ThromboGenics NV has 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 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
• 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.”