Astex Pharmaceuticals,Hammer !

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Chalifmann3:

Astex Pharmaceuticals,Hammer !

 
07.02.12 22:29
I'm humbled frequently by finding a stock I've never come across in 13-plus years of investing. Such was my feeling yesterday when a quick screen-searching for value in the biotech sector turned up Astex Pharmaceuticals (Nasdaq: ASTX  ) .

Astex merged with SuperGen last year to form the company you see today with one marketed drug and more than a half-dozen others in the pipeline. There are three things which I feel could make Astex a compelling buy.

The moneymaker
First, there's the company's already-approved myelodysplastic syndrome treatment, Dacogen. The company has a royalty-based platform in place where it receives between 20% and 30% of all Dacogen sales from its marketing partners which include Eisai Pharmaceuticals in North America and Jaansen Cilag, a subsidiary of pharmaceutical giant Johnson & Johnson (NYSE: JNJ  ) , internationally. Through the first nine months of fiscal 2011, royalty revenue is up 21%, to $45.1 million.

The really exciting news could come when the FDA makes its decision on Dacogen as a treatment for acute myeloid leukemia, which should offer Astex a broader market of potential patients. Admittedly the phase 3 clinical results weren't overwhelmingly open-and-shut. The injections' median survival time was 7.7 months versus the placebo's 5 months. Still, this statistical jump could be enough to get Dacogen approved as a treatment for AML by March.

Band of brothers

Secondly, Astex has built some amazing partnerships despite being such a small company ($267 million). As previously mentioned, it has its own pipeline of drugs under development, as well as collaborative partnerships. It currently has AT7519 in phase 2 clinical trials as a possible treatment for solid tumors and forms of leukemia and has Novartis (NYSE: NVS  ) as a potential marketing partner for the drug. Novartis is also collaborating with Astex on LEE001, an inhibitor that targets specific enzymes of the cell cycle.

These partnerships aren't just limited to J&J and Novartis, either. AstraZeneca (NYSE: AZN  ) and Astex are currently collaborating on two phase 1 clinical trials -- AZD3839 and AZD5363. The former could have implications on treatments for Alzheimer's while the later may offer solutions to various tumor types. It also has pre-clinical studies currently ongoing with GlaxoSmithKline (NYSE: GSK  ) to identify therapies of interest to Glaxo.

Ka-ching!
It already has a drug on the market, another one waiting FDA approval, a vast pipeline of partnerships … and oh, yeah, one last thing -- it has the cash to back it all up.

Astex is currently sitting on $126 million in cash with no debt, offering it the flexibility to undertake many clinical and pre-clinical trials at once. Dacogen as a treatment for MDS has recently been enough to keep the company profitable and, barring an approval of Dacogen as a treatment for AML, could be the final alluring element that coaxes one of these four marketing partners named above to purchase Astex outright.

MFG
Chali
Astex Pharmaceuticals,Hammer ! 483369

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Chalifmann3:

Pipeline

 
07.02.12 22:31
Astex Pharmaceuticals

Astex Pharmaceuticals, headquarted in Dublin, California, specializes in areas of oncology and hematology. Using their fragment-based drug discovery platform, Pyramid, Astex has generated a large number of lead compounds in areas such as oncology, inflammation, viral infection, inflammation and Alzheimer's disease. The company has one FDA-approved product, Dacogen, and many more molecules in their clinical pipeline with a large number of those in partnership with big pharmaceutical companies. Their approved product, Dacogen, is indicated for myelodyplastic syndromes, and is estimated to receive over 60 million in royalties for fiscal year 2011 from their partner Eisai (ESALY.PK). The revenue from Dacogen is adding to the company's extremely strong balance sheet. At 125 million dollars, Astex's cash and equivalents represent half of the company's market capitalization. In addition, Dacogen is seeking FDA approval in the treatment of acute myelogenous leukemia-further expanding treatment indications and revenue for this compound.

With 15 programs-many of which are partnered with big pharma-currently underway, Astex has an impressive and robust pipeline. This is a testament to the lead-generating ability of Pyramid.


Product
Partner
Indication
Clinical Trial Status

Decitabine (Dacogen)
Eisai, Johnson & Johnson (JNJ)
Myelodisplastic syndromes
FDA approved and marketed

Decitabine (Dacogen)
Eisai, Johnson & Johnson
Acute myelogenous leukemia
NDA, with a PDUFA date of March 6, 2012

AT13387
Astex
Advanced refractory tumors
Refractory gastrointestinal stromal tumors
Phase I for advanced refractory tumors

Phase II for refractory gastrointestinal stromal tumors

SGI-110
Cancer centers/Stand Up to Cancer Epigenetics Dream Team
Relapsed/refractory myelodisplastic syndromes
Phase I-2

SGI-110
Astex

Cancer centers/Stand Up to Cancer Epigenetics Dream Team
Relapsed/refractory acute myelogenous leukemia
Phase I-2

