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Transcript of Cholestin ® Product Training Series This material has been prepared by Pharmanex to be used in...
Cholestin®
Product Training Series
This material has been prepared by Pharmanex to be used in conjunction with general educational events and activities only. Alterations or modifications of this presentation without the express approval of Pharmanex is prohibited.
New & Improved Cholestin®
• Cholestin contains policosanol, a novel ingredientextracted from beeswax
• Policosanol is clinically proven*– safe, effective, and well-tolerated
• Proprietary PoliSorb™ † softgel delivery• Convenient once-a-day dosage• Pharmanex is first to market in the US • Pharmanex has exclusive rights for the
network marketing channel
†Policor is a trademark of Hauser, Inc.
NCEP Cholesterol Guidelines
Classification of LDL, Total, and HDL Cholesterol (mg/dL)
LDL Cholesterol < 100 100-129 (+ 2+ RF) 130-159 (+ 0-1 RF) 160-189 > 190
OptimalNear or above optimalBorderline highHighVery High
Total Cholesterol < 200 200-239
> 240
DesirableBorderline highHigh
HDL Cholesterol < 40 > 60
LowHigh
From: Third report of the National CholesterolEducation Program Expert Panel, May 2001
NCEP Cholesterol Guidelines
Using NCEP guidelines,
about 65 million Americans
should make dietary and lifestyle changes
to maintain cardiovascular health
Cholestin® : Health Benefits
• Maintains existing normal cholesterol levels*– Total & LDL-Cholesterol
– HDL-Cholesterol
– LDL/HDL Ratio – Triglycerides
• Helps prevent oxidation of LDL cholesterol*
• Promotes normal blood fluidity*
* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
History of Policosanol
Early 90’s: Beeswax policosanol initially sourced in Cuba
Mid 90’s: Sugar cane policosanol suggested as more economical source Cuban government
Sugarcane policosanol clinically tested and commercialized in Cuba
Pedro P. Perez revives R&D work in US for beeswax policosanol
Perez teams up with top-quality pharmaceutical company; now supplier
2001: Pharmanex
launches Cholestin® - beeswax policosanol
Cholestin Composition
Primary Active Constituent:
• Policosanol from Beeswax (PolicorTM )†
– Novel ingredient - “Cholesterol Breakthrough”
– Extracted from white NF-grade beeswax (GRAS)
– Patent granted to supplier in October 2001 (for use, composition and process)
Pharmanex has been granted exclusivity for Network Marketing Channel
†Policor is a trademark of Hauser, Inc.
Standardization
• Guaranteed minimum 40% policosanol
• Reproducible fingerprint of 5 primary aliphatic long-chain alcoholsmV
0.00
10.00
20.00
30.00
40.00
50.00
60.00
Minutes2.00 4.00 6.00 8.00 10.00 12.00 14.00
C24 -
4.64
7C2
6 - 5.
012
C28 -
5.44
0 C30 -
5.93
7C3
2 - 6.
517
PoliSorb™ † Proprietary Delivery
• Policosanol delivery can be problematic:
– naturally a fat-soluble, waxy substance
– remains solid at body temperature
– tablets & capsules have poor dissolution
• Pharmanex PoliSorb™ proprietary delivery:
– overcomes solubility problems
– emulsified with lecithin phospholipids• natural cell membrane components
PoliSorb softgels have over 10 times better dissolution than policosanol capsules or tablets
†Policor is a trademark of Hauser, Inc.
Policosanol: Clinical Data
Policosanol (sugar cane wax), double-blind clinical trials:**• Blood lipids: 13 studies (total of 1,378 subjects)
• Platelet aggregation: 6 studies
• LDL-oxidation: 1 study
Policosanol from beeswax may be more effective:• Main constituent in sugar cane wax, octacosanol, is not very active in
rats (Kato S, Br J Nutr 1995;73:433)
Beeswax policosanol clinical trials:• Two open-label pilot studies
* Summarized in Healthcare Professionals Product Guide
Clinical Data - Summary
Research with policosanol has shown the following results (10-20 mg/day):*
• Benefits after 8-12 weeks, maximum effect evident after 12 months
• Excellent safety & side effect profile
* Summarized in Healthcare Professionals Product Guide
Policosanol Safety
Beeswax policosanol has excellent safety data:• Clinical data: few & mild side effects*
• Made from purified, white NF-grade beeswax
• GRAS (FDA-Approved) for food & drug use
* Summarized in Healthcare Professionals Product Guide
Drug Interactions
• No clinical reports of drug interactions*
• Preliminary contraindications:– high-dose aspirin therapy
– anticoagulants (warfarin, coumadin, etc.)
– discontinue within 2 weeks of surgery
* Summarized in Healthcare Professionals Product Guide
Summary
• Cholestin maintains existing normal cholesterol levels* • Provides 15 mg per softgel of policosanol• Policosanol is clinically proven• Proprietary PoliSorb™ softgel delivery• Convenient once-a-day dosage• Safe & well tolerated • Pharmanex is first to market in the US • Pharmanex has exclusive rights for the
network marketing channel
* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.