NEWS
February 22, 2007
Kuros receives orphan drug designation for a novel fusion protein for the treatment of solitary bone cysts
 
Kuros reports continuing progress in bone repair

Zurich, Switzerland, 22nd February 2007 - Kuros Biosurgery AG (Zurich, Switzerland) announced today that the Food and Drug Administration (FDA) granted orphan drug designation (ODD) to the novel bioactive substance of Kuros’ bone-repair product, I-040302, for the treatment of solitary bone cysts. This is a further achievement in the development of the product after receiving ODD in Europe in 2006. It is anticipated that a clinical study involving I-040302 will be initiated this year.

Solitary (or unicameral) bone cysts are rare lesions that occur mostly in children between the ages of nine and 14 years of age and present as fractures in 75 percent of cases. The most common complication of bone cysts is persistence or re-fracture, and disturbances of the growth plate. This may result in growth arrest and limb shortening. More rarely, severe and debilitating conditions such as septic or degenerative arthritis and avascular necrosis have been reported.

The ODD is granted to development-stage, novel therapeutics that offer potential value in the treatment of rare diseases. In the United States, ODD provides a variety of incentives, including seven years of market exclusivity, should the product receive FDA approval for this indication.

The bone-repair product, I-040302, is licensed to Baxter International Inc., a diversified health care company, under a 2005 collaboration and license agreement. The product consists of a fusion protein derivative of human parathyroid hormone (PTH) combined with Baxter’s TISSEEL Fibrin Sealant. Upon administration, PTH is covalently incorporated into the fibrin matrix. Kuros’ proprietary biologics delivery technology enables the controlled release of the bone-forming hormone (PTH) at the site of the lesion.

Didier Cowling, President & CEO of Kuros, commented: “We are pleased to have received orphan drug designations in the United States and Europe for our novel combination product designed to treat solitary bone cysts. This is a disease of children that can have a significant negative impact on their quality of life.”

The granting of orphan drug status is a further important milestone under the collaboration and license agreement between Kuros and Baxter. This agreement is focused on developing novel products for the regeneration of bone and soft tissue based on Kuros’ novel biologics and proprietary delivery technologies together with Baxter’s TISSEEL fibrin sealant matrix.

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About Kuros
www.kuros.ch

Kuros is a biotechnology company that develops novel biologics and biomaterial combinations for localised therapy.

Kuros products retain biologically active molecules at the site of action by incorporation into injectable matrices. These products combine ease of application with localised delivery and tuneable release profiles. Kuros uses natural (fibrin-based) or synthetic matrices and has a number of methodologies for the retention and release of the biologically active molecules.

Kuros’ most advanced products are in the fields of bone and tissue repair and regeneration. These products are in various stages of clinical development. The products consist of fusion proteins of naturally occurring bioactive factors, covalently incorporated into fibrin matrices. This approach attempts to mimic the body’s natural healing process.

In addition, Kuros is developing a portfolio of proprietary products that are addressing a number of significant additional therapeutic areas, including other trauma, oncology and cardiovascular indications.

Since its creation in 2000, Kuros has raised over $40 million. The company is located in Zurich, Switzerland.

Press Enquiries

Kuros
Didier Cowling +41 (0)44 200 56 10

Citigate Dewe Rogerson
David Dible, Valerie Auffray, Yvonne Alexander +44 (0)207 638 9571

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