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Advanced Life Sciences Hldgs


Beiträge: 64
Zugriffe: 10.244 / Heute: 1
ADVANCED LIFE. kein aktueller Kurs verfügbar
 
Fratze:

Advanced Life Sciences Hldgs

3
26.11.09 16:13
Advanced Life Sciences Hldgs, Pharmaschmiede aus den USA(www.advancedlifesciences.com).
Derzeit ist ein sehr interessantes Antibiotika in Phase3, Cethromycin.(www.advancedlifesciences.com/product.php?id=1) Es soll neben Lungenentzündung auch gegen Pest und Anthrax(Milzbrand) eingesetzt werden können, für letzteres gibt es bereits den "Orphan Drug Status" der FDA. Sponsoren sind unter anderem das Verteidigungsministerium der USA. Es gibt aber noch zwei weitere Präparate in der frühen Pipeline.(www.advancedlifesciences.com/product.php). Besteht hinsichtlich Cethromycin in kürze Aussicht auf Zulassung gegen die sog. ambulant erworbene Pneumonie ? (de.wikipedia.org/wiki/Ambulant_erworbene_Pneumonie) Fakten, News und Informationen dazu gehören in diesen Thread!
Antworten

Werbung

Entdecke die beliebtesten ETFs von SPDR


Fratze:

Orphan Drug:

 
26.11.09 16:53
Medikamente zur Behandlung seltener Krankheiten:
de.wikipedia.org/wiki/Orphan-Arzneimittel

Derzeitige Zulassung für Pest und Tularämie:
ir.advancedlifesciences.com/...e&ID=1331900&highlight=

Zugegeben, die Pest ist ja gerade nicht mehr so aktuell, aber wenn man in Richtung Bioterrorismus denkt...

Tularämie ist dagegen schon häufiger anzutreffen: de.wikipedia.org/wiki/Tularämie

...wird auch "Lemmingfieber" genannt ;-) ...
Antworten
Fratze:

Ziele für 2009

 
28.11.09 13:48
für dieses Jahr ist bei ADLS noch folgendes geplant:

- Abschluss der Studien im Rahmen des Vertrags mit dem Verteidigungsministeriums (Department of Defense /DoD)
  und Bericht über die Messdaten der pivotalen  Primaten Studie die die schützende Wirksamkeit bei Tularämie belegt.

- Teilnahme am 9. Treffen des FDA Antiinfektiva-Beratungs-Komitees in dem der klinische Aufbau der CAP Studie und  
  deren Endpunkte besprochen werden.

- Zusammenarbeit mit der FDA und Pfizer (ehemals Wyeth) um den Umfang und das Protokoll-Design der zusätzlichen
  klinischen Daten zu klären die erforderlich sind, um dem Antrag der FDA hinsichtlich zusätzlicher Informationen über    
  die Wirksamkeit zu genügen um das klinische Entwicklungsprogramm für CAP zu vervollständigen und die
  behördliche Zulassung zu erhalten.

- Zusammenarbeit mit der FDA um den Rechtsrahmen zu bestimmen der für die Zulassung hinsichtlich der Bio-  
  Abwehr von  Milzbrand, Pest und Tularämie benötigt wird.

- Erweiterte Verhandlungen mit potenziellen Partnern der USA und aus der EU für die Entwicklung und Vermarktung
  von Restanza.

(ir.advancedlifesciences.com/...&ID=1353607&highlight=)

Demnach könnten im Dezember noch einige interessante Bekanntgaben seitens ADLS erfolgen ...
Antworten
Bubblebang:

Hi Fratze

 
28.11.09 19:09

 

Glückwunsch , nett hier , riecht noch ein bischen nach Farbe.

 

Adls wird spätestens im Frühjahr abgehen . Die beiden bestandenen Animaltests haben ja dazu geführt das de Orphanstatus gewährt wurde. Wenn man bedenkt das die auch noch Kohlemäßig gut dastehen ... die US-army auf das Pillchen scharf ist .... und die schon mal bei 1,65 standen ...ist das ne sehr gute Chance , zeitnah  ein gutes Geschäft zu machen. Tjs Fratze , wir werden wohl ziemlich alleine hier sein ))))

 

Macht nix, bringe die Tage mal ein Paar Kerndaten vorbei.

