Dompé and Tanner Pharma Group entered into an agreement for the distribution of Oxervate (cenegermin), used in the treatment of neurotrophic keratitis (NK).
The agreement grants Tanner exclusive rights to distribute Oxervate in countries outside of the United States, Canada, Italy, China, and the Commonwealth of Independent States (CIS), including Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, and Uzbekistan.
Administered as eye drops, Oxervate consists of a recombinant, or lab-made, human nerve growth factor (NGF) protein.
NGF plays a key role in the survival and growth of nerve cells. It promotes wound healing and tear secretion in the cornea, the transparent protective outer layer of the eye. These processes are critical to maintaining the health of the corneal nerves that become impaired during the course of NK.
“We are pleased to be working with Tanner Pharma Group to deliver this innovative treatment to patients with a serious unmet medical need,” said Eriona Gjinukaj, Dompé’s chief operating officer, in a press release. “We believe expanding the distribution of Oxervate will dramatically improve the lives of many now living with this highly debilitating disease.”
The European Medicines Agency granted Oxervate marketing approval in 2017 within the European Union for the treatment of moderate-to-severe NK. The U.S. Food and Drug Administration granted its approval in 2018. Oxervate also is approved for use in Switzerland, Israel, Canada, and Australia.
The new agreement enables Tanner to distribute Oxervate in countries that currently have no therapeutic alternative to the medication.
In general, few treatments exist that are specific to NK. Most therapies are designed to manage patients’ symptoms, but do not target the underlying cause of the disorder.
Oxervate proved safe and effective at healing and reducing corneal lesions, and successfully restored corneal sensitivity in two clinical trials. One trial, called NGF0214 (NCT02227147), took place in the U.S. The REPARO trial (NCT01756456) was conducted across 34 study locations in Europe.
“We are pleased to partner with Dompé on this important initiative,” said Rob Keel, Tanner’s global head of managed access programs. “Our unique delivery model will allow us to effectively and efficiently support physicians and patients worldwide to gain access to Oxervate on a named patient basis in countries where no alternatives are commercially available.”