Press Release: Nerium SkinCare, Inc. and Nerium International, LLC (NeriumAD - Age-Defying Night Cream)
Nerium™ International, LLC of Addison, TX and Nerium SkinCare™, Inc., a subsidiary of Nerium Biotechnology, Inc. ®, of San Antonio, TX are pleased to announce their exclusive licensing partnership. This partnership was designed with the purpose of building a global brand through the development and distribution of breakthrough products in the anti-aging skincare market.
"First Of Its Kind" Topical/Dermal Product – NeriumAD - Age-Defying Night Cream …. is LAUNCHED.
Naturtech manufactures first commercial run of NeriumAD (Age–Defying Night Cream)
Natural Technology, Inc. (Naturtech) initiates the first commercial production run of NeriumAD for exclusive distribution by Nerium International, LLC.
Nerium SkinCare’s initial topical/dermal formulation NeriumAD is provided for by Don Smothers, President, CEO of Natural Technology Incorporated (Naturtech) a GMP manufacturing facility. Mr. Smothers has more than 40 years experience in the formulation, development, and manufacturing of consumer products and also has more than 30 years of experience with Aloe Vera research, Aloe Vera industry affiliations, and Aloe Vera based consumer products.
Nerium SkinCare’s NeriumAD formulation includes utilization of Naturtech’s proprietary naturally grown Aloe Vera processing technology, known as "cold processed, whole leaf aloe vera" as the extraction media with the patent-pending Extraction process NBio-PL²™ and the resulting Nerium extract NAE-8™ which has been clinically tested for safety and efficacy.
Today Naturtech provides for formulation and manufacturing of enhanced skin care products as Nerium SkinCare moves forward with its topical cosmetic and OTC healthcare consumer products.
Final Report: Nerium AD clinical trial is completed (See Final Report as well as clinical trial video)
Clinical trial for Nerium AD is completed. NeriumAD Final Report – Larry K. Fan, M.D.
ST&T Research conducts NeriumAD Clinical Study
Clinical research for NeriumAD product safety, efficacy, and dermal application was initiated with ST&T Research (Science, Toxicology & Technology). ST&T Research is comprised of a group of prominent scientist, including M.D. and Ph.D. pharmacologists/toxicologist and research product development oriented physicians, scientist, and regulatory compliance specialists which include a legal team specializing in US FDA/FTC/Customs regulations. ST&T Research provides product development, product compliance, regulatory compliance, clinical testing, and information and data for safety and efficacy.
Dr. Robert A. Newman as scientific advisor to Nerium SkinCare assisted by providing safety data from previous research, studies, and experience from the FDA safety trial at the University of Texas M. D. Anderson Cancer Center (MDACC). In addition, Dr, Newman provided the analytical method for determination of oleandrin (CG) in blood plasma and MDACC provided for blood analysis.
Background: Anti-aging skin creams are abundant in today’s cosmetic marketplace. Newer ingredients that may provide additional efficacy are sought to improve existing products. This study investigates the safety and efficacy of two such ingredients, a soluble Nerium oleander extract (NAE-8) and proprietary protein blend (collagen, elastin & glycosaminoglycans)
Study Methods: Thirty-five (35) subjects were enrolled in a single-site, open-label Pilot Study to evaluate the safety and efficacy of NAE-8 in reducing aged skin related wrinkles and sun damage. The composition described in this study is a topical skin cream, which was a formulated Nerium extract suspended in a base cream “carrier” to facilitate application.
Subjects were instructed to apply the study product to the face for four (4) consecutive weeks. Subject evaluations were conducted at the initial visit and at the end of weeks 1, 2 and 4.
Primary outcomes included an objective evaluation of changes in the appearance of “aging and sun damaged” skin of the face using an advanced R&D fluorescence spectroscopy skin analyzer (Moritex BTBP Clarity Pro system, San Jose, CA), as well as the subject’s perception of changes in the appearance of their “aged and sun-damaged” face in terms of wrinkling, discoloration, complexion, and tone as reported by questionnaire administered at the end of weeks 2 and 4.
