ThromboGenics' JETREA® Nominated for 2013 Prix Galien USA

LEUVEN, Belgium, October 21, 2013 /PRNewswire/ --

ThromboGenics NV (Euronext Brussels: THR) a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces today that JETREA^® (ocriplasmin) is nominated for the 2013 Prix Galien USA Award in the Best Biotechnology Product category.

The Prix Galien USA, now in its seventh year, is an international award that recognizes outstanding achievements in improving human health through the development of innovative therapies. The winner is selected by a committee of nine experts in the biomedical industry and academia, including five Nobel Laureates.

JETREA^® is the first and only pharmacological drug approved by the US Food and Drug Administration for the treatment of symptomatic vitreomacular adhesion (VMA). ThromboGenics launched the drug in the US in mid-January 2013. The Company employs 100 people in the US, including 35 operating from its US office in Iselin, New Jersey.

JETREA^® was approved in the European Union in March 2013. Partner Alcon, a division of Novartis, launched the drug in the UK, its first market in Europe, in April, and is rolling out the drug across Europe. Alcon acquired the rights to commercialize JETREA^® outside the United States in March 2012.

Dr Patrik De Haes, CEO of ThromboGenics, said: "We are extremely proud that JETREA^® has been nominated for such a prestigious award. JETREA^® is the first pharmacological drug for the sight-threatening condition symptomatic VMA/VMT, and for the first time may allow treatment for earlier stage of the disease and prevent vision from deteriorating further. ThromboGenics is committed to working with the global retina community to ensure that as many patients as possible can benefit from this innovative drug."

JETREA^® contains the active substance ocriplasmin. It is administered through a single intravitreal injection to treat adults with symptomatic VMA.

Symptomatic VMA 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 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.

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

It is estimated that around 500,000 patients in the US and five biggest markets in Europe alone suffer from this condition.^[1]      

There are no other pharmacological treatments available for symptomatic VMA. The current approach is '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]

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, Germany, Denmark, Norway, Finland and Sweden.  

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
[email protected]

Dr. Patrik De Haes, CEO
+32-16-75-13-10
[email protected]

Chris Buyse, CFO
+32-16-75-13-10
[email protected]

Citigate Dewe Rogerson
David Dible/ Sita Shah
Tel: +44-20-7638-9571  
[email protected]

The Trout Group (US investor relations)
Todd James/ Simon Harnest
Tel: +1-646-378-2926
[email protected]

SOURCE ThromboGenics NV