Novartis to clarify Mycograb data for CHMP

Novartis has announced that it will submit extra information to the Committee for Medicinal Products for Human Use (CHMP) regarding the use of Mycograb as a treatment for fungal infections.

Mycograb is a genetically recombinant antibody fragment administered twice a day by intravenous injection for the treatment of the life-threatening invasive candidiasis fungal infection.

When the treatment was originally submitted by UK-based NeuTec Pharma – a company acquired by Novartis in 2006 – it received a negative recommendation from EU regulators as a result of insufficient data concerning the manufacturing and nature of the drug needed to determine its safety.

“Mycograb is a complex biological product produced through microbial fermentation and is produced by third party manufacturers,” Novartis notes.

The company adds that it is collaborating closely with both the CHMP and these manufacturers with the aim of gaining approval for the compound.

In July, Novartis announced that it had acquired or received acceptances for 75.4 per cent of the shares of NeuTec Pharma and subsequently declared an unconditional offer for the company, permitting its delisting and the finalisation of the purchase.

The board of NeuTec Pharma had unanimously recommended an offer for the company a month earlier, with the company being valued at around 305 million pounds.