Secondary outcomes included an assessment of safety to determine if the active ingredient was absorbed systemically and subjective input from subjects regarding skin irritation.
Nerium SkinCare, Inc. initiates formulation of “first of its kind” anti-aging product, NeriumAD
New product formulation:
Nerium SkinCare, Inc. is dedicated to offering solutions that are based on proven science and actual customer use experience. Products offered to the consumer will be founded on continuing research at leading medical institutions using the latest scientific methods and technology. All products will be nature based and scientifically developed.
The foundation of each product will be derived by utilizing the unique patent-pending extraction process NBio-PL² for its skin care products. This extraction technology incorporates pure liquid Aloe Vera (cold processed) as the media to extract the Nerium oleander plant components in a way that preserves the beneficial properties of both plants, without any additional solvents. This natural extraction technology combines the unique beneficial properties of the Nerium oleander plant and the known beneficial properties of Aloe Vera plant. This process provides the core ingredient NAE-8™ extract for product development.
Initial Product Development, Nerium AD
In collaboration with Nerium International, LLC, Nerium SkinCare has identified the anti-aging market as the initial target market for product development and has formulated its initial product for market launch, NeriumAD™ an age –defying night cream. Exclusive distribution of NeriumAD™ is provided for in a licensing partnership agreement with Nerium International, LLC.
Anti-aging skin creams are abundant in today's cosmetic marketplace. New ingredients that may provide additional efficacy are sought to improve existing products. The NeriumAD™ formulation is specifically designed for this market and provides two (2) such ingredients, NAE-8™ extract and a proprietary protein blend (collagen & elastin & glycosaminoglycans) which are unique to this market. Prior to product launch, Nerium SkinCare will now move forward with clinical testing on NeriumAD for product safety, efficacy and clinical application with ST&T Research.
Nerium SkinCare, Inc. signs new exclusive licensing partnership agreement with Nerium International, LLC.
After serious due diligence on distribution options, Nerium SkinCare, Inc. has determined the Direct Sales / Relationship Marketing channel would be the best option to build a global skin care brand. Lengthy discussions with industry leader Jeff Olson has led to an exclusive licensing partnership for skin care product development/distribution between Nerium SkinCare, Inc. and Nerium International, LLC.
This collaboration provides Nerium SkinCare the opportunity to develop for the consumer an ever expanding pipeline of natural botanical and specially formulated Nerium extract-based skin care products. Nerium International provides the opportunity to build and develop a world class marketing company to attract and train Independent Brand Partners to engage in building a national and global sales organization.
New subsidiary of Nerium Biotechnology, Inc. Incorporated – Nerium SkinCare, Inc.
Nerium SkinCare, Inc., a subsidiary of Nerium Biotechnology, Inc. was established to provide for the commercialization and distribution of all skin care/topical applications of Nerium Biotechnology’s botanical extracts. Nerium SkinCare provides for product development, product compliance, regulatory compliance, clinical testing for safety and efficacy, manufacturing, and marketing to the consumer the “first of its kind” natural skincare products for topical use. Nerium SkinCare’s products are founded on the technology, core science, and continuing research of Nerium Biotechnology, Inc.
Nerium SkinCare is charged with harnessing what has been learned over the last ten (10) plus years regarding the safety and healing effects of the Nerium oleander plant and its application to the skin care market. By utilizing Nerium Biotechnology’s patent-pending technology, the knowledge gained through research, and core science on the Nerium oleander plant, Nerium SkinCare will have the opportunity to develop for the consumer an ever expanding pipeline of natural botanical and specially formulated Nerium extract-based skin care products.
Pre-market Consumer Product Research Initiated:
Participation was limited to the company’s shareholders and family. The opportunity was extended to participate in on-going specialized product clinical research and experience Nerium Biotechnology’s new skin care products first-hand prior to market launch. In so doing, they would help gain market experience; provide additional product safety data, and product use feedback. This group is limited in size and only this group will be offered additional new products to sample.
The data collected with this consumer research will assist with evaluation of product formulation/re-formulation. . In addition to providing determination/identification of product to move forward with to market and time to explore distribution options.
