Health Canada Approves ThromboGenics' JETREA® for the Treatment of Symptomatic Vitreomacular Adhesion
LEUVEN, Belgium, August 16, 2013 /PRNewswire/ --
Canada is first market outside the US and Europe where JETREA® is approved
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that Health Canada has approved JETREA® (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA). The priority review of the New Drug Submission for JETREA in Canada was conducted within 180 calendar days. Canada is the first market where JETREA® is approved outside the US and Europe. ThromboGenics' partner Alcon holds the commercialization rights to JETREA® outside the US and will be responsible for the launch of the drug in Canada.
Alcon, a division of Novartis, acquired the rights to commercialize JETREA® outside the United States in March 2012. It launched the drug in the UK, its first European market, in April, followed by launches in Germany, Denmark, Finland, Norway and Sweden.
ThromboGenics is commercializing the drug in the US and 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: "The Priority Review approval of JETREA® in Canada, the first market outside the US and Europe, is further evidence that all stakeholders are committed to making this first pharmacological drug available quickly to as many patients as possible. Symptomatic VMA is increasingly being recognized as an important sight-threatening condition that can lead to distorted vision, and even central blindness. Canada is an important market and we are confident that the Alcon Canada team will be able to grasp this opportunity. We are looking forward to announcing further approvals of JETREA® in other markets shortly."
JETREA® contains the active substance ocriplasmin. It is administered through a one-time, single intravitreal injection to treat adults with vitreomacular traction (VMT).
Symptomatic VMA is an age-related progressive, sight-threatening condition. It is caused by the vitreous 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 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. 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 symptomatic VMA has progressed and caused a small hole in the macula (central part of the light-sensitive layer at the back of the eye).
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 support the regulatory activities and help develop the necessary infrastructure so that patients can access this innovative medicine and receive JETREA® as soon as it becomes available in the respective countries outside US.
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.
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.
Alcon has launched JETREA® in the UK, Germany, Denmark, Finland, Norway 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.
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. Dugel PU, Brown DM, Humayun MS et al. Symptomatic vitreomacular adhesion: diagnosis, pathologic implications, and management. Retina Today 2011;(Suppl):1-14
For further information please contact:
Wouter Piepers, Global Head of Corporate Communications
+32-16-75-13-10 / +32-478-33-56-32
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
The Trout Group (US investor relations)
Todd James/ Simon Harnest