ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, is today issuing a business update and its half year results for the six month period ending 30 June, 2009.
During 2009, ThromboGenics has continued to focus on the activities which are key to its aim of becoming a profitable, integrated company focused on cutting edge ophthalmic medicines. Central to this plan is the Company's lead product, microplasmin, which is in Phase III trials for the treatment of back of the eye disease. Patient recruitment in this Phase III program is running smoothly and the Company expects to report the first results from these studies by mid 2010.
The clinical development of the Company's unique long-acting anticoagulant TB-402, which is in Phase II trials for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery, has progressed more rapidly than originally expected.
Patrik De Haes, CEO of ThromboGenics, said:
"ThromboGenics has seen most of its key programs make significant progress during the course of 2009. We are very happy with the speed of patient recruitment in the microplasmin Phase III program. Microplasmin is central to our aim of building a strong, profitable and integrated company centered on cutting edge ophthalmic medicines. Given our increasing confidence in the clinical merits of microplasmin we are now starting to develop our commercialization plans for this novel product. We are also very encouraged by the progress of the Phase II program for TB-402, as recruitment is ahead of schedule. This clinical study has reinforced our view that we have an attractive out-licensing opportunity for companies keen to enhance their position in the anti-coagulant therapy market. Our partnership with Roche for the novel anti-cancer antibody TB-403 is also going well, as evidenced by the success fee that we received from them earlier in the year."
"ThromboGenics' business has never been so well placed. We have a clear strategy, an exciting lead product in microplasmin and two further assets in TB-402 and TB-403 which will provide us with further opportunities to deliver value for our shareholders."
Financial Update - ThromboGenics achieved revenues of EUR3.6 million in the first half of 2009, nearly all of which came from a success fee from Roche, our partner for TB-403. R&D expenses were EUR8.8 million during this six month period. In addition EUR5.7 million of expenses related to the microplasmin Phase III clinical program (called MIVI TRUST) have been capitalized. General and administrative costs in the first half increased from EUR1.2 million to EUR1.7 million due to higher one-time legal costs, in part due to the merger of ThromboGenics NV and ThromboGenics Ltd. In the first half, ThromboGenics made a net loss of EUR4.7 million. - As of June 30, 2009, ThromboGenics had EUR52.6 million in cash and cash equivalents. This compares to EUR40.4 million on June 30, 2008 and EUR58.9 million on December 31, 2008. The cash figure at the end of June includes the EUR3.1 million that ThromboGenics received in May as a result of the exercise of warrants. The Company's cash resources are expected to allow ThromboGenics to execute its current operational plans for approximately the next two years. Business Highlights Clinical Highlights
Microplasmin - Back of the Eye Disease: Phase III clinical program to evaluate non-surgical treatment of patients with vitreomacular adhesion.
- Phase III program continues to progress well, with recruitment on track
In January 2009, ThromboGenics started the Phase III clinical program of microplasmin for the non-surgical treatment of back of the eye disease. Patient recruitment in this Phase III program is going well and a review by the independent Data Monitoring Committee (DMC) in June led to no changes in the protocols of the two pivotal trials. ThromboGenics expects to be able to report results of these studies from mid of 2010 onwards.
The microplasmin Phase III program comprises two clinical trials, one taking place in the United States (TG-MV-006 trial) and a second combined European/US study (TG-MV-007 trial). The indication for both of these Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Vitreomacular adhesion is a condition in which the vitreous has an abnormally strong adhesion to the retina at the back of the eye. These adhesions can cause vessel and retinal distortion which results in deterioration in the patient's vision. Both of these trials, which will each recruit 320 patients, are using 125ÿ¼g of microplasmin.
Given the good progress that is being made with the Phase III program, ThromboGenics is now starting the initial activities needed to ensure the successful commercialization of this exciting product. Market research is being initiated to provide a clear understanding of how patients with back of the eye diseases are treated. This will provide the detailed market knowledge needed to commercialize the product.
It is ThromboGenics' intention that, if successful, the Company would take this unique product further using its own resources. This is due to the very promising data that the Company has generated to date, the limited competition, and the large potential market for microplasmin with a focused prescribing group. Preliminary market research conducted by the Company suggests that this can be addressed by the small focused commercial organization that ThromboGenics intends to build.
Microplasmin - Diabetic Retinopathy: Phase II trial to evaluate microplasmin for the treatment of Diabetic Macular Edema (DME).
- First unmasked data due to be presented at ASRS Conference in New York, 4 October, 2009
ThromboGenics is currently investigating microplasmin in the treatment of diabetic retinopathy, as it seeks to extend the range of indications for which the product could be potentially used. ThromboGenics completed the enrolment of a Phase II trial of microplasmin intravitreal injection for treatment of DME (MIVI II DME) in March 2009. The first unmasked data from this trial will be presented at the ASRS (American Society of Retina Specialists) Conference in New York on 4 October, 2009 by Professor Stalmans, KULeuven. This trial is designed as the initial step in evaluating the utility of microplasmin in patients with diabetes, a group which is more prone to eye disease such as diabetic retinopathy, due to their underlying medical condition.
Diabetic retinopathy is a major cause of visual loss and the leading cause of blindness in patients aged 20-60. Studies in this patient population have shown that there is a great variability in the type and level of adhesion seen between the vitreous and the retina.
TB-402 - Phase II trial assessing its long-acting anticoagulant TB-402 for the prophylaxis of Deep Vein Thrombosis (DVT) following orthopaedic surgery.
- Phase II trial proceeding well and ahead of schedule
TB-402 is a novel long acting anticoagulant that is being developed for the prevention of deep vein thrombosis (DVT) following orthopedic surgery. The Phase II trial is proceeding well, with the first two cohorts (100 patients per cohort) of the study enrolled in just six months. We expect the third and final patient cohort to start recruiting shortly, after review by the Efficacy Safety Monitoring Board.
The Phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicenter, prospective, randomized, open label trial evaluating TB-402 for the prophylaxis of DVT after knee surgery. Interest around TB-402, which is given as a single injection post surgery and has several weeks of activity, is due to its potential to overcome the major drawbacks, such as spontaneous bleeding and the need for extensive patient monitoring, associated with current anti-coagulant therapy.
ThromboGenics and its development partner BioInvent plan to engage in discussions with potential partners for TB-402.