Release issued 5th August 2009

4 August, 2009, TAIPEI, Taiwan -- Drug development company PharmaEssentia Corp.'s third-generation interferon drug candidate P1101 (PEG-P-IFN-alpha-2b) for the treatment of hepatitis B and C, has received US FDA IND approval, with Phase I clinical trials in both Canada and Taiwan set to begin in the third quarter of 2009.

The announcement was made in Taipei on Tuesday, with PharmaEssentia Founder and CEO Dr. KC Lin stating that the US FDA had sent the company its formal IND approval notice that it had reviewed and accepted the PK/PD and other pre-clinical data submitted in its IND application.

This data showed P1101 was particularly long-acting compared to the two other PEGylated-interferon drugs currently on the market, thus suggesting a less-frequent dosage regime for hepatitis B/C patients taking the drug once it receives market approval, said Lin.

Reducing dosage frequency is considered desirable for minimizing side effects and increasing a drug's efficacy particularly for biopharmaceutical drugs which must usually be administered by injection. 

In explaining what made the drug unique, Lin said that P1101 had 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 currently on the market.

This predominant single form of the structure along with unique PEGylation chemistry joining the PEG molecule with the protein was responsible for its long-acting qualities, and in addition made for a purer drug, leading to a simpler and more cost-efficient manufacturing process and better quality control over the end product, particularly when produced at higher doses.

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

In fact, P1101's lower dosage frequency will be revolutionary, Dr. KC Lin, Founder and CEO of PharmaEssentia, explained. 

"We anticipate a patient undergoing hepatitis treatment will only need to take our drug once every two weeks, perhaps only once a month. It's going to redefine the whole field of hepatitis treatment," he said.

This compared to the current once-a-week dosage frequency demanded of the two other drugs.

With Tuesday's announcement, PharmaEssentia looks well placed to participate in the increasingly hot deal market for HBV/HCV drug candidates. Demand is high from Big Pharma, with nine large deals for such drugs signed over the last six years ranging in value from US$102 million up to US$550 million.

For example, a deal in 2006 between US-based Human Genome Sciences (HGS) and Swiss drug giant Novartis for HGS' long-acting interferon candidate at Phase II development was worth US$506 million, said Shu-Fen Li, Director of Business Development and Strategic Planning. 

"We're actively seeking long term partners and collaborators from the international pharmaceutical community, and from attending overseas partnering events meeting people and presenting the benefits of P1101, we've seen that interest from Big Pharma in us is also high," added Li. 

The drug has been a complete 'Made in Taiwan' effort, explained Dr. Ching-Leou Teng, Executive VP and head of the company's research team.

"With P1101, everything is from and made in Taiwan - from early drug discovery through to manufacturing process development," she said.

P1101 also marks the first time a Taiwan-developed protein drug candidate has received US FDA IND approval, a significant milestone not only for PharmaEssentia but also for Taiwan's burgeoning biotechnology industry.

=============================

Market for interferon hepatitis drugs:
Interferon is the drug of choice for hepatitis patients due to its superior efficacy, but the drug comes with a number of disadvantages, including some side effects and the need for frequent dosage administration. Newer generations of PEGylated interferon have attempted to alleviate these issues, with some success. Dosage frequency remains an issue with versions currently available on the market. According to IMS Health 2005 data, the market for HCV therapy will reach US$5 billion by 2013, up from around US$2 billion in 2004. Of this, 64 percent will be for interferon therapies, up from 56 percent in 2004.  

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-P-IFN-alpha-2b (P1101), 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-P-IFN-alpha-2b is a third-generation long-acting interferon for the treatment of hepatitis B and C. PEG-P-IFN-alpha-2b has only a predominant 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-P-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).

We are currently seeking qualified co-development or out-licensing partners for our PEG-P-INF-alpha-2b drug candidate (HBV, HCV).

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

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

(22nd October 2009) Biosimilar TuNEX® from Mycenax completes Phase I/II clinical trial in Taiwan, Phase I in Korea

(21st July 2009) BioBusiness Asia 2009 opens in Taipei

(28th April 2009) Medigreen announces MAF, a new botanical-based anti-allergy formulation

(16th April 2009) GenMont probiotics products receive China market entry approval

(24th March 2009) PharmiGene obtains European patent for genetic discovery predicting warfarin sensitivity