REGULATED INFORMATION
JETREA ® in the US
- US sales of JETREA ® were €20.2 million in 2013, with close to 7000 patients treated
- In the second half of 2013, the Company recalibrated its US organization in order to focus on establishing JETREA ® as an earlier treatment for patients with symptomatic vitreomacular adhesion (VMA)
- Permanent J-Code in place from 1 Jan 2014 will streamline reimbursement
JETREA ® ex-US
- EC approval of JETREA ® in March for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns
- ThromboGenics received a total of €90 million in milestone payments from Alcon following the approval and first launch of JETREA ® in Europe
- Positive reimbursement decisions in UK, Germany and France - highlighted JETREA's benefits in treating patients with VMT earlier
- Canada approval for the treatment of symptomatic vitreomacular adhesion, and commercial launch
- Alcon/Novartis announced that Novartis Pharmaceuticals (Lucentis) and Alcon teams will collaborate on the joint promotion of JETREA ® from early 2014
Corporate
- Dr Staf Van Reet appointed ThromboGenics' Chairman following the Company's Founder Prof Désiré Collen's decision to retire and step down from the Board in December 2013
- ThromboGenics appointed Dr David Guyer to its Board of Directors in December 2013
- In February 2014, the Board of ThromboGenics decided to explore strategic options for the Company. This decision is intended to increase the Company's ability to realize the significant commercial potential of JETREA ® in the US, and to fully capitalize on the Company's proven product development capabilities. Morgan Stanley is advising on the strategic review.
Financial
- Cash of €172.4 million at the end of December 2013 compared to €148.2 million as of end December 2012
- Revenues of €112.8 million in 2013
- Net income of €26.4 million in 2013
Leuven, Belgium, March 17, 2014 (GLOBE NEWSWIRE) -- ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today issued a business update and its financial results for the full year ending 31 December 2013.
ThromboGenics has developed JETREA ® , the first and only pharmacological treatment indicated for an important sight-threatening condition, symptomatic vitreomacular adhesion (VMA)/ vitreomacular traction (VMT) as known in the US and Europe respectively. Symptomatic VMA/VMT is a progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness.
In mid-January 2013, ThromboGenics launched JETREA ® in the US through its own commercial organization. To-date sales of the product have developed more slowly than anticipated despite market research showing a high level of awareness of the product amongst the US retina community.
In Europe JETREA ® was approved by the European Commission (EC) in March 2013 for the treatment of vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. ThromboGenics, in conjunction with its partner Alcon has focused on establishing a strong market access platform for this novel product. This has been achieved as a result of positive reimbursement decisions in the UK, Germany and France.
Alcon launched JETREA ® in the UK, the first launch market, followed by subsequent launches in key European markets. The EC approval and the first launch of JETREA ® resulted in ThromboGenics receiving a total of €90 million in milestones from Alcon.
In November, Novartis, Alcon's parent company, announced that the two organizations would work more closely to serve the retinal community outside the US. This decision reflects the significant potential of JETREA ® and augurs well for the product's sales development over the coming years.
Dr Patrik De Haes, ThromboGenics' CEO, said: "2013 has proved to be an important learning experience for ThromboGenics as the high awareness of JETREA ® amongst the retina community in the US has not resulted in the sales we had anticipated. Over the past 3 to 6 months, we have recalibrated our US organization so that it can drive the adoption of JETREA ® for the earlier treatment of patients with symptomatic VMA. Our market research has shown that this is a sizable market as retina specialists look to treat before patients experience deterioration in their condition.
"In Europe, in conjunction with our partner Alcon, we have created a strong reimbursement platform for JETREA ® following positive decisions in the UK, Germany and France. With Alcon now working together with Novartis, the right resources and expertise are now in place to build the sales of JETREA ® outside the US.
"The recent Board decision to explore strategic options is designed to realize what we continue to believe is the significant commercial potential of JETREA ® . While the strategic review process is taking place we will continue to work to ensure that the many patients with symptomatic VMA have access to this novel pharmacological treatment option."
For the full report, please visit www.thrombogenics.com .
For further information please contact:
| ThromboGenics Wouter Piepers, Global Head of Corporate Communications +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 <= 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. Any adverse reactions were ocular. The most commonly reported were vitreous floaters, eye pain and photopsia, as well as conjunctival haemorrhage resulting from the injection procedure. Most of the adverse reactions occurred within the first week after the injection. The majority of these reactions was non-serious, mild in intensity and resolved within 2 to 3 weeks. 1
1 Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med 2012;367:606-615
About ThromboGenics
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 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.
In Europe, JETREA ® is approved for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
Alcon has launched JETREA ® in the UK, Germany, the Nordic Region, Benelux and Canada.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403.
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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