Germany's IQWiG Confirms That ThromboGenics' JETREA® Demonstrates Major Added Value for the Treatment of Vitreomacular Traction and Macular Hole

LEUVEN, Belgium, August 2, 2013 /PRNewswire/ --

ThromboGenics NV (Euronext Brussels: THR) a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces today that the German Institute for Quality and Efficiency in Health Care (IQWiG) has confirmed that JETREA^® (ocriplasmin) demonstrates major / significant added value in VMT patients with mild / moderately severe symptoms compared with existing comparative treatment, when treating vitreomacular traction (VMT) including when associated with a macular hole of less than or equal to 400 microns.

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. It was approved for this indication in the European Union in March 2013. Partner Alcon launched the drug in Germany at the beginning of May.

There are no other pharmacological treatments in development for VMT. Currently patients either have to watch and wait before they are considered eligible for surgery. Surgery is typically performed only at a later stage of a patient's disease, once symptoms progress and their sight deteriorates significantly.  

IQWiG is an independent federal organization that evaluates a drug's quality and efficiency, which makes a recommendation to the Federal Joint Committee (G-BA). G-BA is expected to issue final guidance on JETREA^® in mid-October 2013.

IQWiG recognizes that the data submitted by ThromboGenics in the course of the value assessment provides an indication (Hinweis) for a major added value for VMT patients with mild symptoms and a significant added value for patients with moderately severe symptoms. Since the introduction of the Early Benefit Assessment in Germany in January 2011, this is the very first time that IQWiG confirms an indication for a major added value (Hinweis auf einen erheblichen Zusatznutzen) for an innovative new drug substance.

Dr Patrik De Haes, CEO of ThromboGenics, said: "IQWiG's assessment confirming the significant additional benefits of JETREA^®for VMT validates the importance of our novel drug in treating patients with this major sight-threatening disease.  For the first time, patients can be treated at an earlier stage of their disease, rather than having to watch and wait until their symptoms worsen. We, and our partner Alcon, look forward to working with G-BA to ensure that the positive benefits shown by JETREA^®are reflected in its final guidance."  

Earlier this year, JETREA^® was classified as a breakthrough innovation, the highest rating in the so-called 'Fricke and Klaus' assessment¹. This assessment evaluates how innovative the mechanism of action of a new medicine is compared to existing therapies available in Germany.

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).    

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. German pharmaceutical journal PZ online

^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
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 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