Ipsen intends to submit toremifene citrate 80 mg in Europe before year-end 2008
Regulatory News:
Ipsen (Paris:IPN) announced today that GTx Inc. (NASDAQ: GTXI),
from which it licensed the European rights for Acapodene(R)
(toremifene citrate 80 mg) in September 2006, presented the results of
the first phase III study evaluating the efficacy and safety of
toremifene citrate 80mg daily, on multiple side effects of androgen
deprivation therapy (ADT) in advanced prostate cancer patients. On the
basis of these positive results, Ipsen intends to file toremifene
citrate 80 mg for this indication in the European Union before
year-end 2008. Androgen deprivation therapy using either luteinizing
hormone releasing hormone or surgical castration is the most common
treatment for advanced prostate cancer and have clearly demonstrated
their efficacy. However, their impact on testosterone and oestrogen
levels could result in a decrease of bone mineral density (BMD)
potentially leading to osteoporotic fractures, and other adverse
effects such as lipid changes, gynecomastia and hot flashes.
Stephane Thiroloix, Executive Vice President, Corporate
Development of Ipsen, said: "We are very pleased with the results of
this clinical trial, which confirm the efficacy and the good safety
profile of toremifene citrate 80 mg. Subject to regulatory approval,
this drug has the potential to address a significant unmet medical
need by providing a new therapeutic approach to treat the side
symptoms of androgen deprivation therapy. This product is an excellent
fit with Ipsen´s existing Decapeptyl(R) franchise, reinforcing our
positioning in the treatment of hormone-dependent diseases and
broadens the range of our prostate cancer related product portfolio."
About the study
In this large phase III study, 1389 ADT patients were randomized
to evaluate the efficacy and safety of toremifene citrate 80 mg
compared to placebo over two years in approximately 150 clinical sites
in the United States and Mexico. All men enrolled were over 50 years
or older with histologically documented prostate cancer, serum
prostate specific antigen (PSA) 4 ng/ml or less and a history of
orchiectomy, or treatment with GnRH agonist for at least 6 months or
intermittent treatment with a GnRH agonist for at least 12 months. The
primary endpoint of this study was reached with a significant
reduction (pless than0.05) in the incidence of morphometric vertebral
fractures of at least 50% in the toremifene group as compared to the
placebo group with a fracture rate of 2.5% vs 4.9% respectively
(preliminary analysis). Furthermore, Bone Mineral Density (BMD) data
have confirmed the anti-osteoporotic efficacy of toremifene citrate
80mg/day in significantly preventing bone loss (pless than0.0001) at
the spine as well as at the hip and femur level. Toremifene citrate 80
mg treatment compared to placebo also resulted in a decrease in total
cholesterol (p=0.011), LDL (p=0.018), and triglycerides (pless
than0.0001), and an increase in HDL (p=0.001). In regard to the effect
of toremifene citrate 80 mg on hot flashes, the evaluation of these
data is still ongoing and will be reviewed with the final data set.
Tolerance of the treatment was good. Among the most common adverse
events that occurred in over 2% of study subjects were arthralgia
(treated 7.3%, placebo 11.8%), dizziness (treated 6.3%, placebo 5.0%),
back pain (treated 5.9%, placebo 5.2%), and extremity pain (treated
5.0%, placebo 4.4%). There were 17 (2.4 %) venous thromboembolic
events (VTE) in the toremifene citrate 80 mg treated group and 7 (1.02
%) in the placebo group. However the majority of VTE´s occurred in men
with an high risk for a thromboembolic event including: age greater
than80 years, history of VTE, recent surgical procedure and
immobilization.
About toremifene citrate 80 mg
Toremifene citrate 80 mg is a selective estrogen receptor
modulator, or SERM, which GTx is developing as a daily tablet to treat
the multiple estrogen related side effects of androgen deprivation
therapy for advanced prostate cancer. Toremifene citrate was designed
to bind to and selectively modulate estrogen receptors depending on
the tissue type. GTx has rights to and plans to commercialize
toremifene citrate 80 mg in the United States. GTx has licensed
European rights to Ipsen Group, the leading marketer of ADT drugs in
Europe.
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 EuronextTM (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 120 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, or that the regulatory
authorities will be satisfied with the data and information provided
by the Company. 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.
