Italfarmaco SpA entered an agreement with Neupharma to develop and commercialize an inhaled formulation of teicoplanin, one of the most effective antibiotics to treat lung infections caused by resistant strains of Staphylococcus aureus in people with cystic fibrosis (CF).
Under the terms of the agreement, Italfarmaco shall hold the global rights to commercialize the new formulation of teicoplanin worldwide. In return, Neupharma shall receive an upfront payment from Italfarmaco, and be eligible to receive additional royalties for each developmental milestone achieved.
Previous studies show that intravenous teicoplanin is particularly effective against Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), one of the multi-resistant strains of bacteria that may cause serious, difficult-to-treat lung infections in CF patients.
Despite its effectiveness, teicoplanin’s current intravenous mode of administration can be inconvenient, and limits the medication’s access to the lungs. Its use is also linked to potentially serious side effects.
“As a de-risked molecule with safety proven by over 30 years of use, the novel inhaled formulation of teicoplanin, which would deliver the drug directly into the lungs, has the potential to improve the safety, pharmacokinetic, and efficacy profile associated with intravenous teicoplanin,” Antonio Nardi, director of R&D portfolio development at Italfarmaco, said in a press release.
Pharmacokinetics refers to the study of how a therapy is absorbed, distributed, and eliminated from a person’s system.
“As there is currently no defined standard of care for this chronic lung infection, the agreement will allow Italfarmaco to access a new market, as well as provide an improved therapeutic option for cystic fibrosis patients suffering from MRSA,” Nardi said.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) granted orphan drug designation to the inhaled formulation of teicoplanin in potentially treating MRSA lung infections in CF patients.
The antibiotic will soon enter Phase 1 clinical testing in Italy, according to the press release.
“We believe Italfarmaco has the right resources and development expertise that will enable the inhaled formulation of teicoplanin to successfully enter the next stages of clinical development and ideally commercialization,” said Fabio Borella, president and co-founder of Neupharma.