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AstraZeneca and Pieris Enter up to $2.1 Billion Deal in Respiratory Drug Collaboration

AstraZeneca today announced a strategic collaboration in respiratory diseases with Pieris Pharmaceuticals, Inc. to develop novel inhaled drugs that leverage Pieris’ Anticalin® platform. Anticalin molecules are engineered proteins which can mimic antibodies by binding to sites either on other proteins or on small molecules. They are smaller than monoclonal antibodies, offering the potential of direct delivery to the lung.

Under the collaboration, Pieris will be responsible for advancing its preclinical lead candidate, PRS-060 into Phase I clinical trials in 2017. PRS-060 is an Anticalin against interleukin-4 receptor alpha (IL-4Ra) with potential in asthma. AstraZeneca will fund all clinical development and subsequent commercialisation programmes and Pieris has the option of co-development and co-commercialisation in the US from Phase IIa onwards. In addition, the parties will collaborate to progress four additional novel Anticalins against undisclosed targets for respiratory disease.

Mene Pangalos, Executive Vice President, Innovative Medicines and Early Development Biotech Unit and Business Development, said: “At AstraZeneca, discovering and developing innovative new medicines to treat respiratory disease is a key strategic priority. Our alliance with Pieris adds an important new modality to our respiratory portfolio and builds on our scientific expertise in inhaled formulation technologies. Pieris shares our passion for ground-breaking science and we look forward to working together to develop new, life-changing treatment options for patients.”

Stephen Yoder, President and Chief Executive Officer of Pieris, said: “Our partnership with AstraZeneca accelerates the transformation of Pieris into a fully-integrated drug development and commercial organisation, comprising two main pillars in immunology: respiratory disease and immuno-oncology, each of which is now anchored by a major alliance. We recognize AstraZeneca’s unparalleled expertise in the development of inhaled drugs, which will maximize the potential of PRS-060 and other inhaled Anticalin molecules to become valuable assets for both companies.”

AstraZeneca will make upfront and near-term milestone payments to Pieris in the amount of $57.5 million. Pieris has the potential to receive development-dependent milestones and eventual commercial payments for all products not exceeding $2.1 billion as well as tiered royalties on the sales of any potential products commercialised by AstraZeneca.

The collaboration agreement is conditional upon the expiration or early termination of the applicable waiting period (and any extension thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

NOTES TO EDITORS

About PRS-060

PRS-060 is in preclinical studies. It is an Anticalin® potently engaging IL-4Rα, is being developed for patients suffering from moderate to severe asthma, many of whom are not fully controlled with currently available medications. In a large proportion of asthma patients, the Th2 pathway plays an important role. IL-4 and IL-13 are the main cytokines involved in Th2-mediated asthma. Both signal via IL-4Rα, making IL-4Rα a cornerstone intervention point. PRS-060 differentiates from antibody approaches through potential inhaled delivery directly into the lungs which may result in improved ability to target the biological drivers of disease in the lung. Local delivery may allow for lower doses than systemically administered antibodies. Pieris has demonstrated proof of concept in animals as well as feasibility for pulmonary delivery with PRS-060.

About Pieris Pharmaceuticals        

Pieris Pharmaceuticals (NASDAQ: PIRS) is a clinical-stage biotechnology company that discovers and develops Anticalin-based drugs to target validated disease pathways in a unique and transformative way.  Our pipeline includes immuno-oncology multispecifics tailored for the tumor micro-environment, an inhaled Anticalin® protein to treat uncontrolled asthma and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin® proteins are a novel class of protein therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies.  Anticalin® is a registered trademark of Pieris. Pieris has partnerships with Servier, ASKA, Roche, Sanofi, Daiichi Sankyo and Zydus. For more information visit www.pieris.com.

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca’s main therapy areas, and we have a growing portfolio of medicines that reached more than 17 million patients in 2015. Our aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our innovative Co-SuspensionTM Delivery Technology. Our research is focused on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology and autoimmunity.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.AstraZeneca.com and follow us on Twitter @AstraZeneca.

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