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inTervieW - Green Cross Publishing

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issue 10 volume 12 • novemBeR 2010<br />

Prolia: unique new treatment for<br />

post-menopausal osteoporosis now<br />

reimbursed in Ireland<br />

Amgen Ireland and GlaxoSmithKline (Ireland) ltd (GSK) recently announced<br />

that denosumab has become available in Ireland to treat osteoporosis in postmenopausal<br />

women at increased risk of fracture and will be reimbursed under the<br />

General Medical Services and Drugs Payment Schemes.<br />

In Ireland, more than 300,000 people have osteoporosis. Despite the availability<br />

of treatment options, many of these women experience fractures due to poor<br />

compliance with therapy. With proven efficacy and a six-monthly injection, denosumab<br />

offers women with osteoporosis a new alternative to current treatments.<br />

Denosumab works in a different way from other osteoporosis treatments. It<br />

is the first and only approved therapy that specifically targets RAnK ligand, an<br />

essential regulator of osteoclasts (the cells that break down bone). Denosumab<br />

helps stop the process that causes bone loss throughout the skeleton, resulting in<br />

greater bone density, stronger bones, and reduced risk for fractures at the spine,<br />

hip and other non-vertebral sites.<br />

The reimbursement for denosumab follows a review of the therapy’s cost-effectiveness<br />

by the national Centre for Pharmacoeconomics (nCPE) for the prevention<br />

of osteoporotic fractures in postmenopausal women and will be available on both<br />

the GMS and DPS schemes as of October 1st.<br />

Discussing denosumab, specialist in bone health at St James’s Hospital, Professor<br />

Bernard Walsh said: “It is good to have another proven therapeutic arm available<br />

to us in the treatment of osteoporosis. The clinical study results are impressive and<br />

confirm the efficacy of the use of a monoclonal antibody treatment in this disease.”<br />

Dr Gillian Darling, GP Specialist in Women’s Health in leopardstown and the<br />

Dublin Well Woman Centres commented: “As most osteoporosis patients are treated<br />

in primary care it is an advantage to have a treatment that can be administered in the<br />

GP surgery as well as the hospital clinic setting.<br />

“Recent studies would seem to point to a strong efficacy and good tolerability profile<br />

of denosumab in the treatment of osteoporosis in post-menopausal women.”<br />

Denosumab, which is being co-marketed in Ireland by Amgen and GSK, marks<br />

an innovative approach to the treatment of post menopausal osteoporosis. Statistics<br />

show that 90 per cent of hip fractures in senior citizens are due to osteoporosis<br />

and that one in five patients suffering hip fracture die within four months and 30<br />

per cent within a year.<br />

For more information on denosumab’s reimbursement, please visit www.ncpe.ie<br />

ClonMedica now distributing Hedrin<br />

and Virasoothe<br />

Thornton & Ross ltd (T&R) are pleased to announce the appointment<br />

of ClonMedica, the OTC Division of Clonmel Healthcare Company ltd<br />

as its distributor in the Republic of Ireland for the Hedrin range of head<br />

lice treatments and Care Virasoothe Chicken Pox Relief Cooling Gel. The<br />

change is effective from 1st november after which all orders should be<br />

sent to Clonmel Healthcare. T&R would like to thank Allphar Services ltd<br />

for establishing these products in Ireland. Allphar will remain as T&R’s<br />

distributor for the rest of its pharmacy range including the market leading<br />

Galfer and Cerumol brands.<br />

Commenting on the change Rob Purkis, European Market Development<br />

Manager for T&R, says that the move reflects the synergy of Hedrin and<br />

Virasoothe with ClonMedica’s successful children’s product range and<br />

the Company’s contacts with a range of healthcare professionals. A<br />

similar approach in the UK has made Hedrin the market leading head lice<br />

treatment1 and is establishing the more recently launched Virasoothe which<br />

is clinically proven to relieve the symptoms of chicken pox. T&R is keen to<br />

communicate the clinically proven benefits of these products to a wider<br />

group of healthcare professionals than has been possible before and this has<br />

been a key factor in the appointment of ClonMedica.<br />

Martin Gallagher, Marketing and Sales Director of Clonmel Healthcare<br />

ltd, commenting on the appointment, expressed his enthusiasm for this<br />

new venture and is confident that this addition to the Company’s range of<br />

children’s product will result in greater understanding of the benefits of<br />

Hedrin and Virasoothe amongst healthcare professionals.<br />

pRoducT news<br />

Multaq – first-line option<br />

in new 2010 ESC Guidelines for the<br />

Management of Atrial Fibrillation<br />

Sanofi aventis announced recently that the European Society of Cardiology<br />

(ESC) 2010 new Guidelines for the Management of Atrial Fibrillation (AF)<br />

have been released and recommend that Multaq (dronedarone) should be<br />

used for maintenance of sinus rhythm as a first-line treatment option in all<br />

patients with paroxysmal and persistent AF (class of recommendation I, level<br />

of evidence A) other than those with CHF nyHA class III/IV or unstable CHF<br />

nyHA class II (class of recommendation III, level of evidence B).<br />

Multaq was granted a Class I recommendation, a designation assigned<br />

in the guidelines when “there is evidence and/or general agreement that a<br />

given procedure/therapy is beneficial, useful, and effective.” The Task Force<br />

for the Management of Atrial Fibrillation of the ESC recognised the extensive<br />

clinical development of Multaq, giving it their highest ranking A for level of<br />

evidence. Moreover, the guidelines recommend that Multaq may also be<br />

used to achieve rate control in non-permanent AF except for patients with<br />

nyHA class III – IV or unstable heart failure (class of recommendation IIa,<br />

level of evidence B).<br />

Importantly the new guidelines include, for the first time, a statement<br />

on the importance of reducing hospitalisation as a key therapeutic goal in<br />

the management of AF. They also state that Multaq should be considered<br />

in order to reduce cardiovascular hospitalisation in patients with nonpermanent<br />

AF and cardiovascular risk factors (Class of recommendation IIa,<br />

level of evidence B) as well as in patients with AF and stable heart failure<br />

(nyHA Class I, II) (Class of recommendation IIa, level of evidence C). 1<br />

The guidelines do not recommend use of Multaq in patients with nyHA<br />

class III and IV or with recently unstable (decompensation within the prior<br />

month) nyHA class II heart failure.<br />

“Sanofi-aventis is pleased with this first-line recommendation for Multaq<br />

in the AF guidelines which recognises the extensive clinical development for<br />

the product as well as the innovative outcome of reducing cardiovascular<br />

hospitalisation as demonstrated in the ATHEnA trial,” said Marc Cluzel,<br />

Executive Vice President, Research and Development, sanofi-aventis.<br />

Xamiol 60g Gel discontinued<br />

lEO Pharma has announced that Xamiol Gel 60g will be discontinued<br />

from november 2010. Please note that Dovobet Gel 60g will continue<br />

to be available. Dovobet Gel 60g contains the identical product form,<br />

active ingredients and strength as Xamiol (calcipotriol/bethamethasone<br />

dipropionate). Dovobet Gel is indicated for both scalp and mild to moderate<br />

body plaque psoriasis. The price is also identical.<br />

This discontinuation is not due to any safety or quality issues with Xamiol<br />

Gel, therefore pharmacists and patients may continue to dispense or use<br />

Xamiol Gel that they currently have.<br />

If you require any further information, please contact the Marketing<br />

Department at 01 4908924 or email paul.kirwan@lEO-Pharma.com<br />

independent.ie<br />

37

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