23 novembre 2017

Dompé launches first biotechnological therapy for the treatment of moderate to severe neurotrophic keratitis in Germany

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  • Cenegermin eye drops solution for the treatment of moderate or severe neurotrophic keratitis in adults is being launched in Germany.
  • Cenegermin is the first biotechnological treatment authorized for this specific indication and responds to the needs of affected patients.
  • Behind the development of Cenegermin are decades of Italian research, stemming from the studies of Rita Levi Montalcini, winner of the Nobel Prize in Medicine for the discovery of the nerve growth factor (NGF).

Milan, 23 November 2017 - Dompé, an Italian biopharmaceutical company, announces that it has launched Cenegermin in Germany. The country is the first market for the therapy’s global launch. The solution comes in the form of eye drops. This development follows the European Commission’s decision to grant the marketing authorisation of Cenegermin in July 2017 for the treatment of moderate or severe neurotrophic keratitis in adults. Behind the development of the product are decades of research, stemming from the studies of Italian Nobel laureate Rita Levi Montalcini, who discovered the nerve growth factor (NGF).

Cenegermin is the name of the primary active ingredient of the therapy, and it is the recombinant version of the human nerve growth factor (NGF), developed and prepared through a biotechnological production process unique to Dompé. Cenegermin is a protein that is almost identical to the one naturally produced in the human body, which is involved in the development, maintenance and survival of nerve cells1. Administered as eye drops in patients with moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults, this solution can help restore the normal healing processes of the eye and repair corneal damage.

Neurotrophic keratitis is a rare disease that is particularly debilitating, and until now, has been an unresolved health concern for patients. We are very satisfied that we meet our responsibility as a biopharmaceutical company in that we provide a new therapeutic solution to patients in Germany, and soon in the rest of Europe”. Affirms Eugenio Aringhieri, Chief Executive Officer at Dompé. “We are very pleased to say that Germany will be the first market for the launch of Cenegermin eye drops. It is our first biotech drug that was obtained thanks to the constant collaboration with the regulatory stakeholders and an excellent medical community. The latter has greatly contributed to the development of the product through the various phases in national and international centres. Finally, I would also like to thank our skilled and passionate team that has believed in this project from the beginning.

Cenegermin was developed at the Dompé L’Aquila Research and Production Centre. Using recombinant DNA technology, bacteria were infused with DNA to produce the human growth factor on their own.

The launch of Cenegermin in the German market represents a milestone not only for the patients and the ophthalmologic community in Germany, but also in Europe in general. We are pleased to be able to offer our patients a better treatment of this severe eye condition”, says Professor Dr. Elisabeth M. Messmer from the Eye Clinic of the University of Munich Hospital. Professor Messmer reminded that neurotrophic keratitis is a severe rare degenerative disease of the eye, characterized by a damage of the trigeminal nerve, which can result in a loss of vision. “I am confident that with Cenegermin we will help our patients achieve a better quality of life despite this complex and medically challenging disease”, said Professor Messmer.

Dompé Farmaceutici S.p.A. Socio Unico / Capitale sociale € 50.000.000,00
REA MI 289519 - Registro Imprese di Milano / Codice Fiscale e Partita IVA (VAT) IT00791570153