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ThromboGenics NV (TBGNF)' JETREA® Launched in Denmark and Sweden


5/28/2013 9:59:48 AM

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LEUVEN, Belgium, May 27, 2013 /PRNewswire/ --

Roll out in Finland and Norway to follow shortly

ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that its partner Alcon has launched JETREA® in Denmark and Sweden, the third and fourth European markets where the product is now available. Alcon will roll out the drug in Finland and Norway shortly.

In mid-March 2013, JETREA® was approved by the European Commission (EC) for the treatment of vitreomacular traction (VMT), including when associated with a macular hole of diameter less than or equal to 400 microns.

Alcon's first European launch of JETREA® took place in the UK last month, followed by Germany earlier this month. Alcon, a division of Novartis, acquired the rights to commercialize JETREA® outside the United States in March 2012.

Under the terms of this deal ThromboGenics has already received €165 million in upfront and milestone payments, including €90 million following EMA approval of JETREA® and first injection (UK) in patients. The company could receive a further €210 million in milestones plus significant royalties on Alcon's sales of JETREA®.

ThromboGenics launched JETREA® in the US in mid-January 2013 where it is approved for the treatment of patients with symptomatic vitreomacular adhesion (VMA). US sales since launch are in line with the Company's expectations.

Dr Patrik De Haes , CEO of ThromboGenics, says: "We are extremely encouraged by our partner Alcon's rapid progress in making JETREA® available across Europe. We look forward to further launches across the Nordic region and other countries to ensure that patients are able to have access to the first pharmacological treatment for VMT including when associated with a macular hole of diameter less than or equal to 400 microns."

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

VMT, which in the US is referred to as symptomatic VMA, is an age-related 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 humour 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]

Currently the only available treatment in the EU is 'observation' or 'watchful waiting' until a patient becomes a surgical candidate, 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 continues to work closely with Alcon to help develop the necessary infrastructure so that patients across Europe and beyond 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 a 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 a 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 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.

In March 2012, 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 a macular hole of diameter less than or equal to 400 microns. It has been launched by Alcon 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.

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