Pharmaxis--Bioperle - 500 Beiträge pro Seite

[BrauchGeld]

Hallo

Beim stöbern nach günstigen aktien bin ich auf diese Biotechaktie aus australien gestossen.

Pharmaxis besitzt eine gute weit entwickelte pipeline,erstes produkt Aridol(Asthma) steht kurz vor der Zulassung (4Q-05) in europa und australien .

Mk:157mio A$
Cash:39 mio A$

Website:
http://www.pharmaxis.com.au

Pipeline:
http://www.pharmaxis.com.au/clinical-development/product-pip…

Broker analyse von 12 mai 2005
http://www.pharmaxis.com.au/library/PXS20050512.pdf

Mehr Infos gibts hier:
http://www.pharmaxis.com.au/library/2005_March_07.pdf

Für mich ein Kauf ist ubrigens auch in Berlin gelistet aber kein volumen.

Freue mich über euere meinung.

Gruss
B.M.

[BrauchGeld]

Moin

Pharmaxis hat gestern neues Ath erreicht bei 1,68A$ bevor die kleine korrektur einsetzte ,aber bereits heute wieder
gehts aufwärts auf akt.1,66A$.
Bei Thread eröffnung lag der kurs bei 1,17A$,die aktie befindet sich nach wie vor in einem sauberen aufwärtstrend.


Gruss
B.M.

[BrauchGeld]

Hallo

News die fürs 3Q erwartet werden:

1. Bronchitol-Bronchiectasis --Start US Phase3
2. " -Cystic Fibrosis --Final Phase2 Results

http://www.pharmaxis.com.au/library/PXS20050623.pdf

[BrauchGeld]

Hallo


Neue Presentation:
http://www.pharmaxis.com.au/library/2005_July_5_Investor_Pre…


News die fürs 3Q erwartet werden:

1. Bronchitol-Bronchiectasis --Start US Phase3
2. " -Cystic Fibrosis --Final Phase2 Results
3. Zulassung für Aridol in Australien

[BrauchGeld]

Moin

Pharmaxis erhält Orphan Drug Status für Cystic Fibrosis

http://www.pharmaxis.com.au/library/2005_07_20_Orphan_Drug_C…

Und noch eine gute Nachricht

http://www.pharmaxis.com.au/library/2005_07_21_CF202_Canadia…

[BrauchGeld]

Hallo

Pharmaxis macht mich glücklich mit knapp 100% gewinn und die aussichten auf weitere kursgewinne stehen gut.

http://www.pharmaxis.com.au/library/2005_08_23_NASDAQ_Listin…

[BrauchGeld]

Hallo

Pharmaxis kennt nur eine richtung und zwar nach Norden.

Pharmaxis präsentiert positive Daten:
http://www.pharmaxis.com.au/library/2005_08_31_CF201_results…

[BrauchGeld]

Hallo

Eine ausführliche analyse von Wilson:

http://www.pharmaxis.com.au/library/PXS20050831.pdf


Pharmaxis notiert jetzt bei 2,20 a$ und die Markkap. beträgt ca.315 mio A$ (ca.200mio€) dennoch sehe ich genug spielraum nach oben.

[RLD]

Danke für den TIPP!
Ich hab mir den Wert auch mal kurz angeschaut!
Sieht äußerst vielversprechend aus!

Werde mich in den nächsten Tagen näher mit dem Wert beschäftigen!

[BrauchGeld]

Hallo

Enrolment Commenced in Aridol(TM) COPD Study
Friday September 16, 9:00 am ET


SYDNEY, Australia, Sept. 16 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX: PXS - News; Nasdaq: PXSL - News) is pleased to announce that its Aridol(TM) Phase II clinical trial in 140 patients with chronic obstructive pulmonary disease (COPD) has enrolled its first patient. The study is designed to assess the ability of Aridol to predict the usefulness of inhaled corticosteroids as a treatment for COPD. It is being conducted in 12 sites throughout Australia.
All patients in the study will receive an Aridol test at the beginning of the trial, and then begin a 12 week course of inhaled corticosteroids. The trial will record differences in lung function, quality of life and general health of the patient. Full patient recruitment is expected to take about six months and, with a treatment period of three months, results are not expected before the quarter ending September 30, 2006.

Alan Robertson, Pharmaxis chief executive officer said: `This latest trial will assess the potential second use for Aridol. According to our preliminary data, only one in five COPD patients respond to inhaled steroids. Our expectation is that Aridol will be able to identify the responders. If successful, Aridol has the potential to cut the consumption of inhaled steroids and reduce expense and unnecessary side effects for a large number of patients.`

COPD is the world`s fourth largest cause of death, and is estimated to affect about 30 million people in the western world.


