Alliance Pharma plc has announced that it has signed a further licensing and distribution agreement with Duchesnay Inc. of Canada for Diclectin, a proven product to treat nausea and vomiting of pregnancy. Alliance acquired UK rights to Diclectin in January 2015 and this additional agreement secures rights to launch the product in a further nine EU countries including Germany, France and Italy (the "Selected Territories"). This is Alliance's first significant distribution agreement since acquiring the Sinclair Healthcare Products business in December 2015, which substantially increased Alliance's European footprint.
Diclectin has a well-established efficacy and safety profile and is regarded as the standard of care for nausea and vomiting of pregnancy in Canada, where it has been used for over 30 years and has been prescribed for more than 30 million women. In 2013, it was approved in the United States with an FDA Category A safety rating for drugs used during pregnancy. Sales continue to grow strongly in the US, where it is marketed as Diclegis®.
In the Selected Territories there are approximately 2.5 million pregnancies each year, and approximately 70% of women will suffer nausea and vomiting with severe symptoms in 30% of them. It is estimated that 35% of pregnant women need time off work due to nausea and vomiting of pregnancy. Alliance has been progressing Diclectin through the marketing authorisation process in the UK and anticipates the product's launch in the second half of 2017. It is expected that regulatory approvals for the further European territories will follow around a year later.
Commenting on the agreement, John Dawson, Alliance Pharma's Chief Executive, said: "We are delighted to build on our existing partnership with Duchesnay by acquiring the licensing and distribution rights to Diclectin in a further nine EU countries. This new agreement highlights the potential of our strengthened European distribution base following the acquisition last year of the Sinclair Healthcare Products business."
Eric Gervais, Duchesnay's Executive Vice-President, added: "Since we signed the UK rights for Diclectin, our two companies have collaborated closely and we are very pleased to have agreed further rights for Diclectin with Alliance. I know both companies are looking forward to replicating our success in the US and we look forward to making this product available across Europe as soon as possible."