After years of fighting off safety concerns and a perceived sex-related stigma for their HPV vaccines, Merck ($MRK) and GlaxoSmithKline ($GSK) will face another test with their respective jabs in Europe.
On Monday, the European Medicines Agency (EMA) announced a safety review of the vaccines that'll focus on rare reports of two serious conditions. The EMA will sift available data on cases of complex regional pain syndrome--a chronic pain condition affecting the limbs--and postural orthostatic tachycardia syndrome, in which the heart rate increases abnormally after sitting or standing up.
The shots--intended to prevent cervical cancer and other conditions associated with HPV--have been used in about 72 million people worldwide. The EMA's statement said the review "does not question that the benefits of HPV vaccines outweigh their risks."
Merck has marketed Gardasil in Europe since 2006, and last month, it received a European Commission thumbs up on follow-up Gardasil 9. Protecting against 9 HPV types, the new shot is expected to reach $1.9 billion in annual sales; much of that is expected at the expense of Gardasil, predicted to fall in sales to $525 million by 2018 from $1.8 billion in 2013. Merck and Sanofi Pasteur will market the shot in Europe under the joint venture Sanofi Pasteur MSD, which was cleared along with the approval to begin pricing and reimbursement negotiations with EU countries. The FDA approved the follow-up in December.
Glaxo's Cervarix--approved in Europe since 2007--last year pulled in worldwide sales of £118 million (about $183 million), 26% less than 2013.
As solid as these products have been, their sales are far short of original expectations. Early on, the vaccines were anticipated to notch between $4 billion and $10 billion in annual sales, numbers that now seem distant as the pharmas have worked to combat numerous safety concerns and an unfounded perception that HPV vaccines would lead to increased promiscuity.
In its review, EMA's safety watchdogs will seek to clarify the frequency of the conditions after vaccination and to identify any causal link. There are no recommendation changes for the vaccines while the study is underway.
- here's the release