To find out more about Pharmaxis, go to http://www.pharmaxis.com.au .
About the trial

The following information is provided in accord with the ASX and AusBiotech draft Code of Best Practice for Reporting by Biotechnology, Medical Device and other Life Sciences Companies.


Name of Trial DPM-COPD-201 (a Phase II study with Aridol)
Blinding Status Open
Placebo Controlled No
Treatment Method
Route Inhalation
Frequency Once only, before treatment with inhaled
corticosteroids
Dose level 0 - 635mg inhaled mannitol
No of subjects 140
Subject Selection
Criteria Aged 45 - 80 years, male and female, more than 10 pack
years smoking history, spirometry consistent with
COPD (pre-bronchodilator FEV1 more than 60%
(and >1.4L) and FEV1/FVC less than 70%),
symptoms of dyspnoea and/or chronic cough and/or
excess sputum production, untreated with
ICS or oral steroids for a period of 6
weeks, clinically stable for 14 days prior
to study entry.
Trial Location Australia
Commercial partners
involved None
Expected duration 12 months
Primary end point FEV1 for Aridol positive vs Aridol negative
patients
Secondary end points Aridol dose provoking a fall in FEV1 of
10% and 15%
Response dose ratio
Lung function parameters
Quality of life
Exacerbations

[BrauchGeld]

Hallo

Tolle Performance in den letzten 6 monate und weitere kursgewinne sind zu erwarten!

http://finance.yahoo.com/q/bc?s=PXS.AX&t=6m&l=on&z=m&q=l&c=


Australia`s Pharmaxis files to sell 1.4 mln ADSs

WASHINGTON, Sept 26 (Reuters) - Australia-based pharmaceutical company Pharmaxis Ltd. (PXS.AX: Quote, Profile, Research) (PXSL.O: Quote, Profile, Research) filed with U.S. regulators on Monday to sell up to 1.4 million American Depositary Shares, representing 21 million ordinary shares.
The company said it will use the proceeds from the offering for clinical development, commercial product launches and the expansion of its manufacturing facilities.

[BrauchGeld]

Hallo

Auch meine Pharmaxis die Poweraktie aus Australien markiert fast täglich neue hochs.
In 5 jahren wird nach angaben Pharmaxis einen umsatz von über 1Mrd A$ erreichen ,wenn die rechnung aufgeht dann sind noch einige 100% drin.

http://finance.yahoo.com/q?s=pxs.ax

http://www.pharmaxis.com.au/library/2005_Sept_29_Financials_…

[BrauchGeld]

Hallo

Zulassung für Aridol(Asthma) in Europa und Australien steht kurz bevor.
Pharmaxis bronchitol gegen cystic fibrosis zeigt viel bessere wirkung als das aktuelle meißtverkaufte produkt Pulmozyme von Roche.
Tolle aktie mit reichlich potential.

Präsentation Oktober:
http://pharmaxis.com.au/library/2005_Oct_18_Investor_Present…

[BrauchGeld]

Bronchitol Granted Orphan Drug Status in Europe
Monday November 14, 8:45 am ET


SYDNEY, Nov. 14 /Xinhua-PRNewswire-FistCall/ -- Pharmaxis Ltd (ASX:PXS, NASDAQ:PXSL) announced today that the European Medicines Agency (EMEA) has granted Orphan designation to the company`s product Bronchitol(TM), for the treatment of cystic fibrosis.

Orphan designation has been granted on the basis of Bronchitol`s potential to treat cystic fibrosis, a genetic disease which, for the patient, is characterised by recurring respiratory complications.

Alan Robertson, Pharmaxis chief executive officer said: ``This European Orphan designation is another major step forward in the development of Bronchitol. The assistance from the EMEA in the final development of Bronchitol will be invaluable in bringing this product to the cystic fibrosis community.``

Our recent Phase II trial in cystic fibrosis patients was successful, and demonstrated statistically significant improvements in lung function for patients being treated with Bronchitol. Pharmaxis is conducting an additional Phase II trial aimed at determining the optimal Bronchitol dose for cystic fibrosis and is planning to commence the final international Phase III clinical trials in 2006.

Approximately 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis and no products have been approved to improve lung hydration.

European Orphan designation is granted to those products intended for the diagnosis, prevention and treatment of diseases that affect not more than five in 10,000 people in the European Community, or conditions where no current therapy exists. European Orphan designation entitles Pharmaxis to a range of incentives including a ten-year period of market exclusivity, protocol assistance to optimise drug development in the designated indication, reduction in registration fees and eligibilty for grants and initiatives supporting research and development.

