Invion, Hovione sign joint development and licensing deal for inhaled Zafirlukast

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.

Zafirlukast is differentiated from other products being re-purposed for inhalation, given the extensive clinical database illustrating both its safety and efficacy. The collaboration has overcome the major impediment to reformulation and development of INV104 by producing a formulation devoid of banned propellants.

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.

Invion Chief Executive Officer and Managing Director, Dr Greg Collier, said this agreement was a ‘win- win’ for both companies and pivotal to Invion’s plan to rapidly progress development of INV104.

He acknowledged Hovione’s integrated inhalation development expertise and extensive knowledge of device development and noted the drug in oral formulation had an established safety and efficacy profile.

"This drug has already been administered to more than 4 million people to treat respiratory conditions," he said.

"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.

"Hovione is the right partner to help us capitalise on this highly promising commercial opportunity."

Carla Vozone, Hovione’s Senior Director of Product Development and Licensing is delighted that Hovione’s science in inhalation development and manufacturing is the conduit for Invion’s INV104 program.

"Hovione has built through the years a profound and unique skill set in APIs, particle engineering, formulation and devices, being able to approach inhalation development holistically. Hovione’s ability to manufacture all components of the drug product in the same location and solve problems within the same team accelerates development," she said.

Carla Vozone recognized that the co- development partnership entered with Invion illustrates Hovione’s goal of repurposing drugs trough alternative delivery routes with the aim of increasing its safety profile and patient compliance.

"Aligning Hovione’s knowledge in inhalation with Invion’s clinical expertise builds synergies for a winning proposition," she said.

INV104 is a leukotriene receptor antagonist (LTRA) which works by blocking the action of leukotrienes in the lungs, thereby preventing inflammation and narrowing of the airways.

An oral version of the drug marketed as a generic and by Astra Zeneca as ‘Accolate’, is a first-in-class anti-leukotriene and treatment for asthma. All oral prescriptions of the drug come with a side effect warning.