AB569 was granted orphan drug designation by the US Food and Drug Administration (FDA) last November for the treatment of P. aeruginosa lung infections in cystic fibrosis (CF) patients and has successfully completed pre-clinical in vivo and in vitro studies.
Now its developer, Toronto, Canada-based Arch Biopartners is looking to take the candidate into the clinic and has contracted Catalent Inhalation as its contract development and manufacturing organisation (CDMO).
Under terms of the deal, Catalent will begin by undertaking stability and formulation and if these result in positive results, the CDMo will make a supply of AB569 which meets cGMP for first-in-human trials.
Financials details have not been disclosed.
“We are pleased to support Arch Biopartners' program from our recently expanded facility in Morrisville, North Carolina, Catalent's Centre of Excellence in the development and manufacture of inhaled dose forms,” Jonathan Arnold, VP of Catalent’s Advanced Delivery Technologies said in a statement.
The site, located in Research Triangle Park (RTP), is one of ten in the US and offers product development, clinical and commercial manufacturing for pressurised metered dose inhalers (pMDI) and nasal sprays. In 2013, $20m was invested in the site to expand production capacity for its pMDIs.
However, last year the site was issued with an FDA Form 483 with six observations relating to problems found with Catalent’s operational procedures during an inspection in March 2015.