 

Schönes WE , BG

Antworten
Bubblebang:

Hier mal nen Chart

 
28.11.09 20:06

 

der letzte chart ist interessant :

 

 investorshub.advfn.com/boards/read_msg.aspx?message_id=43811562

 

BG

Antworten
Fratze:

Hallo Bubble,

 
28.11.09 22:00
Willkommen an Bord, alles neu, Fussleisten sind auch noch nicht dran ....

Mit dem Chart kann ich nicht wirklich was anfangen, OK, die 0,20 haben gehalten, aber die vielen anderen Kurven...
Gut das so etwas nur bedingt den Kurs beeinflusst, ein paar News wäre mir da schon lieber, aber das kommt alles noch.
Antworten
Gurlik:

off topic

 
30.11.09 07:06
Hi Fratze lese dich schon eine ganze weile bei Genta! Wie hasst du das gemeint du willst Vorbörslich bei Syndication einsteigen? An der OTC gibt es keinen Vorbörslichen Handel?! Was werden denn heute für news erwartet? Habe eben eine Order aufgegeben hoffe ich kann noch auf den Zug aufspringen???? Bei genta habe ich leider den absprung nicht geschafft:.(
Antworten
Fratze:

Hallo Gurlik,

 
30.11.09 10:31
Fratze:

Neues SEC-File

 
30.11.09 23:02
ir.advancedlifesciences.com/...x.zhtml?c=190126&p=irol-sec

Was hat Flavin denn da gemacht ? 10k dazugekauft ? Seltsamer Kurs ...
Antworten
Fratze:

Schade, die 0,21 hat heute nicht gehalten ...

 
04.12.09 21:57
Antworten
Bubblebang:

Hi Fratze

 
05.12.09 20:39

 

kein Problem mit den 0.21 , die Aktie ist zäh , freefloat nicht so hoch , relativ hoher Bestand an Shares in Firmenhand ...ein Test ( Primaten test fehlt noch ) dann sind wi reif für refiling bei der FDA .... oder gar ein neuer Antrag ...alles in Butter 

 

Winni hat mich in seinem Thread gesperrt ...hihihi .... ist das Klasse ))))))) der Guru ...

 

BG

Antworten
Fratze:

Da steht für morgen so'n FDA Meeting an ...

 
08.12.09 21:29
www.fda.gov/AdvisoryCommittees/Calendar/ucm187911.htm
Antworten
Fratze:

Die 21 cent scheinen sich gut zu halten,

 
15.12.09 14:35
eigentlich erstaunlich, da keine News verfügbar sind und im Kalender auch kein Event eingetragen ist, auf das es sich zu warten lohnen würde...
Antworten
Fratze:

Restanza Shows 100%

 
16.12.09 14:52
Survival in Tularemia Pivotal Animal Study !!!

Super News, fangfrisch, das sollte sich doch heute im Kurs wiederspiegeln :-) .....

ir.advancedlifesciences.com/...e&ID=1366498&highlight=
Antworten
Fratze:

Hm, da werden Studienergebnisse präsentiert

 
17.12.09 16:32
die besagen, dass 100% der Probanden in der Wirkstoffgruppe überlebt haben, wo es hingegen in der Plazebogruppe nur ein Zehntel geschafft haben, und der Kurs geht runter? Was versteh ich hier gerade nicht?
Antworten
Bubblebang:

@Fratze

 
22.12.09 16:44

 

Hallo mein Guter ,

es besteht gar kein Grund zur Sorge hier. Wer die letzte CC von ADLS verfolgt hat weiß das nach dem 3.bestandenen Test nun die wesentlichen Auflagen der US-Armee erfüllt wurden.

