Marketing Authorisation for Diclectin in the UK

Alliance Pharma plc (AIM: APH), the specialty pharmaceutical company, announces that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the UK Marketing Authorisation Application for Diclectin®, a prescription product for the treatment of nausea and vomiting of pregnancy.  

Alliance also confirms that the MHRA has approved the brand name Xonvea®, which will be used for marketing Diclectin in the UK. As previously indicated, Alliance anticipates Xonvea's launch in autumn this year as the only medicine licensed in the UK for the treatment of nausea and vomiting of pregnancy.

Xonvea was in-licensed from Duchesnay Inc. of Canada ("Duchesnay") for the UK in 2015 and for a further nine European countries in 2016 - Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Republic of Ireland and Switzerland.

Nausea and vomiting of pregnancy is the most common medical condition in pregnancy affecting approximately 690,000 women in the UK each year according to the Office of National Statistics and the Royal College of Obstetricians and Gynaecologists. Research shows that up to 40% of pregnant women report symptoms of nausea and vomiting of pregnancy sufficiently severe to interfere with daily life whilst NHS data shows that at least 33,000 women with the condition are hospitalised each year.

The Group estimates peak sales for Xonvea in the UK of approximately £10m and across the other nine European countries a further £30m approximately at peak sales. The Group will incur both upfront costs ahead of the launches in the UK and EU markets and further incremental costs to support in-market growth in these countries. Alliance expects to generate meaningful sales of Xonvea from H2 2019.

Xonvea is the most studied medicine in pregnancy, with a proven efficacy and safety profile from use in more than 30 million women over more than 30 years. Following marketing authorisation in the UK, Alliance is preparing to file the necessary applications for regulatory approvals in continental Europe.  

Peter Butterfield, Alliance Pharma's Chief Executive Officer, said:

"Confirmation of the marketing authorisation for Xonvea is another positive step for Alliance and I'm delighted that we are able to launch the product later this year. 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."

Éric Gervais, Duchesnay's Executive Vice-President, added:

"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 30 million women worldwide, will provide pregnant women in the UK with a licensed treatment option. Alliance is also preparing applications to ensure the product's availability in continental Europe."

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