Amuvatinib/MP-470
Astex
Small cell lung cancer
Phase II

AT7519
Novartis (NVS)
Multiple myeloma
Phase II

LEE011
Novartis
Cancer
Phase I

AZD5363
AstraZeneca (AZN)
Advanced solid tumors
Phase I

FGfr Inhibitor
Janssen
Cancer
Candidate Selected

AZD3839
AztraZeneca
Alzheimer's disease
Phase I

AT9283
Astex/Cancer Research UK
Solid Tumors
Pediatric Solid Tumors
Phase I

AT9283
Astex/NCIC Clinical Trials Group in Canada
Refractory multiple myeloma
Pediatric leukemia
Phase II

Multiple targets
GlaxoSmithKline (GSK)
Multiple targets (confidential)
Discovery

Oncology targets
Janssen
Cancer targets (confidential)
Discovery

Astex Pharmaceuticals has a market capitalization of 260 million and currently trading at 2.79 with a 52-week range of 1.51-3.35. The company has 125 million in cash and equivalents and no debt.

MFG
Chali
Abnobagallus:

??? Was bedeutet das denn?

 
07.02.12 22:33
Chalifmann3:

FDA Request

 
07.02.12 22:34
Astex Pharmaceuticals Inc., a drugmaker that specializes in cancer therapies, fell the most in almost eight years after U.S. regulators said the company’s only approved treatment didn’t show a benefit for an expanded use.

Astex, based in Dublin, California, fell 22 percent to $2.19 at the close in New York, the biggest single-day decline since April 2004.

Astex licenses Dacogen, approved for a condition that often leads to leukemia, to Tokyo-based Eisai Co. The Food and Drug Administration said Dacogen “failed to demonstrate benefit based on statistical interpretation” for patients 65 years old and older who have acute myelogenous leukemia, a form of blood cancer. An agency advisory panel is scheduled to review the drug on Feb. 9.

“The wording in the press release may telegraph to investors a more rigorous interpretation by the FDA,” said George Zavoico, an analyst with McNicoll Lewis & Vlak LLC in New York. “Eisai needs to say, ‘Look, the result is really significant if you give us a little bit of leeway. This will be the first drug available for an unmet clinical need.’’

Eisai reported Dacogen sales of $190 million in the fiscal year ended March 31, 2011.

Timothy Enns, a spokesman for Astex, didn’t return a call requesting comment on the FDA staff

MFG
Chali
Chalifmann3:

Buy now !

 
14.02.12 16:07
Just one week ago I was touting with confidence my excitement in discovering what I suspected was a rare gem in the biotechnology sector -- a profitable small-cap company with a deep pipeline of drug hopefuls.

Well, that was last week...

This week, Astex Pharmaceuticals (Nasdaq: ASTX  ) received news that the Oncologic Drugs Advisory Committee had voted 10-to-3 against recommending Dacogen as a treatment for acute myeloid leukemia for patients over the age of 65. One person abstained from the vote.

The ODAC is an advisory panel that the Food and Drug Administration doesn't have to follow, but it is usually a good forecaster of which way the FDA will sway. At the heart of the vote was the notion that Dacogen's risks outweigh the 2.7-month median survival benefit noted against placebo in phase 3 clinical trials. The FDA will have its final say on the matter on or before March 9.

My message to Astex shareholders in the meantime would be, "Relax!" Relax because your investment has $1.35 in cash per share with no debt. It still has Dacogen for the treatment of myelodysplastic syndrome, and the royalty revenues derived from its partnerships with Eisai Pharmaceuticals (OTC: ESALY) and Janssen-Cilag, a subsidiary of Johnson & Johnson (NYSE: JNJ  ) , are currently enough to keep the company marginally profitable even while running multiple clinical studies.

Relax because your pipeline is rich with drug hopefuls and has the potential for major partnerships. Astex is working on two phase 1 clinical trials with AstraZeneca (NYSE: AZN  ) targeting Alzheimer's and various types of tumors. It's also involved with one phase 2 and one phase 1 clinical trial with Novartis (NYSE: NVS  ) for therapies aimed at treating various types of tumors and forms of leukemia.

Was the ODAC news a setback? Obviously it doesn't bode well for the FDA decision on Dacogen as a treatment for AML. But the news also brought Astex back to a very reasonable buy point. At just 84% of book value and still decisively profitable, Astex still looks like a strong long-term buy candidate. I plan on using this pullback in the stock to make a CAPScall of outperform on Astex to show my long-term conviction in its pipeline

MFG
Chali
Leo4Essen:

Astex = unterschätzt + vielversprechend

 
23.07.12 11:02

- Astex Pharmceutical entwicklet kleine Moleküle hauptsächlich gegen Krebs.

- Finanzergebnis Q1/2012: $4.2 M Gewinn ( = 0.04 USD / Aktie) +  hat $126,2 M liquide Mittel zur Verfügung

- Produkte: Astex Pharmecutcal hat ein Pordukt auf dem Markt und wird am Umsatz beteuligt (Royalties); in 2012 geschätzte $65  M (!!);

                    man wird trotzdem noch ca. 12-15 M USD Verlust machen

- Pipeline: Es gibt fünf Produkte, die sich in Phase II befinden + drei weitere in Phase I; Parhner sind u.a. Novartis, AstraZenica, Janssen.

