ThromboGenics NV has announced that its partner Alcon has launched JETREA® in Germany, the second European market where the product is now available.
Since May 1st, 2013, JETREA® is listed in the "Lauer-Taxe" (Große Deutsche Spezialitätentaxe) with an ex-factory price of €3,078.
In mid-March 2013, JETREA® was approved by the European Commission (EC) for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
Today’s kick off in Germany’s private and public market follows Alcon’s first European launch of JETREA® which took place in the UK last 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 has launched JETREA® in the US in mid-January 2013 where it is approved for the treatment of patients with symptomatic vitreomacular adhesion (VMA).
Dr Patrik De Haes, CEO of ThromboGenics, says: “We are very excited to see that JETREA® has quickly become available as a privately and publicly reimbursed drug in Germany. Today’s launch by Alcon in Germany is a key step in making this exciting new pharmacological treatment for VMT available to more patients in Europe.”
JETREA® contains the active substance ocriplasmin. It is administered through a one-time, 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 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 vitreous and 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 lightsensitive layer at the back of the eye).
It is estimated that 250,000 to 300,000 patients in Europe alone suffer from this condition.
Prof. Albert Augustin, Ophthalmology Department Head at Klinikum Karlsruhe, said: The introduction of JETREA® into Germany represents a significant advancement in the way retina specialist can treat vitreomacular traction and certain stages of macular holes. These vision-threatening conditions, associated with many common retinal disorders, are more frequently identified due to the advancement of new ophthalmic diagnostics, optical coherence tomography, and had been previously addressed by the limited options of either physician observation or vitrectomy. JETREA® now offers a new and effective treatment option, particularly for those patients whose conditions are not yet advanced enough to warrant surgery, to help physicians restore patient´s vision and improve overall quality of life.”
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.
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.
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.