Laccure AB and Combe Inc have signed an Exclusive Global License agreement to Laccure’s new Female Health Product.

PRESS RELEASE

Laccure AB, a Swedish development company, and Combe Inc., an international personal care company, have now signed an agreement giving Combe the exclusive license to market and sell Laccure’s female health product globally. The deal, which includes up-front, milestone and royalty payments, will eventually make Combe the owner of the product.

The new product has been developed to help women suffering from bacterial vaginosis, a condition that negatively affects women’s quality of life. Over the past years, Laccure AB has successfully taken the product from innovation through clinical trials to manufacturing. The development work has focused on creating a highly effective, single administration antibiotic-free product that is also user-friendly in terms of being easy to apply, not messy to use and which has a long duration.

Sven-Inge Svensson, Chairman of the Board of Laccure, said: “We are delighted to enter a strategic partnership with Combe, which already has a strong global vaginal health franchise. We are convinced that Combe will be very successful in the commercialization of our product.”

Jeanette Robertsson, CEO of Laccure, said: “Finally, millions of women with bacterial vaginosis that suffer from impaired quality of life day after day can get help, and that really feels great!”

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.

The product is based on a patented substance that releases lactic acid over time to re-adjust vaginal acidity to healthy levels. It only needs to be dosed once to effectively treat bacterial vaginosis, and then once a month to prevent recurrence.  

About Combe
Combe is a privately held manufacturer and marketer of personal care, beauty, and OTC drug products with leading brands in the men’s hair care, women’s health and oral care categories.  Since its founding in 1949, Combe has been a brand and category / segment innovator with the organic development of many successful brands, including Just For Men, Clearasil, Vagisil, Odor-Eaters, Lanacane, and Seabond.  Today, Combe is one of the largest privately held companies in the health and beauty industry in the U.S., and the company continues to explore new ways to innovate organically and through partnerships with other companies to bring truly meaningful, efficacious and differentiated solutions to consumers around the world.

About Laccure
Laccure AB was founded 2007 and is a project company within the life science incubator P.U.L.S. AB (www.pulsinvest.se). The initial development was performed at the Universities of Lund, Sweden, and Gdansk, Poland. Further pharmaceutical development and GMP manufacturing for clinical trials as well as preclinical studies have been performed using various contract service providers. Last year Laccure AB and Recipharm Karlskoga AB entered an agreement for commercial manufacturing of Laccure’s product. 

EVLI Corporate Finance has been the financial advisor to Laccure AB.

Contact information:
Sven-Inge Svensson, Chairman of the board, Laccure AB, This email address is being protected from spambots. You need JavaScript enabled to view it.%20">This email address is being protected from spambots. You need JavaScript enabled to view it. and Jeanette Robertsson, CEO, Laccure AB, This email address is being protected from spambots. You need JavaScript enabled to view it.

 
 

Recipharm and Laccure agree commercial collaboration

Leading contract development and manufacturing organisation (CDMO) Recipharm is entering into a collaboration with Laccure AB for the commercial manufacture and delivery of Laccure® Pessary.

The new product, which has been developed to help women suffering from bacterial vaginosis, will be manufactured, packaged and distributed globally from Recipharm’s facility in Karlskoga that specialises in the production of semi-solid products.

Over the past years, Laccure AB has successfully taken the product from innovation through clinical studies to commercial manufacturing. The development work was focused on creating a highly effective antibiotic-free product that was also user-friendly in terms of being easy to apply and not messy to use.

Recipharm and Laccure AB have now signed an agreement for commercial production of Laccure® Pessary and the exact date for the launch will be announced next year.

Laccure AB is a project company within the life science development organisation Partners for Development Investments in Life Sciences (P.U.L.S.). As it prepares for launch, the owner is endeavouring to sell the company to a buyer with the substantial resources required to bring the product to market.

Jeanette Robertsson, CEO of Laccure AB, said: “We are delighted to be collaborating with Recipharm, they are an expert partner that we can rely on for the commercial supply of our new product.

“Given the potential market for the product, a major benefit of partnering with Recipharm is that they have a high level of production capacity, which of course gives us the possibility to further scale up the batch size to meet market requirements in the future.”

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 and can be used with low frequency dosages.

Laccure® Pessary is based on a patented substance that releases lactic acid, and only needs to be administered once to treat a bacterial vaginosis infection and then once a month to prevent a recurrence.

Ingela Palmkvist, General Manager at Recipharm in Karlskoga, said: “We are really looking forward to the commercial launch of this product, and contributing to something that will make a major difference to the lives of many women across the globe.”

