Pioneered Products of Sabinsa- Sep 16, 2011

National Seminar – Pharma Eminence 2011

A presentation from Sami Labs Ltd. / Sabinsa Corp.

Date: September 16, 2011

Dr. Muhammed Majeed

Group Chairman,

Sami & Sabinsa Group of Companies

Presented by:

Dr. S. Natarajan

Executive Vice President, R&D

Sami Labs Ltd., Bangalore

Edkal CorporationIndia / USA

SabinsaSouth Africa

SabinsaChina

SabinsaJapan

AFI’sUSA

SabinsaUSA

NJ & Utah

SabinsaVietnam

SabinsaEurope (Germany)

Hanbury FZEU.A.E.

Organica Aromatics

ClinWorld Inc.India / USA

SAMI LABSINDIA

SabinsaPhilippines

SabinsaAustralia

Global Presence and Group Companies

Sami DirectIndia

• BioPerine is a patented standardized extract obtained from black pepper, containing not less than 95% Piperine.

• A clinically proven natural bioavailability enhancer for nutrients1

1 Summaries of clinical studies are available at: www.bioperine.com

U.S. PATENTS # 5536506 (1996), # 5744161 (1998)# 5972382 (1999),# 6054585 (2000)

INTERNATIONAL PATENTS:European Patent # EP 0810868 (2001)Japan: # JP 3953513 (2007)Canada: # CA 2247467 (2007)

(Mercy Medical Centre, NY)

BioPerine® increased the absorption of co-administered beta-carotene in human volunteers

(Mercy Medical Centre, NY)

Efficacy of BioPerine (5 mg) on the bioavailability of

Vitamin B6 absorption in human volunteers

Mean serum CoQ10 values during supplementation of 120 mg of CoQ10 with and without 5 mg of piperine

BioPerine® Enhances Bioavailability of Resveratrol-

University of Wisconsin Study

BioPerine® significantly improves the bioavailability of ResveratrolPlasma exposure for Resveratrol increses by 255%Cmax for Resveratrol increases by a phenomenal 1544%Economic impact of such findings very substantial in bringing down the cost of nutrients precipitouslyStudies Directed at Neuroendocrine cancer inhibition by ResveratrolPhase I studies are underway at University of WisconsinFindings have an impact on other nutrients such as Silbinol®Molecular Nutr Food Res., 2011, 55, In Press

L(+)-SELENOMETHIONINE (USP)

www.seleniumselect.com

• L(+)-Selenomethionine : Stereospecific natural form of bioavailable selenium

• Sami Labs - Received Basic Drugs Award (1994) for pioneering manufacture in India; is the largest manufacturer of L(+)-Selenomethionine.

NATIONAL QUALITY AWARD

(BASIC DRUGS, 1994)

FDA allowed qualified health claim:

“Selenium may reduce the risk of certain types of cancers”

SELENIUM IN HEALTH

Supplemental selenium daily dose is generally : 50-200 mcg

High dose selenium (L(+)-Selenomethionine) is being studied as a treatment for various types of cancer.

Potential Role in Clinical Practice

Selenium

Cancer Prevention

Arthritis/inflammatory

diseases

Diabetes Support

Cardiovascular Health

Beneficial effectsin HIV infection

Immunity & Resistance to

Infections

SelenoForce®

Source of selenium with greater efficacy in breast cancer prevention

US Patent # 7014874 (2006)

METHYL SELENOCYSTEINE

Naturally found in garlic and cruciferous vegetables

Sami Labs manufactures the stereospecific L natural form

US Patent 6794537 - Sami Labs (2004) - Process PatentUS Patent 6982273 - Sami Labs (2006) -Human & veterinary use patent

US Patent 8003614- Sami Labs (2011)-Dipeptides Containing Seleneium- Bioavailability-Pharma-Cosmeceuticals

Applications

Selenium Containing Peptides

Setting the Standard….

(Coleus forskohlii Extract)

US 5804596 (1998)EP 0977564 (2005)CA 2281562 (2008)

Role in enhancing lean body massand in the treatment of mood disorders

OCOCH3

OH CH3

Forskolin

ForsLean®, manufactured by

a proprietary process.

It is a standardized extract

from the roots of the Coleus

forskohlii plant, the only

known plant source of the

Forskolin.

