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ThromboGenics NV (TBGNF)' JETREA® Receives Positive Initial National Institute for Clinical Excellence (NICE) Recommendation for Vitreomacular Traction and Macular Hole


6/12/2013 9:03:26 AM

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LEUVEN, Belgium, June 12, 2013 /PRNewswire/ -- ThromboGenics NV (Euronext Brussels: THR) a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces today that the UK's National Institute for Health and Care Excellence (NICE) has provisionally recommended JETREA® (ocriplasmin) for reimbursement within the National Health Service (NHS). The NICE Appraisal Consultation Document (ACD) initially recommends JETREA® as an option for treating vitreomacular traction (VMT) in adults, including when associated with a macular hole of less than or equal to 400 microns, when patients have severe symptoms and an epiretinal membrane is not present.

JETREA® is the first pharmacological treatment indicated for use in patients diagnosed with VMT and macular hole of diameter less than or equal to 400 microns and was approved in the European Union by the European Commission in March 2013. Partner Alcon launched the drug in the UK, its first market in Europe, in April, resulting in ThromboGenics receiving €90 million in milestone payments. Alcon, a division of Novartis, acquired the rights to commercialize JETREA® outside the United States in March 2012.

The NICE appraisal committee considers evidence submitted by the manufacturer and makes a judgment on whether or not the technology should be recommended as a clinically and cost-effective use of NHS resources, or whether it should only be recommended for specific subgroups of patients. This process also takes into account testimony from clinical experts, patient groups and carers.

After publication of the ACD, NICE invites formal consultees, commentators and the general public to comment on the ACD. After considering these comments, the Committee then finalizes its recommendations and submits them to NICE in the form of a Final Appraisal Determination (FAD). The final NICE guidance on JETREA® is expected in the third quarter of 2013.

Dr Patrik De Haes, CEO of ThromboGenics, said: "We are delighted by the preliminary NICE recommendation for JETREA®, the first and only pharmacological treatment licensed for VMT and macular hole. The Institute has concluded that treatment with JETREA® early in the course of the disease represents a step-change in how patients with VMT are currently managed, preserving visual function and quality of life for patients with this distressing, sight-threatening condition. We particularly welcome NICE's endorsement that JETREA® is a cost-effective use of finite NHS resources, and represents good value for money in the patients in whom it is recommended."

"People affected by VMT and macular hole can suffer significant vision distortion that can make it difficult for them to read, watch TV and drive. The draft NICE recommendation published today is important in improving their treatment options. For suitable patients it offers a simple treatment that may avoid the need for eye surgery, and means patients unsuited to surgery can now be treated, often before their condition deteriorates," said Mr Tim Jackson, Consultant Retinal Surgeon at King's College Hospital.

JETREA® contains the active substance ocriplasmin. It is administered through a single intravitreal injection to treat adults with vitreomacular traction (VMT).

VMT is a progressive, sight-threatening condition. It is caused by the vitreous humour having an abnormally strong attachment to the macula, the central part of the retina (the light sensitive membrane at the back of the eye). The macula provides central vision that is needed for everyday tasks such as driving, reading and recognizing faces.

When the vitreous humor shrinks, the strong attachment results in a pulling force on the retina, which may lead to visual distortion, decreased visual acuity and central blindness. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).

JETREA® breaks down the protein fibers which cause the abnormal traction between the vitreous and the macula that causes VMT. By dissolving these proteins, JETREA® releases the traction, and helps to complete the detachment of the vitreous from the macula.

JETREA® can also be used when VMT has progressed and caused a small hole in the macula (central part of the light-sensitive layer at the back of the eye).

It is estimated that 250,000 to 300,000 patients in Europe alone suffer from this condition.[1]

The current approach in the EU is 'observation', 'watchful waiting' or 'watch and wait' until a patient becomes a candidate for surgical treatment, usually at a late stage of the disease.[2],[3] A patient would then receive a surgical procedure and repair of the retina. However, for many patients this is not a suitable option, as irreversible damage to the retina may have already occurred.[4],[5]

ThromboGenics is continuing to work closely with Alcon to ensure patients across Europe and rest of the world can access this innovative medicine and receive JETREA® as soon as it becomes available in the respective countries. References
[1]. ThromboGenics and Alcon internal estimates
[2]. Idiopathic macular hole. American Academy of Ophthalmology; 2008
[3]. Stalmans P. Management and intervention strategies for symptomatic vitreomacular adhesions. Retinal Physician 2011
[4]. Koerner F & Garweg J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc Ophthalmol 1999;97:449-458
[5]. Dugel PU, Brown DM, Humayun MS et al. Symptomatic vitreomacular adhesion: diagnosis, pathologic implications, and management. Retina Today 2011;(Suppl):1-14

About JETREA® (ocriplasmin)

JETREA® (ocriplasmin) is a truncated form of human plasmin. In the US, JETREA® is indicated for the treatment of symptomatic VMA. In Europe, JETREA® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter = 400 microns. 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

ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic and oncology medicines. The Company's lead product, JETREA® (ocriplasmin), has been approved by the US FDA for the treatment of symptomatic VMA and was launched in January 2013.

ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of JETREA® outside the United States. Under this agreement, ThromboGenics could receive up to a total of €375 million in up-front and milestone payments. It will receive significant royalties from Alcon's net sales of JETREA®. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.

In Europe, JETREA® is approved for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. Alcon has launched JETREA® in the UK and Germany. ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403, for the treatment of ophthalmic and oncology indications.

ThromboGenics is headquartered in Leuven, Belgium, and has-offices in Iselin, NJ (US) and Dublin, Ireland. 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. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

For further information please contact:

Thrombogenics
Wouter Piepers, Global Head of Corporate Communications
+32-16-75-13-10 / +32-478-33-56-32
Wouter.piepers@thrombogenics.com

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

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

Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
Tel: +44(0)20-7638-9571
sita.shah@citigatedr.co.uk
The Trout Group (US investor relations)
Todd James/ Simon Harnest
Tel: +1-646-378-2926
tjames@troutgroup.com
SOURCE ThromboGenics

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