Biotech Values

[DewDiligence]

ThromboGenics/BioInvent: I’m skeptical of this anticoagulation program for two
reasons: the unorthodox MoA—inhibiting FVIII—and the slowness of the clinical
progress to date. (The drug finished phase-1 eighteen months ago: #msg-22662024.)
Inhibiting FVIII is a normal place to intervene in the coagulation cascade for a
coagulant but it is not a normal place to intervene for an anticoagulant. The MoA
of inhibiting FVII is tantamount to inducing a mild, artificial state of hemophilia-A
while hoping to avert the major-bleeding events typical of more severe manifestations
of the disorder. (See #msg-16990872 for additional skeptical musings from rfj1862.)

http://finance.yahoo.com/news/ThromboGenics-and-BioInvent-prnews-14435124.html

›ThromboGenics, BioInvent Start Phase-2 Trial of TB-402 for DVT Prevention ,

- Trial to Assess the Benefits of Partial Factor VIII Inhibition in Patients Undergoing Knee Replacement Surgery -

Monday February 23, 2009, 2:00 am EST

LEUVEN, Belgium and LUND, Sweden, February 23 /PRNewswire/ -- ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce today that the first patient has been enrolled in the Phase II trial with their long-acting anticoagulant TB-402 for the prophylaxis of Deep Vein Thrombosis (DVT) following orthopaedic surgery. TB-402, which is given as a single injection post surgery, could overcome the major drawbacks such as bleeding and the need for extensive patient monitoring associated with current anti-coagulant therapy.

TB-402 is a recombinant human monoclonal antibody that targets Factor VIII, a key component of the coagulation cascade. TB-402 is a novel anticoagulant agent, which may deliver important clinical benefits due to it only partially inhibiting Factor VIII activity even when given in very high doses. This novel mode of action is expected to reduce the risk of undesirable bleeding events and the need for patient monitoring, the two main drawbacks associated with current anticoagulants. In addition, TB-402 is a long-acting agent which means that patients are expected to receive just one single dose after surgery to prevent the development of DVT, as opposed to all current treatment options which require daily treatment for up to several weeks.

The Phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicenter, prospective, randomised, open label trial evaluating TB-402 for the prophylaxis of DVT after knee surgery. The study will assess three different doses of TB-402 given as a single intravenous bolus injection post knee replacement surgery. The trial will enroll 300 patients across 36 centers mainly in Central Europe. The primary endpoint is the safety and efficacy of the three escalating doses of TB-402. It is anticipated that the study will conclude by the end of 2010.

Patrik De Haes, CEO of ThromboGenics, commented on today's news "We are very excited about the start of the Phase II trial for TB-402. Our work to date suggests that this novel agent could represent a major advance in anti-coagulant therapy, given our expectation that it will cause fewer unwanted bleeding events and will require no monitoring of patients. This combined with its ability to be used as a "one-off" treatment could make TB-402 the anti-coagulant of choice to prevent DVT in patients undergoing surgery. Given the size of the market opportunity for TB-402 and the sales reach that will be needed to engage with the potential prescribers of TB-402, it is our intention to seek a partner to undertake the later stage development and commercialisation of this exciting new agent."

Svein Mathisen, CEO of BioInvent, also commented, "The initiation of this Phase II trial is another successful step forward in the clinical development of our antibody product development portfolio. TB-402 addresses a broad market and has potentially significant advantages over existing anti-coagulants. We are hopeful it will have application in a number of clinical settings."

About ThromboGenics

ThromboGenics is a biotechnology company focused on the discovery and development of biopharmaceuticals 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 and has subsidiaries in Dublin, Ireland and New York, U.S. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at http://www.thrombogenics.com.

About BioInvent

BioInvent International AB, listed on the OMX Nordic Exchange Stockholm (BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company is currently running innovative drug projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed various strategic alliances around these product candidates and is developing them in collaboration with partners including Genentech, Roche and ThromboGenics.

These projects are based around a competitive and in substance patented antibody development platform. The scope and strength of this platform is also utilised by partners, such as ALK-Abello, Bayer HealthCare, ImmunoGen, OrbusNeich, Sanofi-Aventis, UCB and XOMA. More information is available at http://www.bioinvent.com.‹