Octapharma Group and Fresenius Kabi enter into an Exclusive License, Development and Supply Agreement for a HESylated recombinant protein10-29-2009
Octapharma Group and Fresenius Kabi enter into an Exclusive License, Development and Supply Agreement for a HESylated recombinant protein.
Octapharma Group and Fresenius Kabi have signed a License, Development and Supply Agreement regarding the use of Fresenius Kabi’s HESylation® Technology to develop a HESylated recombinant protein.
Under the agreement, Fresenius Kabi will license its proprietary HESylation® Technology to Octapharma. This technology platform is based on hydroxyethyl starch (“HES”) which will be combined with a recombinant protein from Octapharma`s human cell-line platform – this combination is intended to generate a therapeutic protein with a superior product profile.
Fresenius Kabi will seek to adapt and optimize the protein modification by its HESylation® Technology and will afterwards be responsible for providing the appropriate HES derivative to Octapharma. Under the agreement, Octapharma will oversee the further development and commercialization. Fresenius Kabi will receive up-front and milestone payments, research funding and royalties on sales for licensing of the HESylation® Technology.
Octapharma`s human cell-line platform
Octapharma`s core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell lines. Over the last twelve years, Octapharma has successfully established the human HEK293F cell-line platform for the expression of a variety of recombinant therapeutic proteins on a commercial scale.
An investigational new drug application for Octapharma`s human cell-line derived recombinant FVIII was filed in the U.S. in May 2008. Using a human cell-line expression system instead of e.g. hamster cell-lines is expected to result in possible advantages like improved protein functions, increased tolerability and the opportunity for reduced immunogenicity.
HESylation® Technology is based on the extensive expertise in the field of hydroxyethyl starch (“HES”) that Fresenius Kabi has gathered as the world’s largest producer of pharmaceutical grade HES. HES is derived from waxy maize starch and can be metabolized by the body’s enzymes. HES solutions have been safely administered for over 30 years to treat deficient blood volume and to improve the rheological properties of blood.
HESylation® Technology allows a targeted modification of drugs and their characteristics by a site-specific coupling to HES molecules. This can modify key pharmacological parameters such as absorption, metabolization, half-life, water solubility and safety.
HESylation® Technology is covered by a broad portfolio of intellectual property rights. For further details please visit http://www.HESylation.com.
The Octapharma Group is an independent, Swiss-based biopharmaceutical company operating worldwide. Octapharma's core business is the development, production, and sale of high-quality human proteins for the treatment of life-threatening diseases.
The Group has more than 3'500 employees in 28 countries, and owns five modern, state-of-the-art production facilities in Austria, France, Germany, Sweden, and Mexico, respectively. Sales turnover in 2008 reached Euro 886 million with an EBIT of Euro 256 million.
For more information about Octapharma Group please visit the company’s website: www.octapharma.com.
Fresenius Kabi is focused on products for the therapy and care of critically and chronically ill patients in and outside the hospital. Fresenius Kabi’s core product range includes infusion solutions for fluid substitution, blood volume substitution and intravenously administered drugs as well as parenteral and enteral nutrition and the medical devices for the application.
Fresenius Kabi has more than 20,000 employees worldwide and a global network of around 55 sales organizations and more than 55 production sites. In 2008, Fresenius Kabi achieved sales of € 2,495 million and an operating profit (EBIT) of € 443 million. Fresenius Kabi AG is a 100% subsidiary of the health care group Fresenius SE.
For more information about Fresenius Kabi, please visit the company's web site at www.fresenius-kabi.com.
© Octapharma AG, 2009