with JETREA®. These showed positive outcomes, and a safety profile in line with the Phase III clinical program
• 65 centers are now recruiting patients in the ORBIT (Ocriplasmin Research to Better Inform Treatment) Phase IV post marketing study
• A permanent J-Code for JETREA® has been in place since January 1 2014
JETREA® ex-US
• The Transparency Commission of the French National Health Authority issued a positive opinion for the reimbursement and hospital listing of JETREA® by the French National Health Insurance in January
• In March, JETREA® was approved by Swissmedic for the treatment of adults with vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns
• In April, JETREA® was approved in Malaysia for the same indication, the product’s first approval in Asia
Leuven, Belgium – 22 May, 2014 - ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today issued a business update for the three month period ending 31 March 2014.
ThromboGenics has developed JETREA®, the first and only pharmacological treatment indicated for an important sight-threatening condition, symptomatic vitreomacular adhesion (VMA)/ vitreomacular traction (VMT) as known in the US and Europe respectively. Symptomatic VMA/VMT is a progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness.
ThromboGenics launched JETREA® in the US, in early 2013, through its own commercial organization.
In Europe, ThromboGenics, in conjunction with its partner Alcon, has focused on establishing a strong market access platform for this novel product. Good progress has been made as a result of positive reimbursement decisions in the UK, Germany and France, all of which highlighted the value of JETREA® for the earlier treatment of VMT.
Dr Patrik De Haes, ThromboGenics’ CEO, said: “In the US our organization remains focused on changing clinical practice by driving the adoption of JETREA® for the earlier treatment of patients with symptomatic VMA. We have been encouraged by the real world data presented recently at ARVO which showed that with appropriate patient selection, JETREA® delivered better efficacy with a safety profile in-line with the drug’s Phase III program.
“The strategic review process that we announced in February is ongoing. While this is taking place we are continuing to work towards our goal of ensuring that patients with symptomatic VMA receive earlier treatment with JETREA®.”
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