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2016 Celltrion English


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2016 Celltrion English

  1. 1. Advanced Therapeutics Within Everyone’s Reach
  2. 2. Advanced Therapeutics Within Everyone’s Reach. Our History Since our foundation in 2002, we have concentrated our investments in human resources, facilities and technologies with the singular goal of becoming a global biopharmaceutical company that develops, manufactures and markets affordable advanced therapeutics based on recombinant DNA and molecular biology. As of 2015, we have obtained marketing authorizations for Remsima® and HerzumaTM , our two biosimilar monoclonal antibodies (mAbs). Remsima®, the world’s first biosimilar mAb, has already been approved not only in Korea but also in many countries around the world, including those in Europe and the US. HerzumaTM , the world’s first anti neoplastic biosimilar mAb, has thus far been approved in Korea. Application for its approval is planned to be submitted in other countries. Our bid to become a world-class biopharmaceutical company continues today with our eyes set firmly on serving the needs of patients through development of affordable biosimilar mAbs and innovative next-generation drugs. To promote patient access to advanced therapeutics, we have been committed to bringing affordable drugs to patients who previously had limited access to them. Every patient should have access to advanced therapeutics they need. At Celltrion, we believe that patients deserve the very best treatment without cost considerations being a limiting factor. Feb. 2002 Celltrion is founded Jun. 2005 Supply Agreement with a US pharmaceutical company Jul. 2005 Mechanical completion of Plant 1 (capacity: 50,000L) Dec. 2007 Plant 1 receives cGMP facility approval by the US FDA Aug. 2009 IND approval of HerzumaTM (for breast cancer treatment) Oct. 2009 Completion of global sales network Mar. 2010 IND approval of Remsima® (for rheumatoid arthritis, ankylosing spondylitis treatment) May. 2010 Strategic direct investment by Temasek Dec. 2010 Mechanical completion of Plant 2 (capacity: 90,000L) Dec. 2011 IND approval of biosimilar candidate CT-P10 (for rheumatoid arthritis and Non Hodgkin’s lymphoma) Jul. 2012 Remsima® approved by Korea Ministry of Food and Drug Safety (MFDS, formerly, KFDA) Apr. 2013 IND approval of CT-P27 (for universal influenza treatment) Aug. 2013 Remsima® approved by the EMA Nov. 2013 Completion of global clinical trial phase 1 for CT-P27 Jan. 2014 HerzumaTM approved by the MFDS Remsima® approved by Health Canada Jul. 2014 Remsima® approved by MHLW (Japan), MoH (Turkey) Aug. 2014 Completion of global clinic trial phase 2a for CT-P27 Feb. 2015 Remsima® launched in Europe (12 countries including Germany, France, England, Italy, Spain) Apr. 2015 Remsima® approved by ANVISA (Brazil), INHRR (Venezuela) Oct. 2015 TruximaTM (CT-P10) filed for EMA approval Dec. 2015 TruximaTM (CT-P10) filed for MFDS approval Apr. 2016 Remsima® approved by the US FDA Celltrion
  3. 3. Monoclonal antibodies-paving a new way for biosimilars Biologics, especially mAbs, are revolutionary therapeutics, considered to be one of the fastest growing sectors of the pharmaceutical industry. Biologics have introduced many novel therapeutics to life-threatening and rare diseases since the late 1980’s. Although mAbs have treated many patients through their unique mode of action that targets specific antigens, these highly effective drugs have been beyond the reach of far more patients due to their extremely high price. Annual costs of biologics treatment can be as much as 20 times greater than treatments using chemical drugs. It is estimated that about USD 66 billion of branded biologic sales will lose patent protection over the next few years, including some of the bestselling ones. With this opportune timing, many global pharmaceutical companies are on the rush to develop biosimilar mAbs, with Celltrion at the head of the competition. The market landscape of biosimilars • Patent expiry in many of the world’s largest biopharmaceuticals in the coming years is allowing for biosimilar expansion. • Rising healthcare expenditure outpacing economic growth is boosting demand for more affordable drugs. What do biosimilars mean for the healthcare industry? • For healthcare