PregLem Announces Positive Phase III Results for Esmya(TM)
– PEARL I Trial Meets Primary Efficacy and Safety Endpoints
– PregLem Preparing for Submission to the European Medicines Agency in
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
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
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
Institute of Obstetrics and Gynaecology in City Clinical Hospital (
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
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 http://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
SOURCE PregLem