FDA Approves ZYVOX(TM) - the First Antibiotic in a
Completely New Class in 35 Years; New Treatment Option
for a Significant Public Health Challenge
PR Newswire - April 18, 2000 12:05
PEAPACK, N.J., April 18 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today
approved ZYVOX(TM) (linezolid injection, tablets, and for oral suspension, Pharmacia Corporation)
for the treatment of patients with infections caused by Gram-positive bacteria. With IV and oral
formulations, ZYVOX comes from the first completely new class of antibiotics to reach hospitals in 35
years. The FDA approval follows the recommendations made on March 24, 2000 by the FDA
Anti-Infective Drugs Advisory Committee.
ZYVOX is indicated for adults in the treatment of nosocomial (i.e. hospital-acquired) pneumonia,
community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections and
vancomycin-resistant Enterococcus (VRE) infections caused by indicated bacteria. These indications
also include approval for use in:
-- complicated skin infections caused by methicillin-resistant
Staphylococcus aureus (MRSA);
-- nosocomial pneumonia caused by methicillin-resistant Staphylococcus
aureus (MRSA);
-- concurrent bacteremia associated with vancomycin-resistant Enterococcus
faecium;
-- concurrent bacteremia associated with community-acquired pneumonia
caused by penicillin-susceptible Streptococcus pneumoniae.
Gram-positive bacteria are currently defined by many in the public health and infectious disease
communities as one of the greatest challenges in hospital infections. Clinical studies involving more than
4,000 patients, treated primarily in the hospital, have shown that ZYVOX is effective in treating
infections caused by Gram-positive bacteria, including some that are resistant to other antibiotics.
"ZYVOX has a profile that makes it truly unique. It represents an important discovery in the treatment
of Gram-positive infections," said Robert Moellering, MD, Professor of Medicine, Harvard Medical
School. "The ability to continue patients on ZYVOX tablets following therapy with ZYVOX IV gives
dosing flexibility to physicians and provides convenience to patients as well as other potential benefits
such as completing therapy at home."
ZYVOX is available in IV and oral formulations. ZYVOX tablets are 100 percent bioavailable, meaning
physicians can use the IV and tablet forms interchangeably without making a dose adjustment. The
ability to complete treatment with an oral formulation may help enable some patients to leave the
hospital sooner.
"ZYVOX will be a vital alternative for the treatment of the rising number of Gram-positive infections
seen in hospitals worldwide," said Goran Ando, MD, Executive Vice President and President, Research
& Development, Pharmacia Corporation. "We are proud our researchers recognized the need for a
new class of antibiotics well before this medical challenge existed."
ZYVOX comes from a new class of antibiotics, the oxazolidinones. ZYVOX attacks bacteria by
stopping protein production at a very early point in the process that is different from any other antibiotic.
Without protein production, bacteria cannot multiply and bacteria die.
ZYVOX is generally well tolerated. The adverse events reported for patients receiving ZYVOX and
comparators in clinical trials were similar. The most common events for patients treated with ZYVOX
were diarrhea (8.3 percent), headache (6.5 percent), nausea (6.2 percent) and vomiting (3.7 percent).
Events were usually mild to moderate in intensity and limited in duration. Certain patients should have
periodic monitoring of their blood platelet levels while taking ZYVOX.
ZYVOX is being developed for global use. As part of a European filing strategy, a market authorization
application was submitted to the UK Medicines Control Agency in November 1999. Applications are
also being submitted throughout Asia and Latin America.
Pharmacia Corporation (NYSE: PHA) is a leading global pharmaceutical company created through the
merger of Pharmacia & Upjohn with Monsanto Company and its G.D. Searle unit. Pharmacia has a
broad product portfolio, a robust pipeline of new medicines, and an annual investment of more than $2
billion in pharmaceutical research and development. In its Monsanto subsidiary, Pharmacia has one of
the world's leading fully integrated agricultural businesses.
Certain statements contained in this release, such as statements concerning the Company's anticipated
financial results, current and new product performance, regulatory approvals, currency impact and other
non- historical facts are "forward-looking statements" (as such term is defined in the Private Securities
Litigation Reform Act of 1995). Since these statements are based on factors that involve risks and
uncertainties, actual results may differ materially from those expressed or implied by such
forward-looking statements. Such factors include, among others: management's ability to implement the
strategic initiatives; the Company's ability to successfully market new and existing products in new and
existing domestic and international markets; the success of the Company's research and development
activities and the speed with which regulatory authorizations and product roll-outs may be achieved;
fluctuations in exchange rates; the effects of the Company's accounting policies and general changes in
generally accepted accounting principles; the Company's exposure to product liability and other lawsuits
and contingencies related to actual or alleged environmental contamination; domestic and foreign social,
legal and political developments, especially those relating to health care reform and product liabilities;
general economic and business conditions; the Company's ability to attract and retain current
management and other employees of the Company; and other risks and factors detailed in the
Company's Securities and Exchange Commission filings, including its Proxy Statement and Form 10-K
for the year ended December 31, 1999.
SOURCE Pharmacia Corporation
/CONTACT: Media: Karen Carolonza, 908-901-8515, 908-313-8398, Mobile;
Analyst: Craig Tooman, 908-901-8853, both of Pharmacia/
/Company News On-Call: prnewswire.com or fax,
800-758-5804, ext. 884150/
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Difficult company to assess. I was familar with Dekalb Genetics which was bought out by Monsanto. PR attracted my attention. Now for some DD.
Jack |
