Navigation Links
Phase III Clinical Trial with 4-Month Long-Acting Formulation of,Triptorelin: Ipsen Decides Not to Perform Further Administration

PARIS--(BUSINESS WIRE)--Jun 11, 2007 - Regulatory News-Ipsen (Paris:IPN) announced today that the preliminary data from the ongoing phase III study for its investigational 4-month formulation of triptorelin do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients. Therefore, Ipsen has decided not to perform the second administration as planned in the protocol. No safety concerns have been observed throughout the trial. At the end of their respective monitoring period, patients will be switched to appropriate approved treatment.

The 4-month investigational product, one of Ipsen's new sustained release formulation candidates of triptorelin using one amongst several Ipsen proprietary technologies, has shown an adequate efficacy and safety profile in phase II allowing a move to phase III. Ipsen's goal remains to have a new formulation of triptorelin available when the current patents of the 3-month formulation of Decapeptyl(R) expire.

Jacques-Pierre Moreau, Executive Vice-President, Chief Scientific Officer of Ipsen said: "We are taking all appropriate actions to solve the scale-up issues seen during this phase III, which are inherent to advanced formulations based on cutting edge technologies. From the onset, the introduction of an innovative subcutaneous presentation using a new retro-injection device was well received by patients and investigators. Thus, the teams are now focusing their energy and expertise in order to resume phase III as soon as possible. Our advanced drug delivery platform has already been validated through the success of Somatuline(R) Autogel(R), and we are confident in Ipsen's ability to have a differentiated formulation of triptorelin."

About triptorelin

Triptorelin is a metabolically stabilized analogue of LHRH (Luteinizing Hormone Releasing Hormone) an hypothalamic hormone secreted in a pulsatile fashion. Upon bind ing to its pituitary receptor LHRH triggers the release of luteinizing hormone, a key factor for the regulation of reproductive function. Continuous administration of exogenous LHRH or its agonists such as triptorelin leads to a rapid desensitization of its pituitary receptor resulting in a paradoxical effect that translates into the suppression of gonadal steroids such as testosterone and estradiol. This chemically induced and reversible castration is of therapeutic benefit in the treatment of hormone sensitive tumours such as breast and prostate. Triptorelin is the active ingredient of Decapeptyl(R) and Diphereline(R) available as 1- and 3-month sustained release formulations registered for the treatment of advanced metastatic hormone-dependent prostate cancer.

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 p art 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.

Contact

Ipsen
Didier Véron, Director,
Public Affairs and Corporate Communications
Tel.: +33 (0)1 44 30 42 38 - Fax: +33 (0)1 44 30 42 04
E-mail : didier.veron@ipsen.com
or
David Schilansky, Investor Relations Officer
Tel.: +33 (0)1 44 30 43 31 - Fax: +33 (0)1 44 30 43 21
E-mail: david.schilansky@ipsen.com


'"/>




Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
3. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
4. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
7. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
8. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
9. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
10. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
11. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... , January 19, 2017 ... administration appears serious about reducing the FDA,s regulatory ... innovation in the medical drug industry, many of ... with new clinical trials and development of advanced ... forging ahead with recent developments include:  Moleculin Biotech, ...
(Date:1/19/2017)... 2017  ViewRay, Inc. (Nasdaq: VRAY ... clinical MRI-guided radiation therapy system, announced today that it ... million through a private placement of its common ... financing and was joined by certain of ViewRay,s ... Venture Partners, and an additional new institutional investor, ...
(Date:1/19/2017)... ROCKVILLE, Md. , Jan. 18, 2017 /PRNewswire/ ... a late-stage clinical company developing therapeutics designed to ... health of patients, today confirmed plans to initiate ... the Company,s modified-release reformulation of lovastatin lactone designed ... M. smithii) in the gut to treat ...
Breaking Medicine Technology:
(Date:1/19/2017)... San Francisco, CA (PRWEB) , ... January 19, 2017 , ... ... and financial planning assistance to commercial and residential clients in the California Bay Area, ... promote positive heart health in the region. , Heart disease is the primary killer ...
(Date:1/19/2017)... ... 19, 2017 , ... Attorney Robert “RC” Pate , founder of The ... the Triumph Over Kid Cancer foundation. Each year, 175,000 children are diagnosed with pediatric ... firsthand the effect of the critical funding gap for research into pediatric cancer research. ...
(Date:1/19/2017)... , ... January 19, 2017 , ... Connecticut Dermatology Group ... Kim, a highly experienced and compassionate dermatologist. Dr. Kim brings an extensive background ... , “It is with considerable pleasure to welcome back Dr. Kim to the CDG ...
(Date:1/19/2017)... ... 19, 2017 , ... Each year, the Southeastern Society of ... hundreds of surgeons from over fifteen different countries come together to share and ... augmentation to breast reconstruction for breast cancer patients, teaching these surgical techniques ...
(Date:1/18/2017)... ... 2017 , ... From a health perspective, 2017 will clearly be the Year ... chronic disease, mental health and general physical well-being. The New York Times suggested a ... , For one Charlottesville restaurant, good gut health is clearly on the menu. ...
Breaking Medicine News(10 mins):