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ThromboGenics NV (TBGNF)' JETREA Receives Positive Recommendation From Scottish Medicines Consortium (SMC)



8/11/2014 10:53:02 AM

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LEUVEN, Belgium, Aug. 11, 2014 (GLOBE NEWSWIRE) -- ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that the Scottish Medicines Consortium (SMC) has issued a positive recommendation for the use of JETREA® (ocriplasmin) for the treatment of adults with vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.1

Today's positive recommendation represents a reversal of the original SMC decision made in August 2013 and results from the submission of further data highlighting the economic value of JETREA® when used to treat adults with VMT, a progressive sight-threatening condition that can lead to the loss of central vision, distorted vision, and blindness.

Until recently, the clinical approach has been 'watch and wait' or monitoring of VMT patients, meaning patients must undergo a period of observation before they become eligible for vitrectomy surgery.2,3 Due to potential complications, vitrectomy is mostly performed at later stages of the disease, often with macular hole, when patients have advanced symptoms and any lost vision may not be fully recovered.4,5 Therefore, monitoring of VMT patients can be risky, as it may lead to disease progression, and in some cases, irreversible vision loss or damage to the retina.

Dr Patrik De Haes, CEO of ThromboGenics, says: "The SMC's decision to now recommend the use and reimbursement of JETREA® follows earlier positive assessments and reimbursement decisions in a range of countries, both in Europe and globally . We are pleased that our market access activities are providing such a strong platform for the roll out of JETREA® across Europe, and we trust that this reimbursement support will in time allow the broad use of this novel medicine for the treatment of patients with VMT."

JETREA® is the first pharmacological treatment for this indication and was approved by the European Commission in the European Union in March 2013.

ThromboGenics' partner Alcon holds the commercialization rights to JETREA® outside the US and is responsible for the marketing of JETREA® in Scotland.

Ends

References:
1. Scottish Medicine Consortium, https://www.scottishmedicines.org.uk, August 2014.
2. Carpineto P, Di Antonio L, Aharrh-Gnama A, et al. Diagnosing and Treating Vitreomacular Adhesion. Retina 2011 69-73.
3. Hikichi T, Yoshida A, Trempe C. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1):55-61
4. Bottós, Juliana, et al. Vitreomacular Traction Syndrome. Journal of Opthalmalic and Vision Research. 2012;7(2):148-161.
5. Johnson MW. Perifoveal vitreous detachment and its macular complications. Trans Am Ophthalmol Soc. 2005;103:537-567.

For further information please contact:

ThromboGenics

Wouter Piepers,
Global Head of Corporate Communications / IR
+32 16 75 13 10 / +32 478 33 56 32
wouter.piepers@thrombogenics.com
Citigate Dewe Rogerson

David Dible/ Sita Shah

Tel: +44 20 7638 9571
sita.shah@citigatedr.co.uk

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 less than or equal to 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, a division of Novartis, for the commercialization of JETREA® outside the United States.

ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403, for the treatment of 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 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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