Firebrick Pharma has executed an amended licence and distribution agreement with its current Philippine marketing partner, S.V. More Pharma.
The amended agreement allows SV More to manufacture Nasodine nasal spray locally in the Philippines, facilitating its market debut as a 'disinfectant spray for the nasal passages,' as classified by the Philippines Food and Drug Administration.
Under the terms of the agreement, SV More's contract manufacturer, Hizon Laboratories, will manufacture Nasodine in the Philippines and submit the necessary manufacturing dossier for approval.
No clinical efficacy studies will be required for the approval process.
The classification follows SV More's submission of packaging and labelling details that describe Nasodine's intended use against nasal infections and its potential to 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 Peter Molloy, executive chairman of Firebrick Pharma.
"We expect the whole process to take at least 12 months after which Nasodine could be ready for launch in the Philippines," Molloy supplied.
SV More's Director of Marketing Paul Santillana, expressed enthusiasm for the milestone, stating, "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," Santillan added.
The amended agreement retains a 10-year term, expiring in August 2034, with an option for successive five-year renewals.
Firebrick will receive a 20% fee on the manufacturer's cost of goods for each unit sold, along with a $1.80 fee per unit.