PXS--Pharmaxis Ltd

**stolwyk** · 02-11-2004, 11:42 AM

PXS--PHARMAXIS Ltd.

This is one of the 6 Bio stocks previously selected.

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

Chart: http://bigcharts.marketwatch.com/jav...XS&time=&freq=

Quarterly Report: Outflow: $2.04 mill. Cash: $22.9 mill

There is a trading halt in progress to raise more cash so as to fund completely Phase III of a trial. Current price: 83 cents
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Today's AFR- Street Talk:

Pharmaxis goes solo with Aridol

Respiratory disease drug developer Pharmaxis is achieving something few Australian biotechs can claim by taking its asthma diagnosis test Aridol through Phase III trials and funding the whole process itself.

Pharmaxis was in a trading halt yesterday while it raises $15million in a placement through the same broker it used when it floated last year, Wilson HTM. The biotech will not return to the screens until tomorrow, but is expected to pitch the issue at a 10per cent discount to its last close of 83¢, compared with its float issue price of 50¢.

The company's last cashflow statement shows it had $23million in cash at the end of the last quarter, so it is not in dire need of the money. Pharmaxis's strategy, unlike many biotechs, is to fund drug development through each stage, rather than bring in a big pharmaceutical company to pay for the privilege in return for the bulk of the returns.

Assuming the drug has some merit, the longer it can be funded internally, the more valuable the drug becomes to the big companies.

Aridol is but one part of the company's portfolio, and Pharmaxis also has high hopes for the Bronchitol product, a therapeutic treatment for cystic fibrosis and chronic obstructive pulmonary disease.

Aridol is a patented, inhaleable dry powder designed to identify patients with active asthma and provide information on the disease's severity and the effectiveness of treatment. The dose causes the airway to contract and the amount of air a patient can exhale in one second measures the severity of the illness. As it stands, doctors rely on older tests that can be inaccurate and cumbersome.

Asthma is obviously a significant burden on the health system, costing the United States some $US15billion ($20billion) last year and killing 4500 people there and 400 in Australia. Pharmaxis expects to start generating cashflow from Aridol within the next 12 months.
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Gerry
Holds PXS
Readers, please do your own research and you decide if and when to buy, hold or sell any stocks.

**stolwyk** · 02-11-2004, 12:51 PM

27 Sept: media release: BRONCHIECTASIS CLINICAL TRIAL:

http://stocknessmonster.com/news-ite...E=ASX&N=343430

Extract:

"Pharmaxis announces positive results from Phase II trial of BronchitolTM Pharmaxis (ASX:PXS) today announced that the Phase II BronchitolTM clinical trial has demonstrated the safety and feasibility of using Bronchitol in longer term Phase III clinical
trials in patients with bronchiectasis, a respiratory disease affecting more than 600,000 people worldwide.

Dr Alan Robertson, Pharmaxis CEO said that results from the study were very impressive.

“The success of this bronchiectasis trial is a very significant milestone in the development
of Bronchitol.

The positive outcome from this exploratory study takes us an important step closer to getting Bronchitol into the marketplace,” he said.

Bronchitol is a patented, inhalable, dry powder that can be administered by a convenient, hand-held, pocket sized device. It is manufactured by Pharmaxis in the company’s TGAapproved manufacturing facility.

Bronchitol is being developed for the management of
various chronic obstructive lung diseases, in particular bronchiectasis, chronic bronchitis and cystic fibrosis.

Brett Charlton, Pharmaxis Medical Director, said: “the positive results from this and earlier studies, and feedback from many patients in the study that their lives were improved after only 2 weeks therapy, is very encouraging in this difficult to treat disease”.

The double blind, placebo controlled, crossover trial enrolled 60 adults aged from 18 to 75 who suffer from bronchiectasis, a form of chronic obstructive lung disease. It commenced in November 2003 and was conducted at hospitals in Sydney and Melbourne in Australia, and Auckland in New Zealand.

A statistically significant improvement in a quality of life score was observed after two weeks treatment with
Bronchitol and statistically significant improvements were also seen in sleep quality as reflected in a ‘sleepiness’ score.

The improvement in quality of life was considered
clinically significant. Patients with an unclear chest at commencement of treatment had a highly significant improvement in their bronchiectasis symptoms score on
Bronchitol compared with placebo.

Out of the 60 patients recruited, 3 withdrew during the study; 2 whilst on placebo and one whilst on Bronchitol. Adverse events occurred with similar frequency on both Bronchitol and placebo treatments.

No serious adverse events were recorded and no deleterious effects on lung function or infections were observed.
The primary objective of the trial was to compare the effects of twice daily treatment of Bronchitol on the disability and handicap associated with bronchiectasis before and after treatment and against placebo.

Disability and handicap was assessed by quality of life and symptom questionnaires, as well as exercise testing. The trial was conducted in accordance with the International Committee of Harmonisation (ICH) guidelines for Good Clinical Practice (GCP).

Bronchiectasis is an irreversible dilation of the main airways to the lungs, commonly accompanied by chronic infection. There are many causes of bronchiectasis and the disease can develop at any age, although symptoms may not be apparent until later in life.

Most patients are affected by chronic cough and phlegm. The symptoms often begin quietly, usually after a respiratory infection, and tend to worsen gradually over a period of years.