Diese Tests wurden bekanntlich gemäß der FDA " animal rule " durchgeführt welche - bei bestehen - Grundlage zur Einleitung der NDA im Bereich countermasure biowarfare sind. ( Man kann ja schlecht Testpersonen mit Pest oder Anthrax etc infizieren )

Das NDA-filing benötigt üblicherweise 3-6 Monate. Da man von Seiten ADLS angekündigt hat das im 1Q. die NDA ( new drug aplication ) kommen soll , sind wohl einige Anleger ausgestiegen ,da kurzfristig wohl nicht mit einem deutlichen Kursanstieg zu rechnen ist.

Die US-Armee vergibt , ebenfalls gemäß ADLS letzter CC / Präsentation , Verträge zur Aufstockung von Medikamenten i.H.v. 158 Mio $ . Bekommt ADLS auch nur einen dieser Verträge , dann ist das Papier locker 2,5$ wert .

Meine persönliche Prognose : Das Papier von ADLS ist auch ohne CAP ( comon aquired pneumonia - gewöhliche Lungenentzündung ) ein sicheres ( da alle 3 geforderten Tests bestanden wurden ) Papier. Kein Zock , solide und kopfschmerzfrei . Kaufen und vergessen. Wer dieses Papier zeitnah kauft , hat spätestens nächstes Jahr um diese Zeit mindestens das 6-10 fache seines Kapitals erwirtschaftet. Gerade jetzt wo die allgemeine Aufmerksamkeit von diesem Papier wegzudriften scheint, ist der aktuelle Kurs ein Geschenk. Selbst wenn der Kurs noch nachgeben sollte ist nach oben wesentlich mehr Profit zu erwarten als nach unten hin.

Alles meine private Meinung , aber von diesem Papier bin ich ( ähnlich wie bei KERX ) restlos überzeugt.Jeder mache seine eigene DD !

Frohe Weihnachten !

BG

Antworten
Fratze:

Jo, auch hier,

 
24.12.09 13:53
schön abwarten bis es im neuen Jahr knallt, frohes Fest und guten Übergang ...
Antworten
Menne:

SEC Filing 8-K 04.01.10

 
06.01.10 10:04
www.microcapmarkets.com/...64&market=OTCBB&ticker=ADLS
Antworten
Fratze:

8-K File Edgar

 
06.01.10 17:27
www.pinksheets.com/edgar/GetFilingHtml?FilingID=6966734
Antworten
Menne:

Conference held January 12-14th

 
07.01.10 01:56
Advanced Life Sciences to Present at the 3rd Annual OneMedForum Emerging Company Finance Conference: CHICAGO, Jan. 6 -- 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, cancer and respiratory diseases, today announced that it will present at the OneMedForum Emerging Company Finance Conference held January 12-14th in San Francisco.

www.pinksheets.com/pink/quote/quote.jsp?symbol=adls
Antworten
Menne:

Update Conference, January 13th at 9:30 AM PT

 
09.01.10 09:19
(Logo: 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 on Wednesday, January 13th at 9:30 AM PT. The Company's presentation will be delivered in the Cyprus Room on the 2nd Floor at the Sir Francis Drake Hotel, 450 Powell Street in San Francisco. 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.

www.itsallbull.net/boards.php?id=16630
Antworten
Bubblebang:

ADLS 30% Plus , am Freitag !

 
11.01.10 11:27
Antworten
Fratze:

Wahrscheinlich wegen der

 
11.01.10 16:12
anstehenden Konferenz? Was anderes habe ich nicht gefunden, Menne hatte es ja auch schon gepostet. Aber da passiert doch nichts spannendes ausser einer Präsentation ...
Antworten
Fratze:

So, morgen dann also Präsentation,

 
12.01.10 23:24
bin mal sehr gespannt was dabei herumkommt ...
Antworten
Fratze:

neue Info

 
22.01.10 01:36
ih.advfn.com/...0250&article=41210709&symbol=NB%5EADLS
Antworten
Menne:

Form 424B2, 03.02.10

 
05.02.10 12:36
www.microcapmarkets.com/...20&market=OTCBB&ticker=ADLS
Antworten
Fratze:

von gestern:

 
10.02.10 18:22
finance.yahoo.com/news/...-prnews-4282019356.html?x=0&.v=1
Antworten
Fratze:

Ziel 2010 als Video:

 
13.02.10 19:09
www.advancedlifesciences.com/video/
Antworten
Fratze:

Michael T. Flavin's speech

 
27.02.10 01:52
at Northwestern's Technological Institute:

news.medill.northwestern.edu/chicago/news.aspx?id=158455
Antworten
Menne:

Fourth Quarter and Full Year Financial Results Con

 
05.03.10 12:41
Quartalzahlen 4.Q 2009 und für das gesamte Jahr 2009  -  Thursday, March 11, 2010 at 9:00 a.m. (EST).

