FDA Advisory Committee Recommends Approval of Forest Laboratories’ Ceftaroline Fosamil for the Treatment of Community Acquired Bacterial Pneumonia and Complicated Skin and Skin Structure Infections
Public Company Information:
NEW YORK--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE: FRX) announced that the U.S. Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee voted 21 – 0 in favor of approval of ceftaroline fosamil for the treatment of community acquired bacterial pneumonia (CABP) and voted 18 – 0 in favor of approval for complicated skin and skin structure infections (cSSSI).
Ceftaroline is a novel, bactericidal, broad-spectrum injectable cephalosporin shown in pre-clinical and clinical trials to have activity against both gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and Streptococcus pneumoniae, and common gram-negative pathogens.
The committee’s recommendation will be considered by the FDA as it reviews the new drug application (NDA) for ceftaroline, which was based primarily on data from two Phase III trials in CABP – FOCUS I and FOCUS II – and two Phase 3 trials in cSSSI – CANVAS I and CANVAS II. Forest anticipates action by the FDA during the fourth calendar quarter.
About Ceftaroline and Ceftaroline / NXL104
Ceftaroline is a novel, bactericidal, injectable, broad-spectrum cephalosporin being developed as a therapeutic agent for the treatment of cSSSI and CAP, which include resistant gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) and S. pneumoniae (as well as common gram-negative organisms). Ceftaroline has demonstrated antibacterial activity in vitro against vancomycin-resistant S. aureus (VRSA) and linezolid-resistant S. aureus. Ceftaroline is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. In clinical trials, ceftaroline has been generally well tolerated with an adverse event profile consistent with the cephalosporin class of antibiotics. Forest obtained the worldwide rights (excluding Japan, where Takeda Pharmaceuticals holds rights) to ceftaroline in 2007 when it acquired Cerexa, Inc., a privately held biopharmaceutical company. In August 2009, Forest Laboratories and AstraZeneca (NYSE:AZN) entered into a definitive collaboration agreement to co-develop and commercialize ceftaroline in all markets outside the U.S., Canada and Japan.
Forest is also developing a combination product consisting of ceftaroline and NXL104, a novel beta-lactamase inhibitor. The combination of NXL104 with ceftaroline enhances the in vitro antibacterial activity of ceftaroline against extended-spectrum beta-lactamase-producing (ESBL) gram-negative bacteria that are normally resistant to currently available broad-spectrum cephalosporins.
About CABP Requiring Hospitalization
In 2006, pneumonia, along with influenza, was the eighth leading cause of death in the U.S. and the number one cause of death in those over age 65. The cost of care for patients with CABP in the U.S. has been estimated to be over $10 billion annually.
The primary treatment for CABP is antibiotics, and the rates of resistance to many commonly used antibiotics are increasing. S. pneumoniae accounts for 60 to 70 percent of all bacterial CABP cases and data have shown that, overall, pneumococcal strains had a 28 percent intermediate resistance rate and a 16 percent high-level resistance rate. With increasing rates of pneumonia caused by MRSA and the high rates of resistance to common antibiotics, treatment options are becoming more limited.
cSSSIs are caused by gram-positive bacteria, such as MRSA, and common gram-negative bacteria. cSSSIs are among the most common infections treated in the hospital setting and MRSA infections are becoming more common in patients in both the hospital and community settings, now the most frequent cause of cSSSI presenting to emergency departments in the United States and the cause of over 18,000 deaths in 2005.
According to the Centers for Disease Control and Prevention, about 70 percent of bacterial infections are resistant to at least one drug. Many are resistant to multiple drugs making cSSSIs, especially due to MRSA, challenging to treat. cSSSIs can become extremely serious, leading to hospitalization, an increased risk for morbidity and mortality and increased healthcare costs.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The Company is headquartered in New York. To learn more about Forest Laboratories, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.