GHP August 2015

ghp August 2015 | 29 industry insight Bacterial vaginosis (BV) is one of the most frequent vaginal infections in women of childbearing age and it is estimated that more than 300 million women worldwide are infected each year. The condition is rated as the most common cause for women to visit their gynaecologist. BV is an imbalance in the vaginal bacterial flora resulting in lack of vaginal acidity, inhibition of the normal lactobacilli growth and an overgrowth of mixed anaerobic bacterial flora including Gardnerel- la vaginalis, resulting in odorous vaginal discharge. BV is also associated with a wide range of medical problems including complications following preg- nancy, surgery and an increased risk of sexually transmitted diseases.1-4 The prevalence of BV is estimated at approximately 15-30% among fertile women and frequent recur- rences several times a year are common.5,6,7 BV affects many women’s lives negatively, especially due to odorous vaginal discharge, resulting in embarrass- ment and social isolation. Today, antibiotics such as metronidazole or clinda- mycin, are the most common treatments of BV and in the U.S. recommended by the Center for Disease Control.5,8 Recurrences affect approximately half of the women with BV, which means that many women are treated with antibiotics several times a year.5 The emerging global risk of developing bacterial antibiotic resistance9 makes BV treatment with antibiotics cumbersome. In addition, antibiotic treatment often results in side effects, e.g. vaginal thrush, which also needs to be treated. However, there are alternative treatment options with good efficacy and less side effects. By actively acidifying the vagina to its normal pH-level, a poor microenvironment for the anaerobic bacteria is created so the beneficial lactobacilli have a much better chance to survive and get reestab- lished. This is a safe approach, counteracting the risk of antibiotic bacterial resistance development. Laccure® Pessary Laccure has successfully taken its product from discovery all the way through clinical studies, where 80% of the women got rid of their BV after a single dose, to up-scaled manufacturing. The novel product is based on a proprietary substance that releases lactic acid over an extended period of time in order to normalize vaginal pH. The development work has focused on creating a user-friendly product that is not messy, is easy to insert and highly effective. It only needs to be administered once to treat a BV infection, and once a month to prevent recurrences. The Laccure pessary is a medical device product, class IIa. The intended use covers both treatment and prevention of BV. The product is CE-marked and can thus be sold freely in the entire EU/EES. About Laccure AB Laccure AB is a project company of the life science development company P.U.L.S. (Partners for Devel- opment investments in Life Sciences). It was found- ed in 2007 and is based in Helsingborg, Sweden. The initial development of the company’s product was carried out at Lund University, Sweden, and at Gdansk University, Poland. Further pharmaceutical development and GMP manufacturing for preclinical and clinical studies have been performed in collabo- ration with a number of contract development organ- izations. Laccure’s owners are now aiming to divest the company to a buyer with appropriate resources for the commercialization of the Laccure Pessary. For more information please visit www.laccure.com References 1. Eschenbach DA. Vaginitis, cervicitis and endo- metritis. In: Gorbach SL, Bartlett JG, Blacklow NR, editors. Infectious diseases, 3rd ed. Phil- adelphia; Lippincott Williams & Wilkins; 2004. p.947. 2. Joesoef MR, Schmid GP. Bacterial Vaginosis: review of treatment options and potential clinical indications of therapy. Clin Infect Dis. 1995;20 Suppl. 1:872-79. 3. Hillier SL, Nugent RP, Eschenbach DA, Krohn MA, Gibbs RS, Martin DH, et al. Association between bacterial vaginosis and preterm delivery of a lowbirth-weight infant. N Engl J Med. 1995;333:1737-1742. 4. Schmid G, Markowitz L, Joesoef R, Koumans E. Bacterial vaginosis and HIV infection. Sex Transm Infect. 2009;76(1):3-4. 5. Fredstorp M. Foul-smelling vaginal discharge. A hidden health problem at bacterial vaginosis; outcome from an international web-based survey in 2660 women in the U.S., the U.K. and Ger- many. XXI FIGO World Congress in Gyn & Obstet, Vancouver 2015; Abstract 0988. 6. Koumans E, Sternberg M, Bruce C, McQuillan G, Kendrick J, Sutton M, et al. The prevalence of bacterial vaginosis in the United States, 2001-2004; Associations with symptoms, sexual behaviors, and reproductive health. Sexually Transmitted Diseases. 2007;34(11):864-869. 7. Cauci, S., Driussi, S., De Santo, D., Penacchioni P., Iannicelli, T., Lanzafame, P., et al. (2002). Prevalence of bacterial vaginosis and vaginal flo- ra changes in peri- and postmenopausal women. Journal of Clinical Microbiology, 40(6), 2147- 2152. doi: 10.1128/JCM.40.6.2147-2152.2002 8. 2015 Sexual Transmitted Diseases Treatment Guidelines. Center for Disease Control, U.S. De- partment of Health and Human Services. http:// www.cdc.gov/std/tg2015/bv.htm 9. Laxminarayan R, Duse A, Wattal C, Zaidi AKM, Wertheim HF, Sumpradit N, et al. Antibiotic resistance-the need for global solutions. Lancet Infect Dis. 2013;13(12):1057-98.