VANCOUVER, Oct. 27 /PRNewswire-FirstCall/ -- Patch International Inc. (PAII: OTCBB, PQG: Berlin Bremen Stock Exchange) announced that Pharmaxis (PXS: Australian Stock Exchange) is pleased to announce the Phase III clinical trial of Aridol(TM) 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 authorization 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. Patch holds 11.2 million shares in Pharmaxis and is the company's second largest shareholder behind the Rothschild Group.
Aridol is designed to identify patients with active asthma and provide information on the severity of their disease and the effectiveness of their current treatment. In the trial, Aridol correlated well with patients diagnosed as asthmatic by an expert physician. Importantly, preliminary analysis of the Aridol test results also suggests that 25% of the asthmatic patients studied should have their medication increased or changed to improve control of their disease, and up to 17% could have their medication decreased without adverse effects.
Asthma is a public health problem affecting 52 million people worldwide and 2.2 million people in Australia, and patients often need daily medication for its life-long effects. The diagnosis and management of asthma is most commonly based on observation of symptoms. Recent surveys indicate that only 5% of patients achieve optimum control of their asthma. For a long time, a new tool such as Aridol has been needed that can reduce the cost of asthma to healthcare systems and improve patients well being. Asthma cost the US healthcare system alone US$15 billion last year. In 2003, 400 lives in Australia and 4,500 in the United States were lost to asthma. The study demonstrated the safety of Aridol as a test for assessing the presence and severity of airway inflammation, and its sensitivity and specificity in identifying children and adults with asthma. The trial also demonstrated that Aridol compared well with hypertonic saline (HS), a test used to confirm asthma amongst athletes at the recent Olympic games. No serious adverse events occurred in any subject.
The Phase III, open label, blinded, randomised crossover trial commenced in January 2004, and studied 646 asthmatic and non-asthmatic subjects aged from 6 to 83 years, at 12 hospitals in Sydney, Melbourne, Brisbane, Newcastle and Canberra. The trial was conducted in accordance with the International Committee of Harmonisation (ICH) guidelines for Good Clinical Practice (GCP).
Aridol is a patented, inhalable, dry powder that can be administered using a convenient, hand-held device. The test does not require specialist equipment and can be performed in a general practitioner's surgery. It is manufactured by Pharmaxis in the company's TGA approved manufacturing facility.
Commenting on Pharmaxis, President David Stadnyk said:
"I am pleased that our roots as a pharmaceutical company are beginning to bear fruit. Patch has successfully turned its formation as a pharmaceutical company into a powerful appreciating investment that will grow and grow to the benefit of the company and each and every one of its shareholders. This is reflected in our balance sheet where the asset value increased for the quarter ending August 31, 2004 by 42.1% from the previous quarter ending May 31, 2004(x). With the new higher price level attained by Pharmaxis this week that value has increased substantially again."
ABOUT PHARMAXIS
Pharmaxis is a specialist pharmaceutical company committed to the research, development and commercialization of human therapeutic products for chronic respiratory and autoimmune diseases.
Pharmaxis is focused on the development of its two leading technologies. The first technology includes Bronchitol(TM) and Aridol(TM), which are inhaled non-ionic osmolytes. Bronchitol(TM) is being developed for the treatment of respiratory diseases - in particular, cystic fibrosis, bronchiectasis and chronic bronchitis. Aridol(TM) is an improved lung function test and is currently in a 600 subject multicentre Phase III study and over 250 subjects have been enrolled to date.
The second technology focuses on new immune response modifiers - PXS25 and PXS2000 - for the treatment of multiple sclerosis and rheumatoid arthritis.
The company has a pipeline of products in different stages of development, including four projects at clinical study stage (in patients), two projects in pre-clinical evaluation and one research project to identify a compound for development.
Pharmaxis operates a first class, TGA-licensed manufacturing facility at Frenchs Forest, near Sydney, Australia.
Pharmaxis was founded in 1998 and is chaired by Denis Hanley, former Chairman and CEO of Memtec Limited. He has extensive experience in growing Australian technology corporations to become successful global entities.
Pharmaxis was listed on the Australian Stock Exchange in November 2003. For additional information on Pharmaxis, please visit the corporate website at http://www.pharmaxis.com.au/.
ABOUT PATCH INTERNATIONAL
Patch International was a private corporation acquired by publicly traded Praxis Pharmaceuticals early this year. Patch trades under the symbol PAII. It is also listed on the Berlin Bremen Stock Exchange where it trades under the symbol PQG. In addition to its major investment interest in Pharmaxis Ltd. (PXS: Australian Stock Exchange) where it is one of the largest shareholders, along with CIBC, HSBC, and the Rothschild Group, Patch is involved in oil and gas projects in Saskatchewan, Texas, and the East Corning area in Northern California. Also, the company is involved globally in Ukraine, where it is in the final stages of talks to develop several oil and gas wells in conjunction with the Ukrainian government.
For further information visit our corporate website at http://www.patchenergy.com/.
Contact: Investor Relations Tel: 604-688-2790 Fax: 604-688-5390 E-mail: info@patchenergy.com
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made on behalf of the Company. All such forward-looking statements are, by necessity, only estimates of future results and actual results achieved by Patch International Inc. may differ materially from these statements due to a number of factors. Patch International Inc. assumes no obligation to update these forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting such statements. You should independently investigate and fully understand all risk before you make investment decisions.
------------------------------------------------- (x) This percentage increase is based on the discounted price as per the company balance sheets and not the actual price.
Patch International Inc.CONTACT: visit our corporate website at http://www.patchenergy.com/; InvestorRelations, Tel: (604) 688-2790, Fax: (604) 688-5390, E-mail:info@patchenergy.com
