Meeting Highlights from the Paediatric Committee, March 4-6 2009

Company News Release

Opinions on paediatric investigation plans
The Paediatric Committee (PDCO) adopted opinions agreeing paediatric investigation plans (PIPs) for the following medicines:

* Sieved freeze-dried allergen extract of dermatophagoides farinae/Sieved freeze-dried allergen extract of dermatophagoides pteronyssinus, from Stallergenes, in the therapeutic area of Pneumology-allergology;
* Ulipristal, from Laboratoire HRA Pharma, in the therapeutic area of endocrinology-gynaecology-fertility-metabolism;
* Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1), from GSK Biologicals, in the therapeutic area of vaccines;
* Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1), from GSK Biologicals, in the therapeutic area of vaccines;
* Purified antigen fractions of inactivated split virion Influenza A/VietNam/1194/2004(H5N1), from GlaxoSmithKline Biologicals S.A, in the
therapeutic area of vaccines;
* Dihydroarteminsin /Piperaquine phosphate anhydride, from Sigma-Tau SpA, in the therapeutic area of infectious diseases;
* Sitagliptin phosphate monohydrate, from Merck Sharp and Dohme (Europe), Inc, in the therapeutic area of endocrinology-gynaecology-fertility-metabolism;
* Telcagepant from Merck Sharp and Dohme Ltd, in the therapeutic area of pain and neurology;
* Calcipotriol hydrate / hydrocortisone from LEO Pharma A/S, in the therapeutic area of dermatology;
* Mercaptopurine monohydrate from Nova Laboratories Limited, in the therapeutic area of oncology;
* Recombinant human monoclonal antibody of the IgG1 class to insulin-like growth factor-1 receptor from Roche Registration Limited, in the therapeutic area of oncology.

A PIP sets out a programme for the development of a medicine in the paediatric population. The PIP aims to generate the necessary quality,
safety and efficacy data through studies to support the authorisation of the medicine for use in children of all ages. These data have to be submitted to the EMEA, or national competent authorities, as part of an application for a marketing authorisation for a new medicine or for one
covered by a patent. In some cases, a PIP may include a waiver of the studies in one or more paediatric subsets, or a deferral.

Opinions on product-specific waivers
The PDCO adopted positive opinions for product-specific waivers, recommending that the obligation to submit data obtained through
clinical studies with children be waived in all subsets of the paediatric population, for the following medicines:

* Pasireotide, from Novartis Europharm Ltd, in the therapeutic area of Endocrinology-gynaecology-fertility-metabolism;
* Bismuth subcitrate potassium/ Metronidazole/Tetracycline hydrochloride, from Axcan Pharma SA, in the therapeutic area of gastroenterology-hepatology;

Waivers can be issued if there is evidence that the medicine concerned is likely to be ineffective or unsafe in the paediatric population, or that the disease or condition targeted occurs only in adult populations, or that the medicine, or the performance of trials, does not represent a significant therapeutic benefit over existing treatments for paediatric patients.

The PDCO adopted one opinion on the refusal of a request for waiver for:

* Bromfenac sodium sesquihydrate, from Croma Pharma GmbH, in thetherapeutic area of ophthalmology.

Opinions on modifications to an agreed PIP
The PDCO adopts opinions on Modifications to an agreed PIP; these can be requested by the applicant, when the plan is no longer appropriate, or when there are difficulties that render the plan unworkable.

Extrapolation working group
A working group for devising strategy on extrapolation has been set up with members from the Committee. The first meeting was held during the March meeting and will be followed by regular interactions. The working group will report to the PDCO

Update of the priority list for studies into off-patent paediatric medicinal products
The PDCO started its third wave of meetings to update the priority list for studies into off-patent medicines in advance of the next call from the European Commission for funding through the EU's Seventh Framework Programme. The initial list was drawn up by the Paediatric Working Party (PEG), the Agency's former temporary expert working party on paediatric medicines. The updated list will comprise a number of medicines relating to various therapeutic areas. This will be a reference for applicants for funding from the European Community through the Seventh Framework Programme. Once the updated list is established, it will be published for comments in the 'Medicines for children' section of the EMEA website.

Other issues
* PDCO discussed the possible modification of the class waiver for "menopausal and other perimenopausal disorders".
* The Guideline on the investigation of medicinal products in the term and preterm neonate was reviewed by the Committee to accommodate comments from the public consultation.

The next meeting of the PDCO will be held on 1-3 April 2009.