Italfarmaco Options Inhaled Teicoplanin For MRSA Lung Infections
Executive Summary
Italfarmaco and Neupharma plan to collaborate on the development of a new inhaled formulation of a Gram-positive targeted antibiotic for MRSA infections in cystic fibrosis.
Milan, Italy-headquartered Italfarmaco SPA is adding to its rare disease/specialty R&D pipeline by taking an exclusive option to develop and commercialize globally Neupharma Srl’s inhaled formulation of the antibiotic, teicoplanin, currently entering Phase I studies for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients.
Teicoplanin, which is targeted at Gram-positive bacterial infections, has been available for injectable or oral use for many years, as Sanofi’s Targocid; an inhaled formulation “has the potential to improve the safety, pharmacokinetics and efficacy profile associated with intravenous teicoplanin,” said Italfarmaco’s director of R&D portfolio development, Antonio Nardi, in the 1 August announcement of the option agreement.
Mid-sized privately-held European pharmaceutical companies like Italfarmaco, with a broad range of commercial activities in specialty, branded generics and generic products, as well as fine chemicals and active pharmaceutical ingredients (APIs), have to some extent zeroed-in on the development of novel orphan and severe disease therapies as a way of accessing new markets – Italfarmaco already has the HDAC inhibitor, givinostat, in Phase III for the treatment of Duchenne’s muscular dystrophy, and is expected to start Phase III studies with that molecule in polycythemia veria in the near future.
In a binding term sheet agreement, which is expected to become definitive in the second half of 2019, Italfarmaco will pay an undisclosed upfront, development milestones and tiered royalties to Imola, Italy-based Neupharma, for a total consideration in the “double digit” millions, excluding royalties. There is currently no defined standard of care for MRSA infections in cystic fibrosis, Nardi noted.
According to Informa Pharma’s R&D database, Biomedtracker, a handful of other companies are evaluating investigational products for MRSA, including Savara Inc., which has a vancomycin-containing inhaler, Aerovanc, in a Phase III clinical study, AVAIL. (Also see "In Hindsight, Savara Wishes It Led With Patient-Reported Secondary Endpoint For Molgradex" - Scrip, 13 Jun, 2019.). The US’s Aridis Pharmaceuticals Inc. has a monoclonal antibody, AR-301, in Phase III for S aureus-associated ventilator-associated pneumonia. The UK’s Destiny Pharma is evaluating a product, XF-73, for MRSA in post-surgery patients (see sidebar).
But there have been failures too, including Pfizer Inc.’s multi-antigen S aureus vaccine candidate, PF-06290510, whose Phase IIb study was discontinued at the end of last year because of low efficacy. (Also see "While You Were Out: News In Brief" - Scrip, 31 Dec, 2018.)
Neupharma is a small company which specializes in the development and marketing of health products for cystic fibrosis, including nutritional products and medical devices, and nebulizer solutions containing colistimethate sodium and tobramycin for chronic Pseudomonas aeruginosa lung infections.
The company said it believes Italfarmaco has the right resources and development expertise to develop further the inhaled teicoplanin product, whose use for MRSA in cystic fibrosis has been granted orphan drug status in the US and EU. Intravenous teicoplanin is currently used to treat MRSA infections in cystic fibrosis patients, although administration is inconvenient and associated with side effects and limited lung penetration, the companies noted.
One of the most recent product launches by Italfarmaco, in March, was a biosimilar version of the low-molecular weight heparin, enoxaparin sodium, marketed as GhemaXan in Italy.
Italfarmaco has sales revenues of around €700m annually, and its products include Tiglutik (riluzole) for amyotrophic lateral sclerosis. Earlier in 2019, the company launched Votubia (everolimus) tablets in Italy, for the treatment of brain tumors and seizures associated with tuberous sclerosis complex.