Galen announces exclusive licensing agreement with Italfarmaco for the distribution of Cariban® (doxylamine/pyridoxine) in Ireland for nausea and vomiting in pregnancy

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   

About Galen: Galen is a privately owned pharmaceutical sales and marketing company, headquartered in Craigavon (Northern Ireland) and product presence in 25 locations covering each continent across the globe. With over 55 years’ experience, we have 75+ products across a diverse range of therapy areas. Galen has ambitious expansion plans across new territories and therapeutic areas through the acquisition of new companies and product portfolios as well as product partnerships. Galen aims to provide extraordinary service to healthcare professionals, partners, and patients to create real, long-term value and benefit the health of future generations. For further information please visit: www.galen-pharma.com

About Almac Group: Galen is a member of the Almac Group. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across, and beyond, the drug development lifecycle to the pharmaceutical and biotech sectors globally.  The Group is wholly owned by the McClay Foundation, whose overarching aim is to make a meaningful improvement and advancement in human health.  The international company is a privately owned organisation that has grown organically over the past five decades and now employs over 7,000 highly skilled personnel across 18 facilities including Europe, the US and Asia.  For further information please visit www.almacgroup.com.

About Italfarmaco: Italfarmaco is a private multinational group headquartered in Milan, Italy. Established in 1938, its mission has been to improve patient lives and overall well-being through pioneering research & development, high-quality production and global marketing of branded prescription and non-prescription products. Operating in the pharmaceutical and API development, Italfarmaco Group has a presence in over 90 countries, employs 3,800 individuals, including 300 professionals across its four Research & Development Hubs, and generates a turnover exceeding 1 billion Euros. The group is known for its products in the key therapeutic areas such as Women's Health, Neurology and Psychiatry, Cardiovascular and Metabolic, and Rare Disease. Italfarmaco Group manufactures medicinal specialties adhering to the highest quality standards, including sterile injectables, solid, semi solid, and liquid oral forms, across six state-of-the-art production facilities located in Milan, Frosinone, Madrid, Barcelona, Salvador de Bahia and Santiago de Chile.