Oslo, 24 October 2011 - PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that it has received a response from The Committee for Medicinal Products for Human Use (CHMP) in European Medicines Agency (EMA) regarding the proposed combination pack PC-A11 (a pack containing a single vial of the proprietary product Amphinex® and a vial of the generic cytotoxic bleomycin). It is the CHMP’s opinion that Amphinex® should be developed as a single product for use with bleomycin rather than a combination package with bleomycin for the head & neck cancer indication.

Regulatory interactions with National Health Authorities in the UK, Sweden and Netherlands have previously indicated support for a combination pack strategy. Following these interactions, the company decided to seek advice from CHMP to better understand how EMA will evaluate a marketing authorization application for PC-A11 (Amphinex® in combination with bleomycin) for treatment of head & neck cancer. CHMPs opinion is that Amphinex® should be developed for registration as a single product for use with bleomycin for this indication.

PCI Biotech will develop Amphinex® in combination with the cytotoxic agent bleomycin for head & neck cancer and will consider CHMP’s opinion in the regulatory development strategy for this and future products. The CHMP opinion will not affect the timelines for the Phase II study in patients with recurrent head & neck cancer not suitable for surgery or radiotherapy and without distant metastases.