providers: an opportunity to provide affordable care • For patients: access to affordable advanced therapeutics • For Celltrion: reaching its vision of promoting patient access to advanced therapeutics at affordable price Biosimilars, a new horizon in global pharmaceutical industry A new era of biosimilars has begun. Biosimilars are officially approved subsequent versions of innovator biologics that may provide opportunities for reducing the cost of treatment without compromising quality. Approximately 40 percent of biosimilars currently in development are monoclonal antibodies (mAbs). That percentage is likely to only grow with the rising demand for biosimilar versions of the originator mAbs to offset prohibitive costs of the originator mAbs. BiosimilarIndustry
  4. 4. Stepwise business development to maximize success and minimize risk Since 2002, we have built world-class facilities, developed state-of- the-art technologies and put quality systems in place. We also secured the cash flow necessary for developing our own products through our CMO business. Using the technology and know-how in biologics development we have thus accumulated over the years, we soon succeeded in developing biosimilar mAbs and establishing global marketing and sales network through strategical partnerships with a number of major global pharmaceutical distributors. Strong Capability of Research & Development R&D is at the center of Celltrion’s mission as Celltrion strives to transform innovative research into advanced therapeutics. Over 250 well-experienced researchers (75% MS & 25% Ph.D) are dedicated to the strong biosimilar pipeline and new product pipeline including new monoclonal antibodies and vaccines that target infectious diseases at Celltrion R&D Center. Core research activities range from target screening to non-clinical design. The capabilities of Celltrion R&D combined with well- established infrastructures have led to successful drug development. State-of-the-art manufacturing facilities Celltrion boasts one of the world's largest state-of-the-art mammalian cell culture plants with a total production capacity of 140,000L. These plants were designed and constructed to comply with the US FDA’s cGMP and the EMA’s GMP regulations. Excellence in clinical study design and global biosimilar mAb approval experience From the very earliest stages of our biosimilar mAb development, we have thoroughly reviewed regulatory requirements for each individual country to design global clinical trials that would encompass even the most stringent regulatory requirements. Thanks in no small part to such unrelenting efforts, Celltrion accomplished the historical feat of successfully obtaining approval from the EMA, US FDA and the MFDS for Remsima®, the world’s very first approved biosimilar mAb. Key factors behind Celltrion’s successful biosimilar mAb development Celltrion was already strategically preparing for biosimilar mAb development well before other global biopharmaceutical companies even realized the biosimilar market potential. Biosimilar Candidate Target(INN) Original Product Major Indication CT-P17 Adalimumab Humira Rheumatoid arthritis CT-P16 Bevacizumab Avastin Colon cancer CT-P15 Cetuximab Erbitux Colorectal cancer CT-P14 Palivizumab Synagis RSV Infant CT-P05 Etanercept Enbrel Rheumatoid arthritis BiosimilarDevelopment Affordable solutions for advanced therapeutics Our biosimilar mAb products & pipeline In addition to HerzumaTM and Remsima®, we have a robust pipeline consisting of as many as six biosimilar mAb candidates. From this pipeline, we plan to launch products on an annual basis. Following on the heels of Remsima® and HerzumaTM, the development of CT-P10, our third biosimilar mAb, is progressing on schedule with successful clinical trial phase 1 results. CT-P10 is currently in global clinical trial phase 3. In 2015, Celltrion submitted a Market Authorization Application (MAA) for CT-P10 to the EMA. Product Target(INN) Original Product Major Indication Current Status Remsima® Infliximab Remicade Rheumatoid arthritis ∙ MFDS approval 2012 ∙ EMA approval 2013 ∙ Health Canada, MHLW(Japan) and TITCK(Turkey) approval 2014 ∙ ANVISA(Brazil), INHRR(Venezuela) approval 2015 ∙ US FDA approval 2016 HerzumaTM Trastuzumab Herceptin Breast cancer ∙ MFDS approval 2014 TruximaTM Rituximab Rituxan Non-Hodgkin lymphoma ∙ Filed for EMA, MFDS approval Biosimilar mAb products Biosimilar mAb pipeline
