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Biotech / Medical : Texas Biotech (TXB)

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To: Andrew R. Sicotte who started this subject	4/16/2003 8:02:25 AM
From: mopgcw	of 834

Snip from Wachovia: TXBI: On Tuesday, TXBI and GlaxoSmithKline presented a poster at the annual meeting of the American College of Cardiology (ACC) discussing the results of a new feasibilty study that showed Argatroban in combination with glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors (platelet blockers) provided adequate anticoagulation with an acceptable risk of bleeding during percutaneous coronary interventions (PCI) such as coronary angioplasty and stent placement. The study was a multi-centered, prospective, pilot study of Argatroban in combination with glycoprotein IIb/IIIa inhibitors (ReoPro and Integrilin) in 101 patients undergoing PCI. The primary efficacy endpoint was vascular death, myocardial infarction (MI), or urgent revascularization at 30 days. The safety endpoint was in-hospital major bleeding. Patients were administered a 250 mcg/kg bolus of Argatroban at the start of PCI followed by 15 mcg/kg/min during the procedure until an acceptable level of ‘blood thinning’ was achieved (defined as an activated clotting time (ACT) of between 275 seconds and 325 seconds). Second and third bolus doses of 150 mc/kg were allowed during this study and required in 22 and 7 patients, respectively. GP IIb/IIIa inhibitor was administered simultaneously. The primary efficacy endpoint occurred in 3.0% patients (zero vascular deaths, three MIs and two urgent revascularizations) and there were two major bleeding events. According to the companies, 100% of the patients who received the Argatroban/GP IIb/IIIa inhibitor combination achieved angiographic success and adequate anticoagulation. A follow-up study is currently underway using a higher bolus dose with continuous infusion to investigate an alternate dosing regimen. We did not make any changes to our estimates based on this data. We estimate Argatroban royalty revenues to be $4.5 MM in 2003 and $9.2 MM in 2004.

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