The “Other Products” portfolio is based on the mucoadhesive proprietary Lauriad® technology which reinforces the efficacy profile of a drug.
The mucoadhesive Lauriad® tablet adheres to the oral mucosa and provides early and sustained delivery of high concentrations of the active ingredient to the oral cavity. The tablet acts as a reserve and releases the active ingredient continuously when in contact with the buccal mucosa. Systemic absorption is low.
Oropharyngeal candidiasis is a fungal infection of the oropharynx induced by yeast-like fungi: Candida albicans and non-albicans. This is an opportunistic disease that develops due to a failure of the immune system and/or a local imbalance. Some treatments favour the development of fungal infections such as immunosuppressive therapy, radiation therapy, chemotherapy, long-term antibiotics, and systemic or inhaled corticosteroids taken over long periods. This disease affects the quality of life of patients suffering and struggling to feed themselves.
Loramyc®/Oravig® is a mucoadhesive buccal tablet (Lauriad® technology) containing miconazole. Pharmacokinetic studies in man have shown that Loramyc® (in Europe)/Oravig® (in the US) delivers early and continuous high salivary concentrations of miconazole. Randomized Phase III clinical trials have confirmed the efficacy of Loramyc®/Oravig® in the treatment of oropharyngeal candidiasis in patients with head and neck cancer or AIDS.
Loramyc®/Oravig® is the first product developed by Onxeo and approved in Europe and the USA. Loramyc® is marketed through partnership agreements in Europe with the Therabel Group, in the US with Dara BioSciences, in Southeast Asia with Handok, in China with SciClone Pharmaceuticals, and in Japan with Sosei.
More information related to Loramyc®/Oravig® are available in the Reference document and Half-year financial report.View press releases
Herpes labialis (often called “cold sores”) is an infection that occurs in outbreaks, recurring more or less frequently. It usually appears as vesicular lesions progressing toward ulceration and then turns into a scab located on the lips, accompanied by burning and itching. Herpes labialis is caused by the herpes simplex virus. Herpes labialis is a benign condition but recurrent and contagious.
Herpes labialis is an extremely widespread infection that affects nearly 100 million people in the world each year. It has an estimated annual prevalence at 15% of the adult population or about 40 million people in the United States and more than 100 million episodes of herpes labialis per year. The potential market for Sitavig® can be estimated at several hundred million dollars.
Sitavig® (Europe, USA)/Labiriad® (Italy) is a mucoadhesive buccal tablet (Lauriad® technology) containing acyclovir. Pharmacokinetic studies in healthy volunteers showed that Sitavig® quickly delivers very high concentrations of acyclovir into the saliva for about 24 hours but also onto the lips, the site of infection. An international randomised phase III clinical trial in 775 immunocompetent patients with recurrent herpes labialis showed the efficacy and good tolerance of Sitavig® . This drug also reduces the duration of the herpes episode. Sitavig® is approved in the United States and in nine European countries (France, Germany, Sweden, the United Kingdom, Spain, Italy, Denmark, Finland, and Norway).
In March 2014, a licensing agreement was entered into with Innocutis Holding LLC for the marketing of Sitavig® in the U.S. which launched the product on the U.S. market in July 2014. In April 2015, the licensee Innocutis was acquired by Cipher Pharmaceuticals which pursues the partnership with Onxeo.
Other licensing agreements were signed: with Teva group in Israel, Daewoong Pharmaceutical Co.Ltd in South Korea and EMS S/A in Brazil, including the responsability for registering the product with each country’s regulatory authorities.
More recently, in July 2015, Onxeo signed a license agreement for Sitavig® with specialty pharmaceutical company Bruno Farmaceutici for commercialization in Italy. As a partner, Bruno Farmaceutici will launch Labiriad® (name of Sitavig® in Italy) under its current regulatory status (prescription) and manage the regulatory procedure to obtain an over-the-counter (OTC) designation, allowing pharmacists to deliver Sitavig® to patients directly.
More information related to Sitavig® are available in the Reference document and Half-year financial report.View press releases