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:10/10/2017)... EXTON, Pa. , Oct. 10, 2017   ... leader in innovative solutions for injectable drug administration, today ... of West,s ID Adapter for improving the intradermal administration ... the Fourth Skin Vaccination Summit in May 2017 by ... Team Lead, Polio Department, World Health Organization (WHO), and ...
(Date:10/5/2017)...  In response to the nationwide opioid epidemic, ... (AAOMS) released prescribing recommendations that urge ibuprofen – ... a first-line therapy to manage a patient,s acute ... Recognizing the value and importance of the ... Acute and Postoperative Pain Management" stresses that practitioners ...
(Date:10/4/2017)...  According to the Centers for Disease Control and Prevention (CDC), ... Urgent Care is helping communities across Massachusetts , ... offering no-cost* flu shots through the end of the month. ... regulations. ... a flu shot is by the end of October, according to the ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association ... Featuring a collection of specialty vendors and unique items from across the nation, this ... health and wellness services offered by the VNA. The boutique will be open ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, ... Development, has been awarded a contract by the Center for Medicare and Medicaid ... to accelerate the enterprise use of Agile methodologies in a consistent and high ...
(Date:10/12/2017)... ... 2017 , ... Planet Fitness, one of the largest and fastest growing franchisors ... a flagship location in Covington, LA at 401 N. U.S. Highway 190, in January ... Office Depot in the Holiday Square shopping center. Its location allows it to serve ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information ... we intend to develop to enable prevention of a major side effect of ... loss, especially in pediatric patients. For cisplatin, hearing loss is FDA listed on-label ...
(Date:10/12/2017)... ... 12, 2017 , ... Women-owned and Grand Rapids-based workplace wellness ... in Wellness® by Best and Brightest. OnSite Wellness will be honored at the ... 7:30 a.m. to 2 p.m. at the Henry Autograph Collection Hotel, located at ...
Breaking Medicine News(10 mins):