Arikace poised to start in Phase III studies in CF and non-TB mycobacterial infections.
Biopharmaceutical firm Insmed has taken over inhaled drugs company Transave through a cash and shares-based deal that gives Insmed the acquired firm’s late-stage lung infection candidate, Arikace. The takeover deal, through which Insmed is also paying off Transave’s $7.8 million in debt, will shuffle around about 25.9 million shares of Insmed common stock, 91.7 million shares of Insmed Series B conditional convertible preferred stock, and $561,280 in cash. The merger effectively gives former Transave shareholders a 46.7% equity stake in the combined entity on an as-converted, fully diluted basis.
Transave’s lead candidate, Arikace™ (liposomal amikacin for inhalation), is based on the firm’s liposomal technology for the delivery of drugs to the lung. The drug is poised to start in Phase III trials for the treatment of pseudomonas lung infections in cystic fibrosis patients, and lung infections due to non-TB mycobacteria (NTM). Insmed says it hopes to start parallel Phase III development of Arikace for both indications during the second half of 2011.
The firm admits it has been on the hunt for a late-stage, high-value product candidate. “The drug’s previously completed phase II and earlier stage clinical studies highlighted the potential of Arikace to become a leading treatment in two high-growth orphan indications with significant unmet medical needs,” comments Melvin Sharoky, Ph.D., Insmed board member and previous chairman.
Transave claims the liposomal technology on which Arikace is based may be key in allowing the antibiotic to overcome the physical barriers presented by mucus in the lungs of cystic fibrosis patients and by bacterial pseudomonas biofilm. The firm says in vitro experiments have previously shown Arikace liposomes penetrate both human cystic fibrosis sputum and the biofilm of pseudomonas macrocolonies.
In clinical trials Arikace has been delivered locally via inhalation using Pari Pharma’s eFlow nebulizer system. The drug has been granted Orphan Drug status in both the U.S. and EU for the treatment of pseudomonas lung infections in cystic fibrosis. Transave had in addition been planning to file for orphan drug designation covering the use of Arikace for the treatment of non-tuberculosis mycobacterial lung infections. Arikace has separately been granted orphan drug designation in the U.S. for a third indication, the the treatment of bronchiectasis in patients with infections due to pseudomonas or other susceptible pathogens.