Icelandic. Pure. Effective. SagaPro Icelandic herbal supplement TM for urinary frequency Perla Bjork Egilsdottir, biochemistDeputy Director / Marketing Director SagaMedica ehf.
Summary• Overview SagaPro Angelica archangelica SagaMedica harvesting• Urinary frequency• SagaPro - Clinical study results• Competition – product comparison• Market experience• SagaMedica’s line of products
SagaPro - For Urinary FrequencyReduces the number of bathroom visits at nightMain 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 nightClinically studied
Some background info Where is Iceland? • Between North America and Europe • About the size of Kentucky • Population: 320.000
AngelicaThe Angel’s Herb ...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 • Used in Iceland for 1100 years o Vikings sold it in south Europe because of its healing powers o 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 Iceland o Not endangered • Often considered to be a weed o 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
SagaMedicaIcelandic natural products manufacturer, founded in 2000o Growth: in 2008, 4 employees in 3 full-time positions in 2012, 10 employees in 7,6 positionso Production and harvesting is subcontractedo SagaMedica’s products are very popular in Iceland and SagaPro is leading the natural market.o Voxis launched in Norway 2005o New shareholders January 2010o U.S. and Canada launch in October 2010o 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 Angelica distributionSagaMedica works with local people in several places in IcelandHarvesting• Is performed by local people in a responsible way• Is done in several places in Iceland allowing SagaMedica to Source: The Icelandic Institute of Natural History rest areas if needed• Offers jobs to farmers and young people in the summer
Hrísey IslandNorth Iceland• 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)
Pure and eco friendly Harvesting performed by locals in July and August
NocturiaFrequent nighttime urination Definition: A common problem Nocturia is defined as the Age Prevalence interruption of sleep by the 60 – 70 11% – 50% need to urinate. Weiss and Blavias, 2000 80 80% - 90% Weiss and Blavias, 2000• 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
Icelandic. Pure. Effective.Clinical study on SagaPro Results
Clinical studyPeer reviewed paper on the study has been published in a medical journal:Scandinavian Journal of Urology and NephrologyPharmaceutical 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 ofclincial staff members from Landspitali Háskólasjúkrahúsi (University Hospital Iceland) Hrefna Guðmundsdóttir, MD, specialist in internal medicine and renal diseases Guðmundur Geirsson, MD, specialist in urologyThe study was twice awarded grants from the Icelandic Technology DevelopmentFund
Clinical study Objective, materials and methods•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 weeksClinical characteristics Patients with Average age Average number of sleep N and range nocturnal voids disordersPlacebo 35 67.44 (47 - 85) 2.74 5SagaPro 31 66.31 (49 - 86) 2.81 3
Clinical study Safety and tolerabilityVital signs were monitored andurinalysis performed throughout the study.No severe adverse events were reportedand overall there were no difference betweenthe treatment groups (i.e. SagaPro and Placebo)SagaPro is safe and well tolerated treatment
Clinical study on SagaPro ResultsTest populationThe actual number of Nocturnal voids, Nocturnal polyuriaindex and Nocturnal bladder capacity index decreased but thedifference between the treatment groups was not significantHeterogenous group• Underlying factors related to nocturia Overactive bladder Benign prostate enlargement Nocturnal urine production Sleep disorders, sleeping timeSubgroup analysis
Clinical study on SagaPro ResultsReduction in nocturnal voidsfor a subgroup with reduced nocturnal bladder capacity (NBC-index>1.3) and excluding those with sleep disorders 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. N=29
Clinical study on SagaPro ResultsIncrease in average nocturnal bladder volumeper nocturnal void for subgroup with less than 260 ml volume initially N=49
Clinical study on SagaPro ResultsIncrease in smallest nocturnal bladder volumeper void for a subgroup with less than 260 ml average nocturnal bladder volume initially The SagaPro group had a significant increase in smallest nocturnal void volume of 66 milliliters. N=49
Clinical study on SagaPro Results N=17* A “standard night” of 520 minutes was defined to harmonize different sleeping patterns.
Summary1. SagaPro is safe and well tolerated2. SagaPro increases average nocturnal voided volume, smallest nocturnal void volume and increases nocturnal bladder capacity3. SagaPro reduces nocturnal voids4. SagaPro increases the duration of the first sleep period (HUS) in the oldest group
Conclusion SagaPro• 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
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 bladder and is believed to be helpful for urinary frequency
SagaPro - 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
Line of productsContinuous research and product development SagaVita (tincture 2002 / tablets 2007) Cold and flu prevention - Antiviral SagaMemo Voxis (2003) SagaPro (2005) (tincture 2009 / tablets 2012) For a sore throat For urinary frequency For a healthy memory
US and Canada launch in 2010 vs. For Urinary Frequency Urinary function support* *This statement has not been evaluated by the Food and Drug Pour la fréquence urinaire Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
Voxis - throat lozenges• 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 - North AmericaVoxis premium andVoxis 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. Adoptedfrom www.scigenic.com dated 26.01.2009.
SagaVita• 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
Great publicity – release of clinical study resultsNewspapersNational TVRadio stationsWeb media Response from US regarding further studies