Syngene International Ltd

Syngene International Limited is an integrated research, development and manufacturing services organization serving global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Headquartered in India, the operations are driven by its highly qualified teams comprising ~6000 scientists and its state-of-the-art facilities, spread over 2.2 million sq. ft., across 3 locations in India: Bangalore, Hyderabad and Mangalore. The Company operate into 4 business divisions comprising of Discovery Services, Development Services, Manufacturing Services and the Dedicated Centers. The Company was promoted by Biocon and Kiran Mazumdar Shaw, a promoter of Biocon Limited. The Company's health-related services extend across all major therapeutic areas and modalities. It provides end-to-end services within the Contract Research Organization (CRO) and a growing range of services within the Contract Development and Manufacturing Organization (CDMO). The primary target market for these services is the pharmaceutical and biotechnology (biotech) sectors. The same scientific capabilities that serve human health also serve nutrition, animal health, consumer goods, agri-chemicals, and specialty chemical sectors. Syngene International Limited was incorporated at Bangalore in the year 1993. During the year 1994-1995, the company pioneered in CRO services for both Chemistry and Biology. During the year 2001-2002, the company acquired a new facility inclusive of a cGMP pilot plant. In March 30, 2002, the company's 99.9% equity share was transferred to Biocon and the company became a subsidiary of Biocon Ltd. During the year 2003-2004, the company introduced Process Research and Optimization Services. In October 21, 2004, the company commissioned a new research facility at Boammasandra, Bangalore. In February 15, 2006, the company commissioned new facility at Biocon Park. In August 30, 2006, the company received approval of additional facility to set up as SEZ unit from Cochin Special Economic Zone. During the year 2006-2007, Bristol- Myers Squibb had entered into a long term agreement with the company to set up an exclusive research facility to house more than 400 scientists. During the year, the company had ventured into other area of Biology viz Genetic Engineering, Protein Chemistry, and assay development. The company had developed extensive expertise in the creation of customized stable cell lines expressing proteins / receptors of intersest. During the year 2007-2008, the company entered a long term service agreement with BMS. During the year 2008-2009, the company created an alliance partnership with DuPont Crop Protection. On 21 July 2011, Syngene International and Endo Pharmaceuticals USA announced that they have signed an agreement to expand their collaboration to develop novel biological therapeutic molecules against cancer. Syngene and Endo will partner on two new discovery programmes, strengthening their ongoing alliance in cancer research. Under the agreement, Endo will retain all rights to the molecules developed, while Syngene International will receive research fees, milestone payments and success fees from Endo. On 4 June 2012, Abbott, one of India's largest healthcare companies, inaugurated its first nutrition research and development center in the country, in collaboration with Syngene International. The state-of-the-art Research and Development center will focus on the development of science-based, affordable nutrition products for the country and enable the expansion of Abbott's nutrition product portfolio. In 2012, Syngene International received ANVISA Certification of clinical facilities. During the year under review, Syngene International acquired 100% stake in Clinigene International Limited from Biocon. Syngene International crossed an annual turnover of Rs 500 crore crore in the year ended 31 March 2013. In 2013, Baxter International Inc. collaborated with Syngene International to establish the Baxter Global Research Center'. During the year under review, Syngene International's Control Testing Laboratory received acceptance from the Department of Health & Human Services, US Food and Drug Administration. On 3 June 2014, Bristol-Myers Squibb and Syngene International announced a five-year extension of their drug discovery and development collaboration in India. Financial terms were not disclosed. In 2014, Syngene International's API manufacturing facility received acceptance from Department of Health & Human Services, US Food and Drug Administration. During the year under review, Syngene International established a 75,000 sq. ft. centre to provide stability and analytical services. Syngene International made its debut on the secondary equity market on 11 August 2015. The stock debuted at Rs 295 on BSE, a premium of 18% compared to the initial public offer (IPO) price of Rs 250 per share. The Rs 550-crore Initial Public Offering (IPO) through offer for sale from its parent Biocon Ltd. received an excellent response from investors and was subscribed 32.05 times. The issue opened for subscription on 27 July 2015 and closed on 29 July 2015. In 2015, Syngene International's subsidiary Clinigene International Limited, which provides clinical research and clinical trial services, was amalgamated with Syngene International. Syngene International crossed annual turnover of Rs 1000 crore in the year ended 31 March 2016. On 6 September 2016, Syngene International announced the establishment in Bangalore, India, of an integrated, multi-disciplinary drug discovery and development center for Amgen, Inc. The state-of-the-art dedicated center will be staffed by a team of more than 100 highly qualified Syngene scientists, working in close association with Amgen researchers around the world on the discovery and development of innovative medicines. In addition to being customized to meet Amgen's functional requirements, the facility complies with the highest regulatory standards. Its design includes a range of environmentally-friendly features and flexible layouts, and is configured to minimize solvent and effluent waste with a strong emphasis on laboratory safety and 'green' chemistry. On 21 September 2016, Syngene International Ltd.and Strand Life Sciences announced that they have completed a deal through which Syngene has purchased assets of Strand Life Sciences related to systems biology, Heptox and pharma bioinformatics services. This includes target dossier business and rights to NGS data analytics and Sarchitect platforms, supported by a strong scientific team. Financial details of the deal were not disclosed. This deal gives Syngene access to