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NE-180 (GlycoPEGylated erythropoietin)
In January 2003, we announced the selection of an improved erythropoietin (EPO) as our first proprietary candidate. EPO had $12 billion in worldwide sales in 2005 for indications such as anemia related to oncology chemotherapy, end stage renal disease and chronic renal insufficiency.
We submitted an investigational new drug application (IND) for NE-180 to the FDA in June 2005 and were placed on clinical hold in July 2005 when the FDA informed the Company that it required additional manufacturing and preclinical information in order to complete its review of the IND. A "Complete Response" was submitted to the FDA in early 2006, which addressed the initial issues raised by the FDA. The FDA has raised additional questions which we are working to address.
As part of our global development plan for NE-180, we also filed for authorization to commence a Phase I clinical trial in a Western European country in late 2005. In January 2006, we were cleared to commence a Phase I trial in this Western European country, and in February 2006 initiated such trial. The dosing and safety follow-up for that trial has been completed. While final analysis of pharmacokinetic data and other parameters are ongoing, NE-180 was generally well-tolerated at the doses tested, and the expected increases in reticulocytes and hemoglobin were observed in both the intravenous and subcutaneous dosing groups.
GlycoPEG-GCSF
In October 2003, we selected an improved granulocyte colony stimulating factor (G-CSF) as our second prorpietary candidate. G-CSF had worldwide sales of $4 billion in 2005 for the treatment of neutropenia (a deficiency in infection-fighting white blood cells) associated with oncology chemotherapy. .
In April 2004, we entered into a research, co-development and marketing agreement with BioGeneriX AG, a company of the ratiopharm Group, for the development and commercialization of a next-generation G-CSF. We expect that BioGeneriX will commence a Phase I trial in a Western European country in the third quarter of 2006.
Other Proteins
We have also applied our GlycoPEGylation technology to other proteins, including recombinant follicle stimulating hormone (rFSH), Factors VIIa, VIII and IX, Interferon alpha and human growth hormone (hGH) and generated preliminary data on those compounds.
We have publicly presented data on EPO, G-CSF,rFSH, Interferon-alpha, Factor IX and hGH at investor and trade show conferences. You can access the webcasts of our presentations on the Audio Archives page of the investor relations section of our website.
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