FDA grants Breakthrough Therapy Designation for Xolair (omalizumab) for food allergies

• There are currently no FDA-approved treatments that help prevent severe reactions due to food allergies
• As many as 15 million Americans have food allergies - including approximately 6 million children - and the incidence is increasing

Basel, 13 August 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair^® (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases, and to help ensure people have access to them through FDA approval as soon as possible. This is the 23rd Breakthrough Therapy Designation for Roche's portfolio of medicines.

"Food allergies can have a significant impact on the lives of children and adults, and they are a growing public health concern for which there are currently no FDA-approved treatments," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We are committed to helping address this high unmet medical need and look forward to working with leaders in the field to further develop Xolair as a potential medicine to help people with this condition that can be life-threatening."

Food allergies can be life threatening, and result in an estimated 200,000 emergency room visits each year. Up to 8 percent of children and 4 percent of adults in the U.S. are affected by food allergies, and the incidence is increasing.

Breakthrough Therapy Designation was granted on the basis of data from seven clinical studies over the last decade assessing the efficacy and safety of Xolair against a range of food allergens including peanut, milk, egg and others. These studies of Xolair, as monotherapy or in combination with oral immunotherapy (OIT), were supported by Genentech and independent sponsors including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation are working closely with NIAID and the Consortium of Food Allergy Research (CoFAR) to initiate a potentially pivotal study evaluating the efficacy and safety of Xolair in multiple food allergies and will disclose details at a later date.

In the U.S., Genentech, Inc. and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

About Xolair
Xolair for subcutaneous use is an injectable prescription medicine approved by the FDA to treat:

• Moderate to severe persistent asthma in patients six years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if a patient has allergies to year-round allergens. 
• Chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment.

Xolair is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.


About Roche in Immunology
The Roche Group's immunology medicines include: Actemra/RoActemra (tocilizumab) for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and giant cell arteritis (GCA) and for the treatment of severe or life-threatening chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome (CRS); Rituxan/MabThera (rituximab) for rheumatoid arthritis granulomatosis with polyangiitis and microscopic polyangiitis and for pemphigus vulgaris (PV); Xolair (omalizumab) for allergic asthma and chronic idiopathic urticaria (CIU); Pulmozyme (dornase alfa) for cystic fibrosis; and Esbriet (pirfenidone) for idiopathic pulmonary fibrosis (IPF). Roche has more than 15 investigational medicines in clinical development for immunological diseases that include asthma, autoimmune diseases, rheumatoid arthritis, ulcerative colitis and Crohn's disease.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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