6
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM 8-K
CURRENT
REPORTPURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): July 10, 2001
SCIOS, INC.
_________________________________________
(Exact Name of Registrant as Specified in Charter)
Delaware__ 0-11749 95-3701481
-------------------------------------- --------------------------------- ------------------
(State or Other Jurisdiction of (Commission File Number) (I.R.S. Employer Identification No.)
Incorporation)
820 West Maude Avenue, Sunnyvale, CA 94086
-------------------------------------------------------
(Address of Principal Executive Offices) (Zip Code)
(408) 616-8200_
------------------------------------------
(Registrant's telephone number, including area code)
N/A
------------------------------
(Former Name or Former Address, if Changed Since Last Report)
Item 5. Other
Events.
On July 10, 2001, Scios
Inc., announced that it has received a letter from the U.S. Food and Drug
Administration stating that the Natrecor® (nesiritide) New Drug Application
is approvable. For additional information, refer to the press release attached
as an exhibit to this Current Report on Form 8-K. The contents of the press
release are incorporated by reference herein.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(c) Exhibits
The following exhibits are filed as part of this Report:
No. Exhibit
--- -------
99.1 Press Release dated July 10th, 2001
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned hereunto duly authorized.
SCIOS, INC.
By: /s/ John H. Newman____
--------------------------------
John H. Newman
Senior Vice President, General Counsel and Secretary
Date: July 12th, 2001
EXHIBIT INDEX
No. Exhibit
--- -------
99.1 Press Release dated July 10th, 2001
Exhibit 99.1
------------
Contact:
--------
David Gryska, Scios Inc. (408) 616-8325 (investors)
Ed Bisno, Edelman Public Relations (212) 704-8212 (investors)
Michelle Choi, Edelman Public Relations (212) 704-4580 (media)
Scios Receives Natrecor Approvable Letter
|
SUNNYVALE,
CA, July 10, 2001 Scios Inc. (Nasdaq: SCIO) announced today that it has
received a letter from the U.S. Food and Drug Administration (FDA) stating that
the Natrecor® (nesiritide) New Drug Application (NDA) is
approvable. Scios has developed Natrecor as an intravenous treatment for
patients with acutely decompensated congestive heart failure (CHF). |
|
The
approvable letter is the official communication from the FDA that the agency is
prepared to approve the NDA following finalization of Natrecor labeling and
completion of a pre-approval inspection. The FDAs Cardiovascular and Renal
Drugs Advisory Committee unanimously recommended approval of Natrecor for the
treatment of acute CHF on May 25, 2001. |
|
We
are delighted to receive the approvable letter and are working closely with the
FDA to complete the final steps to approval, said Richard B. Brewer,
Scios president and chief executive officer. When approved by the FDA,
Natrecor will become the first new treatment for acutely decompensated CHF in
more than a decade. Natrecor is a recombinant form of B-type natriuretic peptide
(BNP), and would become the first natriuretic peptide product available as a
therapeutic in the United States. Human BNP is a naturally occurring hormone in
the body that aids healthy functioning of the heart. 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. |
Conference Call
|
Scios
executives will host a conference call and live audio webcast at 2:30 p.m. PDT
(5:30 p.m. EDT) on Tuesday, July 10 to discuss Natrecor and its next steps to
commercialization. To participate, please call (800) 474-8920 at least 5 minutes
prior to start time. To access the live webcast, please log on to
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 July 18, 2001. A replay of the telephonic
conference call will be available by dialing (888) 203-1112, access code 713213.
The telephone replay will be available through July 18, 2001. Scios Inc. |
|
Scios
is a biopharmaceutical company developing novel treatments for cardiovascular
and inflammatory disease. The Companys 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. These include
uncertainties associated with the timing of the final approval of Natrecor, as
well as other risks detailed from time to time in the reports filed by Scios
with the SEC, including the companys annual report on form 10-K for the
year ended December 31, 2000 and form 10-Q for the quarter ended March 31, 2001. |