Strand's patented Virtual Liver model and the NGS analytics platform. The Virtual Liver model is able to predict the toxic effect of different drugs or chemicals on the liver (both rat and human) using information from laboratory-based experiments prior to actual testing on live animals or humans. Strand NGS is an integrated platform that provides analysis, management and visualization tools for next-generation sequencing data. On 2 March 2017, Herbalife, a global nutrition company, announced the launch of its first Nutrition Research and Development Lab in India, in partnership with Syngene International. The strategic partnership will help Herbalife Nutrition develop and formulate world-class nutrition products for Indian consumers. On 27 July 2017, Syngene International announced the expansion of its research collaboration with Amgen Inc. As a result, Syngene will expand the Syngene Amgen Research & Development Center (SARC) in terms of size and scope of its operations. The expansion of SARC will be customized to meet Amgen's functional requirements and will include a range of environment-friendly features that will enable optimal utilization of the laboratory space. On 14 November 2017, Syngene International announced that it has expanded its ongoing collaboration with Bristol-Myers Squibb. The next phase of the partnership will see the addition of a new facility to support future Bristol-Myers Squibb research and development operations, an expansion of the team and the extension of the existing agreement through 2026. As part of the expansion, Syngene will set up a new dedicated facility spread across 25,000 sq. ft. of laboratory and office space for Bristol-Myers Squibb. This facility will house an additional team of 75 Syngene scientists who will work exclusively in support of Bristol-Myers Squibb. On 26 March 2018, Syngene International announced an R&D agreement with GSK, a science-led global healthcare company. The multiyear agreement will focus on accelerating the discovery of new drug candidates using Syngene's discovery services platforms. As part of the agreement, Syngene will set-up a customized discovery research laboratory to support projects across several therapeutic areas. A team of Syngene scientists will work closely with GSK's global R&D teams on discovery research projects to identify new drug candidates with the potential to address some of the world's most pressing healthcare needs. On 30 May 2018, Syngene International announced that the company has entered into a non-exclusive partnering agreement with Zumutor Biologics, an emerging immuno-oncology company, to access Zumutor's proprietary human phage/yeast display library. This collaboration further enhances Syngene's market-leading capabilities in Discovery Biology, providing its scientists with additional tools to help solve complex biology problems in biotherapeutic drug discovery. Under the terms of the agreement, Syngene will screen target antigens against Zumutor's proprietary human antibody libraries to identify and characterize novel antibody clones, which will be further developed by Syngene towards novel biotherapeutics programs for its partners During year 2018-19, the Company commissioned Phase I of its upgraded S2 facility, which brings on board 105,000 sq. ft of space. The Company's Dedicated R&D Centres gained from the extension of the multi-year agreement up to 2024 with Baxter Healthcare Corporation, a global healthcare company. In line with the revised agreement, a new laboratory was commissioned, and the strength of the scientific team supporting Baxter was increased. In line with the contract expansion and extension with Bristol-Myers Squibb (BMS), a multinational pharmaceutical company, Syngene commissioned a new research facility spread across 25,000 sq. ft. of laboratory and office space during the year. The Amgen dedicated centre houses around 75 Syngene scientists. The Company completed the development and clinical supplies manufacturing of a drug product for Amgen. The Company's research collaboration with GSK, signed in FY18, became operational during the year. In year 2019-20, the Company developed and validated a Human Papilloma Virus (HPV) assay, a test system increasingly being used for cervical cancer screening. During year 2020-21, the Company commissioned the first phase of new R&D centre in Hyderabad. It commenced API manufacturing facility in Mangaluru and expanded the R&D facility in Bengaluru. Two 2KL bioreactors were commissioned during the year and a microbial manufacturing facility was set up, to strengthen biologics manufacturing capacity. During year 2021-22, the Company expanded its research facilities in Bangalore and Hyderabad. As part of the third phase of expansion, capacity for 300 scientists was added in Hyderabad, taking the total capacity to around 600 scientists. It also invested in enhancing its scientific capabilities to both sustain as a service provider for fully integrated therapeutic discovery. The Research Informatics unit launched a drug discovery informatics platform to empower the scientists with project information and tools to generate and evaluate hypotheses. The Company signed a five-year agreement with IAVI1 , a USAbased, non-profit, scientific research organization to develop and manufacture three recombinant, monoclonal antibodies (mAbs) for Human Immunodeficiency Virus (HIV). A cGMP microbial manufacturing facility with 500-liter capacity was commissioned in 2021. A fourth additional 2,000-liter single-use bioreactor was introduced to the mammalian biologics facility. During the year 2022-23, Syngene's second campus in Discovery Chemistry operations in Hyderabad grew to over 900 scientists. It commissioned a new PROTAC lab in Hyderabad; commissioned a kilo lab to expedite formulation and process development work and a state-of-the-art sterile Fill-Finish facility for smallscale clinical manufacturing; commissioned the advancement of Amgen's R&D projects. In FY23, the Company launched new differentiated platforms such as SynTACs (targeted degradation), SARchitect (data analysis and virtual collaboration), and SynTIPS (data analysis related to biological targets and pathways). Additionally, existing platforms, Syn.AI (AI-enhanced therapeutic R&D) and SynVent (integrated drug discovery), were enhanced further. The construction of a state-of-the-art, fillfinish facility for sterile injectable drugs was commissioned. The commercial manufacturing of drug substance for Zoetis was started. In addition to growing capabilities in monoclonal antibodies, the portfolio expanded for GMP manufacturing of plasmid DNA and mRNA.