Navigation Links
Advanced Life Sciences Announces Plan to Submit NDA for Cethromycin
Date:4/10/2008

CHICAGO, April 10 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced that, based on a productive meeting with the U.S. Food and Drug Administration (FDA), the Company plans to submit a New Drug Application (NDA) in the third quarter of 2008 for its novel once-a-day oral antibiotic, cethromycin, to treat mild-to-moderate community acquired pneumonia (CAP).

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

"We are pleased with the outcome of the meeting because it allows us to remain on track with our NDA submission goal," said Dr. Michael T. Flavin, chief executive officer of Advanced Life Sciences. "In addition, we believe that achieving this milestone will enable our partnership discussions to continue toward a conclusion in a timely manner."

During the meeting, FDA officials agreed that the Company could submit the NDA for cethromycin to treat mild-to-moderate CAP based on the pivotal Phase 3 trial results previously reported. The FDA will review any submission the Company makes to determine whether it meets the requirements for filing. There can be no assurance that the FDA will file the NDA, or that once filed, it will be approved.

Conference Call Details

The Company will host a conference call and live webcast today, Thursday, April 10, 2008, at 8:30 am (EDT). The focus of the call will be to discuss the planned NDA submission for the Company's novel once-a-day oral antibiotic, cethromycin, as a treatment for mild-to-moderate CAP.

The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website http://www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888-680-0894(domestic) or 617-213-4860(international). The passcode for the conference call is 31431743. A replay of the conference call will be available until April 17, 2008. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 33735345. 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=PXKLGN4DD . 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 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 clinical development for the treatment of respiratory tract infections including CAP. For more information, please visit us on the web at http://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 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.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
3. Advanced Cell Technology Announces Proposed Financing
4. YM BIOSCIENCES, EUROPEAN PARTNER, ONCOSCIENCE AG, ANNOUNCES INITIATION OF ADVANCED NIMOTUZUMAB TRIALS IN ADULT GLIOMA AND PANCREATIC CANCER
5. Advanced Cell Technologys Dr. Robert Lanza Makes List of 100 Most Inspiring People in the Life-Sciences Industry
6. Advanced Life Sciences to Present at 2007 UBS Global Life Sciences Conference
7. CeloNova BioSciences Announces Worlds First Line of Fully Color-Coded Embolic Particles at CIRSE: Embozene(TM) Color-Advanced Microspheres
8. Edwards Lifesciences Grants UC Irvine $5 Million to Establish the Edwards Lifesciences Center for Advanced Cardiovascular Technology
9. Advanced Bionics Deploys CEVA-TeakLite(TM) DSP Core to Enhance Its Harmony(TM) HiResolution(R) Bionic Ear System
10. NIH Announces Advanced Cell Technologys Single Cell Embryo Biopsy Technique as a Means to Derive Embryonic Stem Cells to be Considered for Federal Funding
11. Cell Therapeutics, Inc. (CTI) Receives SPA Approval from FDA and Launches Gender-Specific Phase III Trial for Advanced Non-Small Cell Lung Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... On Thursday, March 23, 2017, ... down 0.07%; the Dow Jones Industrial Average edged 0.02% ... closed at 2,345.96, marginally dropping 0.11%. US markets saw ... 4 sectors finished in red, and 1 sector ended ... reports coverage on the following Biotechnology equities: BioDelivery Sciences ...
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... ... viscoelastic material that exhibits both viscous and elastic characteristics when deformed, which is ... polymer exhibits properties to gently absorb compressive forces and return to its natural ...
(Date:3/23/2017)... March 23, 2017  Northwest Biotherapeutics (OTCQB: NWBO) ... immune therapies for solid tumor cancers, today announced ... financing it announced last Friday, March 17, 2017. ... institutional investors securities totaling 28,843,692 shares, comprised of ... 10,000,000 shares of Class C Warrants pre-funded at ...
(Date:3/23/2017)... MENLO PARK, Calif., March 23, 2017  BioPharmX ... developing products for the dermatology market, today reported ... Jan. 31, 2017, and will provide an update ... from the year. "We are pleased ... productive year for BioPharmX," said President Anja Krammer. ...
Breaking Biology Technology:
(Date:2/27/2017)... 2017   Strategic Cyber Ventures , the industry,s ... a $3.5 million investment in  Polarity , the first ... is DC based and is led by cybersecurity veterans ... Ron Gula , also a longtime cybersecurity veteran ... this series A round of funding. This new funding ...
(Date:2/21/2017)... , February 21, 2017 ... 70 Millionen US-Dollar wachsen. Nach einem Gespräch mit mehr als ... einige Hindernisse zu überwinden gilt, um diese Prognose zu ... ... anderem die Mobilisierung der finanziellen Mittel für die Biobank, ...
(Date:2/10/2017)... 2017 Research and Markets has ... Medicine - Scientific and Commercial Aspects" to their offering. ... ... integrated with therapy for selection of treatment as well for ... prevention of disease in modern medicine. Biochip/microarray technologies and next ...
Breaking Biology News(10 mins):