CRAIGAVON, NORTHERN IRELAND – 30^th July 2024. Galen Ltd announced today that it has entered into an exclusive licensing agreement with Italfarmaco for the prescription medicine Cariban^® (doxylamine/pyridoxine) in Ireland, to alleviate the symptoms of nausea and vomiting in pregnancy (NVP).  This is a significant milestone in Galen’s partnership strategy and an important development for women in Ireland, as the agreement sees the arrival of the first, fully reimbursed supply of the product in the country.

Moderate to severe NVP can severely impact the patient and may also lead to hospital admission for rehydration and treatment¹. Evidence suggests that recognising and managing NVP early may prevent a more severe form from developing which can negatively impact women’s health and quality of life during pregnancy, as well as creating financial burden on the health care system².

Under the terms of the agreement, Galen has licensed doxylamine/pyridoxine from Italfarmaco and will be the exclusive distributor in Ireland. Galen is a privately owned pharmaceutical company established in 1968, with commercial operations based in the UK and Europe, global partners in every continent, and is positioned to distribute products worldwide.

The availability of the medicine will mean that women can more easily access it. In 2023, the Irish government allocated €1 million to facilitate the reimbursement of doxylamine/pyridoxine, ensuring free-of-charge access for women; however, to qualify for the scheme, patients needed to have received their initial prescription from a consultant obstetrician. This proved difficult as most women in early stages of pregnancy would not be registered with an obstetrician, prompting calls from Hyperemesis Ireland, which represents women experiencing a severe form of NVP, hyperemesis gravidarum, to call for simpler and quicker access to the medicine.

Expectant mothers who are not registered with an obstetrician have historically had to pay privately, costing them more than €150 a month for this medication. The total cost throughout pregnancy can reach up to €3,000, greatly impeding women's access to crucial healthcare services.

Speaking about the agreement, Dr Dennise Broderick, Managing Director and President of Galen said: “We are delighted to have signed an agreement with Italfarmaco to license and exclusively distribute Cariban^® (doxylamine/pyridoxine) in Ireland. This partnership aligns with our commitment to customer care and patient outcomes and with our ambitions to deliver innovation, quality and value to healthcare professionals and their patients.”

Sara Mazzuoccolo, Licensing Director, Business & Portfolio Development at Italfarmaco Group said: "We are pleased to have signed this agreement with Galen. At Italfarmaco, we are committed to improving patients’ lives and overall well-being through high quality products. With Galen as our exclusive distributor in Ireland, we are confident we have an excellent partner to deliver this important medicine to expectant mothers."

More information on the partnership and Galen’s outlicensing opportunities can be found at www.galen-pharma.com. 

References

1.  NICE guideline NG201. Management of nausea and vomiting in pregnancy. August 2021.
2.  Campbell K, Rowe H, Azzam H, Lane CA. The Management of Nausea and Vomiting of Pregnancy. J Obstet Gynaecol Can. 2016;38(12):1127-37.

MAT-GAL-UKI-000231. Date of preparation: July 2024.