We are welcoming a discussion with potential partners about the opportunity to acquire Laccure’s proprietary and patent protected vaginal pessary for one-time treatment of the common medical condition bacterial vaginosis.
We are devoted to maximizing the commercial and therapeutic potential of this well-documented product with excellent clinical results with the aim to provide better treatment options for women suffering from bacterial vaginosis.
Laccure® pessary in brief
A medical device product
Laccure® pessary is a medical device product intended for one-time treatment of bacterial vaginosis. This consumer health product is not yet CE-marked or available on the market.
Product development
The development of Laccure® pessary and GMP manufacturing (Good Manufacturing Practice) for clinical studies were carried out in collaboration with several CROs (Clinical Research Organizations) and the Medical University of Gdansk in Poland.
Product manufacturing
To date, the product has been GMP-manufactured (small scale) for clinical trials. We have recently developed a new and simplified manufacturing method which only uses standard equipment and processes, resulting in more attractive COGS (cost of goods sold). The new process is a significant improvement to previous manufacturing method and viewed more attractive for manufacturing of commercial supply.
Market overview – high unmet medical need
Bacterial vaginosis has a prevalence of 10-30 percent in the developed countries. It is estimated that more than 300 million women throughout the world suffer from bacterial vaginosis every year; however, there are currently no effective and safe products available that are also user-friendly.
Odorous vaginal discharge is the most common symptom among women with bacterial vaginosis making this a serious quality of life problem for affected women. It often recurs several times per year and many women suffer in silence with these symptoms according to an international market survey of 2,660 women.1 Today’s treatment consists of antibiotics and short-acting, difficult-to-use pH lowering products.
If bacterial vaginosis is not treated, there is an increased risk for complications during pregnancy (Hay et al., 1994) and after delivery (Minkoff et al., 1984; Gravett et al., 1986). Additionally, the bacterial vaginosis condition has been associated with an increased risk of HIV acquisition (Atashili et al., 2008) and transmission (Cohen et al., 2012) and acquisition of sexually transmitted infections such as gonorrhea, trichomoniasis and infection with herpes simplex virus type 2 (Martin et al., 1999; Cherpes et al., 2003).
Documentation – clinical studies
Two clinical studies with Laccure® pessary have been conducted to investigate its efficacy, side effects and ease of use.
In summary, the two studies comprising 126 women with bacterial vaginosis showed that 80 percent of them got rid of their problems after treatment with a single vaginal pessary. This is a very high treatment effect. The most common side effects were itching and burning sensation, but no one left the study due to these reactions. The doctors could not determine if the side effects were due to the product or if the women had these symptoms without treatment. The women who participated in the studies experienced the treatment as very user friendly.1
In the studies, two pessaries a week were also investigated. Treatment with two pessaries during the course of a week was not statistically significantly superior to treatment with one pessary. However, it is possible to take a further one pessary after four days, if desired. The treatment can be repeated every four days, but not more often than this as the pessary must have time to dissolve.
Biological tests
Biological tests have been completed showing that the vaginal pessary does not cause irritation, sensitization or cell damage.
Intellectual property rights
Laccure has an active patent strategy covering major markets, including the U.S., China, Japan and Europe. as well as eight other countries. The product is well protected by two patent families. The first patent family protects the use of the substance for treatment of gynecological infections. The second patent family protects the formulation and manufacturing of the product.
The trademarks LACCURE and LACQURE are registered in EU. In addition, LACCURE is registered in eight other countries that constitute important markets.
Regulatory
According to the new Medical Device Regulation 2017, which will be fully implemented 2021, Laccure® pessary will be classified as a class IIb product, just like other vaginal products.
A recently performed risk analysis show that the consequences of the new regulation only has a small impact on Laccure’s regulatory file, i.e. Laccure’s documentation is of very high standards.
Laccure® pessary is intended for one-time treatment of bacterial vaginosis. The consumer health product is not yet CE-marked or available on the market.
Marketing
A communication platform, including a brand manual and a consumer webpage, has been developed.
1) Oral presentation at XXI FIGO World Congress of Gyn. & Obstet., Vancouver, Canada, 2015. Abstract No 0988; Foul-smelling vaginal discharge, a hidden health problem at bacterial vaginosis; Outcome from an international web-based survey in 2,660 women in the U.S., the U.K. and Germany.
For more information
Please contact Fredrik Lindgren, Vice President, Chief Business Officer at AQILION AB, one of the major owners and co-founder of Laccure AB. fredrik.lindgren@aqilion.com.