A press release reporting the 2009 fourth quarter and full year results will be issued before the U.S. stock markets open on Thursday, March 11, 2010.

finance.yahoo.com/news/...-prnews-3968080849.html?x=0&.v=1
Antworten
Fratze:

Completion of Special Protocol Assessment

 
11.03.10 22:36
Targeted for Third Quarter 2010:

ir.advancedlifesciences.com/...e&ID=1401434&highlight=
Antworten
Menne:

Form 8-K, 11-Mar-2010

 
21.03.10 08:14
Termination of a Material Definitive Agreement, Results of

biz.yahoo.com/e/100311/adls.ob8-k.html
Antworten
Menne:

Annual Data, 16.03.2010

 
21.03.10 08:16
finance.yahoo.com/q/is?s=adls.ob
Antworten
Fratze:

ADLS erhält 15 Mio.

 
21.03.10 13:29
von der Biomedical Advanced Research and Development Authority (Barda) des US Department of Health and Human Services:

finance.yahoo.com/news/...s-prnews-545629449.html?x=0&.v=1
Antworten
Menne:

ADLS Announces Upcoming Shareholder Meeting

 
02.04.10 13:00
www.microcapmarkets.com/...76&market=OTCBB&ticker=ADLS
Antworten
Menne:

# 35, so jetzt April 8., 11:00

 
02.04.10 13:05
www.microcapmarkets.com/...81&market=OTCBB&ticker=ADLS
Antworten
Menne:

Results of Shareholder Meeting

 
09.04.10 09:49
Aktienerhöhung von 125 auf 625 mio. Commons von 120 auf 620 mio - jederzeit vor dem 08.04.11.


finance.yahoo.com/news/...-prnews-3643713781.html?x=0&.v=1
Antworten
Menne:

Form 8-K, 13-Apr-2010

 
15.04.10 08:18
- Änderungen im BoD

- R/S any time before April 8, 2011 at a specific ratio to be determined by the board of directors within a range from 1-for-2 to 1-for-30 as set forth below



biz.yahoo.com/e/100413/adls.ob8-k.html
Antworten
Fratze:

positive Nachrichten

 
22.04.10 23:27
über In-Vitro-Studie bezüglich Restanza:

ir.advancedlifesciences.com/...e&ID=1415582&highlight=

Also so langsam ... immer nur ein bisschen ...
Antworten
Fratze:

Zahlen erstes Quartal 2010

 
09.05.10 01:02
kommen Montag, 10.05.2010, 09:00 h EDT

ir.advancedlifesciences.com/...e&ID=1423360&highlight=
Antworten
Menne:

Q1 loss per share $0.02

 
11.05.10 14:11
app.quotemedia.com/quotetools/...p=null&webmasterId=100937
Antworten
Menne:

Form 8-K, 10-May-2010

 
11.05.10 14:57
Form 8-K for ADVANCED LIFE SCIENCES HOLDINGS, INC
Entry into a Material Definitive Agreement, Results of Oper

Item 1.01. Entry into a Material Definitive Agreement.
Advanced Life Sciences Holdings, Inc. (the "Company") entered into a letter agreement, effective as of May 6, 2010, with The Leaders Bank ("Leaders"), amending its line of credit in order to extend the maturity date by one year to January 1, 2012 (the "Amendment"). Under the terms of the Amendment, the Company is required to reduce the outstanding loan balance by $1.5 million immediately, $1.5 million by July 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 payment due July 1, 2010 is made. The Amendment also provides that the interest rate on the outstanding loan balance will increase from 8.5% to 10.0%, and the Company's rights as a result of its license agreement for cethromycin with Abbott Laboratories were included in the collateral for the line of credit. The Company agreed to issue Leaders 500,000 warrants to purchase shares of its common stock at the current public trading price per share on the date the final loan documents are delivered and an additional 500,000 warrants on the anniversary of that date.

