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PregLem Announces In-Licensing Deal With Merck Serono for Post-Operative Adhesions & Endometriosis

August 11, 2010

GENEVA, August 11, 2010 /PRNewswire/ — 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 http://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.

———————————

[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

SOURCE PregLem


Source: newswire



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