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PharmaEssentia PEG 5 Product Pipline
PharmaEssentia scientists utilize a novel approach in combining protein
engineering and pegylated chemistry in an aim to create new products to
better treat diseases. These technologies preserve the biological
activities of the therapeutic proteins by targeting attachment of
polymers to the defined regions of proteins. Historically, product
heterogeneity and loss of biological activities have been the two most
common problems encountered in the development of pegylated biologics.
PharmaEssentia's scientists overcome these problems in a revolutionary
fashion and create its so-called Big 5 product pipeline:
PEG-IFN-α; PEG-IFN-β; PEG-GCSF; PEG-rhGH and PEG-EPO. The
most advanced program is PEG-IFN-α for the treatments of
hepatitis B & C and an IND filing is planned in Q2, 2008.
Product Pipeline: New Drug Research and Development
1. PEG-IFN-α (HBV, HCV)
2. PEG-IFN-β (Multiple Sclerosis)
3. PEG-GCSF (Neutropenia)
4. PEG rhGH (Growth Hormone Deficiency)
5. PEG EPO (Anemia)
P1101:
PharmaEssentia's most advanced program: PEG-IFNα-2b(P1101) for the treatments of hepatitis B & C.
PharmaEssentia's P1101, its third generation long-acting interferon, is
currently under preparation for a FDA IND filing in the 3rd quarter of
2008. P1101 has only a single form compared to PEG-INTRON's 14 isomers
and PEGASYS' 8 isomers, thus requiring a potentially less frequent
administration regime of every two weeks or more). Through a unique
refolding process, P1101 also has a better productive yield (up to as
high as 40% compared to wild type INF).
PharmaQ10®
- a new, improved formulation of CoQ10
What is CoQ10?
Coenzyme Q10, or CoQ10, exists in mitochondria and is an essential
component of the cellular energy system. Synthesized in all body
tissues, CoQ10 is fat-soluble material, naturally present in the
foods we eat. Involved in the production of ATP (adenosine tri-phospate,
the energy carrier of human body) CoQ10 also acts as a powerful
antioxidant helping to scavenge free radicals. Any system in the
body involved strong metabolism such as digestion, breathing, the
beating of the heart, or the contraction of muscle requires CoQ10;
the more active the system, the more CoQ10 is required, and the
more CoQ10 retained by the tissues involved in each system.
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CoQ10 contained within the organs
of the human body systems involved in metabolism and activity.
After 40, CoQ10 levels diminish rapidly.
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Since being discovered in 1957, CoQ10 is becoming increasingly
popular, particularly in Japan. It was first approved there as a
prescription drug (1) for use in heart failure situations, and later
as a food supplement. Over the years since there have been a number
of studies undertaken uncovering the positive effects of CoQ10 in
the fields of heart disease, stroke(2), hypertension(3), Parkinson's
disease(4), cancer(5), diabetes(6), immune deficiency(7), among
others. For example, a Phase II study investigating the effects
of CoQ10 on Parkinson's disease in the US showed an improvement
in the disease with no side-effects in 80 Parkinson's patients,
taking CoQ10 for 16 months in the amounts of 300mg, 600mg, and 1200mg
a day.
Because CoQ10 is naturally 'biosynthesized' in the body from trace
elements derived from a healthy diet, it is believed that those
with inadequate diets may also benefit from taking CoQ10 as a nutritional
supplement.
Bert V. Israelsen, executive vice president of US-based chem-pharma
company Frontier Scientific, estimated that the worldwide market
of CoQ10 has now reached US$500 million, with demand far exceeding
current supply. With the global top four suppliers providing CoQ10
with USP-grade quality and metric ton-quantity located in Japan,
PharmaEssentia is now the only supplier meeting such requirements
outside Japan.
Medical grade PharmaQ10®
The purest medical-grade CoQ10
• PharmaEssentia utilizes a proprietary synthesis method to
producing PharmaQ10, the purest CoQ10 available anywhere.
The best formula for human absorption
• Preliminary studies show that the absorption of PharmaQ10
is several times higher than any of the other leading suppliers.
Economical price
• Other CoQ10 suppliers utilize a fermentation process to produce
CoQ10. Such a process leads to a high level of contaminations, which
have to then be removed. This adds to the cost, leading to a final
higher product price. PharmaEssentia's manufacturing process in
comparison produces a purer product at a lower final price.
Steady supply
• Based on our technique, we are confident in our ability to
provide PharmaQ10 in quantities enough to satisfy current and future
global market needs.
