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PregLem and Merck to address adhesion need

PregLem has announced an agreement with Merck Serono to develop Bentamapimod, a compound for the prevention of post-surgical abdominal adhesions and endometriosis

Swiss biotech, PregLem, has announced a worldwide, exclusive in-licensing agreement with Merck Serono for its compound for the prevention of post-surgical abdominal adhesions and endometriosis, Bentamapimod, a novel, orally active, Jun Kinase Inhibitor (JNK-I AS602801). No figure for the deal has been disclosed.

PregLem, which specialises in women's reproductive medicine, will develop the compound for patients with tubal ligation or comparable effective contraception. As there are no pharmacological products to help prevent post surgical adhesions, JNK-I (PGL5) presents the possibility of filling a major unmet medical need.

About four million pelvic and abdominal surgery procedures are performed each year in the US and it is estimated that a similar number occurs in the EU. Adhesion formation is a common outcome, reportedly occurring in 90 to 95 per cent of patients. Approximately 10 to 15 per cent of patients have clinically significant problems that, in some cases, require readmission to hospital.

In addition, endometriosis itself is a leading cause of pelvic adhesions in pre-menopausal women. This condition, characterised by pelvic pain and infertility, affects over 16 million women in the world.

JNK-I (PGL5) is an anti-inflammatory agent which has been shown to reduce the disease burden in several pre-clinical models for endometriosis and has the potential to be effective in addressing the causes of post-operative adhesions. Preclinical data show that the compound is an effective anti-inflammatory with anti-fibrotic properties.

PregLem plans to initiate a clinical proof of concept study and a phase II study in 2011.

Ernest Loumaye, CEO and co-founder of PregLem, said: "Bentamapimod is an innovative compound with the potential of a unique combination of anti-adhesions and anti-endometriosis properties, therefore presenting a significant opportunity in addressing this global market need. It is also a perfect strategic fit with our speciality product portfolio focused on women's reproductive medicine. This agreement further validates our business model of in-licensing promising clinical stage assets for late stage development."

In addition, PregLem has received positive phase III data on its lead drug candidate, Esmya (ulipristal acetate), for the treatment of uterine fibroids (myoma). As a result, the company will submit a Marketing Authorisation Application to the European Medicines Agency (EMA) later this year.

11th August 2010

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