Archimedes Pharma Receives CHMP Positive Opinion for PecFent for the Treatment of Breakthrough Cancer Pain

06-28-2010: Archimedes Pharma announced that its lead product, PecFent, has received a Positive Opinion from the Committee for Human Medicinal Products (CHMP), of the European Medicines Agency (EMA). The CHMP is recommending PecFent, an innovative fentanyl nasal spray, be authorised for marketing in European Union countries for the treatment of breakthrough cancer pain (BTCP) - sudden, unpredictable episodes of intense pain that occur despite background pain medication.

Jeffrey H. Buchalter, President and Chief Executive Officer of Archimedes Pharma, commented: “This is a defining moment for Archimedes Pharma. Breakthrough cancer pain is a poorly served indication and affects up to 95% of all cancer patients with pain. Today’s announcement by the CHMP is an important step towards bringing a new treatment option to these patients in Europe. It also marks a step change in scale for Archimedes Pharma’s already successful European commercial operations and an important landmark in our development as a leading global specialty pharma company. Our clinical development programme delivered excellent results and we look forward to delivering this new option for patients in Europe as soon as we can following the grant of the Marketing Authorisation.”

PecFent is an aqueous fentanyl citrate solution using Archimedes Pharma’s proprietary PecSys™ technology to allow fentanyl to be retained on the nasal mucosa and is designed to produce rapid but controlled absorption into systemic circulation. The positive opinion is based on the results of Archimedes Pharma’s comprehensive clinical development programme for PecFent which comprised three phase III studies including an active comparator study and a large long term safety and acceptability study. The programme included over 650 patients and more than 100 investigational sites from the US, UK, Germany, France, Spain and Italy, and in total 13 countries across four continents.

Archimedes Pharma submitted a New Drug Application (NDA) for PecFent with the US Food and Drug Administration (FDA) in August 2009 and is in the process of establishing its own US commercial organisation to market the drug in the US once approved.