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Alliance Pharma's pregnancy sickness treatment set for approval
Specialist pharmaceutical firm Alliance Pharma on Thursday completed its UK regulatory application for its in-licensed drug Diclectin, a prescription treatment for nausea and vomiting during pregnancy.
The AIM traded company said it anticipates the launch of Diclectin to take place in autumn following issue of the formal marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) in the coming weeks.
The product, which has a proven safety and efficacy profile, was in-licensed from Canada's Duchesnay for the UK in 2015 and for a further nine European territories in 2016.
Peter Butterfield, chief executive of Alliance Pharma, said: "There are currently no licensed treatments for nausea and vomiting of pregnancy in the UK, highlighting a clear unmet need for patients and clinicians. For Alliance, Diclectin represents a sizeable mid-term opportunity and also allows us to further leverage our European footprint."
The treatment has been prescribed to over 30m women in Canada over the 40 years it has been in use and, since 2013, has been approved in the US, South Korea, Singapore and Israel.
Duchesnay, which calculates that nausea and vomiting of pregnancy can affect up to 80% of all pregnant women, said it was continuing to support Alliance in their efforts to provide a licensed treatment.
Alliance said that once formal approval is granted in the UK it will seek regulatory approvals for other European territories ahead of planned international launches in 2019.
As of 1010 BST, Alliance Pharma's shares were up 4.44% at 94.00p.