- Bilanz / Bewertung:

  - es gibt 93 Millionenn Aktien (103 Millionen verdünnt) + 2,13 Euro = 200 Millionen Euro Marktkapitalisierung

  - aufgrund der Porduktroyalties + der großen Cashreserven ist Astex sehr gut finanziert + benötigt wohl in absehbarer Zeit kein Cash

- Aktuelle Highlights: 

  am 20.Juli gibt Astex bekannt, "today announced that Janssen-Cilag International NV was notified that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion recommending approval of DACOGEN® (decitabine) for Injection in the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to the World Health Organization (WHO) classification who are not candidates for standard induction chemotherapy. Janssen is the licensee for DACOGEN in territories outside of  the United States, Canada and Mexico.

 The CHMP is the committee responsible for the scientific assessment of products seeking centralized marketing authorization throughout the European Union. The CHMP's positive opinion is now referred for approval to the European Commission. Janssen anticipates receiving the regulatory decision from the Commission in the end of the third quarter of 2012."

d.h. wenn alles gut geht, könnte das nächste Produkt von Astex in der EU zugelassen werden.

Leo4Essen:

von heute auf seekingalpha

 
23.07.12 16:34

Astex Pharmaceuticals (ASTX): Astex  is engaged in the development of therapeutics targeting life threatening  diseases, with a particular focus on oncology and hematology. It has a broad  pipeline of drugs in early- and mid-stage development. It is developing some of  these drugs independently, and some in collaboration with leading  pharmaceuticals companies, including Novartis (NVS), AstraZeneca (AZN), GlaxoSmithKline (GSK), and others. Besides, it also has one drug on the  market, DACOGEN, that is approved for the treatment of myelodysplastic syndromes  (MDS) in over 30 countries --  including the U.S. and most key markets -- and for which it receives royalties  from its marketing partners.

The strong move Friday, during which the stock initially rose 30% to its  $2.78 intra-day high before finally settling down at $2.50 at the close, was  based on much anticipated news that DACOGEN received positive regulatory  recommendation in the EU for the treatment of acute myeloid leukemia (AML) in  patients aged 65 and above. The strong move attempted to reverse a "mirror" down  move in early February, when the FDA's Oncologic Drugs Advisory Committee voted  10-3 against DACOGEN for the AML indication. The company expects to receive  approval from the European Commission by the end of Q3.

ASTX has a strong balance sheet, with over $1.25 million in cash per share  and no debt, a broad pipeline of oncology drugs in mid-stage development, a  currently globally marketed drug for which it receives royalties, and most  likely another cancer indication that will be approved in Q3. Wall Street  analysts are also bullish on the stock. Both analysts that cover it rate it at  buy/strong buy, with a mean price target of $4.25, well above Friday's closing  price of $2.52.

Bestätigt meine Meining: Ein Zielkurs von $4.25 entspricht  ca. 3,50 Euro  - also noch viel Luft nach oben!

Leo4Essen:

neues zu Astex

 
06.09.12 14:48

Bulls Keep Knocking On Astex's Door, Seekingalpha, 3.Sept. 2012  

Very recently, I stepped the rest of the

... (automatisch gekürzt) ...

http://seekingalpha.com/article/...ulls-keep-knocking-on-astex-s-door
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Leo4Essen:

Super - nächste Zulassung da..:-)

 
28.09.12 15:40

Astex Pharmaceuticals (NASDAQ: ASTX) announced that Janssen-Cilag International  NV was notified that the European CommissionAstex Pharmaceuticals,Hammer ! 14252063  has approved the marketing authorization for DACOGEN (decitabine) for the  treatment of adult patients (age 65 years and above) with newly diagnosed de  novo or secondary acute myeloid leukemia (AML), according to the World  Health…Astex Pharmaceuticals (NASDAQ: ASTX) announced that Janssen-Cilag  International NV was notified that the European Commission has approved the  marketing authorization for DACOGEN (decitabine) for the treatment of adult  patients (age 65 years and above) with newly diagnosed de novo or secondary  acute myeloid leukemia (AML), according to the World Health Organization (WHO)  classification, who are not candidates for standard induction chemotherapy.[i]  DACOGEN also has been granted Orphan Drug designation for the treatment of AML.

Astex darf das Medikament jetzt über den Partner 10 Jahre in der EU verkaufen, d.h. Astex wird geschätzte 80-100 Mio USD Einnahmen aus dem Medikament / Jahr haben. Sensationell, denn damit können die laufenden F&E Programm (mehrere Phase I und II) locker weitergeführt werden und Astex ist bestens finanziert und gerüstet für dei Zukunft.

 

 

Chalifmann3:

läuft verdammt gut hier ....

 
13.09.13 13:20
Bin leider nicht dabei,300% bis jetzt ,nicht schlecht Herr specht !

MFG
Chali
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