Nutracon Award, 2001

Achievements & Recognitions

US Patent # 5804596, won the Thomas Alva Edison Patent Award (R & D Council, NJ USA) on November

11, 2004

1. Open field study (8 weeks) with 6 overweight women subjects. Dr. A. Conte, USA2. Open-field study (6 months) with sixteen obese subjects: Dr. Asano, Japan3. Pilot clinical efficacy and safety study, 19 women subjects, randomized , double blind placebo controlled : University of Memphis TN, USA4. Preclinical toxicology evaluation - CBPRC, Bombay5. 60 subject clinical efficacy study – CBPRC, Bombay6. 24 subject body composition evaluation and body weight Northern Michigan University, USA7.Double-blind placebo controlled study, 30 obese/overweight subjects Kansas State University, USA 8. 60 subject clinical efficacy study – Completed– at Manipal9. 6 month feeding/toxicity study- Completed

10. Micronuclei and dose effects studies- Completed

11. Bone Density and Hormonal Levels Study (3months) with 24 women subjects –Completed Dr. Pankaj Gandhi Hospital, Mumbai

12.Hormonal Study (3months) with 30 male subjects- Completed Kasturba Medical College,Manipal

Clinical Studies

•Lean Body Mass refers to the sum of the weight of your bones, muscles and organs... basically the sum of everything other than fat in your body

• Measurable

•A Better Description of Obesity Conditions

LEAN BODY MASS

Before After 4 weeks After 8 weeks

10Meanweight loss(lbs)

Mean bodyfat (%)

Mean leanbody mass(%)

Effects on Body Weight, Body Fat and Lean Body

Open field study, 6 overweight women subjects, 500 mg ForsLean corresponding to 50 mg forskolin/day for 8 weeks

Majeed et al, Nutracos, Feb 2006, Page 2

Exercise, Supplements and ObesityExercise, Supplements and Obesity

The Ohio State University Comprehensive Cancer Center is conducting a study on Forskolin’s effect on Chronic Myelogenous Leukemia (CML).

Early results on CML patient cells both in culture and in mice showed that forskolin reduced the cancer cells’ ability to grow up to 90 percent.

Anti Cancer Application

CURCUMIN C3 COMPLEX®

Source: Curcuma longa (Turmeric)

Active components: Curcuminoids

Antioxidant, Anti-inflammatory support, Immune support.

Plant part used: Roots

U.S. PATENT US 5861415 (1999)European Patent EP 0839037 (2002)

The first book to comprehensively list the medicinal claims of Curcuminoids was published by SABINSA in

Therapeutic potential of Curcumin

HIV replication

HIV Replication

Curcumin C3 Complex®

ChemopreventiveSkin, liver, colon, stomach

Diabetes

Cardiovascular diseases

Cholesterol, platelet aggregation, inhibition of

smooth muscle cell proliferation

Arthritis

Anti-inflammatory

Chemotherapeutic

Antioxidant

Lung fibrosis

Nephrotoxicity

Cardiotoxicity Wound healing

Cataract formation

Antiangiogenic

Multiple sclerosis

Alzheimer disease

Gall-stones formation

Adopted from Dr.Bharat Aggarwal, MD Anderson Cancer Research Center, Texas

Curcumin and its Multi-targets

www.curcuminresearch.org

Curcumin potentiates the effect of paclitaxel by suppressing the metastasis of the human breast cancer to the lung in mouse xenograft model

Curcumin potentiates the effect of paclitaxel by suppressing the metastasis of the human breast cancer to the lung in mouse xenograft

Clinical Cancer Research 2005 Oct 15;11(20):7490-8

Disease Investigator Institution

Multiple myeloma Saroj Raj-Vadhan, MD UTMDACC, USA

Pancreatic cancer Razelle Kurzrock, MD UT MDACC, USA

Pancreatic cancer Rami Ben Yosef, MD Ichilov, Israel

Melanoma Christopher D. Lao, MD University of

Michigan, USA

Colon Cancer Ernie Hawk, MD National Cancer Institute,

Colon Cancer Dean Brenner, MD University of

Michigan, USA

Colon Cancer William P Steward, MD University of Leicester, UK

Alzheimer’s Disease Milan Fiala, MD UCLA, USA

Safety Studies Dean Brenner, MD University of

Michigan, USA

Myelodysplastic syndrome Azra Raza, MD University Mass., USA

Gall Bladder Cancer V.K.Shukla Banaras Hindu

University, India

Gall Bladder Cancer Nihar Rajan Das AIIMS, India

Ongoing Clinical Trials with Curcumin

Adopted from Dr.Bharat Aggarwal, MD Anderson Cancer Research Center, Texas

Source: Boswellia serrata (Indian frankincense, olibanum)

Active components: Beta-Boswellic Acids

Nutraceutical applications: Supports the management of inflammation.

