European Commission grants mondoBIOTECH’s product Aviptadil the Orphan Designation for treating ALI
European Commission grants mondoBIOTECH’s product Aviptadil the Orphan Medicinal Product Designation for the treatment of Acute Lung Injury (ALI) in European Union
Basel Switzerland, September 21, 2006. mondoBIOTECH AG, a private Swiss biotechnology company, today announced the receipt of an Orphan Medicinal Product Designation (OMPD) by the European Commission for its product Aviptadil for the treatment of Acute Lung Injury (ALI) in the European Union (EU/3/06/395), after the positive opinion given by the European Medicinal Agency (EMEA).
“This is the fourth OMPD that we obtained for Aviptadil and the fifth OMPD overall. It is another milestone and a new validation of our business model to develop novel treatment options in rare and fatal diseases,” commented Fabio Cavalli, Chief Executive Officer of mondoBIOTECH.
“This grant arrives at the perfect moment in our development process,” said Dorian Bevec, Chief Scientific Officer of mondoBIOTECH. “After we licensed-out to Biogen Idec (NASDAQ: BIIB) Aviptadil for the treatment of Pulmonary Arterial Hypertension just last week, we continue to develop Aviptadil and other peptides in more orphan diseases.”
OMPD is granted for products that are intended to treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10.000 persons in the European Union and less than 200.000 patients in the USA. Further criteria include the potential of the product to provide significant patient benefit over available treatment, or to fill an unmet medical need where no treatment exists.
OMPD status confers numerous benefits to the development of new products, including clinical protocol assistance and, upon marketing authorization, assures mondoBIOTECH marketing exclusivity for a period of up to 10 years in the European Union and up to 7 years in the USA.
Acute Lung Injury is a life threatening disease affecting about 80.000 patients in the European Union. It is characterized by the rapid onset of progressive inflammation of the lung tissue and accumulation of fluid in the alveoli (air sacs) that leads to low oxygen levels in the lungs. Clinically, the lung functions become severely impaired. Currently no approved pharmacological therapy for ALI is available. ALI patients are treated with intensive symptomatic support, which includes various strategies for assisted ventilation.
Aviptadil is a synthetically produced version of a natural, endogenous human peptide. Its biological role has been widely researched in a variety of diseases and in healthy situations. Aviptadil is produced by neurons, by endocrine cells, as well as by cells of the immune system. In scientific literature, Aviptadil is considered as one of the body’s ’Molecules that Protect’. Aviptadil received OMPD status for Pulmonary Arterial Hypertension and now for Acute Lung Injury in the European Union, and for Pulmonary Arterial Hypertension and Acute Respiratory Distress Syndrome in the USA.
mondoBIOTECH AG, a private Swiss breathing swiss air™ biotech company headquartered in Basel is focused on development of treatment options for fatal and rare lung diseases. For more information, please visit www.mondoBIOTECH.com
- Contact Information
- Dorian Bevec
- Chief Scientific Officer
- mondoBIOTECH AG
- Contact via E-mail
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