FDA: ThromboGenics NV Main Drug Cleared for U.S. Launch
Published: Oct 18, 2012
JETREA® is the first pharmacological agent approved for the treatment of symptomatic VMA
Conference call scheduled today at 15.00 CET (9.00 ET).
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announced today that the U.S. Food and Drug Administration (FDA) has approved JETREA® (ocriplasmin) in the USA for the treatment of symptomatic VMA, a progressive sight threatening condition. JETREA® is the first pharmacological agent to be approved for this indication.
The recommended dose of JETREA® is 0.125mg (0.1mL) of the diluted solution administered by intravitreal injection to the affected eye once as a single injection. JETREA® is provided as a single use glass vial containing 0.5 mg in 0.2mL solution for intravitreal injection (2.5 mg/mL).
Dr. Patrik De Haes, CEO of ThromboGenics, said: "Today's FDA approval of JETREA® is a major milestone for the Company. We are extremely pleased that we will be able to meet a major unmet clinical need in ophthalmology when we make JETREA®, the first pharmacological agent for symptomatic VMA, available to the many thousands of U.S. patients who could benefit from treatment of this progressive, sight-threatening condition. We are continuing to prepare for the planned launch of JETREA® in January 2013 through our own U.S. commercial organization. This is the biggest step in transforming ThromboGenics into a profitable biopharmaceutical company developing and commercializing innovative ophthalmic medicines."
The approval was based on the data from ThromboGenics' Phase III program where JETREA® was shown to be superior to placebo for the treatment of symptomatic VMA (26.5% versus 10.1%; p<0.01). Treatment with JETREA® was associated with some, mainly transient, ocular adverse events.
Important safety and prescribing information about JETREA®is now available at http://www.jetrea.com.
Prof. Désiré Collen, ThromboGenics' Chairman, said: "Just over a decade ago research with autologous plasmin suggested that JETREA®, a proteolytic enzyme, could play an important role in the treatment of retinal disease. Since then ThromboGenics has successfully developed JETREA®, with the support of our shareholders and a range of collaborators, resulting in today's US approval. ThromboGenics' decision to commercialize JETREA® in the US through its own organization means that we are now in a position to maximize returns for all of our stakeholders by successfully launching this exciting innovative product."
Dr David Boyer, Clinical Professor of Ophthalmology, affiliated with USC/Keck School of Medicine, California and leading investigator during ThromboGenics' clinical trials, stated: "JETREA® represents a major breakthrough for retinal specialists and their patients with symptomatic VMA. For the first time, we have a pharmacological treatment option available for many patients who would normally only be considered surgical candidates, and that is very exciting. JETREA® represents a paradigm shift in clinical practice for the global retina community and a less invasive procedure for their patients."
Symptomatic VMA is a progressive condition that if left untreated frequently leads to retinal distortion, further deterioration in vision and has the potential to cause irreversible damage and complications. Market surveys conducted by ThromboGenics suggest that there are approximately 500,000 patients annually in the U.S. and the major markets of the EU who could potentially benefit from JETREA®.
A conference call for analysts, press and investors will be hosted by Dr Patrik De Haes, CEO of ThromboGenics, and Chris Buyse, CFO of ThromboGenics, today at 15.00 CET (9.00 ET).
The dial-in numbers and Participant Passcode for the call are set out below:
Belgium 0800-746-68 (Toll Free)
France 0805-630061 (Toll Free)
Germany 0800-673-7932 (Toll Free)
Ireland 01436-0959/ 1-800-930-488 (Toll Free)
Netherlands 0800-022-9132 (Toll Free)
UK +44(0)20-3003-2666/ 0808-109-0700 (Toll Free)
USA 1-866-966-5335 (Toll Free)
Participant Passcode: 4871136
We request that participants dial in 5-10 minutes prior to the start time of 15:00 CET (09:00 ET). There will be a replay of the call available shortly after the call which will be accessible for seven days. Click here for international replay numbers followed by the Access Pin 4871136.
About JETREA® ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of symptomatic VMA. 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 medicines. The Company's lead product, JETREA®(ocriplasmin), has been approved by the FDA for the treatment of symptomatic VMA. ThromboGenics has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic VMA, sometimes referred to as Vitreomacular Traction (VMT). The Marketing Authorisation Application (MAA) for ocriplasmin is under review in Europe.
In March 2012, 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®. Upon approval and commercialization outside the U.S. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), formerly referred to as TB-403, for the treatment of ophthalmic 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:
Wouter Piepers, Global 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
Todd James/ Simon Harnest