PregLem, the Swiss specialty biopharmaceutical company focused on women's reproductive medicine, announces a world-wide, exclusive in licensing agreement for Bentamapimod, a novel, orally active, Jun Kinase Inhibitor (JNK-I AS602801) from Merck Serono for an undisclosed amount. PregLem will develop the compound for the prevention of post-surgical abdominal adhesions and endometriosis in patients with tubal ligation or comparable effective contraception.
Approximately four million pelvic and abdominal surgery procedures are performed each year in the US and a similar number is estimated for EU. Adhesion formation is a common outcome of these surgeries, occurring in 90-95% of patients. There can be an adhesion between organs in the pelvis, bowel to bowel, bowel to uterus, bowel to the ovary, or to the abdominal wall. At their most extreme they can result in infertility, pain and bowel obstructions. Approximately 10-15% of patients will have clinically significant problems that in some cases may require readmission to hospital for treatment or reoperation as a result.
In addition, endometriosis itself as well as its surgery are leading causes of pelvic adhesions in pre-menopausal women. Endometriosis, a condition characterised by disturbing pelvic pain and infertility, affects over 16 million women in the world.
There are no pharmacological products available to assist in the prevention of post surgical adhesions. Surgeons currently use medical devices (commonly films, sprays or solutions) which have been shown to be marginally effective and often impractical. The prevention of post surgical adhesion thus presents a major unmet medical need.
JNK-I (PGL5) is a potent 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 during 2011 for the prevention of post-surgical abdominal adhesions and/or endometriosis in patients with tubal ligation or comparable effective contraception.
Ernest Loumaye, CEO & 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 specialty 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."
PregLem recently announced positive Phase III data on its lead drug candidate - Esmya(TM) - for the effective treatment of uterine fibroids (myoma). The results enable PregLem to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) which is expected to take place during the 4th quarter of 2010. Upon approval, PregLem expects to launch the product in major European markets.