SagaProIcelandic herbal supplement

for urinary frequency

Perla Bjork Egilsdottir, biochemistDeputy Director / Marketing Director

SagaMedica ehf.

Icelandic. Pure. Effective.

TM

• Overview SagaProAngelica archangelicaSagaMedicaharvesting

• Urinary frequency

• SagaPro - Clinical study results

• Competition – product comparison

• Market experience

• SagaMedica’s line of products

Summary

SagaPro - For Urinary Frequency

Reduces the number of bathroom visits at night

Main users • Men and women suffering from overactive bladder• Men suffering from prostate enlargement (BPH)

Fast acting and measurable• Results after one packet• Easy to know if it’s working

o Just count the number of visits at night

Clinically studied

 Some background info

Where is Iceland?

• Between North America and Europe

• About the size of Kentucky

• Population: 320.000

...has developed for 8-10 thousand years in Iceland

...is one of or even the only medicinal herb with Nordic origin

...was the first grown vegetable in Scandinavia

AngelicaThe Angel’s Herb

AngelicaThe Angel’s Herb

• Used in Iceland for 1100 yearso Vikings sold it in south Europe because of

its healing powerso So valuable that Iceland’s first lawbook

specifically banned angelica theft

• Named after an archangel o Known as “The Angel’s Herb”o Angelica was thought to cure Plague

• 20 years’ scientific research o by SagaMedica and collaborators from the

University of Iceland

• Grows all over Icelando Not endangered

• Often considered to be a weedo Our “Green Gold”

SagaPro is produced from angelica leaf

SagaMedicaDr. Sigmundur Gudbjarnason

o Co-founder of SagaMedica

o Former president of the University of Iceland

o Respected lecturer

o Professor at Wayne State University School of Medicine in Detroit in 1961-1970

o Was one of the first scientist to study the health benefits of Omega-3 fatty acids in 1970s and their role in cardiac health

o Worked as a “Distinguished Visiting Scientist” at the FDA in 1983

o Began his studies on Icelandic medicinal herbs in 1992

o Steinthor Sigurdsson joined Dr. Gudbjarnason in 1995. Steinthor earned his Phd in 2009 for biochemical research on Icelandic medicinal herbs

o As a team SagaMedica’s scientists have published 6 peer-reviewed studies

SagaMedica

Icelandic natural products manufacturer, founded in 2000

o Growth: in 2008, 4 employees in 3 full-time positionsin 2012, 10 employees in 7,6 positions

o Production and harvesting is subcontracted

o SagaMedica’s products are very popular in Iceland and SagaPro is leading the natural market.

o Voxis launched in Norway 2005

o New shareholders January 2010

o U.S. and Canada launch in October 2010

o Clinical study results on SagaPro published in July 2012

Eco-friendly harvesting

• Angelica grows abundantly in Iceland• Its proliferation is even considered too intense

in some areas• SagaMedica’s harvesting can benefit local

authorities that would otherwise have to eradicate the herb in a costly way

SagaMedica works with local people in several places in Iceland

Source: The Icelandic Institute of Natural History

Angelica distribution

Harvesting•Is performed by local people in a responsible way•Is done in several places in Iceland allowing SagaMedica to rest areas if needed•Offers jobs to farmers and young people in the summer

• this island is one of SagaMedica’s main source for Angelica

• the island has a population of 180 people

• it gets almost 24 hours of sunlight per day during Angelica’s main growth period

• local people, great stories

– inhabitants use Angelica seeds for breakfast cereal

– inhabitants drink Angelica tea

– It is said that they couldn’t start a retirement home (islanders too healthy)

Hrísey IslandNorth Iceland

Pure and eco friendly

Harvesting performed by locals in July and August

NocturiaFrequent nighttime urination

• Increases with age in both men and women

• Nocturia is the most common symptom of prostate enlargement

• The causes of nocturia are many and can be divided into conditions affecting the storage of urine in the bladder (bladder capacity) and those involving excessive production of urine (polyuria)

• Sleep loss is a major cause of stress and can affect brain cell regeneration

• Nocturia is not often talked about

• Spouses are affected too – Getting in and out of bed can be disruptive

Definition: Nocturia is defined as the interruption of sleep by the need to urinate.

Weiss and Blavias, 2000

Age Prevalence

60 – 70 11% – 50%

80 80% - 90%

A common problemA common problem

Weiss and Blavias, 2000

Clinical study on SagaPro

Results

Icelandic. Pure. Effective.

