As per the latest ASX announcement, Pharmaxis Limited (ASX: PXS) has successfully completed the first sales of its asthma cure drug Aridol in United States post the relaunch of the product.
Pharmaxis is a pharmaceutical company based out in Sydney, Australia. The company is entirely focussing on inflammation and fibrosis diseases. PXS has two approved products namely Bronchitol (for the treatment of cystic fibrosis) and Aridol (diagnose and manage asthma), and a few more products in its pipeline.
Bronchitol is a dry powder which is inhaled for the treatment of cystic fibrosis. Currently, it is being sold in Europe, Russia, and Australia. As per the report of 13 June 2017, PXS is targeting the United States market now, for which it is trying to secure approval.
Aridol is a lung function test designed to diagnose and manage asthma. It detects an active airway inflammation through measuring airway hyper?responsiveness. It is available as a standardized test kit that contains mannitol capsules which are pre-filled with a hand?held dry powder inhaler. During the test, the patient inhales increasing doses of mannitol. The lung functioning, i.e., Forced Expiratory Volume in one second? FEV is measured after each dose determining the level of bronchial hyper-responsiveness.
Aridol, manufactured in a facility in Sydney, is approved for sale in Australia, the United States, South Korea, and major European countries and is the first and only approved test for asthma. Today, Asthma affects almost 52 million people worldwide.
Aridol was approved by the Food and Drug Administration (FDA) in 2011, but due to some corporate restructuring, PXS had to withdraw Aridol from the Us market.
PXS relaunched Aridol in the US market, after getting the approval from FDA again, on 15 August 2018 with its distribution partner Methapharm. The management feels confident to be back in the US market and believes that there remains a strong need for objective tests to aid physicians in diagnosing asthma in the US. Two years ago, PXS partnered with Methapharm to re?enter the US market. Today, PXS has released its recent first shipment of Aridol to Methapharm.
Methapharm, a privately held pharmaceutical company, has an experience of over 20 years in the marketing of direct challenge agents to pulmonary function laboratories and clinics in the US. In addition to its respiratory expertise, Methapharm carries a diverse portfolio of hospital products, including neo?natal intensive care, imaging, organ preservation, and cancer care.
Earlier, on 20 November 2018, it announced the completion of its third program, i.e., preclinical package on anti-fibrotic Lysyl Oxidase (LOX). It is aimed towards curing pancreatic cancer. PXS is planning to start the trial in the first quarter of 2019. PXS has associated with the Garvan Institute of Medical Research, an Australian biomedical research institute, to investigate the LOX inhibition in pancreatic cancer.
PXS had conducted a trial for the Phase 1 clinical trial of Lysyl Oxidase Like 2 (LOXL2); and on 15 November 2018, it announced the results to be positive with the aim of curing diseases such as Non-Alcoholic Steatohepatitis (NASH) and Idiopathic Pulmonary Fibrosis (IPF).
The scrip price has declined by roughly 16% over the past six months falling from 31.5 cents on 12 June 2018 to around 26 cents today. From the past two days, there is no movement in the scrip price.