Initial formulation and limited production of two new skin care products was initiated at Naturtech.
From historical/anecdotal use, continuing cancer and antiviral research with Nerium oleander extracts, Nerium Biotechnology, Inc. (Nerium) has identified the potential for Nerium extracts use in topical skincare applications.
The formulation and limited commercial production of 2 new skin care products was initiated at Natural Technology, Inc. (Naturtech) to provide for additional research and testing.
NeriumDerm™ - an amazing and potent skin soothing and repair cream for topical applications. It is designed to enhance skin health and is a dramatic relief cream for aged, blemished, sun-damaged skin, and a variety of common skin conditions. The product is formulated to soothe, moisturize, nourish, and help repair. For best results, apply the cream at least one a day, or as needed. Longer duration of application is associated with better results.
Nerium CS™ - a natural lip repair and cold sore relief serum for topical application. In addition to the NAE-8™ extract, this product has been further enhanced with L-Lysine, Olive Leaf Extract and Clove Flower Oil known compounds used for this condition. It is designed to enhance lip health and is a dramatic relief serum for cold sores and sun-damaged chapped lips. The product is formulated to relieve, soothe, moisturize, nourish, and help repair. We recommend early application to cold sores before any visible symptoms appear (often called the “Tingle Stage”) and continued use through the final stage (the " Healing Stage"). The longer duration of application is associated with better results. Continued use may extend time between additional breakouts.
Provisional patent application submitted for new Nerium oleander-based extraction process.
In July 2008, Science Toxicology and Technology, LLC (ST&T) provided a patentability opinion on a new method of extracting materials from Nerium oleander for medicinal use. The conclusion, after the review of the references cited, was that in their opinion the new extraction process used to extract glycosides and other compounds from Nerium-derived plant material is novel and unobvious. Nerium has provided a description of the invention and ST&T has moved forward with the Plant Extraction Method and Compositions paperwork and filed a provisional patent October 14, 2008. Nerium, if successful with this patent, will have an additional patented process for an Nerium oleander extraction and its cytotoxic component oleandrin.
Two additional human pilot studies initiated with oleander-based dermal cream formulations.
As of August 2008, two additional pilot studies have been initiated. In these studies the cream is applied to a larger surface area on each patient. One study relates to sunburn and the other to acne. In addition we are testing the Nerium dermal creams against well-known products already in the market place.
Pilot studies are initiated with Science Toxicology and Technology, LLC (Nerium oleander-based dermal cream)
After development of a basic Nerium oleander-based cream, Nerium has initiated animal and human pilot studies during the month of July 2008 with Science Toxicology and Technology, LLC. The initial human pilot is on age/liver spots and actinic keratosis. Nerium’s focus remains safety and efficacy with this new dermal application.
Testing agreement for oleander-based dermal products signed with Science Toxicology and Technology, LLC.
In April 2008 Nerium Biotechnology, Inc. signed a research and testing agreement (the first in a series) with Science Toxicology and Technology, LLC (ST&T). Nerium discussions with ST&T provided for a model to bring our dermal formulations to market. Initial product targets would be cosmetic (Neutraceutical) versus a drug. This initial research includes an animal model to confirm safety and a series of human studies on various skin diseases, skin cancer and sun-damaged skin. The agreement also provides for initial patent research and processing for our new Nerium oleander extraction process NBio-PL2.
Formulation and manufacturing agreement for oleander-based dermal products signed with Affiliated Consultants International Incorporated and Natural Technology, Inc.
The dermal market is a multi-billion dollar market and presents an opportunity for Nerium to bring new dermal oleander-based products to market in the USA. Nerium hopes to develop a line of oleander-based dermal products for sun-damaged skin, several specific skin diseases, and skin cancer. In April 2008 Nerium Biotechnology, Inc. signed formulation and manufacturing agreements with Affiliated Consultants (formulation) and Natural Technology, Inc. (manufacturing). These negotiations included an additional new oleander extraction process which provides the opportunity for Nerium to obtain additional intellectual property.