Australian drug development company Invion has partnered with Hovione Scientia, an international pharmaceutical company expert in inhalation development and manufacturing, to progress development of inhaled INV104 (zafirlukast) as a potential new treatment for asthma.
Invion and Hovione will collaborate to develop the proprietary novel technology, a dry powder formulation of the compound INV104 (zafirlukast) delivered by Hovione's inhaler.
Under the terms of the agreement, Hovione will provide expertise on chemistry, particle engineering, formulation, device and GMP manufacturing to develop and manufacture Zafirlukast Dry Powder Inhaler (DPI), which will be delivered using its proprietary device.
The collaboration extends from fully integrated scale-up and manufacture of phase appropriate cGMP Zafirlukast Dry Powder Inhaler for non-clinical and clinical studies to further secure for Hovione the exclusive rights to manufacture commercial supplies of Zafirlukast DPI.
Invion will oversee all non-clinical and clinical development and is moreover responsible for regulatory submissions. As consideration for Hovione's licensing and supply the finished drug product, Invion will pay an annual royalty to Hovione on total net sales of Zafirlukast DPI.
Invion has received agreement from the FDA to proceed in an accelerated development of the novel formulation and device. The collaboration has made excellent progress towards a stable formulation, paving the way for the development of INV104 as a novel non-steroidal anti-inflammatory for use in moderate to severe asthmatics.
Dr Greg Collier, managing director, Invion, commented, "This drug has already been administered to more than 4 million people to treat respiratory conditions. We are reformulating this compound for inhalation and remain confident that delivering this compound directly into the lung in this manner will provide superior benefit and bypass any problems associated with systemic delivery."