ThromboGenics issues business update for the third-quarter of 2009

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on innovative medicines for eye disease, vascular disease and cancer, is today issuing a business update for the period ending 30 September, 2009.

Patrik De Haes, CEO of ThromboGenics, said:

"ThromboGenics' clinical development programs have continued to make significant progress. We are very happy to have completed patient enrolment for the US Phase III study with microplasmin and recruitment in our second Phase III trial is continuing to make excellent progress. Microplasmin is central to our aim of building a successful integrated company focused on cutting edge ophthalmic medicines, that is positioned to deliver significant shareholder value.

We have also recently completed patient recruitment of a Phase II study with TB-402, assessing it as a DVT prophylactic in patients undergoing knee replacement, ahead of schedule. Our experience with TB-402 suggests that this long acting product has the potential to be an important new entrant into the anticoagulant market making it an attractive out-licensing opportunity. Our partnership with Roche for the novel anti-cancer antibody TB-403 continues to make good progress, with results from the Phase Ib trial to be presented later this month at the American Association for Cancer Research conference."

Financial Update - ThromboGenics achieved revenues of EUR3.7 million in the third quarter of 2009, the majority of which came from out-licensing. R&D expenses were EUR12.6 million during this nine month period. In Addition EUR10.4 million of expenses related to the microplasmin Phase III clinical program have been capitalized over the first nine months of this year. - As of September 30, 2009, ThromboGenics had EUR43.1 million in cash and cash equivalents. This compares to EUR60.9 million on September 30, 2008 and EUR58.9 million on December 31, 2008. 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 enrolment

completed for TG-MV 006 and on track for TG-MV 007

In September, ThromboGenics announced the completion of patient recruitment in the US trial (TG-MV-006) of the Phase III program with microplasmin for the non-surgical treatment of vitreomacular adhesion (a back of the eye condition). The trial recruited a total of 326 patients ahead of schedule and we anticipate reporting the results from this study by mid 2010, after a 6 month follow up period.

The second Phase III study with microplasmin, TG-MV-007, which is recruiting 320 patients in Europe and the US, is progressing well and we expect complete enrolment within the first quarter of 2010 and results of this study near the end of 2010.

This Phase III program, referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program, comprises two clinical trials, taking place in the United States (TG-MV-006 trial) and a second combined European and 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 use the 125micro g dose of microplasmin.

Microplasmin - Diabetic Retinopathy: Phase II trial to evaluate microplasmin for the treatment of Diabetic Macular Edema (DME).

- Results from the Phase IIa trial presented at the American

Society of Retina Specialists (ASRS) Conference in New York

In October 2009, ThromboGenics announced results from the Phase II trial of microplasmin intravitreal injection for treatment of DME (MIVI II DME). The trial showed that microplasmin was safe and well tolerated and that microplasmin is able to non-surgically resolve vitreomacular adhesion in some DME patients. The data from this trial were presented at the ASRS Conference in New York on 3 October, 2009 by Professor Peter Stalmans, University Hospitals Leuven, Belgium.

The MIVI II DME trial was designed to be the initial step in evaluating microplasmin in patients with diabetes, a group which is more prone to eye disease, and specifically diabetic retinopathy. ThromboGenics will finalize the next step in the development plan for microplasmin in this patient population once the results from the first Phase III trial (TG-MV-006) are reported. These results will provide significant additional data that will help ThromboGenics to refine the development plans for microplasmin in patients with diabetic retinopathy.

TB-402 - Phase II trial assessing the long-acting anticoagulant TB-402 for the prophylaxis of Deep Vein Thrombosis (DVT) following orthopedic surgery.

- Phase II trial has completed recruitment of 315 patients ahead of schedule - Results are expected in the second quarter of 2010

In October, ThromboGenics announced the completion of patient recruitment for the Phase II trial of TB-402 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. It is anticipated that the results of this study, which has recruited 315 patients, will be presented in the second quarter of 2010.

TB-402 has the potential to be a very important new entrant into the anticoagulant market. TB-402 is a recombinant human monoclonal antibody that partially inhibits Factor VIII, a key component of the coagulation cascade. This novel mode of action is expected to reduce the risk of undesirable bleeding events, even at high doses, as well as the need for patient monitoring. These are the two main drawbacks associated with current anticoagulant therapy. In addition, TB-402 is a long-acting agent, which means it could be given as a single dose to prevent the development of DVT in patients undergoing surgery. This would be an attractive option, as all current anticoagulant treatment options require daily treatment for up to several weeks.

ThromboGenics and its partner BioInvent plan to out-license TB-402 for its later stage development and commercialization. This out-licensing strategy is driven by the large sales potential of the product and the broad range of prescribers that could use an anticoagulant with TB-402's unique profile.

TB-403 (RG7334) - Novel anti-cancer agent partnered with Roche - TB-403 Phase Ib results to be presented at the American Association for Cancer Research (AACR) Conference - ThromboGenics continues to build a strong relationship with Roche

The clinical development of TB-403 is progressing as planned and the results of a Phase Ib trial are to be presented at the AACR conference in Boston, MA USA on November 15-19, 2009. The Phase Ib trial was designed to assess TB-403's tolerability, pharmacokinetics and pharmaco-dynamics in patients with advanced cancer.

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-PlGF). 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 of the overall EUR5 million success fee.


ThromboGenics NV


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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