Silver Spring/Stans -- After completion by Mondobiotech of a Phase II study where inhaled Aviptadil was shown to have a unique safety profile and promising signals of long term efficacy over currently approved therapies in patients affected by Pulmonary Arterial Hypertension (PAH), United Therapeutics Corporation’s Lung Rx subsidiary and Mondobiotech finalized a global strategic partnership focused on the development of Aviptadil for a range of indications, as for example PAH, Sarcoidosis, Idiopathic Pulmonary Fibrosis (IPF) and Acute Respiratory Distress Syndrome (ARDS).

The platform can generate more than 1 billion CHF turnover. United Therapeutics, a successful biotech company, listed at the NASDAQ with a capitalization of over 3 billion USD, and specialized in finding and developing therapies for PAH and other pulmonary diseases with 2 PAH products already on the market, will be responsible for further development and commercialization of the Aviptadil platform.

The Mondobiotech research Community concluded after the clinical trial of Aviptadil in PAH that Aviptadil could also have the potential to be used as a platform medicinal product to treat other diseases, as for several other potential medical products from the Mondobiotech pipeline. This would allow maximal utilization of the beneficial efficacy/great safety profile which these products exhibit.

“Thanks to our Community”, said Fabio Cavalli, founder, CEO and Board Member of mondoBIOTECH holding AG “we are able to research diseases like IPF, Sarcoidosis and ARDS, and surely the arrival of United Therapeutics fosters the possibility to bring Aviptadil to market authorization, as United Therapeutics is the only global expert focused on PAH.”

"We are pleased to help Mondobiotech in its noble mission to accelerate the development of treatments for orphan diseases, of which there are many thousands with no approved medicines,” said Martine Rothblatt, Ph.D., President and CEO of Lung Rx LLC. “Our role will be to do our best in demonstrating the safety and efficacy of Aviptadil for PAH and other indications which afflict fewer than 200,000 people worldwide."

“The Phase II study has demonstrated the safety of administration of Aviptadil to patients with PAH, with encouraging signals of efficacy with longer administration of the higher dose. The collaboration of Mondobiotech and United Therapeutics will bring the unique expertise of these two companies to this important project", commented Prof. Dr. med. Lewis J. Rubin, Professor of Medicine, Pulmonary and Critical Care Division, University of California, San Diego Medical Center.

“Aviptadil has a number of actions that can be applied to the treatment of chronic rare pulmonary disorders including sarcoidosis and idiopathic pulmonary fibrosis (IPF), this latter the most lethal of all fibrosing lung conditions”, commented Prof. Dr. med. Ron du Bois of National Jewish Health, Denver, Colorado. “IPF kills at a rate more rapid than many cancers and is characterized by a progressive accumulation of scar tissue in response to repetitive lung injury. The actions of Aviptadil on the scar-forming process make this an attractive potential treatment option in IPF.

Sarcoidosis is a chronic disease affecting many body organs, especially the lungs, which causes significant patient disability. Preliminary data from a clinical trial with inhaled Aviptadil, conducted by Mondobiotech, have shown that Aviptadil exerts beneficial effects on several mechanisms that are central to the development of this disease, making it a potentially useful treatment option.”

“The European Medicines Agency (EMEA) already adopted an Orphan Drug Medicinal Product status to Aviptadil for the treatment of sarcoidosis,” commented Prof. Dr. med. Luca Richeldi, Associate Professor of Respiratory Medicine in the Department of Oncology, Haematology and Respiratory Diseases, and Director of the Research Center of Rare Lung Diseases at the University of Modena and Reggio Emilia, Modena, Italy. “Promising data on an effect of Aviptadil on a variety of disease-relevant biomarkers in pulmonary sarcoidosis exist. In this context, clinical trials using Aviptadil in chronic granulomatous lung diseases like sarcoidosis are certainly warranted.”

“Having dedicated many years of my life to the study of VIP (Aviptadil) and exploring its therapeutic potential, I am delighted that Mondobiotech is taking the lead in such an important clinical trial. Further trials, for additional indications, will surely follow", commented Prof. Dr. med. Sami I. Said, Distinguished Professor by the State University of New York, and Professor in the departments of Medicine, Physiology, and Graduate Program in Pharmacology at Stony Brook University, Stony Brook, New York.

About Aviptadil

Aviptadil is a synthetically produced version of the natural, endogenous human Vasoactive Intestinal Peptide (VIP). Aviptadil is an abundant biologically active peptide, naturally present in humans as well as in other mammalian species in the identical composition. It is produced by neurons in the peripheral and central nervous system, by endocrine cells, and by the cells of the immune system. Aviptadil is mainly distributed within the respiratory cell linings, the intestines, and the genital tract.

Since the 1970s, the biological role of Aviptadil, its role in a variety of diseases and its role as a therapeutic agent have been widely researched. To date, more than 12’000 scientific publications and more than 1’000 review articles describe Aviptadil’s characteristics.

From the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) Mondobiotech received for Aviptadil 5 orphan medicinal product designations (OMPD) in the indications Pulmonary Arterial Hypertension, Acute Lung Injury/Acute Respiratory Distress Syndrome, and Pulmonary Sarcoidosis.

About United Therapeutics Corporation/Lung Rx

Lung Rx LLC, a wholly-owned subsidiary of United Therapeutics Corporation, is a biotechnology company focused on unmet medical needs in pulmonary medicine and pulmonary delivery of innovative therapeutic products. United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer.

About Mondobiotech

mondoBIOTECH holding AG (SIX Swiss Exchange ticker symbol: RARE), an independent, internet-based biotech research company, discovers drugs for patients suffering from rare and neglected diseases. Mondobiotech has built a continuously growing global community of biologists, biochemists, physicians, patients and patient advocacy organizations who share their passion and skills with Mondobiotech. Together with Mondobiotech, this community is searching for treatments for rare and neglected diseases.

Disclaimer

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