Ipsen: Somatuline(R) Depot Receives Marketing Approval in the United States for the Treatment of Acromegaly
Somatuline(R) Depot Becomes the First Product Originating from Ipsen's R&D to Be Approved by the FDA and Marketed Globally(1)
Regulatory News:
Ipsen (Paris:IPN) today announced that the U.S. Food and Drug
Administration (FDA) has approved for marketing Somatuline(R) Depot
(lanreotide) Injection 60, 90 and 120 mg in the United States.
Somatuline(R) Depot is indicated for the long-term treatment of
acromegaly in patients who have had an inadequate response to surgery
and/or radiotherapy, or for whom surgery and/or radiotherapy is not an
option. Somatuline(R) Depot will be available in a pre-filled syringe
eliminating any need for reconstitution and thus enabling freedom of
easy administration to patients.
In October 2006, Ipsen granted to Tercica the development and
commercialization rights for Somatuline(R) Depot in the US and Canada.
At the same time, Ipsen acquired a 25% stake in Tercica on a
non-diluted basis. According to the terms of the agreement, the FDA
approval of Somatuline(R) Depot triggers a EUR 30 million milestone
payment that Tercica will pay to Ipsen by issuing a convertible bond
(converted into Tercica common stock at a conversion price of EUR
5.92). Tercica will simultaneously issue an additional $15 million
convertible bond to Ipsen (converted into Tercica common stock at a
conversion price of $7.41) which will be paid in cash to Tercica.
Tercica now expects to launch Somatuline(R) Depot in the United
States in the fourth quarter 2007.
Jean-Luc Belingard, Chairman and CEO of Ipsen said "We are very
proud to be able to announce today that a product originated from
Ipsen's R&D will be available globally. This is Ipsen's first ever FDA
approval, a major achievement made possible thanks to the outstanding
dedication and commitment of our teams. We feel confident that our
partner Tercica will market Somatuline(R) Depot very successfully by
offering to patients suffering from acromegaly a new treatment option
that has been proven to be effective, and very convenient to use. With
Somatuline(R), Increlex(R), NutropinAq(R) and its very rich pipeline
of research products, Ipsen confirms its strong commitment to the
progress of endocrinology worldwide."
About acromegaly
Acromegaly is a disorder caused by the over-production of growth
hormone usually by a benign tumour of the anterior pituitary gland.
Acromegaly occurs in approximately 60 people per million of
population. In acromegaly patients, the pituitary gland releases too
much growth hormone ("GH") into the bloodstream, the GH then triggers
the liver to produce IGF-1, which in turn directly stimulates bone and
tissue growth. The most common signs and symptoms of this serious
condition include: enlarged hands, feet, and head, facial changes such
as bulging forehead, enlarged lower jaw, tongue and lips, wider
spacing between teeth, enlarged heart, liver, kidneys, spleen and
other organs, joint pain and fatigue, reduced sex drive and loss of
concentration.
About the approval for marketing
The summary of the approval for marketing will be accessible at
http:///www.fda.gov
This decision follows the filing by Ipsen of a New Drug
Application (NDA) for Somatuline(R) Depot in the USA in December 2006.
The effect of Somatuline(R) Depot on reducing GH and IGF-levels and
control of symptoms in patients with acromegaly was studied in two
long-term, multiple-dose, randomized multicenter studies performed in
the United States and in Europe. Somatuline(R) Depot demonstrated its
ability to decrease the levels of GH and IGF-1 in the majority of
patients over a one year period.
About Somatuline(R) Depot and Somatuline(R) Autogel(R)
Somatuline(R) Depot (also marketed as Somatuline(R) Autogel(R)
outside the USA) is a sustained-release formulation for injection
containing lanreotide, a somatostatin analogue (a hormone that
inhibits the release of growth hormone). Somatuline(R) was initially
developed and continues to be used mainly in the treatment of
acromegaly, a disorder caused by the over-production of growth hormone
or prolactin due to a benign tumour of the anterior pituitary gland.
This product subsequently underwent further development in Europe in
the treatment of symptoms associated with neuroendocrine tumours
(particularly of a carcinoid type). Ipsen believes that the
Somatuline(R) Autogel(R) formulation, to which it holds the patent,
represents a major technological advance. As far as the Group is
aware, this represents the first semi-solid formulation for injection
without any excipient, since the active substance itself controls the
sustained release. Somatuline(R) Autogel(R) releases the active
substance with no excipient other than water over a period of at least
28 days, thus requiring just one injection per month compared with the
two or three injections previously necessary. This product is
presented in a pre-filled syringe for easy administration.
