Geneva, Switzerland, 11 August 2010: 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.1 Adhesion formation is a common
outcome of these surgeries, occurring in 90-95% of patients2. 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
1 U.S. UK, Germany, France, Spain, Italy Surgical Procedure Volumes, Medtech Insight, March 2009
2 Postoperative abdominal adhesions and their prevention in gynecological surgery. Expert Consensus, Gynecol
Surg 2007 (4):243-253
PregLem recently announced positive Phase III data on its lead drug candidate – Esmya™ –
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.
For further information, please contact:
Tel: +41 (0)22 884 03 40
Mary Clark, Anna Davies
Tel: +44 (0)20 7307 5330
PregLem is a Swiss speciality biopharmaceutical company, dedicated to the development
and commercialization of a new class of drugs for women’s reproductive health conditions.
PregLem has an experienced senior management team, with a proven track record in
developing, registering and commercializing reproductive health products. The company is
backed by a blue chip investor base.
Visit www.preglem.com for more information.
About post-operative adhesions & endometriosis
Four million people each year have pelvic and abdominal surgeries in the US. Post-operative
adhesions are a natural consequence of tissue trauma and healing and they occur in 90-
95% of patients. At their most extreme can result in infertility, pain and bowel obstructions.
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.
There is currently no pharmacological treatment available to prevent post-operative
adhesions. Instead surgical techniques and medical devices are currently used as a
preventative measure. However, data shows that this is frequently ineffective.