Plant part used: Exudate (gum resin)

Form in which supplied: Standardized extract (powder)

BOSWELLIN

The FOUR major identified pentacyclic triterpenoids in Boswellin® are…

β -Boswellic acid Acetyl- β -Boswellic acid11-keto- β -Boswellic acidAcetyl -11 –keto –β -Boswellic acid

BoswellinBoswellin®® - - ChemistryChemistry

-Boswellic Acid Acetyl--Boswellic Acid

11-Keto--Boswellic Acid Acetyl-11-Keto--Boswellic Acid

Sabinsa Corporation

H HOOC

Chemistry of Boswellic Acids

Salient Features of Boswellin

Sami Labs/Sabinsa Corporation pioneered the introduction of standardized Boswellia serrata extract to global markets

Correctly standardized for boswellic acids (method submitted to the United States Pharmacopoeia for monograph development)

Promising Clinical trials for the following indications are reported in literature:

Rheumatoid arthritis OsteoarthritisChronic colitisUlcerative colitisCrohn's diseaseBronchial asthmaPeritumoral brain edemas*

* European Union: orphan drug application exists for this indication

Anti-inflammatory Applications of Boswellic acids

Ref: Ammon HP. Boswellic acids (components of frankincense) as the active principle in treatment of chronic inflammatory diseases. Wien Med Wochenschr. 2002;152(15-16):373-8. Review. German

POLICOSANOL

Policosanol is a mixture of fatty alcohols derived from waxy extract of sugarcane.

Policosanol is reported to support healthy blood lipid levels and cardiovascular health

Patents:US 7217546 (2007)IN 229695 (2009)

Clinical Studies

A double-blind placebo controlled study was conducted using Sabinsa’s Policosanol derived from Indian Sugarcane to investigate

– the efficacy of Policosanol vs. Atorvastatin for the treatment of Hyperlipidaemia.

Decrease in Cholesterol Levels

Details Policosanol Atorvastatin

Mean 16.1116.11 19.66

SEM 1.85 2.59

Details Policosanol Atorvastatin

Mean 33.7433.74 35.61

SEM 3.22 4.19

Decrease in Triglyceride Levels

Details Policosanol Atorvastatin%

Mean 20.9120.91 23.87

SEM 3.32 2.69

Decrease in Cholesterol / HDL Ratio

Base LineFinal

Policosanol Atorvastatin

Details ESR

% BASELINE

FINAL VISIT

BASELINE

FINAL VISIT

Mean 23.10 16.33 29.32 Mean 17.26 18.53 7.36

SEM 2.65 1.60 4.33 SEM 2.67 4.24 5.04

ESR, an early marker of inflammation, significantly decreased with Policosanol but increased by 7.36% with Atorvastatin.

Policosanol Atorvastatin

Clinical Trials

• Policosanol compared favorably with Atorvastatin at improving the serum lipid profile.

• Policosanol was well tolerated and no drug-related adverse drug reactions were observed.

• Policosanol is a safe and effective supplement

for lowering of bad cholesterol levels and can be used to lower several cardiovascular disease risk factors.

• Gugulipid is a patented standardized extract obtained from Commiphora mukul (wightii) gum resin (Guggul), containing not less than 2.5% guggulsterones.

• Clinically proven to support cardiovascular health.

• Guggul has been traditionally used in Ayurveda in the management of obesity and inflammation.

1 Summaries of clinical studies are available at: www.gugulipid.com

Commiphora mukul tree

US Patent: US 6436991 (2002)

Lipid disordersCardiovascular health Obesity Arthritis and inflammation Thyroid stimulation Acne management support

Potential Roles in Clinical Practice

Sabinsa, USA sponsored an IND for Gugulipid®. “Randomized, Double Blind, Placebo Controlled Trial

Evaluating the safety and Efficacy of GUGULIPID in Americans with Hypercholesterolemia”.

