Alliance Pharma plc (AIM: APH), the specialty pharmaceutical company, announces that, following discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM), the Marketing Authorisation Application for Diclectin® is now considered approvable. Alliance awaits issue of the formal Marketing Authorisation from the MHRA in the coming weeks, with UK launch anticipated to be in the Autumn of this year.
Diclectin, a prescription treatment for nausea and vomiting of pregnancy, was in-licensed from Duchesnay Inc. of Canada ("Duchesnay") for the UK in 2015 and for a further nine European territories in 2016*.
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 40 years and has been prescribed for more than 30 million women. In 2013, Diclectin (“Diclegis”) was approved in the United States with the highest possible safety rating for drugs used during pregnancy, FDA Category A, and has since been approved in Israel, South Korea and Singapore.
Following the approval of Diclectin in the UK, Alliance then expects to commence the filing of the necessary applications for regulatory approvals for further European territories in advance of launches later in 2019.
Commenting on the news, Peter Butterfield, Alliance Pharma's Chief Executive Officer, said:
“We are delighted by this news and look forward to launching Diclectin later this year. 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.”
Éric Gervais, Duchesnay's Executive Vice-President, added:
”Nausea and vomiting of pregnancy is a common medical condition that can affect up to 80% of all pregnant women. It can be debilitating and can worsen if left untreated. We continue to support Alliance in their efforts to provide a licensed treatment, which has a proven safety and efficacy profile, for women in the UK suffering from morning sickness.”
*Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Republic of Ireland, Switzerland,
Notes to editors:
Alliance Pharma plc is an international specialty pharmaceutical company.
Headquartered in Chippenham, UK, Alliance commenced trading in 1998 and has been listed on AIM since 2003. Alliance has a strong track record of acquiring established niche products and it currently owns or licenses the rights to approximately 90 pharmaceutical and consumer healthcare products. It has sales in more than 100 countries either directly via its affiliates or through its selected network of distributor partners. Alliance joined the AIM market of the London Stock Exchange in December 2003 and trades under the symbol APH.
Duchesnay Inc. is a North American specialty pharmaceutical company.
Headquartered in Blainville, Canada, Duchesnay is a specialty pharmaceutical company with a longstanding commitment to women's health. The company focuses on filling the void in terms of scientific research and education and on developing pharmacological solutions that have established safety and efficacy profiles for use during pregnancy and breastfeeding. With offices in Canada and the United States, Duchesnay also commercializes a broad portfolio of products to offer proven therapeutic options that meet the health and quality of life needs of women and their family members at various stages of their lives.