LEUVEN, Belgium, August 27 /PRNewswire-FirstCall/ -- ThromboGenics NV , 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.”
Microplasmin - Back of the Eye Disease: Phase III clinical program to evaluate non-surgical treatment of patients with vitreomacular adhesion.
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 125AZA1/4g 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).
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.
During this period, additional data from the earlier successful Phase I studies were presented at the XXII Congress of the International Society on Thrombosis and Haemostasis (ISTH) on July 15, 2009 in Boston by Professor Peter Verhamme from KULeuven.
In June 2008, ThromboGenics and its co-development partner BioInvent signed a strategic alliance deal with Roche for its novel anti-cancer agent, TB-403 (anti-PIGF). The partnership continues to run smoothly and enrolment for the Phase Ib trial was completed in the second quarter of 2009. This Phase Ib trial is assessing TB-403’s tolerability, pharmacokinetics and pharmacodynamics in patients with advanced cancer.
The results from this trial are currently planned to be presented at a scientific conference later this year.
In January 2009, ThromboGenics and BioInvent received their first success fee from Roche based on the successful transfer and implementation of technology and process development for TB-403 production. ThromboGenics received EUR3 million (60%) of the overall EUR5 million success fee.
In the first half of 2009, ThromboGenics achieved total revenue of EUR3.6 million, nearly all of which came from its out-licensing activities. Within this amount, EUR3 million came from the first success fee from Roche based on the successful transfer and implementation of technology and process development for TB-403 production. In the same period of 2008, ThromboGenics had revenues of EUR30.3 million due to the upfront payment from Roche which resulted from the signing of its strategic partnership for TB-403.
In the first half of 2009, gross profit amounted to EUR3.2 million. In the same period in 2008, ThromboGenics achieved a gross profit of EUR30.3 million due to the upfront payment from Roche mentioned earlier.
ThromboGenics invested EUR8.8 million in its R&D activities in the first six months of 2009. This compares with a spend on R&D of EUR11.6 million in the same period in 2008. This reduction in R&D spend was the result of the decision to capitalise the Phase III clinical trial costs relating to microplasmin for back of the eye disease. In the first half of 2009, EUR5.7 million of R&D costs were capitalized.
ThromboGenics general and administrative expenses increased to EUR1.7 million from EUR1.2 million due to higher (one-off) legal costs in part due to the merger of ThromboGenics NV with its subsidiary ThromboGenics Ltd.
In the first half of 2009, ThromboGenics reported an operating loss of EUR5.5 million. This compares with an operating profit of EUR17.3 million in the corresponding period in 2008, which resulted from the significant upfront payment received from Roche.
ThromboGenics achieved net financial income of EUR0.8 million in the first half of 2009. In the first half of 2008, the Company also had net financial income of EUR0.8 million.
In the first half of 2009, ThromboGenics had a pre-tax loss of EUR4.7 million. This compares with a pre-tax profit of EUR18.0 million in the first half of 2008. In both periods, ThromboGenics paid minimal tax expenses.
ThromboGenics reported a net loss of EUR4.7 million in the first half of 2009, giving a diluted loss per share of EUR0.17. This compares with a net profit of EUR18.0 million and diluted earnings per share of EUR0.67 in the first half of 2008.
Financial Position and Cash Flow
As of 30 June, ThromboGenics had a strong cash position of EUR52.6 million. This compares to EUR40.1 million in cash and EUR6.7 million in short term investments at 30 June 2008.
These funds will allow ThromboGenics to support its business for approximately the next two years. The Company’s underlying cash burn is expected to increase given the continuing investment in the Phase III program for microplasmin in eye disease, as well as the start of ThromboGenics own commercial activities to ensure the successful launch of this exciting new product.
At the end of June 2009, ThromboGenics had total shareholders equity of EUR61.1 million which compares with EUR67.6 million at the end of June 2008.
ThromboGenics experienced a EUR4.6 million cash outflow in the first half of 2009. This compares with a cash outflow of EUR8.1 million in the first half of 2008, when the Company was still awaiting payment of the EUR30 million upfront payment from Roche.
About ThromboGenics
ThromboGenics is a biotechnology company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company’s lead product microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal indications and as a potential therapy for stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403 (anti-PlGF) for cancer.
ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels 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.
SOURCE ThromboGenics NV
CONTACT: For further information please contact: ThromboGenics : Dr.
Patrik De Haes, CEO , Tel: +32-16-75-13-10,
patrik.dehaes@thrombogenics.com; Chris Buyse, CFO , Tel: +32-16-75-13-10,
chris.buyse@thrombogenics.com; Citigate Dewe Rogerson, Amber Bielecka/
David Dible/ Nina Enegren , Tel: +44(0)207-638-95-71,
amber.bielecka@citigatedr.co.uk
