American Pharmaceutical Partners Receives FDA Approval For Piperacillin Injection

SCHAUMBURG, Ill. -- American Pharmaceutical Partners, Inc., today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to launch Piperacillin for Injection, USP, the generic equivalent of Wyeth's Pipracil. Piperacillin is a third-generation, antibiotic indicated for the treatment of serious infections caused by designated susceptible microorganisms such as P. aeruginosa commonly referred to as pseudomonas. Piperacillin is active against a variety of gram-positive and gram-negative aerobic and anaerobic bacteria.

When Wyeth ceased manufacturing Pipracil in 2002, hospitals had to switch to alternative anti-infectives such as Wyeth's Zosyn, a broader spectrum anti-infective which is a combination of piperacillin and tazobactam, to treat serious gram negative infections like pseudomonas. Piperacillin will be available from APP in 2g, 3g, and 4g vials with anticipated launch by the first quarter of 2004 and complements APP's robust anti-infective offering of more than 14 products. According to IMS, sales of Zosyn reached more than $257 million in 2002 and have a potential to exceed $350 million in 2003.

"While combination antibiotics can be active against a wide variety of bacteria, there is growing concern about the overuse of broad-spectrum anti-infectives and escalating bacterial resistance, resulting in a need for more rational antibiotic use to help dissipate it," said Daryl D. DePestel, Pharm. D., clinical assistant professor and clinical pharmacist in infectious diseases at the University of Michigan College of Pharmacy and Health System.

According to a 2003 study published in Clinical Infectious Diseases, a build-up of resistance to anti-infectives regularly leads to a delay in the administration of microbiologically effective therapy, which may be correlated with adverse outcomes in patients.

"APP's launch of generic Piperacillin is good news to hospitals and pharmacies everywhere looking for a more targeted alternative to susceptible pathogens, thus helping to prevent the emergence and spread of resistance," said DePestel.

"Our mission is to address unmet medical needs in life-threatening disease states and deliver the products our healthcare partners -- hospitals, pharmacies and their patients -- need," said Patrick Soon-Shiong, MD, APP chairman, president and chief executive officer. "Knowing that approximately 6 percent of patients admitted to hospitals develop nosocomial infections as noted in a recent article published in Emerging Infectious Diseases, and that resistance to anti-infectives is reaching a critical level, bringing Piperacillin back to the market fills an urgent need in a cost efficient manner.

"Our commitment to providing a broad array of quality anti-infectives to the hospital-based population and maximize the choices the physician may have to treat these patients, is demonstrated with this development of Piperacillin. We are similarly committed to developing products that fulfill unmet medical needs in the oncology and critical care arena."

Piperacillin brings to six the number of ANDA approvals APP has received thus far in 2003.

Piperacillin for injection is indicated for treatment of serious infections caused by susceptible strains of certain designated microorganisms found in a variety of conditions including, intra-abdominal infections, urinary tract infections, gynecologic infections, Septicimia, lower respiratory tract infections, skin and skin structure infections, bone and joint infections and uncomplicated gonoccocal urethritis. Piperacillin has also been shown to be clinically effective for the treatment of infections at various sites caused by Streptococcus species. As with any antibiotic, Piperacillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets.

Source: American Pharmaceutical Partners, Inc.