ACTIVAERO AND CHIESI ENTER INTO RESEARCH COLLABORATION FOR NOVEL DRUG DEVICE COMBINATION IN CYSTIC FIBROSIS

ACTIVAERO AND CHIESI ENTER INTO RESEARCH COLLABORATION FOR NOVEL DRUG DEVICE COMBINATION IN CYSTIC FIBROSIS

Gemuenden/Wohra, Germany, September 09, 2013 - Activaero GmbH, the therapeutic area specialist for respiratory diseases focusing on novel, pharmacoeconomically meaningful treatment solutions for severe lung diseases, today announced that it has entered into a research collaboration with Chiesi Farmaceutici S.p.A. The companies are going to jointly evaluate the potential of a noveldrug device combination product using Activaero's proprietary FAVORITE inhalation approach and Chiesi's pharmaceutical agent to create a highly mobile and effective treatment solution for Cystic Fibrosis. Chiesi already has an established presence in the Cystic Fibrosis field. The Company obtained approval and markets directly or through partners its proprietary inhaled tobramycin solution (Bramitob®/Bethkis®, 300mg/4ml UDV) in several countries worldwide, including the United States.

Under the terms and conditions of the collaboration agreement, Activaero provides Chiesi with its flow and volume regulated inhalation technology (FAVORITE) incorporated in a customized device solution. Such a solution allows for optimum drug distribution across the entire lung importantly including the small airways. This most distal region of the lung is typically not accessible with standard nebulizer systems due to the obstructions caused by scarred tissue and mucus in the lungs of Cystic Fibrosis patients. The first part of the research work is planned to be completed by the end of 2013. Financial details of the collaboration were not disclosed.

"This exciting research collaboration represents further validation for our proprietary FAVORITE inhalation approach by one of the pioneers in the respiratory arena", commented Gerhard Scheuch, Founder and Chief Executive Officer of Activaero GmbH. "We are highly optimistic that this program can provide a significantly improved treatment solution for Cystic Fibrosis, a detrimental disease with a high unmet medical need."

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"The FAVORITE inhalation approach is highly promising to achieve optimal lung deposition rates with lower drug doses and, ultimately, a better therapeutic outcome in the treatment of Cystic Fibrosis. We are looking forward to work with our new partner Activaero on this promising project", said Paolo Chiesi, Vice President and R&D Director of the Chiesi Group.  

About Cystic Fibrosis

Cystic Fibrosis (CF), also known as mucoviscidosis, is one of the most common genetic disorders amongst Caucasians. The disease is inherited recessively with an improved but still rather low life
expectancy with a median age of currently 33.4 years according to the World Health Organization. CF leads to chronic inflammations of the respiratory tract and also affects other organs, such as the digestive tract, liver, sweat glands and reproductive organs. Symptoms include, heavily salty-tasting sweat, coughing similar to whooping cough, severe bronchitis and pneumonia, an increased production of tough an viscous mucus that leads to frequent bacterial infections as well as disturbed digestions and male sterility. Most patients die from cardiorespiratory complications caused by those symptoms.

About FAVORITE

FAVORITE is Activaero's proprietary, clinically and commercially proven inhalation approach to effectively treat severe respiratory and pulmonary diseases. FAVORITE actively regulates inspiration flow and inhalation volume. By guiding, controlling and supporting the patient's breathing, optimal inhalation patterns are created. Using FAVORITE, inhaled drugs can be selectively targeted to predefined lung regions hence unlocking completely new opportunities for novel aerosol therapies.

About Activaero

Activaero is a therapeutic area specialist developing new, pharmacoeconomically meaningful treatment solutions for patients suffering from severe respiratory diseases, including Asthma, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF), Idiopathic Pulmonary Fibrosis (IPF) and Pulmonary Hypertension. Activaero was founded in 1998 in Germany and is a privately held company with offices in Germany near Frankfurt and Munich as well as in Dublin, Ohio (USA).

www.activaero.de

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About Chiesi Farmaceutici

Founded in 1935 in Parma, Italy, Chiesi Farmaceutici currently has 25 affiliates worldwide and markets its therapeutics in over 60 countries. Chiesi's manufacturing plants in Parma, Blois (France) and Santana de Parnaiba (Brazil), and R&D centers in Parma, Paris, Rockville (USA) and Chippenham

(UK) integrate their efforts to advance the Group's pre-clinical, clinical and registration programs. At the end of 2012, the Chiesi Group's total staff stood at over 3,800 people, more than 350 of whom are dedicated to R&D. The main areas of activity are in respiratory therapeutics and specialistmedicine areas.

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