Pharmaxis is aiming to have all studies completed to enable submission of a general marketing approval for bronchiectasis with the TGA by 2006.

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

ends#
For further information, please contact:
Alan Robertson - Pharmaxis Chief Executive Officer
Ph: (02) 9454 7216 or alan.robertson@pharmaxis.com.au
Released through:
Ashley Rambukwella – Financial & Corporate Relations
Ph: (02) 8264 1004 / m. 0407 231 282 or a.rambukwella@fcr.com.au

About Pharmaxis
Pharmaxis is a developer of innovative pharma

**stolwyk** · 02-11-2004, 12:59 PM

26 Oct: ARIDOL PHASE III ASTHMA TRIAL SUCCESSFUL

http://stocknessmonster.com/news-ite...E=ASX&N=347045

Extract:
Pharmaxis (ASX:PXS) is pleased to announce the Phase III clinical trial of AridolTM achieved its endpoints. The trial was designed to evaluate Aridol as a test for asthma.

The positive results mean the company will apply for marketing authorisation later this year in Australia, and early in 2005 in Europe. Subject to regulatory approval, sales of Aridol are
expected to commence in 2005.

The annual revenue potential of Aridol as a management tool for Asthma is estimated to be in excess of $250 million".

02-11-2004, 05:21 PM

Gerry a new record 100%

**stolwyk** · 03-11-2004, 11:20 AM

Placement of $16.5 Million & Share Purchase Plan

Pharmaxis Announces Placement of $16.5 million and Share Purchase Plan
Strong support has enabled Pharmaxis (ASX:PXS) to raise $16.5 million through a fully underwritten placement to Australian institutions and sophisticated investors.

The placement replenishes the company’s cash funds expended on its successful clinical trials during 2004 and therefore allows Pharmaxis to proceed with a new international Phase III trial for BronchitolTM in 2005.

Pharmaxis will issue 22 million new fully paid ordinary shares at 75 cents, an 8.9 per cent discount to Pharmaxis’s volume weighted average share price over the past 30 days. The shares to be issued will rank equally with existing ordinary shares in the capital of the
company.

The settlement of the placement is fully underwritten by Wilson HTM Limited and is scheduled to take place in two tranches. Sale of the first tranche of 16.2 million shares closes on 12 November 2004, while the issue of the second 5.8 million share tranche is
subject to shareholder approval at a general meeting intended to be held on 13 December 2004.

A share purchase plan will be offered to all shareholders who hold shares on 8 November 2004 and will enable them to purchase up to $5,000 worth of fully paid ordinary shares at the institutional placement price of 75 cents. The share plan offer opens on 10 November
and closes on 3 December 2004.

Alan Robertson, chief executive officer of Pharmaxis said “We are particularly delighted with the strong support from the participating institutions. The proceeds of the placement and the share purchase plan will give the company cash reserves of more than $39 million,
allowing us to embark on the international Phase III clinical trial for Bronchitol and at the same time prepare for the marketing of our asthma management test AridolTM.

The placement follows successful results from Pharmaxis’s Phase II clinical trial of Bronchitol in bronchiectasis and its Phase III Aridol asthma trial. Aridol is the first management tool for asthma and offers an improved health outcome for asthma patients.

Bronchitol is a patented, inhalable, dry powder that can be administered by a convenient, hand-held, pocket sized device. Bronchitol is being developed for the management of various chronic obstructive lung diseases, in particular bronchiectasis, chronic bronchitis and cystic fibrosis. It is manufactured by Pharmaxis in the company’s TGA approved manufacturing facility in Sydney.

To find out more about Pharmaxis, go to http://www.pharmaxis.com.au
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**stolwyk** · 19-11-2004, 03:28 PM

PRESENTATION:
http://stocknessmonster.com/news-ite...E=ASX&N=350403

**stolwyk** · 19-11-2004, 04:13 PM

Pharmaxis Establishes Level One American Depositary Receipt (ADR) Program:

http://stocknessmonster.com/news-ite...E=ASX&N=349461

Extract:
A Level One ADR Program facilitates the purchase of Pharmaxis shares by US investors.

Under the program, one ADR is equivalent to 15 ordinary shares of Pharmaxis.

The ADR’s trade in the US over-the-counter (OTC) market under the symbol PHMXY (CUSIP number
71715J105).

**stolwyk** · 22-11-2004, 11:02 AM

Pharmaxis files Aridol IND in the USA:
http://stocknessmonster.com/news-ite...E=ASX&N=350565

Extract:
"Alan Robertson, Pharmaxis chief executive officer said that the filing of the IND was an important event in the continuing globalisation of Aridol: “The recently completed Australian Aridol trial allows us to apply for marketing authorisation in Europe and Australia.

This study has been designed to extend our authorisation to the American market,” he said.
“The filing of the IND represents the culmination of a significant effort by very many people and is indicative of the quality and expertise of the team we have assembled. The results
from this trial and the recently completed, successful Phase III Australian trial will form the basis of a marketing application to be submitted to the FDA in 2005.” said Dr Robertson.

The Phase III clinical trial will be conducted over ten sites in the US and will recruit 130 subjects. The objective of the trial is to determine sensitivity and specificity of Aridol with respect to clinical diagnosis of asthma".