PregLem Announces Positive Phase III Results for Esmya(TM)

By Preglem, PRNE
Wednesday, June 2, 2010

PEARL I Trial Meets Primary Efficacy and Safety Endpoints

GENEVA, Switzerland, June 3, 2010 - PregLem, the European specialty biopharmaceutical company focused on
women's reproductive medicine, announces positive Phase III data from its
second pivotal study (PEARL I) for its lead product Esmya (ulipristal
acetate), as an effective treatment for uterine fibroids (myoma) - a
condition that affects millions of women worldwide.

The final set of positive Phase III results, combined with the
positive PEARL II results announced in May 2010, will enable PregLem to
submit a Marketing Authorisation Application (MAA) to the European Medicines
Agency (EMA) by the end of 2010. Upon approval, PregLem expects to launch the
product in major European markets.

Ernest Loumaye, CEO & Co-Founder of PregLem, said:

"These results are another important milestone in PregLem's
growth strategy. With positive results from two independent Phase III studies
on our lead candidate, we now have the opportunity to move the company
forward from its current focus on drug development towards our ambition of
becoming a self-sustaining specialty biopharmaceutical company. Our immediate
focus is on preparing the MAA dossier. However, we are simultaneously
leveraging our unique research and market insight to start preparing for the
launch of Esmya, our first product in Europe."

Key Phase III results

PEARL I was designed to demonstrate superior efficacy of Esmya
versus placebo for the treatment of symptomatic uterine fibroids in women
with heavy bleeding leading to anaemia. It was a randomised, parallel group,
double-blind, placebo-controlled, multi-centre study with a total of 242
patients. It compared 5mg and 10mg doses of Esmya and placebo once daily for
three months with concomitant iron administration in all three arms.

The study met its two co-primary efficacy endpoints. Esmya
demonstrated statistically significant superior efficacy to placebo in
reducing excessive uterine bleeding measured as a percentage of patients with
a reduction of PBAC (Pictorial Blood Assessment Chart) score lower than 75
and in reduction of total fibroids volume assessed by centralised MRI
reading.

Esmya also showed superior efficacy to placebo in correcting
anaemia caused by uterine fibroids and suppressing fibroids-related pain
using the McGill Short Form questionnaire (SF-MPQ). Both the PBAC and SF-MPQ
are validated self-reporting tools.

Ernest Loumaye added:

"The combined PEARL I and II data shows that Esmya has the
potential to be the first effective medical treatment for this condition,
with no serious side effects, for millions of women around the world."

Professor Tetyana Tatarchuk, the Principal investigator from
the Institute of Obstetrics and Gynaecology in City Clinical Hospital
(Ukraine), said:

"These data are very convincing. A medical treatment for
alleviating the symptoms related to fibroids and reducing the fibroids volume
would be very useful in our day-to-day management of this significant and
distressing condition. These results clearly illustrate the potential for
Esmya to offer an effective and well tolerated treatment for this condition."

Uterine fibroids affect approximately 40% of women between the
ages of 35 and 55, including 24 million women in Europe and over 20 million
women in North America. The condition is characterised by excessive uterine
bleeding, anaemia, pain and infertility. It significantly impairs the quality
of life for many women, leading in many cases to a hysterectomy. There are no
effective, well tolerated medical treatments available. GnRH agonists are the
only approved treatment of symptomatic uterine fibroids but their use has
been relatively limited due to their side effect profile which causes
suppression of oestrogen to castration levels, resulting in hot flushes,
depression, mood swings, loss of libido, vaginitis and loss of bone mineral
density.

About PregLem

PregLem is a European 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
commercialising reproductive health products. The company is backed by a blue
chip investor base.

Visit www.preglem.com for more information.

About Esmya(TM)

Ulipristal acetate is a first-in-class, orally active
selective progesterone receptor modulator which reversibly blocks the
progesterone receptors in target tissues.

PregLem's Phase III programme for Esmya consists of two
separate, parallel, randomised, double-blind studies identified as PEARL I
and PEARL II. Together the Phase III trials involved 540 patients in 14
countries at 5mg and 10mg doses.

    For further information, please contact:

    PregLem:

    Désirée 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
    anna.davies@capitalmsl.com

For further information, please contact: PregLem: Désirée 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, anna.davies at capitalmsl.com .

YOUR VIEW POINT
NAME : (REQUIRED)
MAIL : (REQUIRED)
will not be displayed
WEBSITE : (OPTIONAL)
YOUR
COMMENT :