PregLem Announces In-Licensing Deal With Merck Serono for Post-Operative Adhesions & Endometriosis
By Preglem, PRNETuesday, August 10, 2010
Expands Pipeline of Women's Reproductive Medicine Products
GENEVA, August 11, 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 patients[2]. 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.
About PregLem
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.
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[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
For further information, please contact: PregLem: Desiree Andrey CEO Office PregLem SA Tel: +41(0)22-884-03-40 desiree.andrey@preglem.com Capital MS&L: Mary Clark, Anna Davies Tel: +44(0)20-7307-5330 preglem@capitalmsl.com
PregLem: Desiree Andrey, CEO Office, PregLem SA, Tel: +41(0)22-884-03-40, desiree.andrey at preglem.com; Capital MS&L: Mary Clark, Anna Davies, Tel: +44(0)20-7307-5330, preglem at capitalmsl.com
Tags: August 11, Geneva, Preglem, Switzerland