ADLS.OB---Sector: Healthcare---Industry: Biotechnology

[setravis]

Profile: 

 
Advanced Life Sciences Holdings, Inc.
1440 Davey Road
Woodridge, IL 60517
United States - Map
Phone: 630-739-6744
Fax: 630-739-6754
Web Site: http://www.advancedlifesciences.com

DETAILS   
Index Membership: N/A
Sector: Healthcare
Industry: Biotechnology
Full Time Employees: 30


BUSINESS SUMMARY   
Advanced Life Sciences Holdings, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of novel drugs in the areas of infectious disease, oncology, and respiratory disease. Its lead candidate includes Cethromycin, a novel once-a-day oral antibiotic under review by the FDA for the treatment of mild-to-moderate community acquired pneumonia. Cethromycin has also completed Phase III clinical trials for the treatment of respiratory tract infections. The company also has an exclusive worldwide license agreement with Abbott Laboratories for the development and commercialization of Cethromycin. Advanced Life Sciences' products under preclinical studies comprise ALS-357, a compound for the treatment of malignant melanoma; and ALS-886, a novel therapeutic for the treatment of inflammation-related tissue damage consisting of tissue damage associated with acute respiratory distress syndrome. Its products under preclinical studies also include product candidates derived from the company's natural products-based chemistry platform. Advanced Life Sciences has collaborations and license agreements with Wyeth Pharmaceuticals, University of Illinois at Chicago, Baxter International, National Institute of Allergy and Infectious Diseases, and Defence Science and Technology Laboratory of the United Kingdom. The company was founded in 1999 and is headquartered in Woodridge, Illinois.

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CHICAGO, May 12, 2009 /PRNewswire-FirstCall via COMTEX/ -- Advanced Life Sciences Holdings, Inc. (ADLS, Trade), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced its financial results for the first quarter ended March 31, 2009.

The net loss allocable to common shareholders for the three months ended March 31, 2009 was $2.3 million or ($0.06) per share compared to a net loss allocable to common shareholders of $3.6 million or ($0.09) per share for the three months ended March 31, 2008. The decrease in the net loss is due to decreased costs involved in the clinical development of the Company's lead compound, cethromycin.

The company ended the first quarter of 2009 with cash and cash equivalents totaling $0.5 million. Cash used during the quarter was approximately $1.6 million.

"Our efforts in the first quarter were focused on preparing for the June 2nd FDA advisory committee meeting which will review the cethromycin New Drug Application," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "We look forward to the opportunity to present the FDA panel with a compelling rationale for recommending the approval of cethromycin in the treatment of community acquired pneumonia."

Operating Expense Analysis


 
    --  Research and development expenses were $0.9 million for the three months 
        ended March 31, 2009 compared to $1.9 million for the three months ended 
        March 31, 2008. 
    --  Selling, general and administrative expenses totaled $1.5 million 
        compared to $1.7 million for the first quarter of last year. 

First Quarter Achievements


 
    --  Received notice from the U.S. Food and Drug Administration (FDA) that 
        the agency's Anti-Infective Drugs Advisory Committee (AIDAC) is 
        scheduled to meet on June 2, 2009, and will discuss the New Drug 
        Application (NDA) for cethromycin, a new once-a-day oral antibiotic for 
        the outpatient treatment of adults with mild-to-moderate community 
        acquired pneumonia (CAP); 
    --  Notified by the U.S. Department of Defense that it would exercise its 
        option to award the Company $2.0 million under the previously announced 
        contract to further study cethromycin as a potential broad-spectrum 
        medical countermeasure; 
    --  Presented a poster titled, "Pro-apoptotic Screening of Novel Aza 
        Triterpenoids through Structure-Activity Relationship 
        Investigation," at the 237th American Chemical Society meeting in 
        Salt Lake City, UT; and 
    --  Provided a corporate update at the 11th Annual BIO CEO & Investor 
        Conference. 

Business Outlook for 2009


 
    --  Advance negotiations with prospective U.S. and E.U. partners for the 
        commercialization of cethromycin; 
    --  Support the regulatory process associated with the FDA's review of 
        the cethromycin NDA and plan for ex-U.S. regulatory filings; 
    --  Under the DOD contract, continue studies of cethromycin as a broad 
        spectrum medical countermeasure; and 
    --  Continue preparing for commercial launch of cethromycin. 

Financial Outlook

To fund ongoing operations in 2009, the Company intends to raise additional capital through commercial partnerships and/or the sale of equity.

Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Tuesday, May 12, 2009 to discuss the company's first quarter financial results.

The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888.713.4209 (domestic) or 617.213.4863 (international). The passcode for the conference call is 17640677. A replay of the conference call will be available until May 19, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 53463919. Investors are advised to dial into the call at least ten minutes prior to the call to register. Participants may pre-register for the call at https://www.theconferencingservice.com/prereg/key.process?key=PC4ENFB8V. Pre-registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.

About Cethromycin

Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated cethromycin 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 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, cethromycin, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CAP. For more information, please visit us on the web at www.advancedlifesciences.com.

Forward-Looking Statements

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, the adequacy of our clinical results, the timing and terms of any commercial partnership, 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.

http://www.advancedlifesciences.com 

Copyright (C) 2009 PR Newswire. All rights reserved
 

[setravis]

ADLS - Momentum......

Discovered this from an industry newsletter.
Rebounding, Chart seems to be expecting good news.
They are pumping out lots of information. If anything in their pipeline gets approved, it would skyrocket.
Nearing a Golden Cross...

52wk Range: 0.14 - 1.45
Volume: 527,536
Avg Vol (3m): 383,273

Technicals
Last Price Quote is:
21.52%above 13-day MA
78.66%above 50-day MA
RS Rating: 98 

Fundamentals
Key Data:
Market Cap (M): $31.73 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 08/06/2009
Last Analyst Rating: Hold

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

[setravis]

Press Release Source: Advanced Life Sciences Holdings, Inc.
Advanced Life Sciences Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Restanza(TM) (cethromycin)
On Friday May 29, 2009, 10:31 am EDT

CHICAGO, May 29 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS - News), 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).

(Logo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO)

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.

About Restanza(TM)

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 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 of inhalation anthrax 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 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 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, 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.

[setravis]

The Golden Cross... 
ADLS has such great potential!

52wk Range: 0.14 - 1.60
Volume: 3,506,823
Avg Vol (3m): 470,995


Technicals
Record Volume
Record Price High
Percentage Gainer

Last Price Quote is:
67.94%above 13-day MA
151.36%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $64.85 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 08/06/2009
Last Analyst Rating: Hold