Lipid Lowering Research Formula with effective control over CRP levels

Mumbai – July 20, 2009 - Exotic Naturals announces the launch of novel research formula E-LL-01, an innovative formula which is scientifically proven to lower lipid levels and CRP (C - Reactive Protein), a key indicator for Ischemic Heart Disease.

According to American Heart Association, high levels of CRP consistently predict new coronary events in patients with unstable angina and acute myocardial infarction (heart attack). Research shows that people have heart attacks not only due to high LDL cholesterol & CRP but also due to metabolic syndrome. Various studies have proven that statins are drugs of choice for patients with high CRP levels. However, statins have few important side effects. The most serious side effect is liver failure as they cause an increase in liver enzyme levels and rhabdomyolysis which can impair kidney function & lead to kidney failure.

To address this medical need, Exotic Naturals has developed a unique formula which helps to reduce lipid & CRP levels considerably. E–LL–01 is an outcome of intensive R&D at Exotic Naturals backed with a 62 patient clinical study. With all ingredients are grandfathered, E-LL-01 passes through toughest quality checks of cGMP & GACP.

An open label randomized study to substantiate the safety and efficacy claims of two doses of E-LL-01 in lowering blood lipids and reducing risk of myocardial infarction was conducted as per ICH-GCP guidelines. 62 patients with LDL > 160 mg/dl and/or Total Cholesterol > 240 mg/dl were put on E-LL-01 as the sole therapy for 12 weeks. Both the doses of E-LL-01 have shown significant reduction (p<0.05) style="mso-spacerun:yes"> There was 34% reduction in CRP levels in one of the dose groups indicating reducing the risk of Ischemic heart diseases.

Exotic Naturals has developed products in some of the fastest growing health categories - Male Sexual Dysfunction, Lipid Lowering and Diabetes Type 2, Allergies, Insomnia, Osteoarthritis & Antioxidants. Exotic Naturals is offering these exclusive opportunities to alliance partners for co-development and co-marketing worldwide.

For more information on Exotic Naturals & its products visit www.exoticnatural.com or contact Rekha Patel (bizdev@exoticnatural.com)

New Research Formula for Diabetics with Cardiovascular Complications

Exotic Naturals announces the launch of E-DM-13, a Support formula for Diabetes. An innovative research formula, which is not only clinically proven to lower blood sugar levels but also controls serum nitrotyrosin, a key indicator for atherosclerotic disease.

“High blood glucose levels are one of the most common killers of Americans, according to new research from Harvard researchers.” (Nutraingredients.com) “About 60% of people with type II diabetes die of atherosclerotic cardiovascular disease.” (National Diabetes Advisory Board, 1987) Most of them are premature deaths when the people concerned are economically contributing to society. This situation is increasingly outstretching the health-care resources devoted to diabetes. (WHO, Fact Sheet N° 236, Revised September 2002). “Increased nitrotyrosine has been found in the plasma of diabetic patients and has been shown to be involved in the pathogenesis of atherosclerosis” (Ceriello A et al).

Exotic Naturals, CEO, Jayesh Chaudhary stated, “As the number of people with diabetes grows up to 230 millions worldwide, treatment of its long term complications take an ever-increasing proportion of national health care budgets. As per Exotic Naturals’ vision to improve human life, the utmost need is created for a natural product which can support diabetics with cardiovascular complications."

Exotic Naturals’ focus was to develop the herbal supplement with clinically proven efficacy & safety. Hence, this research-based firm took up development of E-DM-13, an effective solution to this worldwide phenomenon. In a clinical study of 126 patients with type 2 diabetes investigators were amazed to find that E-DM-13 could dramatically decrease (p<0.001)>

No severe adverse events were noted during the study period. E-DM-13 also clears mutagenecity and genotoxicity tests and has undergone animal research over the last 4 years of development.

Company profile

Exotic Naturals is an innovation driven company which is focused on design and development of dietary ingredients and formulas with substantiated label claims. In keeping with its mission, Exotic has developed products in some of the fastest growing health categories - Male Sexual Dysfunction, Lipid Lowering and Diabetes Type 2, Allergies, Insomnia, Osteoarthritis & Antioxidants and lots more at the R&D stage. Exotic Naturals is offering these opportunities to alliance partners for co-development and co-marketing worldwide.

For more information on Exotic Naturals & its products visit www.exoticnatural.com or contact Rekha Patel (bizdev@exoticnatural.com)

Exporting Countries must document their pre-1994 herbal exports

As per the recent FDA ruling it is no longer possible to use listings such as the Herbs of Commerce compiled by the American Herbal Products Association (AHPA) in 1995 of “grandfathered” or old herbal ingredients (ODIs) to prove the pre- Oct 15, 1994 status of an ingredient in the US. The FDA now requires independently verifiable records in the forms of trade brochures and other communications to accept the ODI status of an ingredient.

According to me, now countries such as India and China who have had substantial herbal exports to the US pre-1994 must organize quickly a database of their exports through customs and other private records so that such information can be shared with the FDA and the existing business of Indian herbal ingredients in the US is not disrupted. Sharing of private records from pre-1994 must be made mandatory by a central information authority and confidential portions may be viewed only by National Regulators like FDA and MHRA to confirm the history of safe use of traditional herbs in their own countries and the countries of origin. The Ayurvedic Drug Manufacturer’s Association (ADMA) has already requested its members to furnish such data for the general benefit of the community but industry response is not yet clear.

In fact, such a program may help in expanding the existing list of ODIs from India and China as more data emerges from Customs and private records. Currently there are 350 ODI herbs from India according to ADMA. Indian dietary supplement companies doing business with the US are still wary of notifying a New Dietary Ingredient to the FDA as past success rates for such notifications have been very low.

Going forward, I think, a robust database of contemporary data on the safety and efficacy of herbal medicines can be generated out of a well-organized program of Pharmaco-epidemiology for herbal medicines. Such a private-public program of Herbal epidemiology powered with modern day IT tools, will go far to document the history of safe and effective use for policy-makers and regulators to take informed decisions on such products in the future.

- Jayesh Chaudhary (jayesh@ayuherbal.com)