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Slide 1:

Nurture & Clarity 

ADHD Definition :

ADHD Definition Attention Deficit Hyperactivity Disorder is a persistent pattern of inattention and/or hyperactivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. Source: DSM IV

Market Highlights :

ADHD is one of the most common childhood psychiatric disorders. Approximately 50% - 70% of children with ADHD will continue to experience symptoms into adulthood. In 2000, it was estimated that 4-5 million individuals (mainly children) were diagnosed with ADHD, 75% of whom were treated with psycho stimulants. Over 8 million adults in the US may exhibit the symptoms of ADHD, while only an estimated 600,000 are being treated. Market Highlights

Market Highlights (Cont.) :

There has been a significant increase in ADHD diagnosis and prescription of medicine since the early 1990s. The value of the ADHD market was US$2.6 billion in 2005, and it is now the 9 th largest segment of the CNS market by sales, with a growth of 8% year-on-year. In May 2006, the FDA asked drug manufacturers to revise product labeling to reflect concerns about possible adverse effects. Market Highlights (Cont.)

Slide 5:

The Number of Articles on ADHD Submitted on PubMed US National Library of Health, NIH: http://www.ncbi.nlm.nih.gov/pubmed/

Slide 6:

Prevalence, Diagnosis and Drug Treatment Rates of Patients with ADHD Across Seven Major Markets

Why is ADHD Controversial? :

Why is ADHD Controversial? Drug treatment of children Diagnosis demanded by others Undefined start and end Signs and symptoms can be detected in anyone The cause is claimed to be biological, but no biological diagnosis method has yet established Stimulant drugs are claimed to be safe, but are classified as schedule II drugs Stimulant drugs are a symptomatic treatment Signs and symptoms of this disorder may be considered an advantage for patients

Slide 8:

Reduced side effect profile Longer acting effect Novel mechanisms of action Lower abuse potential Improved compliance Unmet Clinical Needs

Ritalin®:

Ritalin ® Ritalin® is the No. 1 prescription drug for children and adults with ADD/ADHD. The side effects of these drugs are continuous; many are alarming. Ritalin® is an amphetamine, with a lengthy list of side effects, including nervousness, insomnia, nausea, abdominal pain, loss of appetite, dizziness, palpitations, headaches, irregular heart rhythm and psychic dependence; in a word – addiction (Whitaker, 2004).

Ritalin (Cont.):

Ritalin  (Cont.) Ritalin has such tremendous potential for abuse that it is classified as a controlled substance by the Drug Enforcement Agency. 25%-30% ADHD cannot tolerate taking stimulant medications

FDA Warning Labeling Update (January 25, 2006) Methylphenidate and Amphetamine Products:

FDA Warning Labeling Update (January 25, 2006) Methylphenidate and Amphetamine Products Sudden Death and Pre-existing Structural Cardiac Abnormalities Sudden death has been reported in association with CNS stimulant treatment at usual doses in children with structural cardiac abnormalities. Although some structural cardiac abnormalities alone may carry an increased risk of sudden death, stimulant products generally should not be used in children, adolescents, or adults with known structural cardiac abnormalities.

Adult ADHD Attending to the Needs of the Adult Market:

Adult ADHD Attending to the Needs of the Adult Market 60% of ‘pediatric ADHD’ progress to ‘adult ADHD’ in adulthood. The adult ADHD population is potentially twice the size of the current pediatric population, and is therefore far more lucrative than the pediatric market. Only Adderall XR ® and Strattera ® are approved for adult ADHD, although many other stimulants are frequently prescribed off-label.

Adult ADHD (Cont.) Attending to the Needs of the Adult Market:

Adult ADHD (Cont.) Attending to the Needs of the Adult Market ADHD therapies will increasingly be used in the treatment of adult ADHD, regardless of whether the drugs have been approved for this population or not. If manufacturers wish to capitalize on this expanding patient population, it is recommended that they perform Phase III clinical trials in the adult population, either as a means to approval for adult ADHD, or to demonstrate the efficacy of the drug, driving off-label prescriptions.

Trend of Methylphenidate Prescriptions in Germany, 1992-2005:

Trend of Methylphenidate Prescriptions in Germany, 1992-2005 Methylphenidate prescriptions grew 47-fold from 1992 to 2005. During the same period, total prescriptions in Germany declined by 41%.

