OK, this company is suffering a definite case of lock-up blues. Yet it has a late stage compound it is getting ready to launch, an anti-coagulant called Angiomax that addresses big markets. It has shown good results in clinical trials and follow-up studies. As I write it's within a couple of points of its all time low. Other things appear to be in the pipeline. I'll do some pasting and linking, and hopefully someone with a better understanding of cardiovascular drugs and markets will happen by and say yea or nay.
For openers, the fresh 10-K, filed a week ago:
beta.tenkwizard.com
A brief look at Angiomax, via MedLine:
>>Bivalirudin: a new generation antithrombotic drug.
Expert Opin Investig Drugs 2000 May;9(5):1119-27 (ISSN: 1354-3784)
Scatena R [Find other articles with this Author]
Istituto Chimica e Chimica Clinica, Universita Cattolica del Sacro Cuore, Largo Francesco Vito 1, 00168 Rome, Italy. r.scatena@uniserv.ccr.rm.cnr.it.
Bivalirudin (Angiomax, The Medicines Company) is a synthetic 20 amino acid peptide rationally designed on the basis of structural studies of hirudin, a naturally occurring anticoagulant. Bivalirudin represents a new class of anticoagulant drugs that directly inhibits thrombin, a key component in blood clot formation and extension. With its high binding affinity and specificity for thrombin, bivalirudin acts directly on thrombin, rather than via other clotting factors. The compound has a variety of potential uses as an alternative to heparin in the management of cardiovascular disease and related medical procedures i.e., unstable angina (UA), myocardial infarction (MI) and percutaneous transluminal coronary angioplasty (PTCA).<<
Also via MedLine, a comparison with Heparin shows better safety:
>>Clinical outcomes of bivalirudin for ischemic heart disease.
Circulation 1999 Nov 16;100(20):2049-53 (ISSN: 0009-7322)
Kong DF; Topol EJ; Bittl JA; White HD; Theroux P; Hasselblad V; Califf RM [Find other articles with these Authors]
Duke Clinical Research Institute, Durham, NC 27715, USA. kong0008@mc.duke.edu.
BACKGROUND: Current treatment strategies for percutaneous coronary revascularization and acute coronary syndromes incorporate thrombin inhibition with either unfractionated or fractionated heparin. The peptide bivalirudin (Hirulog) is a direct thrombin inhibitor whose pharmacological properties differ from those of heparin. We conducted a systematic overview (meta-analysis) to assess the effect of bivalirudin on 4 end points: death, myocardial infarction, major hemorrhage, and the composite of death or infarction. METHODS AND RESULTS: Six trials (5674 patients) represent the randomized, controlled bivalirudin experience, including 4603 patients undergoing elective percutaneous coronary revascularization and 1071 patients with acute coronary syndromes. ORs for the 4 clinical end points were calculated for each trial. Four trials (4973 patients) that compared bivalirudin with heparin were combined with the use of a random-effects model. In these trials, bivalirudin was associated with a significant reduction in the composite of death or infarction (OR 0.73, 95% CI 0.57 to 0.95; P=0.02) at 30 to 50 days, or 14 fewer events per 1000 patients so treated. There also was a significant reduction in major hemorrhage for the same trials (OR 0.41, 95% CI 0. 32 to 0.52; P<0.001, or 58 fewer events per 1000 patients so treated). A similar analysis combined 2 dose-ranging trials (701 patients) that compared therapeutic (activated partial thromboplastin time more than twice the control time) with subtherapeutic bivalirudin anticoagulation (activated partial thromboplastin time less than twice the control time). CONCLUSIONS: Bivalirudin is at least as effective as heparin, with clearly superior safety. Thus, it provides an unprecedented net clinical benefit over heparin in patients with ischemic heart disease.<<
Also:
>>A randomized comparison of bivalirudin and heparin in patients undergoing coronary angioplasty for postinfarction angina. Hirulog Angioplasty Study Investigators.
Am J Cardiol 1998 Oct 22;82(8B):43P-49P (ISSN: 0002-9149)
Bittl JA; Feit F [Find other articles with these Authors]
Ocala Heart Institute, Munroe Regional Medical Center, Florida 34474, USA.
The outcome of coronary angioplasty performed for unstable angina is determined, in part, by the acuteness and severity of the clinical presentation. The risk of abrupt vessel closure is increased in patients with postinfarction angina. The Hirulog Angioplasty Study compared the efficacy and safety of bivalirudin with weight-adjusted heparin in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) for unstable or postinfarction angina. We report the results of the intent-to-treat analysis using adjudicated data for the prespecified group of 741 patients who underwent angioplasty within 2 weeks of documented myocardial infarction. Patients received either bivalirudin or heparin immediately before angioplasty. The primary efficacy endpoint was procedural failure defined as abrupt vessel closure, death, myocardial infarction, or revascularization during hospitalization. Bivalirudin significantly (p = 0.004) decreased the incidence of procedural failure compared with heparin (5.1% vs 10.8%, odds ratio 0.45; 95% CI 0.25-0.79). The improved efficacy of bivalirudin was replicated for each individual clinical endpoint. The incidence of major bleeding was significantly (p = 0.001) lower in bivalirudin-treated patients compared with heparin-treated patients (2.4% vs 11.8%, respectively). The benefits observed with bivalirudin are of similar magnitude as those reported for platelet glycoprotein (GP) IIb/IIIa inhibitors, such as abciximab. Bivalirudin may be a more effective foundation anticoagulant than heparin in patients undergoing coronary angioplasty for postinfarction angina.<<
Interestingly, an FDA panel voted against approval two years ago; the drug has nevertheless been approved. Do not know what the panel's concerns were. More on the compound can be parsed with this query:
medscape.com
Have fun!
Cheers, Tuck |
