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Ipsen and Debiopharm Group Announce That Decapeptyl[R] (triptorelin embonate) 6-Month Successfully Completes the European Decentralised Procedure for the Treatment of Locally Advanced or Metastatic Prostate Cancer.


Developed by Debiopharm Group, triptorelin embonate 6-month will be commercialised by Ipsen in Europe

LAUSANNE, Switzerland & PARIS Paris, in Greek mythology
Paris or Alexander, in Greek mythology, son of Priam and Hecuba and brother of Hector. Because it was prophesied that he would cause the destruction of Troy, Paris was abandoned on Mt.
 -- Regulatory News:

Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, and Ipsen (Euronext: FR0010259150; IPN IPN Instant Payment Notification (PayPal)
IPN Instituto Politecnico Nacional (México)
IPN Infectious Pancreatic Necrosis
IPN Interplanetary Internet (JPL) 
), an innovation-driven global specialty pharmaceutical Group, announced that the 6-month sustained-release formulation of Decapeptyl([R]1) (triptorelin embonate2 22.5 mg) successfully completed its European decentralised Adj. 1. decentralised - withdrawn from a center or place of concentration; especially having power or function dispersed from a central to local authorities; "a decentralized school administration"
decentralized
 registration procedure involving nine countries: Germany (reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain and The Netherlands.

Triptorelin embonate 22.5 mg is Debiopharm's new 6-month-formulation of a luteinizing hormone lu·te·in·iz·ing hormone
n.
Abbr. LH A hormone produced by the anterior lobe of the pituitary gland that stimulates ovulation and the development of the corpus luteum in the female and the production of testosterone by the interstitial
 releasing hormone (LHRH LHRH
abbr.
luteinizing hormone-releasing hormone


LHRH Luteinizing hormone-releasing hormone, GnRH, gonadotropin-releasing hormone, LRH, LRF Endocrinology A decapeptide synthesized by hypothalamic neurons which
) agonist for the treatment of locally advanced or metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
, hormone-dependent prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . Debiopharm has licensed the European marketing rights to Ipsen. The first European countries to launch the 6-month formulation should be Germany, The Netherlands and Spain.

"As expected, we are proud to offer patients suffering from prostate cancer a new 6-month formulation of Decapeptyl([R] )with an improved convenience and a consistent and similar efficacy to the already established 1 and 3-month formulations," said Jean-Luc Belingard, Ipsen's Chairman and Chief Executive Officer. "The completion of this procedure represents a major step forward in the development of our uro-oncology franchise."

"It is great news that the completion of the European decentralised procedure for triptorelin embonate 6-month formulation was done in such a timely manner," added Rolland-Yves Mauvernay, President and Founder of Debiopharm Group. "We view this achievement as further evidence of the efficacy and safety of this important product. LHRH-agonists will remain the mainstay of hormone-dependent prostate cancer in the years ahead, and patients can now look forward to receiving a more convenient treatment every six months instead of every three months."

About Decapeptyl([R])

Debiopharm licensed-in triptorelin from Tulane University in 1982.

Decapeptyl([R]) is available in monthly or quarterly sustained-release formulations, as well as a daily formulation. Debiopharm developed and submitted the 1- and 3-month sustained release formulations of triptorelin embonate in Europe and the U.S. The active substance in Decapeptyl([R]) is triptorelin, a decapeptide analogue of GnRH (Gonadotropin gonadotropin /go·nado·tro·pin/ (-tro´pin) any hormone that stimulates the gonads, especially follicle-stimulating hormone and luteinizing hormone.  Releasing Hormone), a hormone secreted by the hypothalamus hypothalamus (hī'pəthăl`əməs), an important supervisory center in the brain, rich in ganglia, nerve fibers, and synaptic connections. It is composed of several sections called nuclei, each of which controls a specific function. , which initially stimulates the release of pituitary pituitary /pi·tu·i·tary/ (pi-too´i-tar?e)
1. hypophysial.

2. pituitary gland; see under gland.


anterior pituitary  adenohypophysis.
 gonadotropins (hormones produced by the pituitary gland pituitary gland, small oval endocrine gland that lies at the base of the brain. It is sometimes called the master gland of the body because all the other endocrine glands depend on its secretions for stimulation (see endocrine system). ), which in turn control hormonal secretions by the testes testes
 or testicles

Male reproductive organs (see reproductive system). Humans have two oval-shaped testes 1.5–2 in. (4–5 cm) long that produce sperm and androgens (mainly testosterone), contained in a sac (scrotum) behind the penis.
 and ovaries Ovaries
The female sex organs that make eggs and female hormones.

Mentioned in: Choriocarcinoma

ovaries (ō´v
.

