Ferring's European Marketing Authorisation Application for controlled release misoprostol vaginal delivery system for the

  Ferring's European Marketing Authorisation Application for controlled
  release misoprostol vaginal delivery system for the induction of labour
  accepted for review

Business Wire

SAINT PREX, Switzerland -- November 05, 2012

Ferring Pharmaceuticals announced today that it has received confirmation from
European health authorities that the Marketing Authorisation Application (MAA)
for its controlled release, removable misoprostol vaginal delivery system
(MVDS) has been accepted for review under the decentralised procedure. Ferring
is seeking approval for the MVDS for induction of labour in women with an
unfavourable cervix, from 36 weeks gestation, in whom induction is clinically
indicated.

The submission was based on the results of clinical studies in more than 3,000
pregnant women at term including the EXPEDITE Study*, a Phase 3, double blind,
randomized, multicenter study of 1,358 patients at 35 U.S. study sites. The
study evaluated the efficacy and safety of Ferring’s controlled release
removable MVDS versus CERVIDIL^®** (dinoprostone) and the results showed that
MVDS decreased the time to vaginal delivery in women with an unfavourable
cervix compared to CERVIDIL. An unfavourable cervix is a cervix that has not
yet softened and thinned so that dilation can take place.

“We are pleased by the action of European authorities in accepting the
Marketing Authorisation Application for review for Ferring’s controlled
release, removable misoprostol vaginal delivery system,” said Pascal Danglas,
Executive Vice President, Clinical and Product Development, Ferring
Pharmaceuticals. “Among expectant mothers, labour induction is an increasingly
common clinical indication. Ferring is committed to developing new and
improved treatments in the area of reproductive health. We look forward to
cooperating with the review process.”

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About Labour Induction

Labour induction is an increasingly common obstetric intervention, with more
than 20 percent of births now being induced.

The need for labour induction occurs when delivery of the baby is necessary,
for a variety of reasons, prior to the start of a natural labour. The
induction process requires the uterus to be stimulated to contract in an
effort to have a vaginal birth. Additionally, it can involve the need for
cervical ripening which is when the cervix is deemed as being “unfavourable”
or when the tissue needs to soften, thin and dilate. This can be achieved
through either pharmacological or mechanical means.

About Ferring’s Controlled Release Misoprostol Vaginal Delivery System (MVDS)

Ferring’s controlled release removable misoprostol vaginal insert is an
investigational vaginal delivery system containing misoprostol. In the
EXPEDITE Study, the MVDS was given as a single dose, with continuous,
controlled release of misoprostol for up to 24 hours. The U.S. Food and Drug
Administration (FDA) has also accepted for review Ferring’s New Drug
Application (NDA) for the MVDS. The MVDS was developed by Ferring Controlled
Therapeutics Ltd. a wholly-owned member of the Ferring Group based in East
Kilbride, Scotland.

About Ferring Pharmaceuticals

Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven,
specialty biopharmaceutical group active in global markets. The company
identifies, develops and markets innovative products in the areas of
reproductive health, urology, gastroenterology and endocrinology. Ferring has
its own operating subsidiaries in 50 countries and markets its products in
more than 90 countries. To learn more about Ferring or its products please
visit www.ferring.com.

*The EXPEDITE Study: A phase III, double blind, randomized, multicenter study
of EXogenous Prostaglandin comparing the Efficacy and safety of the
Misoprostol Vaginal Insert (MVI) 200 mcg to the Dinoprostone vaginal Insert
for reducing Time to vaginal delivery in pregnant women at tErm

**CERVIDIL^® (dinoprostone) is a registered trademark of Ferring, except in
the U.S. where it is a trademark of Forest Laboratories, Inc.

Contact:

Ferring
Patrick Gorman
Tel: +41 (0) 58 301 00 53
patrick.gorman@ferring.com
 
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