Contact information

Ingela Palmkvist, General Manager, This email address is being protected from spambots. You need JavaScript enabled to view it., +46 (0)8 602 52 00
Erik Haeffler, Vice President Manufacturing Services & Head of CSR, This email address is being protected from spambots. You need JavaScript enabled to view it., + 46 (0) 8 6025 285

Sven-Inge Svensson, Chairman of the board, Laccure AB, This email address is being protected from spambots. You need JavaScript enabled to view it.
Jeanette Robertsson, CEO, Laccure AB, This email address is being protected from spambots. You need JavaScript enabled to view it.

For media enquiries, please contact Lindsay Baldry at ramarketing: This email address is being protected from spambots. You need JavaScript enabled to view it., + 44 (0)191 222 1242, ramarketingpr.com, Twitter: @ramarketingpr, Facebook: /ramarketingpr, LinkedIn: /ramarketing

About Recipharm

Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) (in the pharmaceutical industry employing around 3,500 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, and pharmaceutical product development. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. Recipharm’s turnover is approximately SEK 5.0 billion and the Company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Jordbro, Sweden. The Recipharm B-share (RECI B) is listed on Nasdaq Stockholm.

For more information on Recipharm and its services, please visit www.recipharm.com

About Laccure

Laccure AB was founded in 2007 and is based in Helsingborg. Laccure is a project company within the life science development company P.U.L.S. (Partners for Development Investments in Life Sciences). The initial development of the company’s product was carried out at Lund University in Sweden and the University of Gdansk in Poland. Further pharmaceutical development and GMP manufacturing for preclinical and clinical studies was performed in collaboration with a number of contract research companies. Laccure AB is certified according to ISO13485 and the product is CE-marked.

For further information visit www.pulsinvest.se


 

Laccure®Pessary meets the needs of women suffering from bacterial vaginosis, a hidden health problem with reduced quality of life

The new non-prescription product Laccure® Pessary is a breakthrough women’s health product that is effective, safe and user-friendly, addressing the unmet needs of the 300 million women suffering from bacterial vaginosis (BV) every year.

Results from a web-based survey of 2,660 women in the US, UK and Germany show that BV, with an odorous vaginal discharge as the most pronounced symptom, is a common and hidden health problem affecting daily life, often connected with embarrassment, guilt and humiliation. 56% of the women had recurring problems, once or several times a year, and 24% did not seek any treatment. The product-related improvements most often wished for were less frequent administration and smear-free products.

“Laccure® Pessary represents a considerable commercial potential in the OTC market and is ready to be launched. We are aiming to find a partner with resources for efficient commercialisation to ensure that women are offered care and treatment that meets their needs,” says Dr Jeanette Robertsson, CEO, participant at the XXI FIGO World Congress of Gynaecology and Obstetrics, October 4 – 9 in Vancouver, Canada (www.figo2015.org).

Bacterial Vaginosis is the most common vaginal infection in women of childbearing age. Today, there is a lack of effective and safe products that are also user-friendly and can be dosed with low frequency. BV is an imbalance in the vaginal bacterial flora, resulting in a lack of vaginal acidity, discharge with a pronounced foul odour and inhibition of normal lactobacilli growth. Frequent recurrences are common.

Laccure® Pessary is a new, patented product based on a proprietary substance that releases lactic acid over several days in order to decrease the elevated vaginal pH. The developmental work has focused on creating a user-friendly, non-smear product that is easy to insert and highly effective. This has been demonstrated in clinical studies in which 80% of the women were free of their BV after a single dose (www.heraldopenaccess.us/journals/Infectious-&-Non-Infectious-Diseases/current-issue.php).

Laccure® Pessary is CE-marked as a Class IIa medical device that only needs to be administered once to treat BV and once a month to prevent recurrence. It is now ready for market introduction in the EU/EES countries.

Laccure AB is a project company within P.U.L.S. 
www.laccure.com and www.pulsinvest.se

Contact 

Jeanette Robertsson, CEO, This email address is being protected from spambots. You need JavaScript enabled to view it.">This email address is being protected from spambots. You need JavaScript enabled to view it.
Sven-Inge Svensson, Chairman of the Board, This email address is being protected from spambots. You need JavaScript enabled to view it.

Laccure’s antibiotic-free OTC product for bacterial vaginosis ready for commercialisation

The Swedish company Laccure AB has developed a breakthrough women’s health product that is effective, safe and user-friendly. Laccure’s owners are now aiming to divest the company to a buyer with appropriate resources to launch the product.

The manufacturing process for the new product Laccure® Pessary has now been scaled up and the product is ready for market introduction. Laccure has therefore initiated a search for an established company interested in acquiring Laccure and launching the product. The board of directors of Laccure has retained Evli Corporate Finance for the exit process.

“We are proud to announce that the final development stage, the up-scaling of the manufacturing process, for Laccure® Pessary, our new, antibiotic-free, non-prescription product for the treatment and prevention of bacterial vaginosis, is now completed. The product is thus ready for launch. Our objective from the start of the project has been to sell Laccure to an established company that will take the product to market,” says Dr. Jeanette Robertsson, CEO of Laccure AB. 

