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Pfizer's Single-Dose Antibiotic Zmax(Tm) Receives FDA Approval; Over 36M Prescribed Antibiotics for Sinusitis, Pneumonia in 2004(1)

Posted on: Monday, 13 June 2005, 18:00 CDT

NEW YORK, June 13 /U.S. Newswire/ -- Today the FDA approved the first and only single-dose liquid antibiotic treatment for certain types of mild-to-moderate sinusitis and pneumonia in patients appropriate for oral therapy. Zmax(tm) (azithromycin extended release) for oral suspension offers a full course of treatment in a single, high (2 g) dose, compared to current treatments taken in multiple doses over several days.

Zmax's microsphere technology allows for delivery of the entire course of therapy in a single, high (2 g) dose, while maintaining a favorable side-effect profile. Although you take it once, Zmax continues working over time to fight the infection. With a single- dose antibiotic, the chance that a patient fails to complete the course of treatment is reduced.(2) In clinical trials, 100 percent of Zmax-treated patients completed therapy.

Research has shown that more than 40 percent of patients fail to take all of their antibiotics as prescribed.(3)

Common ways patients don't comply with therapy: (2,4)

-- Fail to buy medicines or fill the prescription

-- Fail or delay start of therapy

-- Accidentally or purposefully skip doses

-- Take extra doses early in treatment

-- Stop medication when patient experiences symptom relief, but before completing the full course of treatment

-- Save medication for the next time they get sick, resulting in less than the full course of treatment

In general, not taking antibiotics as prescribed may lead to prolonged illness, relapse and the need for retreatment.(2) A complete course of antibiotics is needed to kill all of the harmful bacteria. An incomplete course of antibiotics often wipes out only the most vulnerable bacteria, which allows relatively resistant bacteria to survive and thrive.(4)

Zmax is indicated for the treatment of mild-to-moderate acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP) due to susceptible organisms(a) in adults appropriate for oral therapy.

The Zmax adult clinical research program included outpatients with mild-to-moderate ABS, CAP, and acute bacterial exacerbations of chronic bronchitis (AECB). Pfizer withdrew its application for the treatment of AECB while the FDA re-evaluates how it reviews investigational antibiotics for this indication.

Zmax offers a safety profile comparable to other antibiotic treatments for certain types of sinusitis and pneumonia and is generally well tolerated. In clinical studies, side effects were generally mild-to-moderate. Overall, the most common treatment- related adverse reactions in adult subjects receiving a single, high (2 g) dose of Zmax were diarrhea/loose stools (11.6 percent), nausea (3.9 percent), abdominal pain (2.7 percent), headache (1.3 percent), and vomiting (1.1 percent). In the majority of Zmax-treated patients, diarrhea resolved within two days.

Please see full prescribing information attached and available at: http://www.zmaxinfo.com.

VISUAL ELEMENTS include:

INTERVIEWS: Michael S. Niederman, M.D., Chairman, Department of Medicine, Winthrop-University Hospital, and Professor of Medicine, State University of New York at Stony Brook

B-ROLL: Animation showing how single-dose antibiotic treatment Zmax works, product packaging, woman demonstrating use of Zmax, Dr. Niederman in his office, Dr. Niederman examining chest x-rays, Pfizer corporate headquarters, Pfizer scientists working in a lab

AVAILABLE ON CNN NEWSOURCE PATHFIRE

SATELLITE COORDINATES

WHAT: FDA APPROVES FIRST & ONLY SINGLE, HIGH-DOSE ANTIBIOTIC TREATMENT FOR MILD-TO-MODERATE SINUSITIS AND PNEUMONIA IN ADULTS

WHEN: Monday, June 13, 2005 from 6:30 - 6:45 pm EDT

COORDINATES: Intelsat A-6 (formerly Telstar)

Transponder 16 C-Band

D/L Frequency: 4020 Horizontal Audio 6.2/6.8

CONTACT: Angela Vallera at 877-544-8400 (toll-free)

Video provided by Pfizer.

Note a: Zmax is indicated for acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae and community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in adult patients appropriate for oral therapy.

Zmax is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, or any other macrolide or ketolide antibiotic. If an allergic reaction occurs, discontinue drug and institute appropriate therapy. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy for the allergic reaction is discontinued. Pseudomembranous colitis has been reported with nearly all antibacterial agents. It is important to consider this diagnosis in patients who present with diarrhea.

Notes:

(1) Verispan, IMS (MAT March 2005)

(2) Kardas P. Review: Patient compliance with antibiotic treatment for respiratory tract infections. Journal of Antimicrobial Chemotherapy. 2002;49:897-903.

(3) Kardas P, Devine S, Golembesky A, et al. A systematic review and meta-analysis of misuse of antibiotic therapies in the community. International Journal of Antimicrobial Agents. (In press).

(4) Mayo Foundation for Medical Education and Research. Using antibiotics sensibly. Mayo Clinic Web site. 2004. Available at: http://www.mayoclinic.com/ invoke.cfm?objectid(equals)64AA7229-F0B8- 4A77-9693F821552DF9D9. Accessed May 19, 2005.

http://www.usnewswire.com

Source: U.S. Newswire

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