BioWorld International Correspondent

OctoPlus BV raised €18.25 million (US$23.6 million) in a second funding round that will enable it to progress its drug development and delivery programs and to widen its product pipeline.

The company, based in Leiden, the Netherlands, has operated profitably as a contract research organization since its formation in 1995, but three years ago it established a drug delivery unit to bring improved formulations of biopharmaceuticals to the market and to engage in new drug development. A peptide, licensed from the Leiden University Medical Center, is undergoing a Phase I/II trial in chronic otitis media.

"Phase II will start in the next quarter of this year," said OctoPlus CEO Joost Holthuis.

The peptide, derived from an epitope of an undisclosed endogenous human protein, binds the microbial products lipopolysaccharide (LPS) and lipoteichoid acid (LTA), each of which can induce inflammatory responses.

"We're not sure about the complete mechanism, but it probably interferes with the infection process," Holthuis said. The company eventually aims to administer the peptide in conjunction with conventional antibiotics, which, on their own, can be ineffective in the indication.

The company's drug delivery unit, OctoPlus Technologies, has two core platforms, OctoDex and PolyActive. The former, Holthuis said, consists of dextran-based biodegradable microspheres that encapsulate hydrophilic proteins and other large molecules in an aqueous environment.

The latter originally was developed by Chienna, a subsidiary of IsoTis SA, of Lausanne, Switzerland, which OctoPlus purchased in 2003. The technology, which encapsulates hydrophobic proteins and peptides, comprises two biodegradable polymeric building blocks, levels of which can be adjusted depending on the characteristics of the target protein. OctoPlus also has partnered with another Dutch firm, Groningen-based Innocore Technologies BV, to develop SynBiosys, a sustained-release technology for small molecules and peptides.

OctoPlus is planning a clinical trial this year of a controlled-release version of interferon-alpha based on PolyActive. The aim is to avoid the "burst effect" that can occur with conventional methods of administration.

"The toxicity of present formulations is related to peak levels in the plasma," Holthuis said.

OctoPlus already has completed a Phase I trial of a sustained-release version of human growth hormone, which employed the OctoDex technology. That delivered a clinical dose of the drug over 10 days to two weeks, but the company plans to improve the product further before undertaking any additional clinical development work, Holthuis said.

The company is seeking to partner its improved biopharmaceutical formulations with their respective originating companies. However, Holthuis said that the European Medicines Agency has indicated that it wants to resolve the disputed status of biogenerics this year.

"If the position of biogenerics is settled, then we have an opportunity to develop products on our own," Holthuis said.

The financing was jointly led by Life Sciences Partners, of Amsterdam, the Netherlands, and S.R. One Ltd., of West Conshohocken, Pa. Other participants included Innoven Partenaires, of Paris; Fortis Private Equity, of Brussels, Belgium; and SurModics Inc., of Minneapolis. The company previously raised €3 million in 2001.

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