BioWorld International Correspondent

Egalet A/S raised a new investment of $27.6 million to fund late-stage development of its controlled-release oral drugs for cardiovascular disease and pain.

Atlas Venture, of Waltham, Mass., and Index Ventures, of Geneva, Switzerland, jointly led the round.

The Copenhagen, Denmark-based company is moving two compounds into pivotal trials shortly and aims to launch both by 2009 or 2010. The cardiovascular product is as yet undisclosed. It comprises a controlled-release version of an existing marketed drug that soon is to come off patent, CEO and company co-founder Jan Quistgaard told BioWorld International.

The pain product is a formulation of morphine, which, he said, exhibits zero order kinetics - that is, it is released into the system at a constant rate. That could give it an advantage in a field in which the problem of dose dumping - dangerously high peak plasma concentrations - has arisen with other morphine formulations. Purdue Pharma LP, of Stamford, Conn., withdrew Palladone (hydromorphone HCL extended-release) last July, just five months after its launch, following FDA concerns about users of the drug consuming alcohol concomitantly. Similar products will be subjected to "enormous focus," Quistgaard said. "We have proven with our clinical studies we do not get alcohol-related dose dumping. That’s a fact."

The company’s erosion-based delivery system, developed by co-founder and vice president of innovation and research Daniel Bar-Shalom, ensures that the rate of release is kept constant, Egalet said. The active drug ingredient is mixed with a polymer formulation and then encased in a matrix coat during an injection-molding based production process. The resulting tablet is open at each end.

Rather than depending on diffusion from a capsule, the tablet containing the active pharmaceutical ingredient is gradually and steadily broken down when in contact with intestinal fluids. The surface area of the exposed tablet ends and the polymer mix both can be adjusted to alter the delivery kinetics, Quistgaard said. "We can do things with compounds that many of the drug delivery companies cannot."

The company so far has one licensee of its technology, London-based GlaxoSmithKline plc, which is applying it to an over-the-counter product. But Egalet’s strategy is based primarily on developing an internal product pipeline. It has two other products in clinical development but is not yet disclosing details on the programs.

The company, which was founded in 1995, raised $13.3 million in first-round financing in 2001. Its existing investors, BioFund, of Helsinki, Finland; QueQuoin Holdings Ltd., of Jersey, UK; and Dansk Kapitalanl g and Danske Bank, both of Copenhagen, Denmark; also participated in the recent transaction. The new cash will fund the company for 24 months, Quistgaard said.

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