ThromboGenics Business Update
- In February, the Board of Directors 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® (ocriplasmin) in the US, and to fully capitalize on the Company's proven product development capabilities
- The strategic review is ongoing. An update will be provided in due course
- Cash of €156.9 million on hand at the end of March 2014, compared to €172.4 million at the end of December 2013
JETREA® in the US
- The Company's US organization continues to focus on establishing JETREA® as an earlier treatment for patients with symptomatic vitreomacular adhesion (VMA)
- New efficacy and safety data presented at The Association for Research in Vision and Ophthalmology (ARVO) in May 2014 highlighted real-world experience with JETREA®. These showed positive outcomes, and a safety profile in line with the Phase III clinical program
- 65 centers are now recruiting patients in the ORBIT (Ocriplasmin Research to Better Inform Treatment) Phase IV post marketing study
- A permanent J-Code for JETREA® has been in place since January 1 2014
The Transparency Commission of the French National Health Authority issued a positive opinion for the reimbursement and hospital listing of JETREA® by the French National Health Insurance in January
- In March, JETREA® was approved by Swissmedic for the treatment of adults with vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns
- In April, JETREA® was approved in Malaysia for the same indication, the product's first approval in Asia
Leuven, Belgium, May 22, 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 for the three month period ending 31 March 2014.
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.
ThromboGenics launched JETREA® in the US, in early 2013, through its own commercial organization.
In Europe, ThromboGenics, in conjunction with its partner Alcon, has focused on establishing a strong market access platform for this novel product. Good progress has been made as a result of positive reimbursement decisions in the UK, Germany and France, all of which highlighted the value of JETREA® for the earlier treatment of VMT.
Dr Patrik De Haes, ThromboGenics' CEO, said: "In the US our organization remains focused on changing clinical practice by driving the adoption of JETREA® for the earlier treatment of patients with symptomatic VMA. We have been encouraged by the real world data presented recently at ARVO which showed that with appropriate patient selection, JETREA® delivered better efficacy with a safety profile in-line with the drug's Phase III program.
"The strategic review process that we announced in February is ongoing. While this is taking place we are continuing to work towards our goal of ensuring that patients with symptomatic VMA receive earlier treatment with JETREA®."
For the full report please visit www.thrombogenics.com.
For further information please contact:
| ThromboGenics |
Global Head of Corporate Communications/ IR
+32 16 75 13 10 / +32 478 33 56 32
| Citigate Dewe Rogerson |
David Dible/ Sita Shah
Tel: +44 20 7638 9571
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.
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.
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.
ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of JETREA® outside the United States. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.
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.