Posted by jd on February 12, 2000, at 15:07:42
In reply to Re: FDA-Rebox. Site with press release, posted by Phil on February 12, 2000, at 9:25:13
Here it is: The following press release was pulled from Bloomberg.com, as accessed through the coreynahan.com site mentioned by Phil above. Doesn't it seem ridiculous to question reboxetine's efficacy because a single study showed BOTH reboxetine and prozac to be comparable to placebo? Since prozac's efficacy would seem tough to question at this point, all this would seem to mean to me is that the study was overloaded with placebo responders!
---------------------------------------------Pharmacia & Upjohn in Dialogue with FDA Regarding VESTRA(TM)
PEAPACK, N.J., Feb. 10 /PRNewswire/ -- Pharmacia & Upjohn, Inc.
(NYSE: PNU) today announced that is has initiated additional dialogue with the
U.S. Food and Drug Administration (FDA) regarding its New Drug Application
(NDA) for VESTRA (reboxetine mesylate tablets) in anticipation of a
February 23, 2000 FDA action date. VESTRA, an antidepressant, is a selective
norepinephrine reuptake inhibitor (selective NRI) that works on the
norepinephrine chemical pathway in the brain.The company submitted an NDA for VESTRA on April 29, 1998, and received an
approvable letter on July 28, 1999. The original submission was based on data
from studies conducted outside the U.S. At the request of FDA, the company
submitted data from two additional U.S. studies which were in process at the
time of the original submission. While one of the two studies showed some
positive results, the second study comparing VESTRA and Prozac (fluoxetine) to
placebo did not demonstrate difference from placebo for either Prozac or
VESTRA for the primary efficacy endpoint. A high placebo response rate is not
uncommon in clinical trials for antidepressant products. The safety and side
effect data for VESTRA from the two U.S. studies are consistent with the data
in the original NDA filed by the company which support the safety and
tolerability profile of VESTRA.Pharmacia & Upjohn is a global, innovation-driven pharmaceutical and
health care company. Pharmacia & Upjohn's products, services, and employees
demonstrate its commitment to improve wellness and quality of life for people
around the world.This news release contains certain forward-looking statements, including,
among other things, statements regarding the company's results of operations,
regulatory actions, and expected closing date of the merger. These forward-
looking statements are based on current expectations, but actual results may
differ materially from anticipated future events or results. Certain factors
which could cause the company's results to differ materially from expected and
historical results are described in the company's periodic reports filed with
the Securities and Exchange Commission, including the company's 1998 annual
report on Forms 10-K and Exhibits 99 thereto.The company has filed a preliminary joint proxy statement and prospectus
with the United States Securities and Exchange Commission (the "SEC"), and
will be filing a definitive joint proxy statement/prospectus and other
relevant information and documents concerning the merger with the SEC.
PHARMACIA & UPJOHN URGES INVESTORS TO READ THE DEFINITIVE JOINT PROXY
STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS TO BE FILED WITH THE
SEC, BECAUSE THEY CONTAIN IMPORTANT INFORMATION. Investors will be able to
obtain the documents free of charge at the SEC's website, www.sec.gov. In
addition, documents filed with the SEC by Pharmacia & Upjohn will be available
free of charge from the Corporate Secretary of Pharmacia & Upjohn, 100 Route
206 North, Peapack, NJ 07977, Telephone 888-768-5501. READ THE DEFINITIVE
JOINT PROXY STATEMENT/PROSPECTUS CAREFULLY BEFORE MAKING A DECISION CONCERNING
THE MERGER.Pharmacia & Upjohn, its directors, executive officers and certain other
members of management and employees may be soliciting proxies from Pharmacia &
Upjohn stockholders in favor of the merger. Information concerning the
participants in the solicitation is included in filings under Rule 425 made by
Pharmacia & Upjohn with the SEC on January 27, 2000.SOURCE Pharmacia & Upjohn, Inc.
-0- 02/10/2000
/CONTACT: Media: Paul Fitzhenry, 908-901-8770, or Analysts: Craig Tooman,
908-901-8853, both for Pharmacia & Upjohn, Inc./
/Company News On-Call: http://www.prnewswire.com/comp/884150.html or fax,
800-758-5804, ext. 884150/
/Web site: http://www.pnu.com/
(PNU)CO: Pharmacia & Upjohn, Inc.
ST: New Jersey
IN: MTC
SU:-0- Feb/10/2000 11:11
EOS (PRN) Feb/10/2000 11:11 85
-0- (PRN) Feb/10/2000 11:26
poster:jd
thread:21167
URL: http://www.dr-bob.org/babble/20000209/msgs/21295.html