new cholestin, overview new & improved cholestin: red yeast rice-free formula equally safe and...

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New Cholestin, Overview New & Improved Cholestin: • Red yeast rice-free formula • Equally safe and effective as RYR* • Contains novel ingredient extracted from beeswax: Policor™ extract with Policosanol • Better tolerated - no liver function testing, muscle weakness issues • Much more convenient - once a day! * These statements have not been evaluated the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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Page 1: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

New Cholestin, Overview

New & Improved Cholestin:

• Red yeast rice-free formula

• Equally safe and effective as RYR*

• Contains novel ingredient extracted from beeswax: Policor™ extract with Policosanol

• Better tolerated - no liver function testing, muscle weakness issues

• Much more convenient - once a day!

* These statements have not been evaluated the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Page 2: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

Overview of Health Benefits

Promotes Complete Blood Lipid Balance already within the normal range*

– Total & LDL-Cholesterol

– HDL-Cholesterol

– LDL/HDL Ratio – Triglycerides

Promotes normal blood fluidity (platelet aggregation)*

Helps protect LDL from oxidation by free radicals*

* These statements have not been evaluated the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Page 3: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

Cholestin Composition

Primary Active Constituent:• 15 mg policosanol from PolicorTM extract

• Policor is:– Novel ingredient, “Cholesterol Breakthrough”

– Extracted from white NF-grade beeswax (GRAS)

– Patent pending (use, composition and process)

– Global Exclusivity granted to Pharmanex for network markets

Page 4: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

Policosanol’s History

• Originally developed in Cuba as a natural, cholesterol-lowering agent– Early 90’s: initially identified

beeswax policosanol as the preferred source material

– Mid 90’s: Cuban government ‘suggested’ sugarcane policosanol as a more economical source

– Sugarcane policosanol clinically tested and commercialized in Cuba

Page 5: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

Policosanol’s History

• Inventor, Pedro P. Perez, revived R&D based on a beeswax source

• worked with a top-quality extraction company, Hauser

• Pharmanex has Network Marketing exclusive!

Page 6: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

Beeswax Policosanol

Pharmanex Double-Blind Clinical Study• Double-blind, placebo-controlled clinical study of new

Cholestin (15 mg policosanol) in 90 hypercholesterolemic subjects.

• Main outcome: Changes in blood lipid profile at 6 & 12 weeks.

• Rippe Lifestyle Institute, Tufts University, Boston, MA.

• Started June 2001; To be finished in 1Q 2002.

Two further double-blind, placebo-controlled clinical studies testing 10 mg beeswax policosanol planned in 2002.

Page 7: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

Summary, Clinical Data

10-20 mg/day policosanol

• Lowers LDL-C by 20-30 %

• Lowers TC by 16-23 %

• Increases HDL-C by 21%

• Lowers TG by 12 % (if TG > 200 mg/dl)

• 8-12 weeks, maximum after 12 months

• Excellent safety & side effect profile

Page 8: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

Policosanol Safety

Beeswax policosanol has excellent safety data:• Clinical data: very few side effects • post marketing study, only 86 of 27,879 patients

(0.3%) reported minor side effects

• Beeswax policosanol has LD50 > 5 g/kg, with no adverse effects

• No carcinogenic, mutagenic or teratogenic effects• Made from purified, white NF-grade beeswax, GRAS

(FDA) for food & drug use

Page 9: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

Drug Interactions

• No clinical reports of drug interactions

• However, – policosanol lowers platelet aggregation– w/o affecting clotting time

• Conservative precautions:– high-dose aspirin therapy– anticoagulants (warfarin, coumadin, etc.)– within 2 weeks of surgery

Page 10: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

PoliSorb™ Proprietary Delivery

• Policosanol delivery can be problematic:– tablets & capsules: poor dissolution (USP XXIV)– policosanol, a fat-soluble, waxy substance – remains solid at body temperature

• Pharmanex PoliSorb™ proprietary delivery:– overcomes policosanol’s solubility problems– emulsification with lecithin phospholipids

• natural cell membrane components

– PoliSorb softgels have over 10x better dissolution than policosanol capsules or tablets

Page 11: New Cholestin, Overview New & Improved Cholestin: Red yeast rice-free formula Equally safe and effective as RYR* Contains novel ingredient extracted from

Cholestin, Summary

• Promotes Complete Blood Lipid Balance already within the normal range*

– Total & LDL-Cholesterol

– HDL-Cholesterol

– LDL/HDL Ratio – Triglycerides

• 15 mg policosanol from Policor™ extract

• Safe & well tolerated

• Proprietary PoliSorb™ softgel delivery

• Convenient once-a-day dosage* These statements have not been evaluated the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.