Pharmaxis (ASX:PXS) exports the first shipment of Bronchitol® to the US

Summary

  • Australian pharmaceutical research player Pharmaxis has shipped the first batch of Bronchitol to the American city. Atlanta.
  • The Company said its US distributor initiated a further US$3 Mn-milestone payment.
  • Pharmaxis anticipates that US Bronchitol sales will contribute strongly to worldwide sales and profit growth.

An Australian specialist pharmaceutical company, Pharmaxis Ltd (ASX:PXS) has updated the market with a significant milestone with the shipping of the first batch of its cystic fibrosis (CF) treatment to the US. The Company develops and manufactures the CF drug, Bronchitol® in Australia.

Post the key update, PXS shares moved up and were trading at A$0.091 up by 3.409% at AEDT 12:28 PM. The market capitalisation of Pharmaxis stood at A$34.95 million.

Let us discuss in detail:

Pharmaxis starts exporting its CF drug

On 9 February 2021, Pharmaxis updated the market that the Company will commence the sale of Bronchitol®(mannitol) in the US following the FDA approval. The US Food and Drug Administration (FDA) had given the green light to Bronchitol on 30 October 2020.

The Company stated that after the receipt of an initial payment of US$7 million from its exclusive US distributor Chiesi, a further US$3 million milestone payment had been initiated.

After completing the manufacturing at its purpose-built factory in the Sydney suburb of Frenchs Forest, the Company shipped the first batch of Bronchitol to Atlanta, Georgia. 

Image Source: PXS AGM Presentation (4 November 2020)

Pharmaxis further notified that the drug had been developed for export by its employees at the Company’s high-tech facility in French Forest. The facility is approved by the Therapeutic Good Administration (TGA) and is FDA approved.

Strong global sales and profit growth

The Company anticipates that the US Bronchitol sales will contribute strongly to the product’s worldwide sales and profit growth. Pharmaxis is confident that this will make its mannitol respiratory business cash flow positive from the financial year 2021.

The Company is also aware that the US CF market constitutes more than 65% of the global market. The market doubles the global CF patient opportunity for the PXS with attractive pricing.

Image Source: PXS Investor Presentation (2 November 2020)

Chiesi Group will be responsible for Bronchitol commercialisation in the US. Bronchitol is the second Pharmaxis' commercial product that the FDA is approving.

Pharmaxis’ first FDA-approved product of was Aridol®, a lung function test. The test was designed to help physicians in the diagnosis and management of asthma by identifying active airway inflammation.

Gary Phillips CEO Pharmaxis commented:

Mr Phillips also added that the manufacturing of medicines for delivery to the lungs is one of the most challenging methods undertaken in medicine production. 

Pharmaxis is fully equipped with the expertise and technology to engineer a powder with precise control of the particle size appropriate for hand-held inhaler delivery. The powder is placed into capsules and then packed with all the information required to use the drug (twice a day) by CF patients.

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