Dept. of General Internal Medicine.University of Pennsylvania 9 Penn Tower, 3400 SpruceSt,. Philadelphia, USA. 1st Publication: Gugulipid® for the treatment of

Hypercholesteremia.A randomized trial. JAMA, August 13, 2003,

Vol. 290 No. 6

2nd Presentation: Metabolic Effects of Gugulipid®. 10th Annual symposium on Complementary

Healthcare, Royal Collage of Physicians, London, UK.

Clinical efficacy study: Mercy Medical Center, Bronx, New York

Dr. Edward Norkus Double Blind Cross over study-ongoing

Pharmacology & Clinical Trials

Comprehensive indices of cardiovascular health were measured:

Oxidative stress

C-reactive protein (CRP)

Levels of uric acid

Lipoprotein (a)

Role in Cardiovascular Health

Summary of results

RESULTS OF RANDOMIZED DOUBLE BLIND PLACEBO-CONTROLLED CROSSOVER STUDY

Active therapy: Gugulipid® (75 mg guggulsterones daily dose, 12 weeks, 30 volunteers )

0 0.5 1 1.5 2

SerumMDA

(mg/dl)

Serum hs-CRP

(mg/dl)

Placebo

Gugulipid

hs-CRP: high-sensitivity C-reactive protein, marker of oxidative stress - associated with inflammationMDA: Malondialdehyde, marker of oxidative stressNo dermatologic hypersensitivity observed during treatment

(Mercy Medical Center, NY, October 2004)

RESULTS OF RANDOMIZED DOUBLE BLIND PLACEBO-CONTROLLED PARALLEL DESIGN STUDY ON Lp(a) levels

Active therapy: Gugulipid® (75 mg (standard dose, SDG) or 150 mg (high dose, HDG)

guggulsterones daily, 8 weeks, 42 volunteers with elevated Lp(a) )

-8-7-6-5-4-3-2-1012

SDG HDG Placebo

Szapary, PO et al. JAMA, Aug 13, 2003, 290(6): 765-772

Source: Garcinia cambogia (Fam. Clusiaceae)

Plant part used: Fruits

Active constituents : (-) Hydroxycitric acid, (-)HCA, Garcinol

Nutraceutical benefits: Weight management support

Patents: AU 773081 (2004), NZ 518116 (2005), US 7063861 (2006), EP 1254209 (2006), and JP 4205943 (2008)

Ocufors Eye Drops – for Glaucoma

• First natural drug to go through full fledged clinical documentation to obtain a drug approval

Normal visionSame scene as viewed

by a person with glaucoma

Vision of a Glaucoma patient

Patents Granted:USA : US 6960300 (2005); Singapore: SG 121197 (2008)Mexico : MX 260326 (2008); South Africa: ZA 2006/01898 (2008)

Application in Glaucoma

Ocufors – from Coleus forskohlii

Ocufors™ Eye drop solutions for Glaucoma Treatment

Ocufors™, a patented ophthalmic solution containing 1-2% forskolin, for the treatment of glaucoma

First time the Government of India has approved a product developed from natural sources for use as a pharmaceutical grade drug

A stable, water-soluble forskolin solution shown in clinical trials to be 30 % more effective than the most popular glaucoma treatment in the world market today

Forskolin TimololIn

-6-6.4*

*p<0.05

Right eye

Left eye

IND # 3305/115Human Study Completed and drug status granted

Summary Data

First NDA – MF 6746 received in 2006 from Drug Control General of India for Forskolin eye drops in the treatment of Open Angle Glaucoma

First natural drug to go through full fledged clinical documentation to obtain a

drug approval

The solution for Psoriasis“An autoimmune disorder with not

much therapy in modern medicine”

Sornip – from Boswellia serrata(Patented by Sami Labs & marketed by Cipla)

BASELINE VISIT FINAL VISIT

An open Multicentric Phase III clinical trial to investigate the efficacy and safety of a natural compound formulation for management of Psoriasis - study has been successfully completed and approved by DCGI.

