On 12th March 2013, the Pharmaxis' Board of Directors appointed Gary Phillips to the position of CEO, with immediate effect. Dr Alan Robertson has stepped down from the position of CEO, and will leave the company after 13 years of service as the founding CEO. He has agreed to assist Pharmaxis in a consulting capacity to help the company generate value from its pipeline of early-stage assets. Phillips has served as the company's C for five years and has more than 30 years experience in the pharmaceutical sector. He was previously a CEO of Novartis in Europe, Asia and Australia.
Phillips outlined some of the key initiatives to be undertaken by Pharmaxis in the near future:
The company is expecting to receive a response from the FDA concerning its application for marketing approval for Bronchitol (mannitol) in cystic fibrosis patients aged six and above. Pharmaxis anticipates it will need to request a meeting with the FDA in the second quarter of 2013 to clarify any additional requirements the FDA may have. A clear analysis of the cost and likely timing of fulfilling any FDA requirements is fundamental to the company's review of its business model.
Bronchitol remains the only airway clearance product worldwide in Phase III trials for bronchiectasis. There are no products currently approved for this serious respiratory disease. The company's current trial (B305) is the largest and longest study ever conducted in bronchiectasis, and reached a major milestone recently when the last patient in the study had their last clinic visit. The primary endpoint of the study is a reduction in exacerbations. Data from the study will soon be collated and analysed. Pharmaxis expects to report the top-line results in the second quarter of 2013. The result from B305 will have significant implications for Bronchitol, potentially providing access to significant markets. The outcome is therefore central to the company's review of its business model.
Sales growth of Bronchitol in Europe
Pharmaxis is approaching a 10 per cent market share of adult patients in Germany. The company is learning more about how the product is being used and has a number of initiatives planned for the months ahead to improve growth rate and patient adherence. Clearing reimbursement hurdles in the remaining EU countries is a challenge given the current economic climate and fast changing regulations. Pharmaxis has, however, succeeded in the UK and is pushing into other EU markets.
Sales growth of Bronchitol in Australia
Restrictive entry criteria for reimbursement has led to a slower than expected uptake of new patients. The company is working with the Australian government to refine the wording of these restrictions.
Expand territories for Bronchitol
The company aims to leverage the approvals it has in Europe and Australia to enter new markets in Eastern Europe, the Middle East and South America.
Changes to the company's business model
The outcome of the likely meeting with the FDA regarding Bronchitol and the outcome of the B305 trial are key to determining any necessary changes to the company's business model.
Generating value from the company's pipeline of early stage assets
The company has a number of new projects in various stages of development. In the coming six months, the company will be assessing a range of options to fund some or all of these programmes through to clinical trials. Assets that fall into this category are:
â¢ Oligonucleotide portfolio - including ASM8, which is in Phase II development for moderate and severe asthma; and PXS1100 and PXS2200, which are for chronic obstructive pulmonary disease and asthma respectively, and are both at a preclinical stage.
â¢ Orbital â a respiratory device that is capable of delivering respiratory drugs that require a high dose (such as mannitol and antibiotics) without the need for multiple doses.
â¢ PXS4728 â an SSAO inhibitor that is in preclinical development as an antiinflammatory/antifibrotic once-daily oral drug for several indications.
â¢ LOX / LOXL2 inhibitor programme - a small molecule active against a well known target important in several fibrotic diseases and some cancers.
â¢ PXS64/PXS25 - an antifibrotic drug that has completed preclinical development inhibits the function of TGFb and is targeting the treatment of lung fibrosis.