Peer reviewed paper on the study has been published in a medical journal: Scandinavian Journal of Urology and Nephrology

Pharmaceutical study. Approved by IMA (Lyfjastofnun) and NBC (Vísindasiðanefnd). (EudraCT, 2010-019668-35)

The first clinical study to be conducted on an Icelandic natural product. The study was managed and monitored by Encode Clinic under the supervision of clincial staff members from Landspitali Háskólasjúkrahúsi (University Hospital Iceland) Hrefna Guðmundsdóttir, MD, specialist in internal medicine and renal diseasesGuðmundur Geirsson, MD, specialist in urology

The study was twice awarded grants from the Icelandic Technology Development Fund

Clinical study

•Investigates the effects SagaPro has on nocturia in men

•Parallel, randomized, double-blind and placebo controlled

•69 were randomized to receive SagaPro or Placebo (3 LTFO)

•Average of ≥2 nocturnal voids

•Duration 8 weeks

Clinical characteristics

N Average age and range

Average number of nocturnal voids

Patients with sleep disorders

Placebo 35 67.44 (47 - 85) 2.74 5 SagaPro 31 66.31 (49 - 86) 2.81 3

Clinical study Objective, materials and methods

Vital signs were monitored and

urinalysis performed throughout the study.

No severe adverse events were reported

and overall there were no difference between

the treatment groups (i.e. SagaPro and Placebo)

SagaPro is safe and well tolerated treatment

Clinical studySafety and tolerability

Test populationThe actual number of Nocturnal voids, Nocturnal polyuria index and Nocturnal bladder capacity index decreased but the difference between the treatment groups was not significant

Heterogenous group

•Underlying factors related to nocturiaOveractive bladderBenign prostate enlargementNocturnal urine productionSleep disorders, sleeping time

Subgroup analysis

Clinical study on SagaProResults

Results

N=29

Low nocturnal bladder capacity is directly related to urinary frequency. NBC index indicates reduced bladder volume at night – a higher index indicates less nocturnal bladder volume.

The SagaPro group experinced a sgnificant reduction in voiding frequency and NBC index.

Reduction in nocturnal voidsfor a subgroup with reduced nocturnal bladder capacity (NBC-index>1.3) and excluding those with sleep disorders

Clinical study on SagaPro

Results

N=49

Clinical study on SagaPro

Increase in average nocturnal bladder volumeper nocturnal void for subgroup with less than 260 ml volume initially

Results

N=49

The SagaPro group had a significant increase in smallest nocturnal void volume of 66 milliliters.

Increase in smallest nocturnal bladder volumeper void for a subgroup with less than 260 ml average nocturnal bladder volume initially

Clinical study on SagaPro

* A “standard night” of 520 minutes was defined to harmonize different sleeping patterns.

Results

N=17

Clinical study on SagaPro

Results

N=24

Clinical study on SagaPro

1. SagaPro is safe and well tolerated

2. SagaPro increases average nocturnal voided volume, smallest nocturnal void volume and increases nocturnal bladder capacity

3. SagaPro reduces nocturnal voids

4. SagaPro increases the duration of the first sleep period (HUS) in the oldest group

Summary

• has beneficial effect on bladder capacity

• can benefit men and women

• safe and well tolerated

• according to the study SagaPro has most beneficial effects for those who have more severe symptoms

Conclusion

SagaPro

SagaPro - How does it work?

• Research suggests leukotriene inhibition is the most likely explanation

• Leukotrienes have been shown to contract smooth muscle cells, which are found in the bladder and urethra

- Which causes an increased and urgent need to urinate

• Overactice detrusor (bladder muscle) can lead to a reduced bladder capacity and cause nocturia

• SagaPro contains isoquercitrin which is thought to calm leukotriene induced contraction

• SagaPro may relax smooth muscle cells in the bladder by

inhibiting leukotriene activity

• SagaPro does not reduce libido

SagaPro contains isoquercitrin

Isoquercitrin is thought to calm contraction in the bladderand is believed to be helpful for urinary frequency

Market experience

• Sold domestically since 2005• Most popular Icelandic herbal

supplement• Has replaced Saw Palmetto as

#1 product for urinary frequency in Iceland

SagaPro - For Urinary Frequency

Line of products

Continuous research and product development

SagaVita (tincture 2002 / tablets 2007)Cold and flu prevention - Antiviral

SagaPro (2005)For urinary frequency

SagaMemo(tincture 2009 / tablets 2012)For a healthy memory

Voxis (2003)For a sore throat

For Urinary FrequencyPour la fréquence urinaire

Urinary function support**This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

vs.

US and Canada launch in 2010

• For a sore throat– Made from angelica leaf

– Most popular lozenges in Iceland

– “Voice of Iceland”

• Sugar free version being developed. With isomalt (from beets)

Voxis - throat lozenges

Voxis - North America

Voxis premium and Voxis sugarfree

SagaMemo• For healthy memory

– Made from angelica seeds and Wood cranesbill– Synergy occurs between the two herbs– Mixture of the herbs increases amount of

neurotransmitter important for a healthy memory• Peer-reviewed study published

– Clinically studied in Korea on Alzheimer patients*

Ref: 1. INM176 Clinical Trial at Korea’s Samsung Seoul Medical Center Lifts Hope for Prevention and Treatment of Alzheimer disease. 2001/11/272. Adopted from www.scigenic.com dated 26.01.2009.

• Cold and flu prevention

– made from angelica seeds

– has antiviral properties and is used for cold and flu prevention

– may alleviate stress since it reduces cortisol production

SagaVita

Great publicity – release of clinical study results

NewspapersNational TVRadio stationsWeb media

Response from US regarding further studies