The Psoriasis Trial

Psoriasis

Before After

BASELINE VISIT FINAL VISIT

Psoriasis Trial

Patents Granted:South Africa: ZA 2007/0694 (2007);Singapore: SG

136165(2009);Russia: RU 2366412 (2009); New Zealand: NZ

552027 (2010).64

• LactoSpore is a lactic acid bacillus preparation in the form of a light colored powder manufactured and distributed by Sabinsa.

• The source of Lactic acid bacillus was originally known in literature as Lactobacillus sporogenes.

• It is also known as Bacillus coagulans.

• Lactobacillus sporogenes produces only L(+) Lactic acid.

Sabinsa provides LactoSpore® of the following strengths 6 Billion spores/g 15 Billion spores/g

LACTOSPORE®EC - Under development

LactoSpore®

An ideal probiotic for the following reasons:

Room temperature stable Naturally microencapsulated for stability and

ease of processing Proliferates within the GI tract Produces L(+) Lactic acid only Aids in protein, lipid and carbohydrate digestion Compatible with nutrients and antibiotics Not artificially made resistant Japanese FDA approved probiotic

LactoWise® a Synbiotic, is a proprietary composition comprising of beneficial human intestinal microorganisms and a source of dietary fiber for promoting gastrointestinal health.

The composition includes

• Bacillus coagulans, a probiotic marketed by Sabinsa Corporation, US under the brand name LactoSpore®.

• Soluble Fenumannans from the dietary fibers FenuFibers®, from Sabinsa Corporation US.

TETRAHYDROCURCUMINOIDS(White Turmeric)

Skin lightening effects ( inhibition of melanogenesis)

Antioxidant action

Anti-inflammatory action

COLOR FREE compounds derived from yellow Curcuminoids extracted from Curcuma longa (turmeric) roots.

Patents: US 6653327 (2003), EP 1171144 (2007), AU 2006235807 (2008), NZ 514884 (2008), EP 1328263

(2009)

Freeze dried Powder from tender green coconut water

A natural reservoir of nutrients and growth factors to support healthy cell growth , nutrition, hydration and cell rejuvenation

Proprietary process to retain optimum bio-potency

Patented: US 7300682 (2007) and EP 1341547 (2006)Affirmed GRAS for Food and Beverage Applications 71

(Tetrahydropiperine)

Patented: GB 2380675 (2003) US 6849645 (2005) and JP 4098985 (2008)

Prepared by a patented proprietary process from black pepper Acts as a skin permeation enhancer for other active ingredients in formulations

Transdermal Absorption Study with

Betamethasone Dipropionate (BMDP)

THP increased permeation of BMDP, when combined with THP as compared to BMDP application alone. Reference: Research Report, Sami Labs Ltd. (April 2000)

Winner of 2005 Thomas Alva Edison Patent Award –NJ R&D Council

Ayurveda’s Original Rasayana

ORAC Dense Phytonutrient

Recognized in Ayurvedic tradition of Indian medicine, Amalaki or Amla and is known for its traditional used in hair care and skin care.

Saberry® is a light colored and water soluble powder obtained from the fruits of Emblica officinalis or Amla.

Salient Features of Saberry®

100% Natural New biomarker β Glucogallin, in Amla

extracts Novel extraction technology to preserve

the efficacy International Patent Pending Published in Journal of Agricultural and

Food Chemistry, Volume 57(1) 2009 GRAS Affirmed

In addition to the active Boswellic acids, Boswellin® PS* also contains Polysal which contributes to its immediate anti-inflammatory action.

Boswellin® PS* is standardized to contain:

AKBBA 10% Total Identified Boswellic Acids 20% Total Organic Acids 35%

* Patent pending

Boswellin®PS*

CHILITENOIDS®

• Chilitenoids® are Sabinsa’s standardized extract obtained from dried fruits of Capsicum annuum.

• Chilitenoids® are natural xanthophyll carotenoids with a bright red color.

• Chilitenoids® are available as Soft extract containing minimum 5% Capsanthin.

• Sabinsa’s Chilitenoids® are stable.

Capsanthin

Chilitenoids® - Specification

Content of Total Carotenoids : Not less than 10.0%

Content of Capsanthin : Not less than 5.0%

Color value : Between 1x105 to 1.5x105

Applications

Chilitenoids® can find applications

As a Nutraceutical, for antioxidant and heart health support

As a Natural color in food applications

As a Natural color in Color Cosmetics due to its photoprotective potential.

