Advanced Life Sciences Hldgs
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Was weiss denn ich ob und wann die Zulassung kommt. Ich denke wenn die Studien durch sind, und sieht es nach den aktuellen Informationen zumindest zahlenmässig gegen CAP ganz gut aus, geht's hier aufwärts. Ein Zulassungszock wie halt bei vielen anderen Bioschmieden auch. Ich bin davon überzeugt das hier noch was geht, und versuche Infos darüber einzustellen, mehr nicht. Werde mich auch nicht auf eine Pro-Contra-Diskussion einlassen, hier soll sich jeder seine eigene Meinung bilden, wer das nicht hinbekommt ist mit solchen Werten komplett falsch bedient.
Und lies mal die Info unten auf der Seite: fdacal.com/fda-calendar
Da steht:"Disclaimer: FDACal.com is not associated with U.S Food and Drug Administration."
Das heisst für mich, dass diese Seite offiziell nichts mit der FDA zu tun hat...
"Michael T. Flavin, Ph.D., Vorsitzender und CEO von Advanced Life Sciences erklärte: "Wir möchten der FDA für ihre schriftlichen Stellungnahmen und Beratungen während des Prozesses der Erstellung eines gesondertes Bewertungsprotokolls (SPA / Special Protokoll Assessments) danken. Wir haben die Anregungen der Agentur in unseren endgültigen Berichtsentwurf aufgenommen und in die SPA-Vorlage integriert, damit die FDA eine abschließende Überprüfung vornehmen kann und wir die Zusammenarbeit mit ihnen aufnehmen können. Auf Basis des FDA SPA Bewertungsablaufes erwarten wir Mitte August dieses Jahres eine Antwort auf unsere Vorlage. Eine Einigung über das SPA wird der nächste Schritt in der klinischen Entwicklung von Restanza sein und wird einen Rahmen für die regulatorische Zulassung und Kommerzialisierung in CABP schaffen."
(Teilübersetzung aus: http://ir.advancedlifesciences.com/...e&ID=1443324&highlight= vom 30.06.2010)
http://ir.advancedlifesciences.com/...e&ID=1455596&highlight=
http://ir.advancedlifesciences.com/...e&ID=1456431&highlight=
http://ir.advancedlifesciences.com/...e&ID=1460575&highlight=
http://ir.advancedlifesciences.com/...e&ID=1462678&highlight=
Advanced Life Sciences to Present at 12th Annual Rodman and Renshaw Healthcare Conference
Advanced Life Sciences (OTCBB:ADLS)
Historical Stock Chart
1 Month : August 2010 to September 2010
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), 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 that it will present at Rodman and Renshaw's 12th Annual Healthcare Conference held September 12-15th in New York City.
(Logo: http://photos.prnewswire.com/prnh/20080218/ALSLOGO)
(Logo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO)
Advanced Life Sciences' President and Chief Financial Officer, John Flavin, will make a corporate presentation to investors at Rodman and Renshaw's Global Investment Conference on Tuesday, September 14 at 3:15 PM ET. The Company's presentation will be delivered in the Fahnestock Salon at The New York Palace Hotel, 455 Madison Avenue in New York City. The webcast can be accessed through the Investor Relations page on the Advanced Life Sciences website, www.advancedlifesciences.com. Those interested in listening to the presentation should log on a few minutes in advance in order to download any software or complete any sign-in that may be required.
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 once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including community acquired bacterial pneumonia (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.
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 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.
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Wertpapier: ADVANCED LIFE SCIENC |
Advanced Life Sciences (OTCBB:ADLS)
1 Month : August 2010 to September 2010
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today participated in the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (www.icaac.org). The International conference is being held in Boston, Massachusetts this week.
As an exhibitor at this year's conference, Advanced Life Sciences was successful in updating and interacting with more than 10,000 physicians, researchers and other healthcare professionals from around the globe who have gathered at the 50th ICAAC to focus on solutions to the problem of infectious disease. Data on the Company's lead product, Restanza™ (cethromycin), its novel once-daily oral antibiotic, was presented showing the drug's efficacy against 30 strains of Burkholderia pseudomallei, a serious, life-threatening bacterial pathogen that is also a potential agent of biological warfare or bioterrorism, and is listed on the Centers for Disease Control list as a Category B bioterrorism agent. Restanza showed significant in vitro activity against clinical and environmental strains of B. pseudomallei as measured by minimal inhibitory concentration (MIC), the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after 24 hours of incubation. Restanza demonstrated antibacterial activity with MIC values ranging from 0.5−8 ug/ml and an MIC90 value of 4 ug/ml. Most notably, Restanza also demonstrated positive activity against strains that were resistant to a commonly used antibiotic, azithromycin, for which MIC values were all greater than 64 ug/ml.
About Restanza
Restanza is a novel oral once-a-day antibiotic that is in late stage development for the treatment of community acquired bacterial pneumonia (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 Science recently announced that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study of Restanza to treat CABP.
About Burkholderia pseudomallei
Burkholderia pseudomallei is a Gram-negative, rod-shaped bacteria, and is the causative agent of the disease melioidosis. This bacterium can be found in contaminated water, soil and on market produce. It causes deadly infectious diseases endemic to Southeast Asia and northern Australia, and which may occur in other tropical and subtropical regions. Transmission to humans and animals occurs through direct contact with the organism via ingestion, inhalation, or through open wounds and skin abrasions. Treatment of this disease requires prolonged therapy with antibiotics. Few antibiotics are effective against this disease, and there is currently no effective vaccine. The severe course of infection, high mortality, aerosol infectivity and worldwide presence of this pathogen has resulted in its inclusion as potential agent of biological warfare or bioterrorism, and is listed on the Centers for Disease Control list as a Category B bioterrorism agent.
