PharmaEssentia

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Project overview
With the achievement of third generation interferon-alpha, P1101, PharmaEssentia has been actively developing new long-acting protein drugs with its novel PEGylaltion platform in order to sustain its leading position in this field.

Uutilizing its PEGylaltion platform to develop new biologic drugs for the market, PharmaEssentia's 'PEG-Four' project includes the four biologics:

1. P1104 (PEGylated-Interferon-beta, or PEG-IFN-β) used for the treatment of multiple sclerosis
2. P1116 (PEGylated-Erythropoietin, or PEG-EPO) used for dialysis and cancer patients
3. P1118 (PEGylated-Growth hormone, or PEG-GH) used to treat deficiency unrelated short stature
4. P1130 (PEGylated Granulocyte-colony-stimulating factor, or PEG-GCSF) used with certain cancer patients to
accelerate recovery from neutropenia after chemotherapy, allowing higher-intensity treatment regimens

PharmaEssentia is initially focusing on both P1104 and P1116 currently in preclinical studies, with plans to begin Phase I clinical trials in 2010. 40K PEG molecular has been successfully coupled to both IFN-β and EPO with PharmaEssentia PEGylaltion technology platform to produce the predominant single form of P1104 and P1106, both having completed the purification, bioactivity assay, and scale-up production stages. To date, rat PK studies show that both P1104 and P1116 induce prolonged blood circulation competing favorably with its competitors on the market. The experience gained from developing P1101 makes PharmaEssentia confident to accelerate the PEG-Four project, such that the planned-for IND filing for P1104 and P1116 is scheduled for Q4, 2009. P1104 and P1116 will begin Phase I clinical trials in Q1, 2010, and enter Phase II in Q3 2010, at which stage they will be available for out-licensing to global pharmaceutical companies with a total package of US$120 million.