OXYRESVENOX™ – Oxyresveratrol

• OxyResvenox™ is the registered trademark of Sabinsa’s Oxyresveratrol.

• Oxyresveratrol is the analog of Resveratrol and is of synthetic Origin.

• Sabinsa's 34th US Patent 7,253,324, specifically protects the process for the synthesis of biologically active polyphenolic compounds like Pterostilbene, Resveratrol, Oxyresveratrol and Gnetol.

Dose-dependent inhibitory effects on mushroom tyrosinase by Oxyresveratrol,

Resveratrol, and Kojic acid.

A – Oxyresveratrol B - Resveratrol C – Kojic Acid

Lower the IC50 value Better the activity84

SabiLize (Natural Preservatives)

A natural proprietary preservative blend, under the brand name “SabiLize

“Helps Stabilize formulations the natural way”

SabiLize in creams are significantly effective against• Staphylococcus aureus (Gram positive bacteria) at

0.5% • Escherichia coli (Gram negative bacteria) at 0.5% • Candida albicans (Yeast) at 0.5% • Aspergillus niger (Filamentous fungi) at 1.0%

Ocular and Dermal Irritection Assays classified that SabiLize is,

Minimal irritant for ocular irritation potential Non irritant for dermal irritation potential

3’- Hydroxypterostilbene (3’-HPT)

• 3’-Hydroxypterostilbene is a stilbene isolated from Pterocarpus marsupium, Sphaerophysa salsula and certain types of propolis.

• It is an analog of Resveratrol and Pterostilbene.

• 3’-HPT is about 30 times more potent antioxidant than Resveratrol, 70 times than vitamin E, 80 times than vitamin C, 90 times than BHT.

• Potent skin lightening agent.

• Supports weight management.

• Supports general health and wellness.

Turmerones• Sabinsa’s Turmerone is a powdered standardized

extract from the dried rhizomes of Curcuma longa and contains a minimum of 25% Turmerones.

• Turmeric root contains 5 -6% of Turmeric oil.

• The chief components of Turmeric oil are sesquiterpene ketones (50 – 60%) in the form of

Turmerone and ar-Turmerone.

• Potent anti-inflammatory and anti-arthritis agent.

Ar-Turmerone

Arthritis, joint health,

inflammation

Osteoporosis

Abnormal blood lipid levels

Hyperglycemia

Cardiovascular health

Prostate health

Menopausal symptoms

Obesity

Cancer/chronic disease

prevention

NUTRACEUTICALS – COMMON HEALTH CONCERNS ADDRESSED

Skin Lightening

Sunless tanning

UV protection

Antioxidants & Anti inflammatory

Anti Ageing

Wound Healing

Sebum Regulation

Barrier function restoration

Anti Cellulite

Stretch marks prevention

Hair fall prevention

COSMECEUTICALS – COMMON COSMETIC CONCERNS ADDRESSED

Always on the Trail of New Products…

New Developments..New Applications…

• Broad Institute (Harvard & MIT) discovered Piperlongumine has an unique anticancer mechanism (Nature July 2011, 475, 231-4)•Piperlongumine increases Reactive Oxygen Species selectively in cancer cells, thus killing them, compared to normal cells •Piperlongumine occurs in Piper longum L•Piperlongumine already extracted by Sami Labs in multi-kg quantities •M D Anderson Cancer Center in Houston, USA is presently doing studies on anticancer application.

Exploring ways to reduce the burden of diseases

Patent Awards

US Patent # 5,804,596, won the Thomas Alva Edison Patent Award (R & D Council, NJ USA) in 2004 for ForsLean

Thomas Alva Edison Patent Award 2005 for THP

Thomas Alva Edison Patent Award 2009 for Garcitrin

U.S. & International Patents issued: 68

Patent Coverage: India, U.S.A., European Patent Office, Sweden, Netherlands, Italy, United Kingdom, Ireland, Luxembourg, Monaco, Portugal, Spain, France, Denmark, Greece, Switzerland, Belgium, Austria, Germany, Japan, Australia, New Zealand, Canada and Russia.

Intellectual Intellectual PropertyProperty

Innovating for the Future from the Past…

THANK YOUTHANK YOU

www.sabinsa.com

www.samilabs.com

Pioneered Products of Sabinsa- Sep 16, 2011

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