Advanced Life Sciences Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Restanza(TM) (cethromycin).ADLS ADLS Auckland District Law Society (New Zealand)
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ADLS Activities of Daily Living Skills (developmental disabilities) ) , announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the June 2, 2009 Anti-Infective Drugs Advisory Committee (AIDAC) meeting. At the meeting, the AIDAC will review and discuss Advanced Life Sciences' New Drug Application (NDA) for Restanza(TM) (cethromycin) in the proposed indication of outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP).
Briefing documents from FDA and Advanced Life Sciences can be found on FDA's website at http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4425b1-00-FDA-index.htm.
Advanced Life Sciences is planning a conference call for the morning of Wednesday, June 3, to discuss the results of the June 2nd AIDAC Meeting. Additional call information will be forthcoming.
Restanza(TM) is a second generation ketolide antibiotic that is administered once a day through oral dosing. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract respiratory tract
The air passages from the nose to the pulmonary alveoli, including the pharynx, larynx, trachea, and bronchi.
Respiratory tract infections, and, again in in vitro tests, it 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 CAP, Restanza(TM) is also being investigated for the prophylactic treatment prophylactic treatment
The institution of measures to protect a person from a disease to which he or she has been, or may be, exposed. Also called preventive treatment. of inhalation anthrax inhalation anthrax Pulmonary anthrax, woolsorter's disease Pulmonology Occupational anthrax caused by inhalation of Brucella anthracis spores, affecting those exposed to aerosols during early processing of goat or other infected animal hair Clinical post-exposure. The FDA has designated Restanza(TM) as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any other indication.
About Community Acquired Pneumonia (CAP)
CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. CAP affects 5.6 million patients in the United States each year, with 10 million physician visits and 2 million hospitalizations occurring annually.
Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CAP. 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. For more information, please visit us on the web at http://www.advancedlifesciences.com/.
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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.
When a person begins a civil lawsuit, the person enters into a process called litigation. , dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences' filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.
CONTACT: Joe Camp of Advanced Life Sciences Holdings, Inc., +1-630-754-4352, email@example.com
Web Site: http://www.advancedlifesciences.com/ PRN (PRiNter) The DOS name for the first connected parallel port. See DOS device names. Photo Desk, firstname.lastname@example.org
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|Date:||May 29, 2009|
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