About Bacterial Vaginosis

Bacterial vaginosis (BV) is the most common vaginal infection in women of childbearing age and it is estimated that more than 300 million women worldwide are infected each year. Today there is a lack of effective and safe products that are also user-friendly and can be dosed with low frequency. Women are often embarrassed at having BV and their quality of life is negatively affected. BV is an imbalance of naturally occurring vaginal bacterial flora, resulting in a lack of vaginal acidity, discharge with a pronounced foul odour and inhibition of normal lactobacilli growth. Many women suffer from frequent recurrences several times per year.  

About Laccure® Pessary

Laccure has successfully taken its patented product from innovation all the way through successful clinical studies, in which 80% of the women were free of their BV after a single dose, to up-scaled manufacturing. The new product is based on a proprietary substance that releases lactic acid over several days to decrease the elevated vaginal pH. The development work has focused on creating a user-friendly product that is not messy, is easy to insert and highly effective. Laccure® Pessary only needs to be administered once to treat a BV infection, and once a month as prevention for women with frequent recurrences. The product is CE-marked as a Class IIa medical device and its intended use covers both treatment and prevention of BV. Laccure® Pessary is now ready for market introduction in the EU/EES countries.

About Laccure AB 

Laccure AB is a Swedish company, founded in 2007 and based in Helsingborg. Laccure is a project company of the life science development company P.U.L.S. The initial development of the company’s product was carried out at Lund University, Sweden, and at the University of Gdansk, Poland. Further pharmaceutical development and GMP manufacturing for preclinical and clinical studies were performed in collaboration with a number of contract development organisations. Laccure’s owners are now aiming to divest the company to a buyer with appropriate resources for the launch of the Laccure® Pessary.

To read more visit www.pulsinvest.se

For more information please contact

This email address is being protected from spambots. You need JavaScript enabled to view it., Chairman of the Board, Laccure AB, This email address is being protected from spambots. You need JavaScript enabled to view it.

This email address is being protected from spambots. You need JavaScript enabled to view it., CEO, Laccure AB, This email address is being protected from spambots. You need JavaScript enabled to view it.

Excellent clinical results for new treatment of bacterial vaginosis

The Swedish company Laccure AB has developed a  breakthrough product for treatment and prevention of bacterial vaginosis (BV) with a proven cure rate of 80 percent already after one vaginal tablet. The product recently got CE marking as a Class IIa medical device. Addressing the unmet needs of the 300 million women suffering from BV infection, the new treatment represents a considerable commercial potential in the OTC market.

Laccure’s novel, non-prescription vaginal tablet has been tested in randomized controlled clinical multicenter studies including 126 women. The results show a cure rate of 80 percent following a single administration of one (1) vaginal tablet. Along with a good safety profile and by fully meeting women’s need for user-friendly comfort, this represents a major improvement in the treatment of BV. Moreover, the use of this new treatment might significantly reduce the need for antibiotics and consequently limit the risk of antibiotic resistance. The product is based on a proprietary substance that releases lactic acid over an extended period of time to decrease elevated vaginal pH.

“Showing such high cure rates already a week after single administration exceeded our ambitious expectations for this product. The study results have been confirmed in two independent studies which led to the successful CE marking, says Dr. Jeanette Robertsson, CEO of Laccure AB.

 “As there is a lack of effective and user-friendly treatment that is also effective in preventing recurrent episodes of bacterial vaginosis, this product will truly fill an unmet need in the market.  Product launch in early 2013 is entirely possible if we can find the right marketing partner”, says Dr. Lennart Bruce, Board Member of Laccure AB.
 

Contact information:

Lennart Bruce, +46 705 90 66 52
Jeanette Robertsson, +46 708 63 74 19, This email address is being protected from spambots. You need JavaScript enabled to view it.">This email address is being protected from spambots. You need JavaScript enabled to view it.
 

About Bacterial Vaginosis

Bacterial Vaginosis (BV) is the most common vaginal infection in women of childbearing age. It is estimated that more than 300 million women worldwide are infected each year. BV is caused by an imbalance in the naturally occurring bacterial flora of the vaginal mucosa resulting in lack of vaginal acidity, discharge with a pronounced foul, fishy odor and inhibition of the normal lactobacilli growth. Many women suffer from frequent recurrences.  Today, there is a lack of effective and safe products that are also user-friendly. Women are often embarrassed having BV and quality of life is negatively affected.
 

About Laccure AB

Laccure was founded in 2007 and is a Swedish project company of the life-science incubator P.U.L.S. AB. Initial product research was carried out at the University of Lund, Sweden, and University of Gdansk, Poland. Further pharmaceutical development and GMP manufacturing for clinical trials as well as preclinical and clinical studies have been performed in collaboration with a number of contract development organisations. Laccure is certified by TÜV.

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