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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: aknahow who wrote (5975)	3/20/2002 12:09:58 PM
From: Biomaven	Respond to of 52153

Important news today from BMY on Vanlev. Angiodema still a problem, and other news reports today have it performing no better than Vasotec in heart failure. Stock is halted. Wednesday March 20, 10:58 am Eastern Time Press Release SOURCE: Bristol-Myers Squibb Company Bristol-Myers Squibb Discloses VANLEV(TM) Data From Landmark OCTAVE Study Investigator Brochure Updated with New Efficacy and Safety Profile NEW YORK, March 20 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY - news) said today that it is providing clinical investigators with information from the landmark OCTAVE* study with VANLEV (omapatrilat). In accordance with federal regulations and company procedures related to clinical trial management, Bristol-Myers Squibb has included OCTAVE data in an update to the Investigators' Brochure, the document used by clinical investigators as a reference in conducting studies with drugs in development. Although an Investigators' Brochure is confidential in nature, Bristol-Myers Squibb is also disclosing OCTAVE data to the general public in order to avoid the possibility of speculation about and misrepresentation of the data. VANLEV is a novel investigational vasopeptidase inhibitor in development for the treatment of hypertension and heart failure that works by simultaneously inhibiting two key enzymes - neutral endopeptidase (NEP) and angiotensin-converting enzyme (ACE). On December 14, 2001, the company resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for VANLEV in the treatment of hypertension. The NDA includes data from the OCTAVE study and its review by the FDA is ongoing. The OCTAVE study, which included approximately 25,000 hypertensive patients, assessed multiple treatment strategies with VANLEV, versus the ACE inhibitor enalapril, including patients initiating therapy, replacing current therapy or adding-on therapy to other antihypertensive drugs. The study was designed to allow physicians to electively increase dosage of study drug (VANLEV or enalapril) or add other antihypertensive therapies as needed to control blood pressure. This design allowed for the possibility that both treatment groups would yield equivalent blood pressure results at the end of the trial. At the end of the study, more patients treated with enalapril required an increase in dosage or the addition of other antihypertensive therapies in order to reach target blood pressure. Despite more frequent increases in dosage and the addition of other antihypertensive therapies with enalapril patients, the OCTAVE study demonstrated consistently greater systolic blood pressure reductions with VANLEV in all patient groups, by an average of 3 mmHg (millimeters of mercury), whether used alone or in combination with existing antihypertensive therapies (p<0.001). The proportion of patients who reached blood pressure goals of less than 140 mmHg systolic and less than 90 mmHg diastolic was consistently about 9 percentage points higher with VANLEV than enalapril (p<0.001). Greater systolic blood pressure reductions were also consistently observed with VANLEV, compared to enalapril, across a broad range of patient types including people with diabetes, renal disease, severe hypertension, isolated systolic hypertension, and prior coronary or cerebrovascular events (p<0.005). In the OCTAVE study, the safety profiles of VANLEV and enalapril were similar, except for a higher risk of a side effect known as angioedema observed in VANLEV-treated patients. For OCTAVE, a new broad procedure was developed for evaluation of angioedema based on comprehensive, prospectively collected reporting of all potential cases of angioedema (including all cases of head and neck swelling), followed by adjudication by an expert committee. The most common manifestation of angioedema in patients treated with VANLEV or enalapril was face or lip swelling. More than half of all cases of angioedema required no treatment or treatment with antihistamines only (1.28% with VANLEV vs. 0.52% enalapril). In the remaining cases, patients were treated with epinephrine or steriods (0.89% with VANLEV vs. 0.17% with enalapril). Two cases of airway compromise occurred, both in VANLEV-treated patients. One of these patients experienced an anaphylactic reaction that responded promptly to treatment with epinephrine and did not require mechanical airway protection. The other patient required mechanical airway protection prior to resolution. All patients with angioedema fully recovered. The overall incidence of angioedema over 24 weeks was 2.17% with VANLEV and 0.68% with enalapril. With both drugs, the risk of developing angioedema was higher in black patients (5.54% with VANLEV versus 1.62% with enalapril) than in non-black patients (1.78% with VANLEV versus 0.55% with enalapril). Angioedema is a swelling that may affect the face, throat, lips, tongue or larynx and can also be triggered by certain foods and commonly used drugs such as ACE-inhibitors, nonsteroidal anti-inflammatory agents and some antibiotics. Hypertension, or high blood pressure, affects more than 600 million people worldwide and is the most important modifiable risk factor for cardiovascular disease. Even though there are a large number of available therapy options, three out of four people with high blood pressure in the U.S. have not attained the generally recommended target of less than 140 mmHg systolic and less than 90 mmHg diastolic, and remain, unnecessarily, at higher risk of heart attack, stroke, heart failure and kidney disease. Research has demonstrated that systolic blood pressure may be the best predictor of risk. Bristol-Myers Squibb is a $19 billion global pharmaceutical and related health care products company whose mission is to extend and enhance human life. OCTAVE (Omapatrilat Cardiovascular Treatment Assessment Versus Enalapril) This leaves BMY in a pretty vulnerable position. After IMCL they aren't likely to rush into another biotech deal, and their pipeline now is pretty sad in view of the patent expirations they have to deal with. Peter