Insmed Incorporated a biopharmaceutical company, announced that the Paediatric Committee of the European Medicines Agency (EMA) has issued a positive opinion on the company's Paediatric Investigation Plan (PIP) for Arikace (liposomal amikacin for inhalation), Insmed's phase III-ready compound for Cystic Fibrosis (CF) Pseudomonas and Non-TB Mycobacteria (NTM) lung infections. The PIP covers children from birth to 18 years of age with cystic fibrosis that suffer from Pseudomonas lung infections.

An accepted PIP is a pre-requisite for European approval of new drugs, according to legislation passed in Europe in January 2007. The aim of the legislation is to facilitate the development of new medicines for children without subjecting them to unnecessary clinical trials or delaying the authorization of those medicines for use in adults.

“The acceptance of our PIP by the EMA is an important milestone in Insmed's regulatory submission plan for Arikace in Europe,” said Renu Gupta, MD, executive vice president Development & Chief Medical Officer of Insmed. “As previously disclosed, we intend to initiate our phase III clinical trials for Arikace in the CF indication, as well as in NTM, in the second half of this year. Data in both indications are expected during the first half of 2013.”

Insmed Incorporated is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of serious lung diseases, and has a proprietary protein platform aimed at niche markets with unmet medical need.