FDA Advisory Committee Recommends ThromboGenics' Ocriplasmin for the Treatment of Symptomatic Vitreomacular Adhesion (VMA)
LEUVEN, Belgium, July 27, 2012 /PRNewswire/ --
- ThromboGenics to hold conference call to discuss the panel recommendation
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grant ocriplasmin approval for the treatment of symptomatic Vitreomacular Adhesion (VMA). The Committee voted 10 to 0 at its meeting held yesterday that the benefits of administering ocriplasmin for the treatment of vitreomacular adhesions outweigh the potential risks.
The recommendation of the Advisory Committee will form part of the FDA's overall assessment of the ocriplasmin Biologics License Application (BLA). The FDA has assigned the ocriplasmin BLA a Prescription Drug User Fee Act (PDUFA) goal date of 17 October, 2012.
Dr Patrik De Haes, ThromboGenics' CEO, said: "We are pleased that the Advisory Committee has made a positive recommendation supporting the approval of ocriplasmin for the treatment of symptomatic VMA. We will continue to work with the FDA as it completes its assessment of the ocriplasmin BLA. Symptomatic VMA is an area of unmet medical need and ThromboGenics is looking forward to making this novel treatment option available to the many patients in the U.S. who could benefit."
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 in the U.S. and the major markets of the EU who could potentially benefit from ocriplasmin annually. If approved, ocriplasmin will be the first pharmacological treatment for symptomatic VMA.
A conference call for analysts, press and investors will be hosted by Dr Patrik De Haes, CEO of ThromboGenics, on Friday, 27 July at 15:00 CET (09:00 ET).
The dial-in numbers and Participant Passcode for the call are set out below:
Belgium +32-27-920-435 / 0800-74656 (Toll Free) UK +44(0)20-3003-2666 / 0808-109-0700 (Toll Free) USA +1-866-966-5335 (Toll Free) Participant Passcode: 7290677
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 7290677.
For further information please contact:
ThromboGenics Dr. Patrik De Haes, CEO Tel: +32-16-75-13-10 email@example.com Chris Buyse, CFO Tel: +32-16-75-13-10 firstname.lastname@example.org Citigate Dewe Rogerson David Dible/ Nina Enegren/ Sita Shah Tel: +44-20-7638-9571 email@example.com The Trout Group Todd James/ Simon Harnest Tel: +1-646-378-2926 firstname.lastname@example.org
ThromboGenics is a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company's lead product, ocriplasmin, has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic Vitreomacular Adhesion (VMA), otherwise termed Vitreomacular Traction (VMT). The MAA for ocriplasmin has been accepted for review in Europe and in the U.S. the FDA has accepted the BLA filing and granted it Priority Review. A FDA Advisory Committee has recommended the approval of ocriplasmin for the treatment of symptomatic Vitreomacular Adhesion (VMA),
In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States. Under this agreement,
ThromboGenics could receive up to a total of €375 million in up-front and milestone payments, plus an attractive level of royalties on Alcon's net sales of ocriplasmin. ThromboGenics and Alcon intend to share the costs equally of developing ocriplasmin for a number of new vitreoretinal indications.
ThromboGenics is also developing TB-403, a novel antibody therapeutic, in collaboration with BioInvent International, for cancer and non-cancer, including ophthalmology, indications.
ThromboGenics is headquartered in Leuven, Belgium. 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.
SOURCE ThromboGenics NV