PRODUCT PROFILE PRODUCT PROFILE Description Soothing, hydrating and protective gel For external use only Regulatory status Cosmetic Dosage 1 application per day Principle ingredients 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 In combination therapy with pharmacological treatment or during the menstrual period to reduce skin irritation due to the use of sanitary napkin or tampon Suggested Public Price € 12,00. 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 VAGINAL GEL MARKET REFERENCE MARKET: ITALY Sell-out UN MAT/7/2009 (Absolute) 12D9 ALTRE PREP.GINECOLOGICHE COMBE ITALIA VAGISIL CREMA 2% 20G PROGINE FARMACEUT. COLPOFIX GEL VAG. 10 20ML GEL+EROG DIFESAN CPR.VAG+APPL 7 CORMAN LADY P. ACTIGEL GEL BIOADES 50ML SANDOZ CLOMIREX T GEL VAG 20G MIPHIL GEL 20G 85D4 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 C/APPLICAT. TUBO 7 RECKITT BENCKIS.HC DUREX MASSAGE DUREX TOP GEL DUREX O GEL 15ML GANASSINI VIDERMINA INTIMO Sell-out UN MAT/7/2010 (Absolute) 3.823.117 827.510 54.533 38.102 30.555 7.547 13.008 13.008 79.090 79.090 79.090 50.233 23.909 23.909 24.411 24.411 1.890.386 366.549 227.381 191.245 36.135 110.919 110.919 17.646 17.646 10.541 10.541 63 63 367.371 160.466 102.705 104.200 104.200 327.785 141.643 Sell-out UN MAT/7/2011 (Absolute) 4.508.664,3 766.534,7 75.194,5 39.689,3 30.750,7 8.938,6 13.155,1 13.155,1 86.209,5 86.209,5 86.209,5 55.194,3 33.411,9 33.411,9 21.651,3 21.651,3 2.115.651,5 366.742,8 238.705,7 201.194,4 37.511,3 104.816,5 104.816,5 13.485,1 13.485,1 9.681,2 9.681,2 54,2 54,2 413.442,5 164.366,8 115.801,4 78.244,1 78.244,1 331.289,7 138.852,5 4.840.650 759.570 99.649 44.702 33.619 11.082 20.857 20.857 93.251 93.251 93.251 61.365 41.321 41.321 10.507 10.507 2.279.789 353.192 237.737 201.487 36.250 94.959 94.959 11.007 11.007 9.480 9.480 9 9 411.641 207.800 114.330 39.924 39.924 320.655 131.591 VAGINAL GEL MARKET REFERENCE MARKET: ITALY 12D9 ALTRE PREP.GINECOLOGICHE COMBE ITALIA VAGISIL CREMA 2% 20G SAGINIL GEL C/DISP. 30ML MONODOSE 6 4.5ML SAGINIL IN MONODOSE 10 4.5ML PROGINE FARMACEUT. COLPOFIX GEL VAG. 10 20ML GEL+EROG DIFESAN CPR.VAG+APPL 7 CORMAN LADY P. ACTIGEL GEL BIOADES 50ML SANDOZ CLOMIREX T GEL VAG 20G MIPHIL GEL 20G 85D4 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 C/APPLICAT. TUBO 7 RECKITT BENCKIS.HC DUREX MASSAGE DUREX TOP GEL DUREX O GEL 15ML GANASSINI VIDERMINA INTIMO Sell-out EUR/PUB MAT/7/2009 (Absolute) 40.498.736,8 6.802.929,7 534.746,0 440.207,2 94.538,8 95.749,7 95.749,7 1.035.541,1 700.779,7 603.173,4 97.606,2 256.743,2 256.743,2 1.083.128,6 1.083.128,6 1.083.128,6 818.023,6 334.149,9 334.149,9 457.232,7 457.232,7 23.294.053,4 4.348.021,5 2.805.924,3 2.359.788,1 446.136,2 1.194.778,5 1.194.778,5 211.596,8 211.596,8 135.079,5 135.079,5 642,4 642,4 3.898.381,0 1.567.417,9 797.163,1 1.533.800,0 1.533.800,0 4.201.203,6 1.869.624,5 Sell-out EUR/PUB MAT/7/2010 (Absolute) 48.115.086,6 6.540.131,9 507.304,3 500.807,1 6.497,2 257.478,3 257.478,3 1.493.100,5 724.565,5 609.504,2 115.061,2 259.881,7 259.881,7 1.201.202,6 1.201.202,6 1.201.202,6 874.294,2 467.441,6 467.441,6 405.018,5 405.018,5 25.969.580,4 4.457.749,5 3.021.515,8 2.546.483,4 475.032,4 1.139.195,6 1.139.195,6 171.476,1 171.476,1 124.992,7 124.992,7 569,3 569,3 4.574.650,4 1.575.763,8 919.965,8 1.148.497,0 1.148.497,0 4.289.037,9 1.834.970,2 Sell-out EUR/PUB MAT/7/2011 (Absolute) 55.596.422 6.610.647 532.991 531.995 996 319.409 319.409 1.999.851 810.641 666.988 143.653 412.190 412.190 1.373.141 1.373.141 1.373.141 952.345 577.599 577.599 196.537 196.537 27.533.327 4.319.877 3.020.698 2.560.217 460.481 1.034.771 1.034.771 141.639 141.639 122.670 122.670 98 98 4.225.871 1.999.741 907.804 579.975 579.975 4.181.924 1.739.148 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 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. 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. 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