Company Prepared to Launch in U.S. Hospitals by End of August
SUNNYVALE, Calif., Aug. 13 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
announced today that the Company has received final approval from the U.S.
Food and Drug Administration (FDA) to market Natrecor(R) (nesiritide) for the
intravenous treatment of patients with acutely decompensated congestive heart
failure (ADCHF) who have shortness of breath (i.e., dyspnea) at rest or with
minimal activity.
Scios also announced that it has established the marketing, sales and
manufacturing capability necessary to launch Natrecor in U.S. hospitals by the
end of August, where it will become the first new drug to treat this patient
population in 14 years.
"This remarkable achievement is the culmination of years of hard work by
Scios employees and the hundreds of dedicated clinicians and their teams who
have developed a novel agent that may benefit patients who suffer from this
debilitating disease," said Richard B. Brewer, Scios' president and chief
executive officer.
Natrecor is the first of a new drug class, called human B-type natriuretic
peptides (hBNP), to be made available as a therapeutic for human disease in
the United States. Natrecor is a recombinant form of hBNP, a natural protein
found in the body.
This approval allows Natrecor to be used in the United States for the
intravenous treatment of patients with acutely decompensated congestive heart
failure who have shortness of breath at rest or with minimal activity. In
this population, the use of Natrecor reduced pulmonary capillary wedge
pressure, an important measure of heart function, and improved breathing.
Natrecor is the first product to receive FDA approval for ADCHF showing an
improvement in breathing in these patients.
"The extensive data collected and reported on nearly 1,000 patients
treated with Natrecor to date suggest an important role for this drug. ADCHF
is a large and growing medical problem for which we have had no new drugs in
over a decade," said James B. Young, M.D., Head, Section of Heart Failure and
Cardiac Transplant Medicine and Medical Director of the Kaufman Center for
Heart Failure, Cleveland Clinic Foundation. "Natrecor helps improve breathing
and decreases pulmonary capillary wedge pressure, the two most important
things we can do for these patients."
Natrecor may cause hypotension. In the pivotal trial, the incidence of
symptomatic hypotension in the first 24 hours was similar for Natrecor
(4%, n=273) and intravenous nitroglycerin (5%, n=216). When symptomatic
hypotension occurred, however, the duration was longer with Natrecor (mean
duration was 2.2 hours) than with nitroglycerin (mean duration was 0.7 hours).
Asymptomatic hypotension was reported in both Natrecor and nitroglycerin
treated patients (8% vs. 8%, respectively). Natrecor should be administered
only in a setting where blood pressure can be monitored closely, and the dose
of Natrecor should be reduced or the drug discontinued in patients who develop
symptomatic hypotension. Another reported side effect of Natrecor was
headache (Natrecor [8%], nitroglycerin [20%]). Natrecor may affect renal
function in susceptible individuals. At the recommended dose, the incidence
of elevations in creatinine to >0.5 mg/dL above baseline through day 30 was
28% and 21% in the Natrecor and nitroglycerin groups, respectively. Natrecor
should be initiated at the recommended dose. At doses higher than the
recommended dose, Natrecor is associated with a higher risk of hypotension and
increases in creatinine. Natrecor should not be used for patients with
cardiogenic shock or in patients with a systolic blood pressure <90 mm Hg.
Administration of Natrecor should be avoided in patients suspected of having,
or known to have, low cardiac filling pressures.
Marketing and Sales Infrastructure Established for Commercial Launch
To fully realize the market opportunity for Natrecor, Scios has
established a marketing, sales and customer service organization to help
educate physicians, nurses and other caregivers, and to generate rapid uptake
of the drug. The company has completed the recruitment and training of
165 sales people led by 20 of the most experienced sales managers in the
industry. Scios conducted its national sales meeting earlier this week and
has prepared all of its promotional materials to support marketing and
educational efforts, particularly those planned for upcoming conferences and
meetings, such as The Heart Failure Society of America annual meeting in
September and the American Heart Association annual meeting in November.
"We have scaled up manufacturing to meet market demand, which could be
substantial," added Brewer. "All of these efforts, combined with clinical
data and publications, a growing market, and clinicians who we believe are
ready for and excited to learn about Natrecor, should enable us to make a
strong impact in this market."
Acutely Decompensated Congestive Heart Failure
During an episode of ADCHF, the heart's inability to adequately circulate
blood throughout the body worsens beyond its already compromised state,
causing symptoms to become so pronounced that hospital treatment is required
to stabilize the patient's condition. A sudden increase in dietary sodium
(salt), failure to take chronic oral medications, or the development of a new
heart event can precipitate ADCHF. Virtually all CHF patients will have at
least one acute episode, where the symptoms are so severe that often only
intravenous (IV) medications administered in the hospital can improve
patients' health.
Roughly five million Americans suffer from heart failure, with 550,000 new
cases diagnosed each year. There are approximately one million
hospitalizations each year in the United States due to acute CHF, which cost
the healthcare system $15 billion annually. Another two million Americans are
hospitalized each year with acute CHF as the secondary diagnosis. In the
U.S., CHF accounts for the largest cause of hospitalizations for patients over
age 65. The impact of Natrecor on these costs is not known.
Conference Call
Scios executives will host a conference call and live audio webcast at
7:00 a.m. Pacific Time on Monday, August 13, 2001, to discuss the Natrecor
approval and its imminent commercialization. To participate, please call
800-810-0924 at least 5 minutes prior to start time. To access the live
webcast, please log on to http://www.sciosinc.com approximately fifteen minutes prior
to the call to register, download and install any necessary audio software.
A replay of the live webcast will be made available on the Scios website
shortly after the conclusion of the call through August 20, 2001. A replay of
the telephonic conference call will be available by dialing 888-203-1112,
confirmation code 769512. The telephone replay will be available through
August 20, 2001.
Scios Inc.
Scios is a biopharmaceutical company developing potential treatments for
cardiovascular and inflammatory disease. The Company's disease-based
technology platform integrates expertise in protein biology with computational
and medicinal chemistry to identify novel targets and rationally design small
molecule compounds for large markets with unmet medical needs.
The statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties. We generally
identify such forward-looking statements using words like "believe," "intend,"
"expect," "may," "should," "plan," "project," "contemplate," "anticipate" or
similar statements. Because these statements reflect our current views
concerning future events, these statements involve risks, uncertainties and
assumptions. Actual results may differ significantly from those described in
these forward-looking statements and are subject to risks and uncertainties,
including the sales penetration and success of Natrecor, as well as other
risks detailed from time to time in the reports filed by Scios with the SEC,
including the Company's quarterly report filed on form 10-Q for the quarter
ended June 30, 2001 and annual report on form 10-K for the year ended
December 31, 2000.
For Natrecor full prescribing information, please see http://www.sciosinc.com .
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Wendy Carhart of Scios Inc., +1-408-616-8325;
or press, Jim Weiss of Weisscomm +1-415-389 5055; or Michelle
Choi of Edelman PR Worldwide, +1-212-704-4580; or investors, Ed
Bisno of Edelman PR Worldwide, +1-212-704-8212
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