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EU approval for new Sanofi, Merck vaccine

Published on 18/06/15 at 11:29am
Gardasil 9 image
Gardasil 9 could reach $1.9 billion in annual sales

Sanofi and Merck are looking forward to a successor to their blockbuster Gardasil now that the European Commission has granted marketing authorisation for a new vaccine in Gardasil 9.

Known as Sanofi Pasteur MSD the joint venture between the firms has already seen the jab receive a positive opinion from of the European Committee for Medicinal Products for Human Use (CHMP) in March. 

This new development means they have the go-ahead to market the 9-valent HPV vaccine in member nations, which allows them to engage in pricing and reimbursement negotiations with each country. 

“We are delighted to receive the EU Commission approval for this important vaccine that provides an opportunity to further prevent cancer in women and men throughout Europe", says Dr Jean-Paul Kress, president of Sanofi Pasteur MSD.  

"This vaccine is a significant step forward for public health; by vaccinating boys and girls we can help prevent not only 90% of cervical cancers but also anal, vulvar and vaginal cancers caused by HPV, for which there is no current systematic screening". 

Gardasil 9 is a 9-valent HPV vaccine for active immunisation of females and males from the age of nine years against premalignant lesions and cancers affecting the cervix, vulva, vagina or anus – and also against genital warts caused by the HPV types covered by the vaccine. 

Launched in 2006 sales for the original vaccine Gardasil immediately soared to $1.5 billion a year later – but by 2010 these had fallen to nearly $1 billion. Enter 2014 and they whittled down to $590 million, due to lower purchases by US government programmes.

Analysts predict the new Gardasil 9 could reach $1.9 billion in annual sales, but at the expense of the money coming in from Gardasil such is the nature of the market.

Dr Robin Crawford who is a consultant gynaecological oncologist at Cambridge University Hospitals NHS Foundation Trust, says: “Cervical cancer is still the fourth most common cancer type in women and while we are optimistic that the continued high uptake seen in the first eight years of a national immunisation programme will be maintained, I feel that there remains a high unmet need for young men, in particular, to receive access to this vaccine. 

“I welcome the news that a 9-valent vaccine has been granted a licence in Europe and I look forward to following its progress in the UK.”

Gardasil 9 will be commercialised in Western European countries by Sanofi Pasteur MSD, and in the US and Canada and elsewhere by Merck.

Brett Wells

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