BioWorld International Correspondent

LONDON - Archimedes Pharma Ltd. completed the biggest fundraising by a private European biotech in 15 years, raising £65 million (US$96.9 million) to set up U.S. operations and begin commercialization of PecFent, a fast-onset nasal formulation of the pain killer fentanyl.

The round was led by new investor Novo Growth Equity, the equity fund of Novo A/S, and there was further backing from Warburg Pincus, the fund that financed the founding of the company by three former executives of Shire Pharmaceuticals Group plc in 2004.

Archimedes also announced the appointment of the former CEO of Enzon Pharmaceuticals Inc., Jeffrey Buchalter, to succeed the founding CEO Richard D'Souza.

Buchalter noted that Archimedes is at a transformational stage in its development. "It has built up a successful specialty pharma business in Europe and has filed its lead product, PecFent, for product approval in both Europe and the U.S." He said his aim now is to accelerate the expansion of Archimedes' business in Europe, support the commercialization of PecFent and build the operations in the U.S. market.

PecFent, previously known as NasalFent, is expected to receive European and U.S. approval during 2010. The product, developed for the treatment of breakthrough cancer pain, demonstrated onset of relief within five minutes of dosing in the Phase III trials. There were statistically significant improvements in pain relief vs. immediate-release morphine, and high levels of patient acceptability.

Simon Turton, managing director of Warburg Pincus, said the major injection of funding and the appointment of Buchalter mark the beginning of a new phase in Archimedes' growth.

"We have supported Archimedes since its foundation in 2004 and are delighted to invest again," he said.

That is the first investment by Novo Growth Equity following its formation in 2009. Ulrik Spork, the firm's managing partner, said investing in Archimedes "supports our strategy to take major stakes in promising late-stage life sciences companies with near-term commercial potential."

Archimedes was founded in 2004 around the $7.1 million acquisition of the U.S. company West Pharmaceutical Services Inc., with Warburg Pincus also putting in $40 million for product development, and promising more money to fund the acquisition of a European pharma or biotech company with marketed products and a sales and marketing infrastructure.

That acquisition was sealed in November 2006 when Archimedes bought Link Pharmaceuticals Ltd. at an undisclosed price, providing a commercial infrastructure of about 40 staff with operations in the UK, France and Germany, and a portfolio of niche products including Gliadel, a locally administered chemotherapy for treating high-grade glioma, and Nozinan, an anti-emetic for cancer patients.

In its in-house development portfolio, Reading, UK-based Archimedes is applying its ChiSys, bioadhesive formulation, and PecSys, a pectin-based gelling technology, to reformulate and improve the characteristics of existing products. That includes a nasal formulation of apomorphine in treating Parkinson's disease symptoms, and a nasal formulation of diazepam for treating seizures in refractory epilepsy.

PecFent is a liquid formulation delivered through a nasal spray pump, producing a fine mist of droplets, which are deposited into the front of the nostril. Calcium ions present on the nasal mucosa cause the pectin in the product to form a thin gel layer.

That allows fentanyl to be retained on the nasal mucosa, providing rapid but controlled absorption, and avoiding the problems associated with simple solutions used in nasal sprays, such being unable to control the dose and dripping, or swallowing, of the drug solution.

Similarly, ChiSys' bioadhesive qualities increase the residence time of molecules on mucosal. That has been shown to enhance immune response in nasally administered vaccines.

Published  March 3, 2010