Germany's G-BA Confirms That ThromboGenics' JETREA® Demonstrates Significant Therapeutic Benefits for Vitreomacular Traction (VMT) Patients, Including When Associated With Macular Hole

LEUVEN, Belgium, October 17, 2013 /PRNewswire/ --

Decision confirms therapeutic benefits for treatment of VMT patients suffering from mild and moderate symptoms, or 94% of the indicated VMT population

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces today that the Final Early Benefit Assessment from the German Federal Joint Committee (G-BA) has concluded that JETREA^® (ocriplasmin) demonstrates significant added benefit for VMT patients with mild and moderate symptoms when compared with existing comparative treatment (watchful waiting). The mild to moderate VMT population, as referred to by G-BA in its final assessment, represents the vast majority (94%) of the total patient population covered by the approved label.

G-BA is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany.  Since the introduction of the early benefit assessment procedure in Germany in January 2011, G-BA has assessed more than sixty innovative new drugs. JETREA^® is to-date one of only six innovative medicines appraised by G-BA to provide significant additional therapeutic benefits for patients.

'Significant' demonstrates a sustained and large improvement in the therapy-relevant benefit. In its assessment, G-BA particularly considered the potential improvement in visual acuity and the avoidance of surgery in the back of the eye by JETREA^® as beneficial for patients.

G-BA's final guidance confirms the recommendation made by the German Institute for Quality and Efficiency in Health Care (IQWiG) in August 2013. IQWiG is an independent federal organization that evaluates a drug's quality and efficiency and makes recommendations to G-BA.

"Given the low risk profile of the injection, it is now possible to intervene in patients with VMT at a very early stage", says Prof. Dr. Anselm Kampik, Director of the eye clinic of the University of Munich (LMU). "Many early stage patients still have a good visual function which, with a timely intervention, can be preserved, or even improved. So a better functional outcome can be expected, than when only treating the patient after a period of watchful waiting."

Dr Patrik De Haes, CEO of ThromboGenics, said: "The confirmation from G-BA that JETREA^® represents a significant value treatment for patients with mild VMT is a very positive development. For the first time, patients can be treated early, meaning that they can avoid the adverse consequences of the current watch and wait approach. With the NICE FAD in the UK also supporting the use of JETREA^® in patients with the early symptoms of VMT such as metamorphopsia, our partner Alcon now has a solid platform to start building the European sales of this innovative new drug in the largest population of VMT patients."  

JETREA^® is the first pharmacological treatment indicated for use in patients diagnosed with VMT, also when associated with macular hole of diameter less than or equal to 400 microns. It was approved for this indication in the European Union in March 2013. ThromboGenics' commercial partner Alcon launched the drug in Germany at the beginning of May.

There are no other pharmacological treatments available for this condition. At present, patients 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.  

JETREA^® contains the active substance ocriplasmin. It is administered through a single intravitreal injection to treat adults with 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 disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).

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.^[1],[2] 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.^[3],[4]

References

^[1]. Idiopathic macular hole. American Academy of Ophthalmology; 2008

^[2]. Stalmans P. Management and intervention strategies for symptomatic vitreomacular adhesions.  Retinal Physician 2011

^[3]. Koerner F & Garweg J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc Ophthalmol 1999;97:449-458

^[4]. 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.

About German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA)

The Federal Joint Committee (G-BA) is the supreme decision-making body of the so-called self-governing system in Germany. Physicians, dentists, hospitals, sickness funds and patients are represented in the G-BA. The G-BA issues directives and thus determines the benefit package of the statutory health insurance (GKV) covering about 70 million people. Finally, the G-BA is responsible for reimbursement decisions in the GKV. The directives issued by the G-BA are legally binding for insured people as well as for the providers and payers of health care: physicians, hospitals and sickness funds. They are valid for ambulatory treatment, dentistry, hospital care and psychotherapy. Furthermore, the directives define the provision and reimbursement of pharmaceuticals, diagnostic and therapeutic procedures, medical devices and non-medical treatment. In addition, the G-BA has responsibilities regarding quality assurance measures for in- and out-patient care.

About Alcon

Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. The three Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the widest spectrum of eye care products in the world. Alcon is the second largest division of the Novartis Group with sales of USD 10.2 billion in 2012. Headquartered in Fort Worth, Texas, USA, Alcon has more than 24,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, visit http://www.alcon.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