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Purer, Less Costly Interferon for Hepatitis C and B Treatment

The Editors at Hepatitis Central
June 23, 2008

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The Taiwan-based biopharmaceutical company PharmaEssentia Corp. is testing P1101, its third-generation PEG-interferon-alpha drug candidate. Because it is a longer-lasting, purer interferon that is less costly to produce, P1101 could enhance the treatment options for Hepatitis C and B.

PharmaEssentia announces milestone in development of new third-generation interferon hepatitis B and C drug candidate

www.biotecheast.com
(Press release, PharmaEssentia Corp.)
18 June, 2008

(Taiwan) Drug development company PharmaEssentia Corp. today announced that new PK/PD data on P1101, its third-generation PEG-interferon-alpha drug candidate for hepatitis B and C, showed the drug is particularly long-lasting compared to the two other pegylated-interferon drugs currently on the market. This indicates that PharmaEssentia’s drug may only need to be injected once every two or more weeks by the patient, compared to the usual once-a-week administration.

Reducing dosage frequency is considered desirable for minimizing side effects and increasing the efficacy; and is more convenient for the patient as such biopharmaceutical drugs must usually be administered by injection.

Additionally, the modified structure of PharmaEssentia’s PEG-INF-alpha makes for a purer drug, leading to a simpler manufacturing process and better quality control over the end product, particularly when produced at higher doses. P1101 has only a predominant single positional isomer connecting the PEG molecule on the protein, compared with 8 to 14 isomers found in the two other pegylated-interferon drugs, respectively.

Less frequent dosage should also mean a lower end cost and better compliance for the patient.

Assuming that upcoming clinical trails are all completed successfully, Dr. KC Lin, founder and CEO of PharmaEssentia, sees the drug gaining rapid acceptance and market share upon launch.

“Our drug will be purer, easier to manufacture, and more importantly, a more convenient and cheaper interferon option for doctors and patients. It’s set to transform the whole picture of HCV/HBV treatment,” explained Lin.

Summary of pharmacokinetics (PK) and pharmacodyamics (PD) studies:

PK results: Mean serum concentrations of PEG-IFN after a single subcutaneous dose of 30ug/kg of one of the two other pegylated-interferon drugs currently on the market, or P1101 (PharmaEssentia) were measured. PEG-IFN was detectable in all four animals through 14 days after P1101 administration, while PEG-IFN was only detectable in two out of four monkeys for the 14 days duration after administration of the two other pegylated-interferon drugs.

PD results: A single subcutaneous dose of 30 ug/kg of one of the two other pegylated-interferon drugs currently on the market, or P1101, resulted in significant increase in serum 2’,5’-OAS (biomarker of IFN-alpha exposure) concentration. Serum 2’,5’-OAS concentration reached its Cmax 72 hours after dosing and gradually declined for the animals treated with the other two pegylated-interferon drugs. For animals receiving the P1101 dose, serum 2’,5’-OAS concentration also reached Cmax 72 hours after dosing. However, 2’,5’-OAS concentration only decreased slightly throughout the 14 days of the study period.

About PharmaEssentia Corp.:

PharmaEssentia Corp., a Taiwan-based biopharmaceutical company, is focusing its efforts on making improvements to the biologics family of drugs using a combination of its own proprietary novel site-specific PEGylation, a medicinal chemistry approach, and protein engineering technologies to create new “PEGylated” biologics.

Through its novel technology platform, PharmaEssentia Corp. has a series of PEGylated biologics called the “PEG-5 biologics”: PEG-IFN-alpha-2b, IFN-beta, GCSF, EPO, GH, undergoing various stages of research and development. The current market for the diseases targeted by these drugs is estimated at around US$25 billion with an annual growth rate of 9 percent.

PharmaEssentia’s PEG-IFN-alpha-2b a third-generation long-acting interferon for the treatment of hepatitis B and C, is currently in preparation for US FDA IND filing in the 3rd quarter of 2008. PEG-IFN-alpha-2b has only a single form compared to 14 and 8 with the two other pegylated-interferon drugs currently on the market, thus requiring a potentially less frequent administration regime. Through a unique refolding process, PEG-IFN-alpha-2b has a better yield (up to as high as 40 percent compared to wild type INF) and longer half-life (administration every two weeks or more) at a competitive CMC (Chemical Manufacturing Control).

PharmaEssentia at BIO 2008, San Diego:

We are currently seeking qualified co-development or out-licensing partners for our PEG-Interferon-alpha drug candidate (HBV, HCV). Please contact us to arrange a meeting during the partnering sessions at BIO 2008, 17-18 June, in San Diego, or feel free to visit us at booth 2501 at the Taiwan Pavilion.

PharmaEssentia CEO Dr. KC Lin will also be giving a presentation at the BIO 2008, Business Forum, Room 5B, 3:00pm, 18 June, 2008. You are very welcome to attend.

Contact:

PharmaEssentia Corp.
13F, No. 3 YuanQu St., Nankang District
Taipei 115, Taiwan
Tel: 886 2 2655 7688
Fax: 886 2 2655 7626
www.pharmaessentia.com
Ms. Shu-Fen Li, MBA
Director of Business Development and Strategic Planning
Ph: +886-2-2655-7688 ext. 7812
[email protected]
For editors:
PEG-IFN-alpha-2b = PEG-IFN-α-2b
IFN-beta = IFNβ

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