Download - Sagapro, introduction sept12
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