In addition, on May 7, 2010, the Company entered into an agreement with Dr. Flavin providing that the $2 million promissory note with Dr. Flavin will be exchanged for equity securities of the Company (the "Debt Exchange Agreement"). The exchange is expected to occur at the same price and time as a contemplated concurrent sale of equity securities and will result in cancellation of the outstanding indebtedness.

The Amendment is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference herein. The Debt Exchange Agreement is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated by reference herein. The above descriptions of the material terms of the Amendment and the Debt Exchange Agreement do not purport to be complete and are qualified in their entirety by reference to Exhibit 10.1 and Exhibit 10.2.

Item 2.02. Results of Operations and Financial Condition.*
On May 10, 2010, the Company issued a press release announcing its financial results for the first quarter ended March 31, 2010. A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01. Financial Statements and Exhibits.

(d)   Exhibits:

10.1  Letter agreement between Advanced Life Sciences Holdings, Inc. and The
     Leaders Bank, effective as of May 6, 2010.

10.2  Debt Exchange Agreement dated as of May 7, 2010.

99.1* Press Release dated May 10, 2010.



biz.yahoo.com/e/100510/adls.ob8-k.html
Antworten
Fratze:

Restanza zeigt Wirkung gegen Malaria

 
13.06.10 17:40
mit grösserem Effekt als herkömmliche Antibiotika

www.prnewswire.com/news-releases/...inst-malaria-94911754.html
Antworten
Fratze:

Zusammearbeit mit der Regierung ausgeweitet

 
13.06.10 17:48
um mit Restanza sexuell übertragbare Infektionen zu behandeln:

ir.advancedlifesciences.com/...e&ID=1432254&highlight=
Antworten
Fratze:

und noch einen

 
13.06.10 17:59
Advanced Life Sciences Offers Congressional Testimony on Critical Importance of Antibiotic Drug Development to Address Bacterial Resistance

ir.advancedlifesciences.com/...e&ID=1436482&highlight=
Antworten
Chalifmann3:

Hi bubble

 
18.06.10 21:39
wird das hier noch was ? Was ist das Problem hier,etwa der negative buchwert von ADLS,der durch die 12 Mio.-$ Schulden hervorgerufen wird ? Unglaublich,das "1 year target liegt bei 2$/share,aktueller Kurs 0,07$ !!

Ich wünsch dir was,meld dich mal wieder ?

P.S. Na,wer hatte Recht mit Genta von uns beiden ?!

MFG
Chali
Antworten
Fratze:

ADLS Announces Pricing of Securities Offering

 
01.07.10 15:37
ir.advancedlifesciences.com/...e&ID=1443509&highlight=
Antworten
Fratze:

neue positive Ergebnisse

 
08.07.10 22:33
über intravenöse Applikationen von Cethromycin:

ir.advancedlifesciences.com/...e&ID=1445582&highlight=

Restanza IV was administered as a single dose up to 60 mg/kg/day, the highest dose tested. Results demonstrated Restanza IV was well tolerated and generated 10-fold greater plasma exposure compared to oral administration. The studies were conducted in rats in accordance with good laboratory practices (GLP). The increased bioavailability of Restanza IV may allow for the treatment of serious hospital infections as well as the treatment of bioterror pathogens, such as anthrax, plague and tularemia after signs and symptoms are present.

"Restanza has potential to be the first ketolide antibiotic to have an intravenous formulation available in the U.S.," said Michael T. Flavin, Ph.D., Chairman and CEO. "Having an IV formulation allows for the potential treatment of serious hospital infections with an opportunity for an IV-to-pill switch as the patient moves from an in-patient setting to an outpatient setting. This is a significant feature that enhances the overall Restanza value proposition for physicians and patients."

