Out-licensing

o                   Background Information: 

Consumer Needs: pre-, peri-, and post-menopausal syndrome

After menopause, when ovarian function declines, women experience a state of estrogen deficiency. It results in various symptoms including hot flush/night sweat, mental awareness problem, sleep disorder, vaginal dryness, urine inconsistency, and joint pain, etc. Deficient level of estrogen also influences adversely the maintenance of skeletal integrity, cardiovascular profile, cognitive function, prevention of colon cancer, and protecting against tooth loss and macular degeneration. Women spend about half of their lives post-menopause in case of the longer life expectancy of the age of 100. Hormone replacement therapy (HRT) was a popular method to alleviate or lessen those symptoms.

Benefits of EstroG-100

With the market condition of 1) having one sixth of the population (menopause ladies) as target consumers, 2) no competition with ethical drugs due to the lethal side effects of HRT, and 3) the vulnerabilities on the effects and safety the existing phytoestrogen such as black cohosh, pomegranate, and isoflavones suffered, EstroG-100 has been developed by screening 71 different herbal extracts, and its effectiveness was proven by a couple of animal researches and a randomized double-blind placebo-controlled clinical study at Samsung Cheil Hospital of School of Medicine, Sungkyunkwan University in South Korea. Based on the positive data gained from the 1 year-long clinical trial with 48 patients, it significantly improved the various menopausal symptoms, bone markers, bone density of femoral bone neck, and triglycerides without any serious side effects and without increasing weight, BMI, and the serum level of estrogen and follicle stimulating hormone that were observed in the study with HRT. In addition, a randomized double-blinded placebo-controlled clinical study was performed for non-Asian American women at Friends Medical Group and Shady Canyon Medical Group in U.S.A., EstroG-100 showed statistically significant improvement in the various menopausal symptoms such as hot flush and night sweats, paresthesia, insomnia, nervousness, melancholia, vertigo, fatigue, rheumatic pain and vaginal dryness compared to the placebo group. No adverse effects were reported with EstroG-100. There were no significant changes in the body weight, BMI, serum E2 and FSH level, and liver enzyme that have been observed to be changed in the treatment with HRT and other phytoestrogen. EstroG-100 was observed to be a novel safe phytoestrogen that significantly improved the menopausal symptoms in pre-, peri-, and post-menopausal women.

Competition and Comparables

1) No ethical drugs in the market competition

According to Women’s Health Initiative (WHI) study result published on the Journal of the American Medical Association, July 2002, a mutli-center randomized double-blind placebo-controlled study was performed with some 16,000 post-menopausal women for 5 years and announced that hormone replacement therapy (HRT) increased the number of cases with breast cancer by 26%, heart disease by 29%, and stroke by 41%. Blood clot rates were more than twice as high in those getting HRT. The Federal Drug Administration (FDA) has since made it a rule to add a black warning label to all HRT products, which makes most of doctors and patients avoid HRT and rely on safe phytoestrogen.

2) Vulnerability of Isoflavones

-  Daily 30-50mg of isoflavones is recommended by American Journal of Clinical Nutrition. Japanese, Chinese and Korean women take enough isoflavones in a daily diet while there are the same rate of patients with menopausal symptoms as in U.S. and Europe. In fact, 1,150mg of isoflavones was reportedly to be included per kg of tofu, 424mg per bean sprouts, 263 mg per bean paste (miso). One research showed there were more than enough isoflavones in oriental diet. The result is shown below.

                                                         (mg/kg dry basis)

Kim et al., Isoflavone contents and β-glucosidase activitites of soybeans, Meju, and Doenjang. Korean J. FOOD SCI. TECHNOL., 31(6): 1405-1409 (1999)

-  NIH reported that genistein, a major isoflavone aglycone of soybean, may cause cancers: exposure to genistein for 2 years caused mammary gland/pituiatary adenoma in female rat (NIH & FDA- National Toxicology Program, Genistein Final, Jan, 2008)

- Daily Intake of above 30 mg of isoflavone aglycone per day is not allowed by Food Safety Commission of Japanese government due to the toxicity of isoflavone.

3) Vulnerability about the Effect and Safety of Black Cohosh

“There was no significant difference seen between the number of daily hot flashes and/or night sweats in any of the herbal (black cohosh) groups compared to the placebo group” (Natural Products Insider January 15, 2007). “The committee reviewed case reports suggesting a potential link between ingestion of the extracts (black cohosh) and liver damage” (Natural Products Insider July 30, 2007). The Medicines and Healthcare Products Regulatory Agency (MHRA) of U.K. reported 31 reports of suspected adverse reactions associated with black cohosh have been received through the Yellow Card Scheme. Of these 22 have been reports of liver reactions - ranging in severity from abnormal liver function (15 people) to various forms of hepatitis (6 people) including one case of hepatic failure. Generally the individuals recovered or were recovering after stopping black cohosh. It said warnings were being added to the labels of all black cohosh, and MHRA is working with the industry and marketers to ensure the public is fully aware of the potential risks associated with the use of these products.

4) Truth of Pomegranate: it is just a fruit.

Japanese government investigated to provide the information on pomegranate since tens of industry marketers lied to public the fruit extract includes estrogen and phytoestrogen. In result, as http://www.kokusen.go.jp/news/data/n-20000406_2.php3 reads, there is no estrogen included in this prove with the fruit and 7 different processed products. Coumestrol the phytoestrogen was not detected in the supplements, either. The industry marketers had been brought to justice.

o        If combination product, please list ingredients and percentages for each ingredient