According to Pharmaxis, the company has obtained up to $40 million from NovaQuest Pharma Opportunities Fund III for development, manufacturing, and commercialization of Bronchitol mannitol inhalation powder in the US and EU. At the same time, the company announced that Bronchitol had received a negative recommendation for the treatment of cystic fibrosis patients from the FDA’s Pulmonary‐Allergy Drugs Advisory Committee (PADAC), which met on January 30.
The company will get $20 million from NovaQuest within 30 days and may choose to get another $20 million after January 30, 2014 if it meets “certain commercial and regulatory performance criteria.” According to the agreement, payments to NovaQuest based on sales of Bronchitol are to continue over 8 years in the EU and 7 years from the US launch.
In regard to the PADAC vote, Pharmaxis CEO Alan Robertson noted, “The Committee vote is disappointing, however, we are aware that these recommendations are not binding on the FDA and we will continue the process of working with the FDA to bring Bronchitol to patients in the US. It is important to remember that we are in a process and that opportunities remain to discuss the issues that were raised by the Committee before the FDA makes its final decision on 18 March 2013.”
The committee voted negatively in response to questions about Bronchitol’s efficacy and safety, as well as the question of whether evidence supports approval of the product.
Pharmaxis says that it will not comment further until after the FDA announces its decision in March.
Read the Pharmaxis press release on the financing agreement.
Read the Pharmaxis press release on the PADAC vote.
