Pharmaxis Ltd (ASX:PXS) has entered into an agreement with drug delivery solutions provider Aptar Pharma that could net it A$2.5 million plus royalties on any income it generates from developing or selling Orbital technology to pharmaceutical companies.
Aptar, which works with world-leading brands, is a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions.
Its range of solutions serve a variety of end markets including pharmaceutical, beauty, personal care, home, food and beverage.
Option agreement
Under the agreement, Aptar will receive an exclusive 12-month option for a worldwide licence to Pharmaxis’ high payload, dry powder Orbital technology.
The inhaler, developed by Pharmaxis, delivers large payloads of drug in a convenient easy-to-use format.
Pharmaxis CEO Gary Phillips said: “The Orbital Inhaler is an innovative device that eliminates the need for manual reloading of multiple powder‐containing capsules needed for a single dose of drug,”
“This can deliver improvements in the patient experience, compliance, market share and also effectively extend patent life of drugs that use the device.
Payment arrangements
Pharmaxis will receive an upfront US$250,000 payment for the 12‐month option and a further US$2.5 million if Aptar decides to exercise the option. In doing so, it will also pay Pharmaxis industry-standard royalties on income received for Orbital.
To determine whether it will move ahead, Aptar will evaluate the commercial applications for the Orbital device, while further developing the prototype device to meet unmet market needs.
Aptar management believes Orbital can expand its range of drugs administered by inhalation.
“We are pleased to partner with Pharmaxis on this novel technology, which continues the development of Aptar Pharma’s industry‐leading portfolio of devices for inhalation,” Aptar Pharma’s vice-president Global Pulmonary Category Howard Burnett said.
“Coupled with our broad services offering, we will seek to expand the range of drugs administered by inhalation.”
How does Orbital work
Built on Pharmaxis patents, the Orbital technology allows powder payloads of up to 400mg or more to be inhaled by patients in divided doses without the need to reload.
Orbital is a unique platform originally developed as a life cycle extending product for the Pharmaxis cystic fibrosis drug Bronchitol®(mannitol). However, it also meets an increasing global need to deliver high doses of other drugs, such as antibiotics, to the lungs.
Bronchitol® is approved and marketed in the United States, Europe, Russia and Australia.
Another product in this market is Aridol® for the assessment of asthma, which is approved and marketed in the United States, Europe, Australia and Asia.
Generating opportunities
Phillips said: “I am delighted with the forthcoming partnership with Aptar Pharma, who are one of the world’s foremost drug delivery device companies.
“In their hands, we hope to fully exploit the potential of the Orbital technology in other drugs and secure a return on the work we have already completed.
“Today’s announcement is a further example of our strategy to generate non‐dilutive cash from the mannitol respiratory business and also generate the opportunity for future income streams.”
It should be noted that Pharmaxis retains the rights to devices containing Orbital intellectual property used to deliver inhaled mannitol.
About Pharmaxis
Pharmaxis is an established Australian clinical-stage drug development company with expertise developing drugs for inflammatory and fibrotic diseases.
The company has a highly productive drug discovery engine, drug candidates in clinical trials and two respiratory products approved and supplied in global markets: Bronchitol® and Aridol®
Pharmaxis has also developed two respiratory products which are approved and supplied in global markets, generating ongoing revenue.
The company is currently developing its drug PXS‐5505 for the bone marrow cancer myelofibrosis which causes a build‐up of scar tissue that leads to loss of production of red and white blood cells and platelets.
The US Food and Drug Administration has granted Orphan Drug Designation to PXS‐5055 for the treatment of myelofibrosis and permission under an Investigational Drug Application (IND) to progress a phase 1c/2 clinical trial that commenced recruitment in Q1 2021.
PXS‐5505 is also being investigated as a potential treatment for other cancers such as glioblastoma, liver and pancreatic cancer.
For more on the Aptar agreement, Gary Phillips speaks with Proactive's Andrew Scott:
