ThromboGenics Business Update

LEUVEN, Belgium, May 16, 2013 /PRNewswire/ --

  • JETREA® gaining acceptance from the US retina community. US sales through end of April 2013 have exceeded $10 million

  • Phase IIa study evaluating JETREA® in wet AMD patients shows 24% VMA resolution rate for JETREA® treated patients, versus 12% for sham injection. This positive trend and safety profile warrant further larger studies to confirm clinical benefits

  • Company Cash position: over €200 million

ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic and oncology medicines, today issued a business and financial update ending 30 April, 2013.

During 2013, ThromboGenics delivered a number of key corporate milestones, the most important of which was the launch of JETREA® (ocriplasmin) in the US on 14 January via its own commercial organization. ThromboGenics' partner outside the US, Alcon, launched JETREA® in the UK and Germany after its approval by the European Commission in March 2013. The EU approval and the launch of JETREA® in the UK led to ThromboGenics receiving two equal milestones from Alcon amounting to a total of €90 million.

Following these launches, patients and physicians in the US and the EU now have access to the first pharmacological treatment for the sight-threatening condition known as symptomatic vitreomacular adhesion (VMA)/ vitreomacular traction (VMT) respectively. The launches of JETREA® complete ThromboGenics' transformation into an integrated company with operations in R&D through to full-scale commercialization.  

ThromboGenics and Alcon are now focused on generating greater awareness of the drug and driving JETREA® adoption and revenues in the US and Europe.  

Highlights (including post-period events):

Commercializing JETREA®(ocriplasmin) in the US

  • JETREA® launched in the US on 14 January as the first pharmacological treatment for symptomatic vitreomacular adhesion (VMA)
  • Highly focused commercial team, including specialty sales force, now working to drive the US sales of JETREA®
  • In absence of J-code, reimbursement specialists educate physicians on ThromboGenics' comprehensive reimbursement support program to assist US physicians in gaining reimbursement for JETREA® and explaining relevant patient assistance programs
  • Code (reimbursement code) should be in place from 1 January 2014  - J-code will automate 'bill and payment' process for practices

Positive reaction to JETREA® from US retina community:

  • Sales of $10.2 million since the product's US launch through the end of April
  • 40% of total targeted retina practices have ordered JETREA®
  • 50% of these practices have reordered the product

Commercializing JETREA®in Europe and ROW

  • In March 2013, the European Medicines Agency (EMA) approved JETREA® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns
  • The EU approval led to ThromboGenics receiving a €45 million milestone payment from Alcon
  • Thrombogenics received a further €45 million payment from Alcon in April 2013 for the first order of JETREA® in Europe

JETREA®Phase IIa wet AMD trial reporting:

  • ThromboGenics today reports positive data from a Phase IIa study showing that JETREA® has potential to resolve VMA in patients with wet age-related macular degeneration (wAMD)
  • In the study, at Day 28 (primary endpoint, p=0.26), 24% of the treated patients achieved resolution compared to 12% in the sham injection arm
  • No unexpected safety issues were identified, and the safety profile is in keeping with the previous pivotal trial data
  • To confirm these clinical results, further larger studies to confirm clinical benefits are warranted

Financial Update

  • At the end of April 2013, the Company had a cash balance exceeding €200 million
  • In March, the Company's shares started trading as part of the BEL20 index on the Euronext stock exchange.

Dr Patrik De Haes, CEO of ThromboGenics, said: "The start of 2013 has been a very positive period for ThromboGenics with our lead product JETREA® being launched in the US and Europe. As a result, patients and physicians on both sides of the Atlantic now have access to the first pharmacological treatment for symptomatic VMA/VMT, an important sight-threatening condition. We are pleased with the positive reaction to JETREA® from the US retina community, and are confident that this momentum will continue.

"The EU approval of JETREA® and its recent launch in the UK and Germany triggered a total of €90 million in milestone payments from Alcon. These funds strengthen our financial position, and will allow us to invest further in the US commercialization of JETREA®, develop new indications for this novel medicine and expand our R&D pipeline. Over the next 12 months we expect to generate further shareholder value as the US sales of JETREA® continue to build and we receive royalties from Alcon as JETREA® continues to be rolled out across Europe."  

Ends

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]

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 (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 and Germany.  

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

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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  

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:

ThromboGenics

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

Dr. Patrik De Haes, CEO
+32-16-75-13-10
Patrik.dehaes@thrombogenics.com

Chris Buyse, CFO
+32-16-75-13-10
Chris.buyse@thrombogenics.com

Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
Tel: +44-20-7638-9571  
sita.shah@citigatedr.co.uk

The Trout Group (US investor relations)

Todd James/ Simon Harnest
Tel: +1-646-378-2926
tjames@troutgroup.com


SOURCE ThromboGenics NV




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