(Taiwan) PharmaEssentia's long-acting HBV/HCV drug candidate P1101 (PEG-P-IFN-alpha-2b) receives FDA IND approval :: BiotechEast - Taiwan and China biotechnology, medical devices, pharmaceuticals, ^¤å½s×, ^¤å×§ï ::

(BiotechEast staff)

4 August, 2009
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.

Founder and President of PharmaEssentia, Dr. KC Lin, speaking in Taipei, Taiwan, announcing that the company's P1101 hepatitis drug candidate had receiving US FDA IND approval.

The announcement was made in Taipei last week, 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, maybe even less often, 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.

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