Firebrick Pharma Limited (ASX:FRE) (Firebrick, Company) is pleased to announce that it has executed an amended agreement with its existing marketing partner in the Philippines,
S.V. More Pharma Corporation (SV More). Under the amended agreement, SV More will have the right to manufacture Nasodine® Nasal Spray ("Nasodine") in the Philippines, rather than import the product from Australia. This will allow Nasodine to be launched in the Philippines.
The amended agreement follows from advice obtained by SV More from the Philippines Food and Drug Administration (PFDA) that Nasodine would be classified as a 'disinfectant spray for the nasal passages.'
Prior to marketing approval, SV More's local contract manufacturer, Hizon Laboratories Inc, will need to manufacture the product in the Philippines and submit a manufacturing dossier to the PFDA, but no clinical efficacy studies would need to be submitted for approval.
The advice from the PFDA follows a submission by SV More that included packaging and labelling of the product as 'Nasodine Antiseptic Nasal Spray' and with stated use and claims as follows: 'Disinfectant spray for the nasal passages: Povidone-iodine kills bacteria and viruses that may cause nasal infections, such as the common cold. May reduce the severity of the common cold.'
"Now that this amended agreement has been signed, we will complete the tech transfer to SV More's local manufacturing partner so they can make the product and complete the paperwork for PFDA approval," said Firebrick Executive Chairman, Dr Peter Molloy. "We expect the whole process to take at least 12 months after which Nasodine could be ready for launch in the Philippines."
SV More's Director of Marketing, Mr Paul Santillana, commented as follows:
"SV More is excited to announce our partnership with Firebrick, marking a significant milestone in introducing Nasodine, the world's first-of-its-kind nasal disinfectant spray, to the Philippines.
Since the onset of the pandemic, we have been committed to making this innovative product available, and we are thrilled to be one step closer to seeing it on drugstore shelves across the country. Our extensive discussions with leading ENTsi have revealed strong anticipation for Nasodine, and we are confident that doctors nationwide will be key advocates for this groundbreaking solution. We look forward to enhancing the health and well-being of Filipinos with this vital addition to the market."
Agreement Overview
The original Exclusive Distribution Agreement, as disclosed in the Company's Prospectus dated 26 November 2021, required SV More to buy Nasodine exclusively from Firebrick in Australia. The now amended License and Distribution Agreement provides for local manufacturing of Nasodine by SV More's contract manufacturer, Hizon Laboratories, Inc.
There are no quantities committed for distribution under the agreement with Firebrick being paid a Licence Fee for every unit sold. The Licence Fee includes a 20% fee on the manufacturer's cost of goods for each unit sold plus a fee of AUD 1.80 fee for each unit sold.The term of the agreement remains at 10 years, with the amended agreement expiring August 2034, with an option for SV More to renew the agreement for successive five year terms thereafter. The agreement contains standard provisions for immediate termination by either party for cause.
