Biocon Biologics & Just - Evotec Biologics Sign Licensing Deal for a Biosimilar Asset

• Biocon Biologics in-licenses an early-stage biosimilar asset, will undertake development, manufacturing and commercialization under its own label
• Just - Evotec Biologics has received a license fee and will receive milestone payments

Bengaluru, India; Hamburg, Germany and Seattle, USA, October 10, 2019:

Biocon Limited ( ‘Biocon Ltd’) (BSE code: 532523, NSE: BIOCON) and Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that Biocon Biologics, a wholly owned subsidiary of Biocon Ltd, and Just - Evotec Biologics, wholly owned by Evotec, have entered into a strategic licensing agreement for an early-stage, pre-clinical biosimilar asset.

Biocon Biologics will take this biosimilar asset through end-to-end development, IND filing, manufacturing and commercialization post-regulatory approval, under its own label in global markets. Biocon Biologics aims to address the needs of a large patient pool through this differentiated therapy. Through this in-licensing deal, Biocon Biologics has expanded its current therapeutic basket of biosimilars going beyond diabetes, oncology and immunology.

Just – Evotec Biologics has a unique platform with deep experience in the fields of protein, process and manufacturing sciences, which it has leveraged to develop this complex molecule. Just – Evotec Biologics has received an undisclosed license fee from Biocon Biologics and will be eligible to receive development, regulatory and commercial milestone payments.

Dr Christiane Hamacher, CEO, Biocon Biologics, said: “We are extremely confident of the quality of the biosimilar asset developed by Just – Evotec Biologics and this collaboration will provide a head start for Biocon Biologics to commercialize a biosimilar under its own brand. Leveraging our R&D skills and manufacturing expertise, we aim to take this differentiated therapy from ‘bench to bedside.’ This product expands our therapeutic basket and will enable us to address unmet patient needs for a high quality affordable therapy.”

Dr James N. Thomas, EVP, Global Head Biotherapeutics & President US Operations at Just - Evotec Biologics, said: “We are excited to enter into this partnership with Biocon Biologics, a multinational company with a strong presence in biosimilars. Just – Evotec Biologics’ optimised product and process platform has generated an excellent early-stage product candidate which we have licensed to Biocon Biologics for further development using their late-stage development, manufacturing and commercial capabilities to bring a compelling treatment to patients. We look forward to providing support to the Biocon Biologics team as their program advances towards the clinic.”

“This is the beginning of a great relationship between Just – Evotec Biologics and Biocon Biologics,”

Dr Thomas added.

Under the agreement, Biocon Biologics will now assume all development and commercialization responsibilities for the program. Biocon Biologics will benefit from Just – Evotec Biologics’ vast experience in the process development domain particularly with respect to optimised manufacturability.

R&D is at the core of Biocon Biologics’ journey towards meeting its strategic long-term goal of addressing the needs of millions of patients worldwide. Biocon Biologics’ scientific expertise and world class R&D and manufacturing facilities have enabled it to bring multiple biosimilar therapeutics to the US and Europe.

Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz, and is developing many independently. The Company’s therapeutic basket includes molecules from diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases.

Financial details of the licensing transaction have not been disclosed.

About Biocon Biologics:

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

About Biocon Limited:

Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases. The Company has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe. It also has a pipeline of promising novel assets in immunotherapy under development. For further information, please visit www.biocon.com & follow Biocon Limited on Twitter @bioconlimited

About Just - Evotec Biologics:

Just – Evotec Biologics, wholly owned by Evotec SE, has a unique platform that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. The focus is to create access and value for a global market through scientific and technological innovation. Learn more at www.just.bio.

About Evotec SE:

Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 2,800 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry’s need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases and fibrosis. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Celgene, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to www.evotec.com and follow us on Twitter @Evotec.

Forward Looking Statement: Biocon

This press release may include statements of future expectations and other forward-looking statements based on management’s current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release.

Forward Looking Statement: Evotec

Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.