The product is now marketed worldwide for the treatment of advanced prostate cancer, endometriosis endometriosis (ĕn'dəmē'trē-ō`sĭs), a condition in which small pieces of the endometrium (the lining of the uterus) migrate to other places in the pelvic area. , precocious puberty Precocious Puberty Definition

Sexual development before the age of eight in girls, and age 10 in boys.
Description

Not every child reaches puberty at the same time, but in most cases it's safe to predict that sexual development will
, in-vitro fertilisation programs, and uterine fibroids Uterine Fibroids Definition

Uterine fibroids (also called leiomyomas or myomas) are benign growths of the muscle inside the uterus. They are not cancerous, nor are they related to cancer.
.

The marketing authorisation application for the 6-month-formulation was submitted to the registration authorities of nine European countries in September 2008, in accordance with the decentralised procedure. It was supported by data from a phase III study on the efficacy, pharmacokinetics and safety of two consecutive injections of triptorelin 6-month-formulation in 120 patients with advanced prostate cancer. The results showed that 97.5% of patients achieved castrate castrate /cas·trate/ (kas´trat)
1. to deprive of the gonads, rendering the individual incapable of reproduction.

2. a castrated individual.


cas·trate
v.
1.
 levels of serum testosterone 28 days after the first injection, and 93.0% of the patients maintained castrate levels of testosterone (defined as 1.735nmol/L or 50 ng/dL) from week 8 to 48. Furthermore, at month 6 and 12 98.3% of the patients were castrated cas·trate  
tr.v. cas·trat·ed, cas·trat·ing, cas·trates
1. To remove the testicles of (a male); geld or emasculate.

2. To remove the ovaries of (a female); spay.

3.
. Overall the phase III data demonstrated that the treatment was well tolerated. The local tolerance of the product was very good with few patients (6.7%) experiencing local side effects, the majority of them being mild. These efficacy results are similar to those obtained previously with repeated administrations of the 1- and 3-month-formulations of triptorelin.

About Debiopharm Group

Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses promising biological and small molecule drug candidates. It develops its products for global registration and maximum commercial potential. Once registered, the products are out-licensed to pharmaceutical partners for sales and marketing.

Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.

Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed four products with global combined sales of $2.6 billion in 2008.

For more information on Debiopharm Group, please visit: www.debiopharm.com

About Ipsen

Ipsen (Paris:IPN) is an innovation-driven global specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,200. Its development strategy is based on a combination of specialty medicine, which is Ipsen's growth driver, in targeted therapeutic areas (oncology, endocrinology, neurology and haematology), and primary care products which contribute significantly to its research financing. The location of its four Research & Development centres (Paris, Boston, Barcelona, London) and its peptide and protein engineering platform give the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. More than 800 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. This strategy is also supported by an active policy of partnerships. In 2008, Research and Development expenditure was about [euro]183 million, close to 19% of consolidated sales, which amounted to [euro]971 million while total revenues exceeded [euro]1 billion. Ipsen's shares are traded on Segment A of Euronext Paris (stock code: IPN, ISIN Isin (ĭs`ĭn), capital of an ancient Semitic kingdom of N Babylonia. The city became important after the third dynasty of Ur fell to the Elamites and the Amorites (c.2025 B.C.). The phase from c.2025–c.1763 B.C.  code: FR0010259150). Ipsen's shares are eligible to the "Service de Reglement Differe" ("SRD SRD Suriname Dollar (ISO currency code)
SRD Sustainable Resource Development (Alberta, Canada)
SRD Short Range Devices (wireless networking)
SRD System Reference Document
") and the Group is part of the SBF SBF Studium Biblicum Franciscanum (Franciscan School of Biblical Investigations; Jerusalem, Israel)
SBF Small Block Ford (automotive engine)
SBF Single Black Female
SBF Société des Bourses Francaises
 120 index. For more information on Ipsen, visit our website at www.ipsen.com.

Ipsen Forward Looking Statement

The forward-looking statements, objectives and targets contained herein are based on the Group's management strategy, 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 targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Notably, future currency fluctuations may negatively impact the profitability of the Group and its ability to reach its objectives. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties. The Group does not commit nor gives any guarantee that it will meet the targets mentioned above. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to 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. The Group 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. The Group's business is subject to the risk factors outlined in its registration documents filed with the French Autorite des Marches Financiers.

1 depending on the countries, Ipsen commercialises Decapeptyl([R]) under different brand names (Diphereline([R]), Pamorelin([R]), Arvekap([R]))

2 triptorelin pamoate is similar to triptorelin embonate
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Geographic Code:4EXSI
Date:Oct 13, 2009
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