Alliance Pharma's morning sickness treatment gains UK marketing approval
Alliance Pharma on Friday received approval from the medicines and healthcare products regulatory agency for a UK marketing authorisation application for the company’s morning sickness treatment.
The AIM-traded specialty pharmaceutical company said Diclectin will be marketed under the brand name ‘Xonvea’, following approval from the MHRA, when the product is launched in the UK in autumn.
Peter Butterfield, chief executive of Alliance Pharma's, said: "There are currently no licensed treatments for nausea and vomiting of pregnancy in the UK so this is excellent news for patients and clinicians as it fulfils a significant unmet medical need."
Alliance Pharma estimates peak sales for Xonvea in the UK of approximately £10m and £30m across the other nine European countries at peak sales.
40% of pregnant women report symptoms of nausea and vomiting while a total of 33,000 are hospitalised with the problem each year, according to NHS data.
Éric Gervais, executive vice-president of Duchesnay, said: "Pregnant women across the UK will now have access to an effective treatment for morning sickness with a proven safety profile. Alliance Pharma's focus and drive will ensure that this needed medication, used to date by more than 30m women worldwide, will provide pregnant women in the UK with a licensed treatment option."
The treatment was in-licensed from Duchesnay of Canada for the UK in 2015 and for Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Republic of Ireland and Switzerland in 2016.
As such, the company is also understood to be preparing applications to ensure the product's availability in continental Europe.
As of 0914 BST, Alliance Pharma’s shares were up 1.22% at 99.20p.