[BrauchGeld]

Pharmaxis macht sehr gute fortschritte ,schon in wenigen wochen wird die kasse klingeln.

Präsentation Feb 06:
http://www.pharmaxis.com.au/library/2006_02_10_investor_pres…

Wilson Analyse Feb 06:
http://www.pharmaxis.com.au/library/PXS20060213.pdf

PHARMAXIS ADMITTED TO S&P/ASX 300 AND ALL ORDINARIES INDICES
http://www.pharmaxis.com.au/library/2006_03_03_SP_ASX_300__A…

ARIDOL RECOMMENDED FOR MARKET AUTHORISATION BY ADEC
http://www.pharmaxis.com.au/library/2006_02_13_ADEC_decision…

Upcoming Milestones
Aridol
Potential Aridol approval in Australia & EU: 1H06
Data from Phase II COPD trial: 2H06
Data from Phase III US trial 2H06
Bronchitol
Initiate bronchiectasis pivotal trial: 4Q05/1Q06
Initiate US bronchiectasis pivotal trials: mid-06
Initiate CF pivotal trials: 2006
Data from CF dosing study: Mid-06
Pipeline
US IND for PXS64 for multiple sclerosis: 2006
Nominate IND candidate for PXS2076 for RA: 2006

[BrauchGeld]

Cash:110 mio A$
MarktKap:460 mio A$
Kurs:2,47 A$

März 06 Präsentation:
http://www.pharmaxis.com.au/library/2006_Mar_21_Investor_Pre…

Aridol
Approval – Aus 1Q 2006
Approval – EU 2Q 2006
Launch – Aus 2Q 2006
Launch EU 3Q 2006
COPD clinical data 2Q 2006
Ph III US clinical data 2Q 2006

Bronchitol – cystic fibrosis
Dosing study data 2Q 2006
Commence PIII trial 3Q 2006
Pulmozyme trial enrolled 4Q 2006

Bronchitol – bronchiectasis
Commence Ph III trial 2Q 2006

Bronchitol – chronic bronchitis
Commence Ph II trial 3Q 2006

[BrauchGeld]

Antwort auf Beitrag Nr.: 16.747.377 von BrauchGeld am 30.05.05 13:22:01

Pharmaxis hat für australien die zulassung erhalten im nächsten Quartal ist Europa dran.

Australia approves Pharmaxis asthma test kit

Thursday March 23, 2006, 1:42 pm



(Adds CEO comments)

MELBOURNE, March 23 (Reuters) - Australia's drug regulator has approved Pharmaxis Ltd.'s (ASX: PXS.ax) first product, an asthma diagnosis test, for sale in Australia.

The lung function test kit could generate annual sales between A$200 million and A$250 million ($144 million to $180 million) once it is available globally, Pharmaxis Chief Executive Alan Robertson said.

Pharmaxis expects to have its first sale of Aridol in Australia shortly after it is launched this weekend and hopes to have first sales in the United States in 2007.

"I expect the uptake to be very rapid," Robertson told reporters.

Unlike most Australian biotech groups which license out their drug discoveries, Pharmaxis developed the drug from the lab to the market and is negotiating agreements for it to be sold in Europe.

Aridol measures the symptoms of asthma in a patient's airways to identify how severe it is and how effective the patient's current treatment is.

Pharmaxis plans to sell the product to respiratory specialists and laboratories. It is equipped to produce 1 million kits a year, and expects to expand that to 30 million kits a year from 2008. Each kit will be priced at A$50.

"It fills a gap. Currently there is no way of determining the level of airway inflammation in a person's lungs without an invasive procedure," Robertson said.

Pharmaxis is one of a handful of publicly traded Australian biotech groups seen by several biotech investment experts as having strong potential, with its focus on developing products to treat and manage respiratory and autoimmune diseases.

"It's one of the better prospects in the market," said Intersuisse analyst Darren Grubb.

Its main advantage over most other biotechs is that it has products in the later stages of development which fill unmet clinical needs.

Pharmaxis expects to secure European approval for Aridol in the second quarter of this year, and it expects to complete a clinical trial of Aridol's effectiveness in the United States in mid-2006.

Pharmaxis also expects to start a Phase III trial of its drug Bronchitol to treat cystic fibrosis in the middle of this year, which it expects to complete by the end of 2007.

"It's a project of very high priority for us," Pharmaxis' Robertson said.

Following its listing on the Nasdaq and a capital raising in Australia last year and with expected revenue from Aridol, the group has enough cash to cover the launch of Aridol and clinical trials and a launch of Bronchitol, he said. Pharmaxis shares last traded steady at A$2.47, valuing the group at A$433 million. The group was added to Australia's S&P/ASX 300 index on March 17. ($1=A$1.39)