METFIZZ

Metformin for treatment of polycystic ovary syndrome in children

Coordinatore	EFFRX PHARMACEUTICALS SA    more  Organization address address: WOLLERAUSTRASSE 41 B city: FREIENBACH postcode: 8807 contact info Titolo: Ms. Nome: Ana Cognome: Johansson Email: send email Telefono: +41 799636606 Fax: +41 44 503 78 66
Nazionalità Coordinatore	Switzerland [CH]
Totale costo	8˙624˙558 €
EC contributo	5˙999˙962 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2013-INNOVATION-1
Funding Scheme	CP-FP
Anno di inizio	2013
Periodo (anno-mese-giorno)	2013-10-01   -   2017-03-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	EFFRX PHARMACEUTICALS SA  Organization address address: WOLLERAUSTRASSE 41 B city: FREIENBACH postcode: 8807 contact info Titolo: Ms. Nome: Ana Cognome: Johansson Email: send email Telefono: +41 799636606 Fax: +41 44 503 78 66	CH (FREIENBACH)	coordinator	1˙839˙700.00
2	KLIFO AS  Organization address address: FRUEBJERGVEJ 3 city: KOBENHAVN postcode: 2100 contact info Titolo: Ms. Nome: Alejandra Cognome: Moerk Email: send email Telefono: +45 39179939	DK (KOBENHAVN)	participant	1˙681˙637.00
3	CAMPBELL CHARLES ASSOCIATES (2000)LIMITED  Organization address address: STATION ROAD 48 city: STOKE D ABERNON postcode: KT11 3BN contact info Titolo: Dr. Nome: Ignazio Cognome: Di Giovanna Email: send email Telefono: +44 1932869933	UK (STOKE D ABERNON)	participant	1˙486˙921.00
4	RCTS - RANDOMIZED CLINICAL TRIALS  Organization address address: RUE DU PLAT 38 city: LYON postcode: 69002 contact info Titolo: Mr. Nome: Yves Cognome: Alamercery Email: send email Telefono: +33 437451748	FR (LYON)	participant	398˙875.00
5	SERMES PLANIFICACION  Organization address address: CALLE RUFINO GONZALEZ 14 city: MADRID postcode: 28037 contact info Titolo: Mr. Nome: Antonio Cognome: Berlanga Email: send email Telefono: +34 913756930	ES (MADRID)	participant	366˙229.00
6	SCIPROM SARL  Organization address address: RUE DU CENTRE 70 city: Saint-Sulpice postcode: 1025 contact info Titolo: Dr. Nome: Kirsten Cognome: Leufgen Email: send email Telefono: +41 216940412 Fax: +41 216940419	CH (Saint-Sulpice)	participant	177˙000.00
7	THE UNIVERSITY OF LIVERPOOL  Organization address address: Brownlow Hill, Foundation Building 765 city: LIVERPOOL postcode: L69 7ZX contact info Titolo: Ms. Nome: Jenny Cognome: Lawson Email: send email Telefono: +44 151 795 0314	UK (LIVERPOOL)	participant	49˙600.00

Mappa

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 Obiettivo del progetto (Objective)

'PCOS, a common disorder affecting 5-10% of women of reproductive age is characterized by cystic ovarian morphology, androgen excess, and/or irregular periods and emerges during or shortly after puberty. The common off-label use of metformin for treating PCOS in children appears to have no greater risk than that in adults; drug tolerance is good with limited adverse effects. However, clinical trials are needed and requested by EMA to validate the safety and efficacy of this agent in PCOS. In January 2012, the EMA released a revised priority list of PUMA generic medicines and Metformin was identified as a requested drug for treatment of PCOS in children. The call requests data on pharmacokinetics, efficacy and safety in this indication. A PIP was submitted to EMA in August 2012. In its final opinion of 17 May 2013 the PDCO recommend to agree to the PIP. The PDCO and the consortium have agreed that by restricting exposure to no more than 2000 mg metformin / day, no additional pharmacokinetic investigations are required or even requested by EMA. METFIZZ will conduct the required product development and clinical studies to establish efficacy and safety of administering age-appropriate innovative effervescent soluble formulations of metformin. The studies will focus attention on ethics in this psychologically sensitive condition, guided by the current legislation and by engaging patients and caregivers along with an independent ethics expert. Currently, there are no age-appropriate dosing forms of metformin for treatment of PCOS in paediatric populations. This can result in over or under dosing, lack of medication compliance, dangers of iatrogenic harms. METFIZZ embraces clinical development, manufacturing scale up, and registration aspects of this pharmaceutical development programme. Coordinator SME EffRx together with 4 SME-CROs and at least 20-30 related study centres will carry out the clinical study in 4 EU member states. The statistical analysis plan requires approximately 150 patients to be randomized into the PCOS study. EffRx will lead the METFIZZ product commercialisation to benefit children in Europe.'