  5. 5. 1) : “Indications approved vary among countries. This is a collective list of indications approved by countries in which CT-P13 is approved. Country-specific information is available upon request at Remsima® global clinical trial overview Clinical trial period March 2010 - November 2012 Number of patients Total 874 | Phase 1: 250, Phase 3: 606 Number of countries and sites Phase 1: 10 countries 46 sites Phase 3: 19 countries 100 sites • INN: Trastuzumab • Approval status: Approved by the MFDS • Indications: Metastatic breast cancer, early stage breast cancer and metastatic gastric cancer with over-expression of human epidermal growth factor receptor 2 protein (HER2) • Protein type: Monoclonal antibody (mAb) • Mechanism of action: The antibody specifically binds to the antigen and suppresses the antigen signals to target and destroy tumor. • Trastuzumab market size: Approximately USD 7 billion (as of 2015) HerzumaTM is our trastuzumab biosimilar which had been demonstrated comparable with the originator trastuzumab for breast cancer treatment by multinational randomized double blind clinical trials. HerzumaTM global clinical trial overview Clinical trial period (MBC) August 2009 - June 2012 Number of patients Total 557 | Phase 1: 174, Phase 3: 383 Number of countries and sites Phase 1: 7 countries 31 sites Phase 3: 22 countries 99 sites Remsima® is an alternative to the originator infliximab in approved countries. In more than seventy countries Remsima® is approved and used for treatment of rheumatoid arthritis and certain other autoimmune diseases. Remsima®&HerzumaTM the world’s first approved biosimilar mAb the only oncology biosimilar mAb approved based on global clinical trial results • INN: Infliximab • Approval status: Approved by the EMA, US FDA, Health Canada, MHLW (Japan), ANVISA (Brazil) and the MFDS (Korea), etc. • Indications1) : Rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, psoriasis and psoriatic arthritis • Protein type: Monoclonal antibody (mAb) • Mechanism of action: Neutralizes tumor necrosis factor (TNF-alpha), a common cause of autoimmune diseases such as rheumatoid arthritis • TNF antagonist market size: Approximately USD 32.9 billion (as of 2015) *Under Phase 3 for EBC protocols
  6. 6. Universal influenza antibody CT-P27 Most notably, in August 2014, Celltrion completed phase 2a clinical trial for CT-P27, a novel therapeutic antibody under development for treatment against various types of influenza viruses. CT-P27, a cocktail injectable made up of two different monoclonal antibodies developed by Celltrion, has been drawing keen interests from the US and Chinese governments for targeting neutralization of a broad spectrum of influenza viruses including seasonal strains and potential pandemic strains. Through its mode of action which is distinct from existing influenza treatments, CT-P27 aims to neutralize even those influenza viruses that have become resistant to currently existing neuraminidase inhibitors. Celltrion projects that its non-clinical and clinical studies have the potential to demonstrate CT-P27 as possible treatment of various types of influenza virus infection. Beyond biosimilar mAbs Our novel Therapeutics Beyond biosimilar mAbs, Celltrion is also developing its own novel biopharmaceuticals using the R&D capabilities and technologies it has accumulated over the years through its biosimilar development. Project Target Indication CT-P27 (mAb) Influenza virus infections CT-P26 (ADC) Breast cancer CT-P25 (cell-based vaccine) Influenza CT-P24 (mAb) Hepatitis B virus CT-P19 (mAb) Rabies In addition to CT-P26, Celltrion is developing an antibody-drug conjugate (ADC) for breast cancer. ADC’s are mAbs chemically linked to cytotoxic drug so as to minimize side effects and maximize efficacy. We are also developing an antiviral medication for pandemic and seasonal influenza which we hope will overcome the limitations of existing vaccines and synthetic drugs. NovelTherapeutics Novel therapeutics pipeline Innovation at work Our novel therapeutics pipeline
  7. 7. Contact Information Celltrion, Inc. 23, Academy-ro, Yeonsu-gu, 406-840, Incheon, South Korea T. +82-32-850-5000 F. +82-32-850-5078 Webpage. E-MAIL・Business :・Investment :・Legal :・Careers : @2016.05Celltrion