3 PRODUCT PROFILE Description Regulatory status Dosage Principle ingredients Soothing, hydrating and protective gel For external use only Cosmetic 1 application per day Zinc Gluconate and Taurine (natural substances present in an healthy body characterized by important activities. They work together and are able to reduce vaginal inflammation, restore the mucosa integrity preventing ulcers and infection and reduce bacterial colonization) Indication Suggested Public Price In combination therapy with pharmacological treatment or during the menstrual period to reduce skin irritation due to the use of sanitary napkin or tampon 12,00.
4 MARKET NEEDS Including drugs and medical devices, the Italian market of Vaginal gel is about 4,8 million units. Vaginal dryness can be often the origin of vulvo-vaginal irritation or phogosis and the consequence could be a local infection Most common cases are gynecological explorations, contraceptive prosthesis applications, difficulty in sexual relationships due to various physiological causes, skin irritation due to the use of vaginal tampons during the menstruation period The use of specific products, especially in form of gel could be the solution. The gel formulation is a specific market requirement, highly recommended by the physicians The major needs are: soothing and refreshing action, itch reduction, natural ingredients based products
5 VAGINAL GEL MARKET REFERENCE MARKET: ITALY Sell-out UN MAT/7/2009 Sell-out UN MAT/7/2010 Sell-out UN MAT/7/ D9 ALTRE PREP.GINECOLOGICHE , COMBE ITALIA VAGISIL CREMA 2% 20G , PROGINE FARMACEUT , COLPOFIX , GEL VAG ML , GEL+EROG , DIFESAN , CPR.VAG+APPL , CORMAN , LADY P. ACTIGEL , GEL BIOADES 50ML , SANDOZ , CLOMIREX T , GEL VAG 20G , MIPHIL , GEL 20G , D4 LUBRIFICANTI INTIMI , ROTTAPHARM , SAUGELLA , IDROCREMA 30ML , GEL DI ATTIV 30ML , SAUGELLA GEL IG , TUBO 30ML , INTILAC PLUS , GEL VAG. MON 7 5ML , SAUGELLA GEL M/DOS , MONODOSE 6 5ML , INTILAC 63 54,2 9 C/APPLICAT. TUBO ,2 9 RECKITT BENCKIS.HC , DUREX MASSAGE , DUREX TOP GEL , DUREX O , GEL 15ML , GANASSINI , VIDERMINA INTIMO ,
6 VAGINAL GEL MARKET REFERENCE MARKET: ITALY Sell-out EUR/PUB MAT/7/2009 Sell-out EUR/PUB MAT/7/2010 Sell-out EUR/PUB MAT/7/ D9 ALTRE PREP.GINECOLOGICHE , , COMBE ITALIA VAGISIL CREMA 2% 20G , , SAGINIL , , GEL C/DISP. 30ML , , MONODOSE 6 4.5ML , ,2 996 SAGINIL IN , , MONODOSE ML , , PROGINE FARMACEUT , , COLPOFIX , , GEL VAG ML , , GEL+EROG , , DIFESAN , , CPR.VAG+APPL , , CORMAN , , LADY P. ACTIGEL , , GEL BIOADES 50ML , , SANDOZ , , CLOMIREX T , , GEL VAG 20G , , MIPHIL , , GEL 20G , , D4 LUBRIFICANTI INTIMI , , ROTTAPHARM , , SAUGELLA , , IDROCREMA 30ML , , GEL DI ATTIV 30ML , , SAUGELLA GEL IG , , TUBO 30ML , , INTILAC PLUS , , GEL VAG. MON 7 5ML , , SAUGELLA GEL M/DOS , , MONODOSE 6 5ML , , INTILAC 642,4 569,3 98 C/APPLICAT. TUBO 7 642,4 569,3 98 RECKITT BENCKIS.HC , , DUREX MASSAGE , , DUREX TOP GEL , , DUREX O , , GEL 15ML , , GANASSINI , , VIDERMINA INTIMO , ,
7 PRODUCT VS. MARKET NEEDS Ginoxil Gel is, actually, the perfect answer to the reference markets needs: Soothing and refreshing Action Inflammation reduction Strictly based on Natural ingredients which do not interfere with any drugs or specific treatment Itch reduction Gel presentation with high patients compliance For external use only
8 MARKET POSITIONING Ginoxil Gel, with its soothing, refreshing and anti- itching activity is based on natural ingredients and it is indicated for sensitive and irritated intimate areas Zinc and Taurine,natural active ingredients, are well known for their safety and synergic action and efficacy to reduce local inflammation and risks for microbial infection.
9 ARGUMENTS Zinc is present in the healthy body and it is essential for the function of at least 70 enzymes and is involved in a variety of metabolic processes. Zinc is also a limiting factor in zinc-dependent enzymes such as RNA and DNA polymerases, deoxythymidine kinase, and reverse transcriptase, which are responsible for the regulation of RNA and DNA metabolism. Zinc supplementation has been shown to markedly improve wound healing. Zinc supplementation is recommended as a ROS scavenger and anti inflammatory agent, as well as anti-aging. Moreover Zinc increase T helper lymphocyte and Zinc salts are known to inhibit bacterial and viral growth. It seems to have activity similar to insulin, antioxidant activity protecting mucosal cells. Taurine, or 2 aminoethanesulfonic acid, is an organic acid. It is also a major constituent of bile and can be found in the lower intestine and in small amounts in the tissues of many animals and in humans as well. The association between Zinc and Taurine has demonstrated anti inflammatory action, protection and repairing the vaginal mucosa, preventing local ulcers. Both substances has antimicrobial activity, and they show a synergic action to get a significant reduction of microorganisms.
10 CLINICALS GINOXIL WASH & GINOXIL GEL, starting October 2012 Purpose of the trial : evaluation of the efficacy of topical Zinc gluconate and Taurine based products on vulvo-vaginal inflammation Participants : 30 subjects, between 18 and 70 years Methods: 10 subjects treated with Ginoxil gel for 10 days 20 subjects treated with Ginoxil gel for 10 days & Ginoxil wash every other day Primary endpoint: evaluation of itch, dryness, pain and leuchorrea Secondary endpoint: evaluation of the tolerability and acceptance of the products
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