FDA Reply on SPA Submission Anticipated in August
CHICAGO, June 30 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company developing Restanza™, a novel once-a-day oral antibiotic, today announced that it has submitted a final Special Protocol Assessment (SPA) with the FDA for the proposed Phase III clinical program of Restanza in the treatment of patients with community acquired bacterial pneumonia (CABP). The Company has been engaged in the SPA process with the FDA over the last year and just recently met with officials from the FDA to establish the clinical trial design needed to gain approval in CABP. As filed, the updated SPA incorporates written and oral comments from the FDA's Division of Anti-Infective and Ophthalmology Products.
Michael T. Flavin, Ph.D., Chairman and CEO of Advanced Life Sciences stated, "We would like to thank the FDA for their written comments and guidance during the SPA process. We have incorporated the Agency's input into our final protocol design and SPA submission for FDA's final review and concurrence. Based on the FDA's SPA review cycle, we expect a reply to our submission by mid-August of this year. Reaching an agreement on the SPA will be the next step in the clinical development of Restanza and establish a framework for regulatory approval and commercialization in CABP."
About Special Protocol Assessments
An SPA is a written agreement between the FDA and a drug sponsor concerning the clinical trial design, clinical endpoints and other clinical trial issues that can be used to support regulatory approval of a drug candidate. The process is intended to provide assurance that if the agreed upon clinical trial protocols are followed, the clinical trial endpoints are achieved and there is a favorable risk benefit profile, the data may serve as the primary basis of an efficacy claim in support of a New Drug Application.
Restanza is a novel oral once-a-day antibiotic that is in late stage development for the treatment of CABP and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria including CA-MRSA and pathogens associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CABP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.
Advanced Life Sciences met with officials from the FDA's Anti-Infectives Division in March to gain clarity on the registration pathway for Restanza. In the meeting, the FDA guided that, to assess the approvability for Restanza to treat CABP, the Company should establish a SPA using a superiority clinical trial design comparing Restanza to a marketed macrolide antibiotic in two clinical trials. In light of this guidance, Advanced Life Sciences has been working with the FDA to finalize a SPA using a superiority design for the outpatient CABP indication. Clinical cure rate in the macrolide-resistant Streptococcus pneumoniae (MRSP) population will be the primary endpoint.
About Community Acquired Bacterial Pneumonia (CABP)
CABP is the sixth most common cause of death in the United States. CABP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. Approximately 5.6 million cases of CABP are diagnosed each year in the United States with 10 million physician visits, resulting in an estimated total annual expenditure of $2.0 billion for prescribed antibiotics to treat CABP. CABP is potentially fatal if not treated properly, and the bacteria that cause CABP are developing resistance to current standard of care treatments. Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CABP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. The Company's lead candidate, Restanza, is a novel oral once-a-day antibiotic in late-stage development for the treatment of respiratory tract infections including CABP and biodefense pathogens including anthrax, plague and tularemia. For more information, please visit us on the web at www.advancedlifesciences.com or follow us on twitter at http://twitter.com/advancedlifesci.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management's judgment regarding future events. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.
SOURCE Advanced Life Sciences Holdings, Inc.