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 once-a-day oral 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.
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 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://ih.advfn.com/...mona&article=44378481&symbol=NB%5EADLS
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Wertpapier: ADVANCED LIFE SCIENC |
Date : 09/15/2010 @ 5:01PM
Source : Edgar (US Regulatory)
Stock : (ADLS)
Quote : 0.0486 0.0011 (2.32%) @ 3:50PM
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 9, 2010
ADVANCED LIFE SCIENCES HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Delaware
000-51436
30-0296543
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
1440 Davey Road
Woodridge, Illinois
60517
(Address of principal executive offices)
(Zip Code)
(630) 739-6744
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
--------------------------------------------------
Item 1.01. Entry into a Material Definitive Agreement.
On September 9, 2010, the Company entered into a Second Amended and Restated Business Loan Agreement and related loan documents with The Leaders Bank (“Leaders”) (the “Amendment”) amending its existing loan facility to give effect to the previously disclosed letter agreements between the Company and Leaders, effective as of May 6, 2010 and June 17, 2010.
Among other things, the Amendment extends the maturity date of the credit facility by one year to January 1, 2012 and requires the Company to reduce the outstanding loan balance by $1.5 million by October 1, 2010 and an additional $1.0 million by April 2011. Dr. Michael T. Flavin, the Company’s Chief Executive Officer, will provide a personal guarantee for the line of credit until the principal balance on the line of credit is reduced to $7.0 million. The Amendment also provides that the interest rate on the outstanding loan balance will increase from 8.5% to 10.0% and, subject to Abbott’s consent, the Company’s rights under its license agreement for cethromycin with Abbott Laboratories shall be included in the collateral for the line of credit. Additionally, the Amendment provides that the Company will issue to Leaders 500,000 warrants to purchase shares of the Company’s common stock at a price of $0.042 per share on September 9, 2010 and an another 500,000 warrants on September 9, 2011.
Item 3.02. Unregistered Sales of Equity Securities.
As noted in Item 1.01 above, pursuant to the Amendment entered into by the Company and Leaders, on September 9, 2010, the Company issued 500,000 warrants to purchase shares of the Company’s common stock at $0.042 per share. The warrants may be exercised at any time after the date of issuance and will expire in five years.
Neither the warrants nor the shares of common stock issuable upon exercise of the warrants have been registered under the Securities Act or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from the registration requirements. The Company relied on the exemption from the registration requirements of the Securities Act provided by Section 4(2) thereof and the rules and regulations promulgated thereunder. The private placement was made without general solicitation or advertising. The shares of common stock were offered and sold only to a purchaser that is an “accredited investor” as such term is defined in Rule 501 under the Securities Act.
2
--------------------------------------------------
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ADVANCED LIFE SCIENCES HOLDINGS, INC.
Dated: September 15, 2010
By:
/s/ Michael T. Flavin
Name:
Michael T. Flavin, Ph.D.
Title:
Chairman and Chief Executive Officer
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Wertpapier: ADVANCED LIFE SCIENC |
Date : 10/04/2010 @ 9:00AM
Source : PR Newswire
Stock : Advanced Life Sciences (ADLS)
Quote : 0.044 0.0 (0.00%) @ 7:30AM
Advanced Life Sciences Offers Testimony at Senate Hearing on Defending Against Public Health Threats
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), 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 that the company provided testimony at the U.S. Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services (HHS) Hearing on "Defending Against Public Health Threats" on September 29, 2010 in Washington, D.C.
Advanced Life Sciences chairman and chief executive officer, Michael T. Flavin, Ph.D., commented on the critical need to invest in the development of late-stage medical countermeasures that can defend against public health threats, such as emerging infectious diseases as well as bioterrorism. He commended the efforts of HHS to support development of medical countermeasures to combat public health threats, and urged the department to balance its portfolio by including late-stage products nearing FDA approval which can be efficiently and cost effectively studied and which, if approved, could rapidly be made available to protect the public.
"Advanced Life Sciences has responded to the critical threat of bioterrorism by developing its novel antibiotic, Restanza™, to protect against infection from inhaled anthrax, plague and tularemia," said Dr. Flavin. "Consistent with the priorities articulated by HHS, our company is committed to advancing Restanza through the final stage of clinical testing with the goal of gaining FDA approval and providing a safe and effective new countermeasure against lethal pathogens. We intend to continue to explore opportunities to work collaboratively with the US government to protect the public health."
Secretary of HHS Kathleen Sebelius testified at the hearing that "In today's world, the range of threats is ever-widening to include biological, chemical, nuclear, and radiological hazards in addition to conventional threats." Secretary Sebelius went on to say that "the greatest danger we may face is a microbe that we may have never seen before and for which we do not have a countermeasure. We clearly need the capacity to develop a medical countermeasure quickly." Senator Tom Harkin, Chairman of the Committee, added that the US Government "needs a stronger partnership with biotech companies that could produce next-generation countermeasures."
A link to the video archive of today's hearing can be found at the U.S. Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services website at:
http://appropriations.senate.gov/...71f5d-a28d-42a7-95ea-fd0e567d817c
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Wertpapier: ADVANCED LIFE SCIENC |