BioWorld International Correspondent

LONDON - NovaThera Ltd. raised £2.75 million (US$4.8 million) in its first funding round and signed licensing deals for its bioglass drug delivery technology with Advanced Bio-Technologies Inc. and Pharming Group NV.

Gareth Roberts, CEO, told BioWorld International, "We were very pleased that the round was oversubscribed, and we expect this funding to take us through to profitability in late 2006, when the first product hits the market."

NovaThera was spun out of the Tissue Engineering and Regenerative Medicine Centre (TERM) at Imperial College London by Julia Polak, an expert in stem cells, and Larry Hench, a specialist in biomaterials who invented the bone substitute bioglass.

The company was set up initially to develop regenerative therapies using bioglass to deliver stem cells.

"When I got involved, it was recognized that this was probably too ambitious at this stage because of the huge regulatory uncertainties," Roberts said. "It was decided to refocus and concentrate first on commercializing new applications of bioglass. We can make it very easily and it can be used to deliver drugs ranging from small molecules to growth factors and proteins."

The first licensing agreement gives Advanced Bio-Technologies Inc., of Columbia, Md., the right to commercialize bioglass in dermatology applications. The lead product is a silver/bioglass combination for infected wounds.

The deal with Pharming, of Leiden, the Netherlands, involves combining bioglass with recombinant proteins including human collagen, fibrinogen and lactoferrin. Both deals involve up-front payments, milestones and royalties, and Roberts said that further licensing agreements are under discussion.

In the meantime, NovaThera was selected as lead partner in a £3.75 million government-funded project to devise an automated GMP process to produce mature, differentiated stem cells. The overall aim is to identify the factors that control the reproduction and differentiation of stem cells and their interaction with biomaterials and scaffolds. That will lead to the development of bioprocesses that are reproducible and automated.

"Bioglass provides a route for delivering stem cells, but there's no point in worrying about the regulatory hurdles if you can't make the cells. That's the bit of the equation we are working on now," Roberts said. "Once we have a GMP-type process, the regulatory issues get easier to deal with."

Hench originally developed bioglass at the end of the 1960s as a replacement for bone, since the material stimulates bone regrowth. But it is only recently that Hench and Polak uncovered the mechanism by which that occurs, when they discovered a family of genes involved in bone formation that can be regulated by bioactive materials. That shifts the emphasis from using biomaterials to replace tissue, to using them to stimulate regeneration.

Polak and Hench retain their positions as directors of TERM and NovaThera has preferential rights to commercialize technologies developed at the center.

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