Purdue to Market Spectracef Oral Antibiotic in the U.S.

STAMFORD, Conn. -- Purdue Pharmaceutical Products L.P. announced today that it will market Spectracef Tablets (cefditoren pivoxil) in the U.S. and Puerto Rico under an exclusive licensing agreement with Meiji Seika Kaisha, Ltd. of Japan. Purdue has also acquired the Canadian rights to Spectracef. Spectracef, a third-generation oral cephalosporin antibiotic, was approved by the U.S. Food and Drug Administration in 2001 and subsequently marketed in the U.S. by TAP Pharmaceutical Products, Inc. Purdue expects to launch Spectracef nationwide in the U.S. during the second half of 2003, once adequate commercial supplies are available to meet the anticipated demand.

Spectracef is approved in the U.S. for use in adults and adolescents (12 years and older) to treat mild to moderate infections caused by susceptible strains of the designated microorganisms in conditions such as acute bacterial exacerbations of chronic bronchitis (ABECB), pharyngitis/tonsillitis, community-acquired pneumonia (CAP), and uncomplicated skin and skin-structure infections.

This product is one of the leading oral cephalosporins in Japan, where it is sold by Meiji Seika under the brand name Meiact. Total U.S. sales of competitive products for these indications were $1.8 billion in 2002, while the total adult oral antibiotic market in the U.S is valued at more than $8.4 billion.

"We are very excited about the opportunity to market Spectracef, which will allow us to use our considerable office-based and hospital field sales and marketing resources to establish the important benefits of this product with prescribing physicians," said Michael Friedman, president and CEO of Purdue. "I feel that we have attained the necessary critical mass to support a product for primary care physicians, which makes this acquisition a key driver in our overall growth and diversification plan. Spectracef marks our entry into the major therapeutic category of antibiotics," Friedman added. "Antibiotics are regarded as one of the single most important therapeutic discoveries in the history of medicine. The rise of new infectious diseases and antibiotic-resistant bacteria makes it critical to provide physicians with advanced antibiotics."

Spectracef 200 mg b.i.d. is indicated to treat mild to moderate infections in adults and adolescents 12 years of age and older from pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes (S. pyogenes); and uncomplicated skin and skin structure infections caused by susceptible strains of Staphylococcus aureus or S. pyogenes; and 400 mg b.i.d. for the treatment of community-acquired pneumonia (CAP) and acute bacterial exacerbations of chronic bronchitis (ABECB) caused by susceptible strains of Haemophilus influenzae (H. influenzae), H. parainfluenzae, S. pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis. Similar to some other antibiotics it should be taken twice a day for 10 to 14 days.

Overall side effects in Spectracef-treated patients were generally mild and self-limiting. The most commonly reported adverse events for Spectracef in clinical trials were diarrhea, nausea, vaginal moniliasis, headache, abdominal pain, dyspepsia and vomiting.

Spectracef is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components, and in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency. Spectracef should not be administered to patients with milk protein (sodium caseinate) hypersensitivity (not lactose intolerance).

If Spectracef is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10 percent of patients with a history of penicillin allergy.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Spectracef, and may range in severity from mild to life-threatening.

Source: Purdue Pharmaceutical Products L.P.