Outlook
Bacterial Vaginosis (BV) is the most common reason for women to see their gynecologist. Frequent recurrences are common. Yet most women with BV problems do not seek their gynecologist, as they prefer to have easy access to BV products and also want to avoid frequent treatment with antibiotics (market analyses on 256 women, data on file).
BV is caused by an imbalance of the naturally occurring bacterial flora of the vaginal mucosa, resulting in increased vaginal alkalinity (too high pH), inhibition of the normal lactobacilli growth and excessive discharge with a strong foul fishy odour. Many women suffer in silence with these symptoms
The prevalence of BV among fertile women is around 10-30 %, or more than 45 million women in the developed countries. Today BV patients are mostly treated with oral or vaginal antibiotic products. There is clearly a need for a convenient and long lasting complementary therapy to prevent the recurrence of BV by adjusting the vaginal pH, thereby reducing the need for antibiotic prescriptions.
The market potential for Laccure’s prodcut is estimated to 60-120 M €/year.
Business area
Laccure is developing a new product for use in the treatment of Bacterial Vaginosis (BV), based on a proprietary substance that releases lactic acid to establish a physiologically low vaginal pH in BV patients. The product will quickly normalise vaginal pH and help keep it normal for a prolonged period of time, optimally one week per dosing. The substance released is identical to physiological lactic acid, which means it can be safely used as often as needed. In addition, the focus is on developing a user-friendly non-smear product which is easy to insert.
The product will be developed as a medical device, with claims initially relating to pH regulation.
Development to date
Patent applications are pending in a number of countries and territories with internationally important markets. A GMP method of manufacturing of the novel substance is under development. Substance production for the commercial phase is secured in an agreement. Pharmaceutical pre-formulation work has been completed, including tests of release properties, pH-decrease and mucoadhesiveness. Tolerability has been tested in an in vivo model. Product development is in its final stage. A clinical multicentre trial is being planned.
Publications
Laccure publication in European Life Science Journal spring 2010.
News
2010 06 21 - Laccure tar in 10,8 miljoner för att färdigutveckla sin produkt för bakteriell vaginos.