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

Released on: June 24, 2008, 3:02 am

Press Release Author: PharmaEssentia Corp.

Industry: Biotech

Press Release Summary: 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.

Press Release Body: 18 June, 2008, TAIPEI, 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).


For editors:
PEG-IFN-alpha-2b = PEG-IFN-α-2b
IFN-beta = IFNβ



Web Site: http://www.pharmaessentia.com

Contact Details: 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
shufen_li@pharmaessentia.com

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