Invion to oversee clinical development with first studies expected to begin Q2 2016
Portuguese API manufacturer Hovione has agreed with Invion to progress the development of inhaled INV104 (zafirlukast) as a potential new treatment for asthma.
Hovione and the Australian drug developer will collaborate to develop the proprietary novel technology – a dry powder formulation of the compound INV104 (zafirlukast) delivered by Hovione’s inhaler.
No financial details have been revealed.
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 will be responsible for regulatory submissions. The company will pay an unspecified annual royalty to Hovione on total net sales of Zafirlukast DPI.
We are reformulating this compound for inhalation and remain confident that delivering it directly into the lung in this manner will provide superior benefit
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 US FDA to proceed in an accelerated development of the novel formulation and device. The collaboration has made good 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 and Managing Director Dr Greg Collier said this agreement was a ‘win-win’ for both companies.
He added that INV104 has already been administered to more than four 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,' he said.
'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, added: 'Hovione’s ability to manufacture all components of the drug product in the same location and solve problems within the same team accelerates development.
'Aligning Hovione’s knowledge in inhalation with Invion’s clinical expertise builds synergies for a winning proposition.'
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 is marketed as a generic and by AstraZeneca as Accolate.
Invion has an exclusive, worldwide licence to develop and commercialise all inhaled formulations and applications of zafirlukast.
The global market for asthma therapeutics is said to be in excess of US$22bn a year.