Company Highlights
The first subject has enrolled in Pharmaxis’ second pivotal Phase 3 study of Bronchitol in cystic fibrosis sufferers.
The study aims to recruit more than 250 subjects throughout the United States, Argentina and Germany.
The new trial is the second of two required for a U.S. marketing application. Initial data from the trial is not expected before the end of 2009.
Pharmaxis is confident the results from both studies will reinforce the positive outcomes from three Phase 2 studies, which resulted in Bronchitol being awarded fast-track status in the U.S., and orphan drug designation in both the U.S. and EU.
Cystic fibrosis is a fatal disease, affecting more than 75,000 people worldwide.
In September 2008 Pharmaxis submitted a marketing application in Australia for Bronchitol as a treatment for bronchiectasis.
This follows a long-term Phase 3 safety study of more than 360 subjects finding that Bronchitol is safe, with no serious adverse events attributable to the medicine.
This supports results from an earlier stage of the trial showing that Bronchitol delivered a highly significant improvement in users' quality of life.
The medicine is expected to be approved for bronchiectasis first in Australia, and later in the U.S. and Europe following the completion of a further Phase 3 trial.
Bronchitol will be the first targeted medication for sufferers in over 20 years.
I still remember the sharemarket crash of 1987. I remember it well as since that time I have not used leverage in my personal investing activities. Instead I have chosen my portfolio carefully so that the growth component of my portfolio comes from wealth creating growth businesses such as Pharmaxis. 2008 seems to me to be among the most difficult market conditions since 1987. I do not think leverage will be used to the same extent in the portfolios of many investors as it has been in the recent past and to that extent I believe companies like Pharmaxis may eventually benefit.
While market downturns affect individual investors differently depending on their individual circumstances, the effect of the downturn is entirely different for our company and its operation. We cannot be immune from the short term market price movements but the business of our company, which is well funded, proceeds independently of market conditions.
It is within this context that I note that Pharmaxis is well advanced with its commercial development. The numerous clinical trials commenced, enrolled, continued, completed and reported this past year (two Phase 2 and three Phase 3) have properly positioned us to achieve our goal of becoming a significant pharmaceutical business.
If we look forward twelve months for the Bronchitol cystic fibrosis indication alone, this time next year we expect to have reported a successful Phase 3 clinical trial and therefore be waiting on the European regulators for approval to market Bronchitol for CF in the European Union. Across the Atlantic meanwhile, we expect to have closed recruitment for our second Phase 3 trial required to obtain marketing approval for the same condition in the United States.
For our second chronic Bronchitol indication, bronchiectasis, we satisfactorily completed the negotiation of the clinical and regulatory requirements of both the US FDA and the EU EMEA in June of this year. In a year’s time we expect to be well advanced in this pivotal Phase 3 trial. In Australia, we filed a marketing approval application for bronchiectasis with the Therapeutics Goods Administration late September and expect a response from them in approximately 12 months time.
In December 2007 we commenced the construction of our new facility in Sydney. By this time next year we expect to be completing the final validation steps that will gives us the capacity to supply Bronchitol to the world markets.
So, while 2008 has been a big year for Pharmaxis, 2009 holds the promise of being even bigger.
I wish to acknowledge the contributions of Dr Alan Robertson and his management team for their leadership, tireless efforts and successes in the growth and development of our Pharmaxis business.
I also wish to thank the Board for their oversight and strategic direction of the company, and the Pharmaxis management and staff for again delivering on our plan.
Progress continues on the new Pharmaxis headquarters and factory in Frenchs Forest, Sydney.
The new facility will house Australia's largest spray dryer for pharmaceutical manufacturing - a state-of-the-art machine from Denmark measuring more than three stories high.
It will be capable of producing 260 million capsules of Bronchitol a year, enabling the company to supply world markets efficiently and rapidly as soon as the product is approved.
The 7,000 square metre facility is on track to be completed in early 2009.