It's Purity, plain and simple
There are two ways to produce CoQ10 - by chemical synthesis or
by fermentation. A common misconception is that CoQ10 produced by
fermentation is somehow 'safer' and 'more natural'. However, the
fermentation process produces not only CoQ10 but also many other
by-products, which must be removed from the final product. In comparison,
the synthesis process produces a much purer CoQ10.
We have developed a proprietary manufacturing process technology
that enables it to produce the purest CoQ10 in the world today.
PharmaQ10 is manufactured under the strictest manufacturing techniques
and protocols, at our GMP-certified facility in Taiwan. PharmaQ10
is even purer than the standard deemed '100 percent pure' by the
USP, the US pharmaceutical standards body.
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The sum of two types of impurities
of under UPS regulations must not exceed 1.5%. According
to a study by the testing institute Eurofins, the impurities
of PharmaQ10 in these two categories were 0.255% and 0.233%,
much lower than the USP limit.
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With the USP 'Pure grade material'
treated as 100% pure, Eurofins' study showed that the PharmaQ10
exceeds 100% purity in repeated tests (100.7% and 101.4%
respectively).
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It's PharmaEssentia's synthetic manufacturing method that makes
the difference. In comparison, the fermentation method results in
too many impurities in the end product, impurities that are difficult
to remove entirely.
The danger of long-term ingestion of such impurities is unclear,
but what is clear is that PharmaQ10 is the safest and purest CoQ10
product on the market.
Innovation formula to improve absorption
According to a study published in NUTRA Ingredients Europe 2006(8),
PharmaEssentia is currently the fifth largest CoQ10 manufacturer
in terms of production. However, quantity means nothing without
quality; at PharmaEssentia we are committed to producing the finest
CoQ10 product formulation available.
Pure CoQ10 is highly hydrophobic, the result being that the purer
the product, the more difficult it is to be absorbed into the tissues
at the sites in the body where it is needed. Because of this most
suppliers are forced to increase the percentage of CoQ10 in their
formula to guarantee the effect of health, but it means the higher
cost of the final formulation.
Each scientist of PharmaEssentia has decades of experience in the
research and development of new drugs or active pharmaceutical ingredients.
With this expertise we have engineered a product that delivers an
increased tissue CoQ10 absorption rate.
Study shows PharmaQ10 formula results
in absorption rates 5 times higher than world market leader.
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Groups A to C used PharmaQ10
formulation and demonstrated superior absorption in rats.
Blood CoQ10 levels in rats after given PharmaQ10 near average
5 times higher than those of the leading brands, Group D.
Please note that peak absorption rate of D is more than
two times greater than that of dry CoQ10 powder, as claimed
by the leading brand company.
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Groups A to C consumed PharmaQ10 and the results showed superior
absorption as measured in blood CoQ10 concentration, with levels
near on average 5 times higher (based on Area Under Curve (AUC),
18495 hr*ng/ml for group A verse 2900 hr*ng/ml for group D) than
those of the leading brand. The pharmacokinetic study showed similar
results.
PharmaQ10® formula and product
• 100% CoQ10 powder
• 5% water-soluble CoQ10 powder/liquid
• 10% water-soluble CoQ10 powder/liquid
• ODM cosmetic/food supplement containing CoQ10
• Pastille
• Capsule
• Drink
References:
1. http://www.nlfd.gov.tw/ShowModule.aspx?tab=411&mtab=Doc&act=Detail&docid=3975
2. Folkers K,et al. "Biochemical Rationale and Myocardial Tissue
Data on the Effective Therapy of Cardiomyopathy with Coenzyme Q10"
Proceeding of National Academy of Sciences 1985 82(3): 901-904.
3. Langsjoen P, et al. "Treatment of essential hypertension with
coenzyme Q10" Mol Aspects Med 1994, 15: S265-72.
4. Shults CW, et al., and the Parkinson Study Group. "Effects of
coenzyme Q10 in early Parkinson disease: evidence of slowing of
the functional decline." Archives of Neurology, 2002, 59(10): 1541-1550.
5. Lockwood K, et al. "Progress on Therapy of Breast Cancer with
Vitamin Q10 and the Regression of Metastases" Biochemical and Biophysical
Research Communications 1995: 212(1): 172-7
6. Henriksen JE, et al. "Impact of ubiquinone (coenzyme Q10) treatment
on glycemic control, insulin requirement and well-being in patients
with Type 1 diabetes mellitus" Diabetic Med 1999, 16(4): 312-8.
7. Folkers K, et al. "Biochemical deficiencies of coenzyme Q10 in
HIV-infection and exploratory treatment" Biochemical and Biophysical
Research Communications 1988, 153(2): 888-96.
8. http://www.nutraingredients.com/news/ng.asp?id=68202
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