November 2020 – Dompé farmaceutici Spa and FarmaMondo entered into an exclusive Managed Access Program distribution agreement appointing the FarmaMondo Group as the exclusive partner to make their EMA,FDA,NMPA approved innovative product Oxervate™ (Cenegermin) available for patients affected by Neurotrophic keratitis in Russia and other CIS countries.
The agreement appoints FarmaMondo as the exclusive provider of access for those NK patients with unmet need through a Named Patient Managed Access Program. The possibility to access the therapy shall bring great hope for NK patients and their families in the region.
“We are pleased to be working with FarmaMondo to deliver this innovative treatment to patients with a serious unmet medical need. We believe expanding the distribution of Oxervate will dramatically improve the life of many now living with a highly debilitating disease” said Eriona Ginukaj, Chief Operating Officer of Dompé.
About Neurotrophic Keratitis
Neurotrophic keratitis is a rare, degenerative disease of the cornea which results in persistent epithelial defects, corneal ulcers, melting, perforation and vision loss. It is an orphan disease with an estimated prevalence of less than 5/10,000 individuals, and previous treatment options had been limited to symptomatic treatments which do not target the underlying disease pathology.
Oxervate (cenegermin) is a first-in-class treatment for neurotrophic keratitis, with a mechanism of action that targets the root pathology of the disease. It is the first-ever application of a human nerve growth factor as drug or treatment and is the first-ever topical biologic medication approved in ophthalmology. Dompé’s Cenegermin Nerve Growth Factor-based therapy was awarded Breakthrough Therapy designation by the US Food and Drug Administration (FDA) and marketing authorized by the European Medicines Agency (EMA) in July 2017, by the FDA in August 2018 and by the NMPA in China in August 2020.
FarmaMondo is a Swiss-headquartered pharmaceutical group focused on providing market access and specialty distribution services, through a unique infrastructure and geographical footprint, targeted to facilitate patient’s access to medicines across the unlicensed and licensed product lifecycle phases. FarmaMondo support biopharmaceutical companies in their mission to extend greater access for their medicines by ethically supplying product to patients in markets where it has not been commercially launched yet.
For more information about FarmaMondo please visit www.farmamondo.com.
Dompé is an Italian bio-pharmaceutical company that focuses on innovation, with a long tradition in the field of personal wellness that goes hand in hand with a commitment to research and development to meet the unsatisfied therapeutic needs of patients. Dompé, based in Milan with a presence in the United States, Europe and China, focuses specifically in the field of rare diseases within its biotechnology unit, in recent years moving into the area of ophthalmology. For more information, visit www.dompe.com