Urgent Market Need for Potent Hospital-Based IV Antibiotics

There is an urgent market need in the U.S. and worldwide to identify and rapidly develop novel, safe and effective antibiotics that can overcome resistance to currently available drugs and that can be used in a variety of settings, such as an IV treatment in the hospital, and an IV-to-pill switch for stabilized patients and an oral treatment for outpatients.

Ketolide antibiotics, which represent a newer and promising class of therapeutics with greater potential against bacterial strains that are resistant to macrolides and penicillins, are typically very difficult to formulate in a clinically viable IV formulation due to low water solubility. Advanced Life Sciences has achieved a major breakthrough by successfully developing an IV formulation of Restanza. The formulation can be stored in a stable powder form and reconstituted on site in the hospital. The key features of this formulation support developing Restanza IV for use in the hospital setting.

The next step in the program is to initiate additional IND-directed preclinical studies of the Restanza IV formulation to support future Phase I clinical trials in normal healthy volunteers to evaluate its safety and pharmacokinetics.
Antworten
Chalifmann3:

Alles schön und gut ,fratze ...

 
09.07.10 11:20
aber warum steht ADLS nicht im FDA-Calendar für 2010 ? Wann kommt denn das NDA ?
Kommt es überhaupt ?

MFG
Zuki
Advanced Life Sciences Hldgs 331364
Antworten
Chalifmann3:

?

 
09.07.10 11:31
Fratze:

Was soll ich dazu schreiben?

 
11.07.10 20:57
Hältst du mich für einen Hellseher?
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...
Antworten
Fratze:

Mitte August kann mit Neuigkeiten

 
14.07.10 14:51
seitens der FDA gerechnet werden:

"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: ir.advancedlifesciences.com/...e&ID=1443324&highlight=  vom 30.06.2010)
Antworten
Fratze:

ADLS erweitern ihre Antibiotika-Pipeline

 
26.07.10 19:26
ir.advancedlifesciences.com/...e&ID=1451738&highlight=
Antworten
Fratze:

Antrag auf Fast Track bei der FDA für CABP

 
28.07.10 21:04
ir.advancedlifesciences.com/...e&ID=1452885&highlight=
Antworten
Fratze:

ADLS Applies to IRS for Cash Grant

 
05.08.10 13:34
Advanced Life Sciences Applies to IRS for Cash Grant Under the Qualifying Therapeutic Discovery Project

ir.advancedlifesciences.com/...e&ID=1455596&highlight=
Antworten
Fratze:

Advanced Life Sciences to Host Second Quarter 2010

 
05.08.10 13:36
Advanced Life Sciences to Host Second Quarter 2010 Conference Call and Live Webcast

ir.advancedlifesciences.com/...e&ID=1456431&highlight=
Antworten
Fratze:

Vereinbarung mit der FDA über SPA getroffen

 
10.08.10 18:38
ir.advancedlifesciences.com/...e&ID=1458596&highlight=
Antworten
Fratze:

Artikel in der Bio World:

 
17.08.10 21:28
phx.corporate-ir.net/...gzOTZ8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1
Antworten
Fratze:

ADLS auf der 50. Interscience Conference

 
17.08.10 21:31
on Antimicrobial Agents and Chemotherapy vom 12. bis 15.09.2010:

ir.advancedlifesciences.com/...e&ID=1460575&highlight=
Antworten
Fratze:

Auf der Suche nach weiterer Unterstützung

 
25.08.10 22:39
durch die Regierung:

ir.advancedlifesciences.com/...e&ID=1462678&highlight=
Antworten
Menne:

Present at 12th Annual Rodman and Renshaw Healthca

 
07.09.10 09:41
September 12-15th in New York City.

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: photos.prnewswire.com/prnh/20080218/ALSLOGO)

(Logo: 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 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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Participates in Key Infectious Disease Conference

 
20.09.10 12:11
Advanced Life Sciences Participates in Key Infectious Disease Conference
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 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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Current report filing (8-K)

 
20.09.10 12:16
- Current report filing (8-K)
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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News 04.10.10

 
08.10.10 14:12
Advanced Life Sciences Offers Testimony at Senate Hearing on Defending Against Public Health Threats

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:

appropriations.senate.gov/...71f5d-a28d-42a7-95ea-fd0e567d817c

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