ADHD Treatment Options in Germany and England :

Active Comp. Trade Name Manufacturer Authorization Cost / Day Assumption Dexamphetamine sulphate Dexedrine  UCB (Celltech) ≤ 2000 £ 0.43 / n.a 20 mg/d Methylphenidate hydrochloride Ritalin  UK: Cephalon; D: Novartis ≤ 2000 £ 0.56 / €1.58 30 mg/d 3 daily doses Methylphenidate hydrochloride Concerta  XL Janssen-Cilag UK: 2002 (Feb., 19) £ 1.23 / €2.94 36 mg/d Methylphenidate hydrochloride Equasym  XL UCB (Celltech) UK: 2005 D: 2006 £ 1.17 30 mg/d Atomoxetine hydrochloride Strattera  Eli Lilly UK: 2004 D: 2005 £ 3.80 / €7.76 Administration divided into two daily doses ADHD Treatment Options in Germany and England

Market Case Study (Germany and England):

Market Case Study (Germany and England) Demographic data 9.72 million (Germany) and 8.1 million (England) at the age 6–18 years. An estimate of the prevalence of ADHD is 6% ,assuming that DSM-IV criteria will be used in clinical practice. ADHD diagnosis rates Administrative prevalence of ADHD increased from 1.24% in 1998 to 2.95% in 2003 and 4.5% in 2010. ADHD treatment rates In 2003, 40% of children and adolescents diagnosed with ADHD were treated with stimulant medication. It was assumed that the rate of ADHD patients receiving pharmacotherapy would continue to increase through 2010

Slide 17:

Market diffusion rates Generic market penetration was assumed to reach 60-70%. Prescribing patterns Pediatricians: 50% ; psychiatrists: 30% (data available for Germany only) In England, spending for ADHD-related pharmacotherapy increased from 1998 (₤3.1 million) to 2005 (₤24.4 million) by +695%. Average costs per prescription rose from ₤13.68 in 1998 to ₤46.94 in 2005, driven by price increases and a shift to more expensive new products. Child Adolesc Psychiatry Ment Health. 2007; 1: 13. Market Case Study (Germany and England, Cont.)

Combination Therapy :

Combination Therapy The treatment of ADHD is a highly individualized challenge. Discovering the most effective combination of the proper medications and other forms of therapy may mean attempting to use several medications in various combinations, as well as in varying doses. What is appropriate for one child or adult may not be either appropriate or effective for another.

Slide 19:

The lifetime prevalence of herbal therapy in patients – children and adults – was 20%. Recommendations from a friend or relative resulted in the administration of herbal medicines by 61%. Almost 83% of caregivers gave herbal medicines alone, whereas 13% gave herbal medicines with prescription drugs. Most caregivers (78%) supervised the administration of herbal therapy in their children, while the children's psychiatrists (70%), pediatricians (56%), or pharmacists (74%) were not aware of the use. Pharmacotherapy. 2003 Feb;23(2):222-30 Herbal Therapy for ADHD

Herbal Therapy for ADHD (Cont.):

Herbal Therapy for ADHD (Cont.) The use of herbal medicine for treating ADHD is of high interest to the many families and professionals looking for alternatives to drug therapy or “add on” treatments. Various combinations of sedative and stimulating herbs have been widely used in naturopathic and herbal practice as one aspect of treatment for ADHD. In traditional Chinese medicine, herbal formulas are used in synergistic combination to nourish and balance the body’s systems.

Herbal Therapy for ADHD (Cont.):

Herbal Therapy for ADHD (Cont.) The philosophy of 'restoring balance' lends itself in particular to ADD/ADHD, in which the affected individual suffers from multiple biochemical, neurological, and behavioral symptoms for which there is no clear-cut etiology.

Advanced Alternatives to Ritalin or Other ADHD Medications :

Advanced Alternatives to Ritalin  or Other ADHD Medications No other natural product claimed to be a remedy for ADHD has been proven to be successful in a controlled clinical trial

Nurture & Clarity® Overview:

Nurture & Clarity® Overview Unique and safe medicinal plant formulas based on traditional Chinese medicine principles. Specifically engineered to help support the function of the central nervous system via different mechanisms. Help reduce stress and frustration, focus attention and improve concentration. Validated in a scientific clinical trial. Accepted for publication by the Journal of Attention Disorders.

Slide 24:

Produced in adherence to pharmaceutical standards by ISO certified Frutarom Industries Ltd. Approved by the Israeli Ministry of Health as safe. Nurture & Clarity® Overview (Cont.) http://www.frutarom.com/

Safety:

Safety Nurture & Clarity® was approved by the Israeli Ministry of Health as safe for consumption. A pre over-the-shelf marketing test conducted with more than 1000 children as participants – none reported any adverse side effects.

How Does Nurture & Clarity® Work? :

How Does Nurture & Clarity® Work? Nurture & Clarity® contains essential nutrients that promote concentration and facilitate learning. Nurture & Clarity-H® also contains a natural calming ingredient Nurture & Clarity® also promotes the development of new neurons and reinforces existing neurons, thus improving memory retrieval. Moreover, Nurture & Clarity® supplies nutrients that are vital for proper brain growth and development in children.