Active substance
The active substance in Somatuline(R) and Somatuline(R) Autogel(R)
is lanreotide, which inhibits the growth and secretion of several
endocrine, exocrine and paracrine functions. It is particularly
effective in inhibiting the secretion of growth hormone.
Indications
Somatuline(R) is used primarily in the treatment of acromegaly
when circulating levels of growth hormone remain high despite surgery
or radiotherapy. Somatuline(R) inhibits growth hormone release and
thus controls the therapeutic and relieves the symptoms associated
with elevated levels of this hormone.
Intellectual property
Ipsen holds an exclusive worldwide license granted by Tulane
University (United States) to manufacture, use and market the active
substance in Somatuline(R) (lanreotide) and is the direct holder of
the patent covering the Somatuline(R) Autogel(R) or Depot formulation.
The Group holds patents to the Somatuline(R) Autogel(R) formulation,
which are set to expire in 2015 in Europe and in the United States.
The patent protecting the active substance expired in 2006 in the
United States and expired in December 2005 in Europe, except in
Belgium, France, Italy, Luxembourg and the United Kingdom where
additional certificates of protection remain valid until 2009.
Marketing
Somatuline(R) Autogel(R) is marketed in almost 60 countries
(including 26 in Europe) by Ipsen for the treatment of acromegaly and
neuroendocrine tumours or acromegaly alone. Somatuline had sales of
EUR 92 million in 2006, out of which 68% were generated in the Major
Western European Countries (France, Germany, Italy, Spain, United
Kingdom). Somatuline(R) Autogel(R) accounted for 86% of total sales of
this product. Somatuline(R) and Somatuline(R) Autogel(R) are
prescribed mainly by endocrinologists, gastroenterologists,
oncologists, surgeons and intensive care specialists.
About Ipsen
Ipsen is an innovation driven international specialty
pharmaceutical group with over 20 products on the market and a total
worldwide staff of nearly 4,000. The company's development strategy is
based on a combination of products in targeted therapeutic areas
(oncology, endocrinology and neuromuscular disorders) which are growth
drivers, and primary care products which contribute significantly to
its research financing. This strategy is also supported by an active
policy of partnerships. The location of its four Research and
Development centres (Paris, Boston, Barcelona, London) gives the Group
a competitive edge in gaining access to leading university research
teams and highly qualified personnel. In 2006, R&D expenditure was EUR
178.3 million, i.e. 20.7% of consolidated sales, which amounted to EUR
861.7 million while total revenues amounted to EUR 945.3 million (in
IFRS). 700 people in R&D are dedicated to the discovery and
development of innovative drugs for patient care. Ipsen's shares are
traded on Segment A of Eurolist by Euronext(TM) (stock code: IPN, ISIN
code: FR0010259150). Ipsen's shares are eligible to the "Systeme a
Reglement Differe" ("SRD") and the Group is part of the SBF 250 index.
For more information on Ipsen, visit our website at www.ipsen.com.
Forward-looking statements
The forward-looking statements and targets contained herein are
based on Ipsen's management's current views and assumptions. Such
statements involve known and unknown risks and uncertainties that may
cause actual results, performance or events to differ materially from
those anticipated herein. Moreover, the Research and Development
process involves several stages at each of which there is a
substantial risk that the Group will fail to achieve its objectives
and be forced to abandon its efforts in respect of a product in which
it has invested significant sums. Therefore, the Group cannot be
certain that favourable results obtained during pre-clinical trials
will be confirmed subsequently during clinical trials, or that the
results of clinical trials will be sufficient to demonstrate the safe
and effective nature of the product concerned. Ipsen expressly
disclaims any obligation or undertaking to update or revise any
forward looking statements, targets or estimates contained in this
press release to reflect any change in events, conditions, assumptions
or circumstances on which any such statements are based, unless so
required by applicable law. Ipsen's business is subject to the risk
factors outlined in its information documents filed with the French
Autorite des marches financiers.
About Tercica
Tercica is a biopharmaceutical company committed to improving
endocrine health by partnering with the endocrine community to develop
and commercialize new therapeutics for paediatric and adult growth
disorders, and for adult metabolic disorders. For further information
on Tercica, please visit www.tercica.com.
(1) Somatuline(R) Depot is marketed outside the United States of
America as Somatuline(R) Autogel(R) with the exception of Japan, where
the product is developed by Ipsen's partner Teijin and is currently in
phase II clinical trial.