Australia-based pharmaceutical company Invion Ltd. recently signed a partnership agreement with Hovione Scientia Ltd., a multinational pharmaceutical company focused on developing inhaled therapeutics, for the advancement of INV104 (zafirlukast) as a promising new solution for asthma. The two companies will be working closely together to bring Zafirlukast Dry Powder Inhaler (DPI) closer to regulatory approval, with Hovione overseeing chemistry, particle engineering, formulation, device and GMP manufacturing.
The partnership will cover the development of phase appropriate cGMP Zafirlukast Dry Powder Inhaler for both non-clinical and clinical research to further secure the company’s exclusive rights to manufacture commercial supplies of Zafirlukast DPI. In the meantime, Invion will be in charge of non-clinical and clinical development and any necessary regulatory submissions, and will pay Hovione a yearly royalty fee on total net sales of the drug.
Zafirlukast, a leukotriene receptor antagonist (LTRA), is a novel inhaled therapeutic in that it has successfully exhibited a superior safety and efficacy profile in previous testing. According to the companies, the therapy has come a long way in product development thanks to this partnership, and is now formulated without the use of prohibited propellants and is well on its way to being an established NSAID for moderate to severe asthma.
Invion’s Chief Executive Officer and Managing Director, Dr. Greg Collier, believes this collaboration greatly benefits both companies and is vital to the Company’s strategy to pursue FDA-approved accelerated development of INV104 for delivery using Hovione’s device.
“This drug has already been administered to more than 4 million people to treat respiratory conditions,” Dr. Collier added. “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.”
In an earlier report on therapeutics for asthma, Synairgen, a drug discovery and development company focused on advancing novel approaches for severe respiratory conditions recently announced that AstraZeneca has initiated its Phase IIa clinical trial of AZD9412.
The drug, which was originally developed by Synairgen (SNG001), is inhaled interferon beta that supports the immune system by correcting a deficiency that makes patients vulnerable to respiratory tract viral infections.