Bio Active Therapeutic Mechanisms :

Bio Active Therapeutic Mechanisms Nurture & Clarity ® ’s active components include, for example: Withania Somnifera: Withania Somnifera has been found to stimulate growth of axons and dendrites in human neuroblastoma cells (Kuboyama et al., 2002, Tohda et al., 2000, Zhao et al., 2002), in addition to increasing acetylcholine receptor capacity (Bhattacharya et al., 1997), and a cetylcholinesterase (AChE) inhibitory activity (Vinutha et al., 2007). Centella Asiatica: Centella Asiatica demonstrated increased neurite elongation, dendritic growth (Soumyanath et al., 2005 Moser, 1999), and improved learning and memory (Nalini et al., 1992, Engert & Bonhoeffer, 1999). Centella Asiatica is especially high in B-vitamins (Brinkhaus et al., 2000): cofactors in the synthesis and functioning of serotonin, norepinephrine, dopamine, acetylcholine, as well as GABA (Baynes & Dominiczak 1999, Coleman et al., 1979).

Historical “proof of concept” clinical studies on Clarity® Plants/Nutrients:

Historical “proof of concept” clinical studies on Clarity® Plants/Nutrients Clarity® remedies have been used in traditional medicine for years to support the healthy functioning of the brain and nervous system, helping to encourage normal and efficient concentration and memory functioning. In more recent times, research has confirmed this traditional wisdom. There are now many published clinical studies demonstrating the ability of a range of Clarity® herbs to support healthy volunteers, children and adults which support: Normal functioning of the brain and nervous system Improve memory performance Cognitive enhancer

Slide 29:

Clarity® Scientific Validation: Clinical Trial

Pre- and Post-Trial Mean TOVA Scores:

Pre- and Post-Trial Mean TOVA Scores

Reported Adverse Events:

Reported Adverse Events

Clarity® Safety :

Clarity® Safety Clarity® has been used for many years to safely, without any records of side affect Clarity® is a 100% safe, non-addictive, natural, herbal remedy has been used for many years to safely

Clarity® Legislation:

Clarity® Legislation Belgium Israel Italy Netherlands USA ( in process)

Daily treatment :

Daily treatment The efficient functioning on the brain and nervous system depends Clarity daily consumption

Clarity® and “Add on” / combination treatments :

Clarity® and “Add on” / combination treatments Clarity® can be used safely with other therapies (In combination with a healthy lifestyle diet and drugs) Clarity® can be used alone or with stimulant drugs (Ritalin) for ADHD Customers who choose to use a combination of Clarity® and Stimulants (Ritalin) reports: “add on” effect (increase the therapeutic effect of Ritalin) Lowering Ritalin side effects like “rebound effects” Improve Ritalin’s appetite suppression and Sleep problem individual who develops tics while on a stimulant, Clarity® helps to reduce it

Clarity® for cognitive enhancer, learning and memory improvement :

Clarity® for cognitive enhancer, learning and memory improvement Clarity® formula is base on several herbs that each one of them, had tested in a clinical trails, for cognitive and memory enhancement in adults There are more than 22 scientific publications of those clinical trial studies: Bradwejn, J., Zhou, Y., et al., "A Double-Blind, Placebo-Controlled Study On The Effects of Gotu Kola ( Centella asiatica ) on Acoustic Startle Response in Healthy Subjects", J. Clinical Psychopharmacology 2000 Dec; 20(6):680-4 Brinkhause, B., Lindner, M., et al., "Chemical, Pharmacological and Clinical Profile of The East Asian Medical Plant Centella asiatica", Phytomedicine 2000 Oct; 7(5):427-48 B. M. Hausen (1993) " Centella asiatica (Indian pennywort), an effective therapeutic but a weak sensitizer." Contact Dermatitis 29 (4), 175–179 doi:10.1111/j.1600-0536.1993.tb03532.x Mato L , Wattanathorn J , et al., Centella asiatica Improves Physical Performance and Health-related Quality of Life in Healthy Elderly Volunteer. Evid Based Complement Alternat Med. 2009 Oct 30 . A Double-Blind, Placebo-Controlled Study on the Effects of Gotu Kola ( Centella asiatica ) on Acoustic Startle Response in Healthy Subjects". Journal of Clinical Psychopharmacology . 20(6):680-684, December 2000. Bradwejn, Jacques MD, FRCPC C. Stough, J. Lloyd, J. Clarke, L. Downey, C. Hutchison, T. Rodgers, P. Nathan (2001). "The chronic effects of an extract of Bacopa monniera (Brahmi) on cognitive function in healthy human subjects". Psychopharmacology (Berl) 156 (4): 481–4

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