Pharmacia's zyvox achieves regulatory milestone

PHARMACIA'S ZYVOX ACHIEVES REGULATORY MILESTONE GRANTED APPROVAL IN THREE KEY GLOBAL MARKETS IN LESS THAN ONE YEAR PEAPACK, NJ, (April 5, 2001) - Pharmacia Corporation (NYSE: PHA) today announced ZYVOXtm (linezolid injection, tablets and for oral suspension), its novel antibiotic to treat Gram-positive infections, has achieved a major milestone, securing approvals from regulatory bodies in the United States, Europe and Japan all within a 12-month period. Achieving this milestone represents a common global need for ZYVOX in treating patients with Gram-positive infections, the most frequent cause of hospital infections. ZYVOX is the first antibiotic in a new class in more than 30 years. The latest regulatory decision regarding ZYVOX came on April 4, 2001, when the Japanese Ministry of Health, Welfare and Labor approved the drug for the treatment of patients with infections caused by vancomycin- resistant Enterococcus (VRE) faecium. ZYVOX is the first drug in Japan to be approved for the treatment of VRE infections. While only a small number of patients are infected with VRE in Japan, ZYVOX received an expedited approval due to the unmet need for an effective treatment of VRE. Pharmacia will conduct clinical trials in Japan to gain broader approval of ZYVOX in other indications. "This is a tremendous achievement for ZYVOX, our research team and our company," said Pharmacia Corporation's Goran Ando, Executive Vice President and President, Research and Development. "We are pleased to receive this indication and will continue pursuing additional indications for ZYVOX in Japan in the future." The United States Food & Drug Administration approved ZYVOX on April 18, 2000, for treatment of adult patients with the following infections caused by susceptible strains of designated micro-organisms: vancomycin- resistant E. faecium (including cases with concurrent bacteremia), nosocomial pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infections, and community acquired pneumonia, including cases with concurrent bacteremia. ZYVOX was granted a product license on January 5, 2001, by the UK Medicines Control Agency (MCA). Consequently, regulatory filings in other European countries are underway to seek pan-European approval for ZYVOX under the Mutual Recognition process. In addition to the US, UK and Japan, ZYVOX has been approved in 15 countries throughout Latin America, Europe and Asia, and applications for regulatory acceptance are pending approval in many more. ZYVOX is available in intravenous (IV) and oral formulations. ZYVOX IV and tablets are 100 percent bioavailable, meaning physicians can use the IV and tablet forms interchangeably without making a dose adjustment. One study has shown that patients treated with ZYVOX had more discharges in the first week of treatment and fewer days of IV therapy than vancomycin-treated patients. . Because there is an oral formulation, patients can be started on ZYVOX IV therapy in the hospital and then changed to an oral formulation as clinically indicated that can, in some cases, be completed at home. ZYVOX is generally well tolerated. The adverse events reported for patients receiving ZYVOX and comparators in clinical trials were similar. The most common adverse events for patients treated with ZYVOX were diarrhea, nausea, headache and vomiting. Myelosuppression has been reported in patients receiving Zyvox. Therefore, complete blood counts should be monitored weekly. Discontinuation of Zyvox should be considered in patients who develop or have worsening myelosuppression. Pharmacia Corporation is a leading global pharmaceutical company created through the merger of Pharmacia & Upjohn and Monsanto Company with its G.D. Searle & Co. unit. Pharmacia (NYSE:PHA) has a broad product portfolio, a robust pipeline of new drugs, and an annual investment of more than $2 billion in pharmaceutical research and development. Certain statements contained in this release, such as statements concerning the Company's anticipated financial results, current and new product performance, 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, 2000. Media Contacts: Analyst Contact: Mark Krajnak Huw Gilbert Craig Tooman Pharmacia Edelman PR Pharmacia Corporation Worldwide Corporation Tel. (908) 901- Tel. (312) 240- Tel. (908) 901- 8769 2728 8853 ### ------------------------------------------------------------ This information was brought to you by BIT The following files are available for download: