The document provides an investor presentation for Biocon, an emerging global biopharmaceutical company based in India. It discusses Biocon's vision, business structure, product portfolio including branded formulations in India, research and development pipeline including potential new molecules and biosimilars. It also outlines strategic partnerships with Pfizer and Mylan to commercialize biosimilar insulins and monoclonal antibodies globally. Financial highlights show strong revenue and profit growth over the past years and in the first half of fiscal year 2012.
The document discusses Biocon, an Indian biopharmaceutical company. It summarizes Biocon's business structure and holdings, product portfolio including branded formulations, insulin business in India, and strategic partnerships. Notably, Biocon has entered a global commercialization partnership with Pfizer for biosimilar versions of insulin and insulin analogs, which provides upfront and milestone payments totaling $350 million to Biocon.
The document provides an investor presentation for Biocon, an emerging global biopharmaceutical company. In 3 sentences:
Biocon has a portfolio approach across small molecules, biosimilars, branded formulations and novel molecules. It has strategic partnerships for commercialization and research. Financial highlights showed steady revenue and profit growth over 2008-2011, with revenues reaching $402 million and net profit of $74 million in fiscal year 2011.
The document provides an overview of Biocon's business including:
1) Biocon is an emerging global biopharmaceutical company focused on developing affordable therapies for chronic diseases like diabetes and cancer.
2) In FY2012, Biocon saw 16% revenue growth and a 27% EBITDA margin, initiated several clinical trials, and formed new strategic partnerships.
3) Biocon has a diversified portfolio spanning small molecules, branded formulations, biosimilars, and research services.
The document provides an overview of Biocon's financial and operational performance in FY2012, highlighting 16% revenue growth and margins of 27% and 16%. It discusses Biocon's focus on developing affordable biologics and biosimilars through strategic partnerships, as well as its leadership in the Indian insulin market. Biocon is committed to reducing therapy costs for chronic diseases through innovation and global access.
The document provides profiles of students enrolled in the MBA program at NIPER, including their summer training experiences and credit seminar topics. It lists the names of over 20 students, the organizations they did their summer training at, and the topics of their credit seminars, which generally relate to the pharmaceutical industry. The profiles demonstrate the diverse experiences and areas of focus of NIPER's MBA students.
“Comparability of biotherapeutic products following manufacturing process improvement. Quality aspects and comparability issues”
Focuses on improvements in manufacturing processes of biotherapeutics
Cipher Pharmaceuticals is a drug development company focused on commercializing formulations of marketed molecules using advanced drug delivery technologies. It has three products in its portfolio, including Lipofen which is currently on the US market. CIP-TRAMADOL ER received FDA approval and is expected to launch in early 2011, while CIP-ISOTRETINOIN is in its final Phase III trial and expected to launch in 2012. Cipher's business model involves in-licensing products, advancing them through clinical trials, and then out-licensing them to international partners once approved to generate royalty streams.
This document provides an executive summary of key information about biosimilars, biogenerics, and follow-on biologics. It discusses how biosimilars represent one of the most rapidly evolving areas in the pharmaceutical industry as patents on the first generation of biopharmaceuticals expire. The EU has legislation in place for biosimilar approval, while the US is working to pass similar legislation. The report profiles 15 companies involved in biosimilars development and forecasts that the global biosimilars market will grow from $30 million in 2006 to $3.2 billion in 2011, with Europe leading the way. It also summarizes the document's coverage of potential biosimilar targets, scientific and regulatory issues
The document discusses Biocon, an Indian biopharmaceutical company. It summarizes Biocon's business structure and holdings, product portfolio including branded formulations, insulin business in India, and strategic partnerships. Notably, Biocon has entered a global commercialization partnership with Pfizer for biosimilar versions of insulin and insulin analogs, which provides upfront and milestone payments totaling $350 million to Biocon.
The document provides an investor presentation for Biocon, an emerging global biopharmaceutical company. In 3 sentences:
Biocon has a portfolio approach across small molecules, biosimilars, branded formulations and novel molecules. It has strategic partnerships for commercialization and research. Financial highlights showed steady revenue and profit growth over 2008-2011, with revenues reaching $402 million and net profit of $74 million in fiscal year 2011.
The document provides an overview of Biocon's business including:
1) Biocon is an emerging global biopharmaceutical company focused on developing affordable therapies for chronic diseases like diabetes and cancer.
2) In FY2012, Biocon saw 16% revenue growth and a 27% EBITDA margin, initiated several clinical trials, and formed new strategic partnerships.
3) Biocon has a diversified portfolio spanning small molecules, branded formulations, biosimilars, and research services.
The document provides an overview of Biocon's financial and operational performance in FY2012, highlighting 16% revenue growth and margins of 27% and 16%. It discusses Biocon's focus on developing affordable biologics and biosimilars through strategic partnerships, as well as its leadership in the Indian insulin market. Biocon is committed to reducing therapy costs for chronic diseases through innovation and global access.
The document provides profiles of students enrolled in the MBA program at NIPER, including their summer training experiences and credit seminar topics. It lists the names of over 20 students, the organizations they did their summer training at, and the topics of their credit seminars, which generally relate to the pharmaceutical industry. The profiles demonstrate the diverse experiences and areas of focus of NIPER's MBA students.
“Comparability of biotherapeutic products following manufacturing process improvement. Quality aspects and comparability issues”
Focuses on improvements in manufacturing processes of biotherapeutics
Cipher Pharmaceuticals is a drug development company focused on commercializing formulations of marketed molecules using advanced drug delivery technologies. It has three products in its portfolio, including Lipofen which is currently on the US market. CIP-TRAMADOL ER received FDA approval and is expected to launch in early 2011, while CIP-ISOTRETINOIN is in its final Phase III trial and expected to launch in 2012. Cipher's business model involves in-licensing products, advancing them through clinical trials, and then out-licensing them to international partners once approved to generate royalty streams.
This document provides an executive summary of key information about biosimilars, biogenerics, and follow-on biologics. It discusses how biosimilars represent one of the most rapidly evolving areas in the pharmaceutical industry as patents on the first generation of biopharmaceuticals expire. The EU has legislation in place for biosimilar approval, while the US is working to pass similar legislation. The report profiles 15 companies involved in biosimilars development and forecasts that the global biosimilars market will grow from $30 million in 2006 to $3.2 billion in 2011, with Europe leading the way. It also summarizes the document's coverage of potential biosimilar targets, scientific and regulatory issues
Medgenics presented an overview of their Biopump technology for sustained protein delivery and their lead product candidates. The Biopump uses skin tissue to continuously produce and deliver therapeutic proteins from a patient's own skin for 6-36 months to treat chronic diseases like anemia, hepatitis, and hemophilia. Clinical trials have demonstrated sustained protein levels and disease treatment for this duration from a single treatment. Medgenics' experienced management team is advancing lead programs in Phase I/II trials while pursuing strategic partnerships for their disruptive platform technology addressing large markets exceeding $130 billion annually.
CorMedix Inc. (AMEX:CRMD) is a pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease.
The Ayurvedic Pharmacopoeia of India is the official book of standards for single drugs and formulations in Ayurveda. It was established in 1962 and provides standards for identity, purity, strength and quality to ensure uniformity of finished formulations. It has published 8 volumes describing over 500 single drugs and 635 compound formulations. The Pharmacopoeia Laboratory for Indian Medicines was established in 2010 to analyze samples and provide reference standards to help regulate quality in Ayurvedic medicines.
Innovative Science Affordable Medicine - JP Morgan_Biocon Health Conference J...Biocon
Biocon is an emerging global biopharmaceutical company focused on developing affordable products for patients worldwide. It presented on its research and product pipeline at the JP Morgan Healthcare Conference. It has a risk-balanced approach developing generics, biosimilars, novel molecules, and branded formulations. It is leveraging emerging markets which offer high growth opportunities, with 50% of its current revenues coming from emerging markets. Its product pipeline includes several biosimilars including insulin analogs, monoclonal antibodies, and novel molecules like Itolizumab which is in Phase III trials in India for the treatment of psoriasis.
This document discusses the rise of biopharmaceuticals and monoclonal antibodies. It notes key milestones in the pharmaceutical industry including the discovery of insulin in the 1920s and the development of genetic engineering in the 1970s. The document highlights that biological therapeutics now lead the pharmaceutical industry, with the top 5 drugs being biopharmaceuticals and 50% of the top 100 drugs being biopharmaceuticals. It also discusses the complexities of developing biopharmaceuticals and monoclonal antibodies due to their large molecular size and dependence on living systems for production. The challenges of developing biosimilars that are similar but not identical to original biologics are also outlined.
The document provides tips for quitting tobacco use. It recommends making a plan to quit on a specific date and getting support. Withdrawal symptoms like cravings can occur for weeks after quitting. Nicotine replacements can help with cravings. Tips include avoiding places one used tobacco, keeping busy, and remembering the health benefits of quitting like reduced risk of heart attack and improved circulation and taste. It encourages trying again if the first attempt at quitting fails.
Q4 & FY13 Post Earnings Conference Call April 26, 2013Biocon
The document is a transcript of Biocon's Q4 & FY13 earnings conference call. Key points include:
- Group sales grew 18% to Rs. 2,428 Crores, with strong growth in Research Services (36% to Rs. 557 Crores) and Healthcare (34% to Rs. 348 Crores).
- Group net profit grew over 50% to Rs. 509 Crores due to exceptional income from re-licensing generic insulin analogs to Mylan.
- Biocon extended its partnership with Mylan for generic insulin analogs, which significantly reduces Biocon's development costs and changes the profit sharing structure.
- The reading of Q4 numbers was impacted by exceptional income and
Understanding heart attacks and strokes - by World Health OrganizationBiocon
Heart attacks and strokes are major killers worldwide that are often preventable. A heart attack occurs when blood flow to the heart is blocked, damaging heart muscle, while a stroke happens when blood flow to the brain is interrupted. Both are usually caused by a buildup of fatty deposits in arteries from smoking, an unhealthy diet, and lack of exercise over many years. Taking steps to address risk factors like maintaining a healthy lifestyle can help prevent these conditions.
Integrative Research In Oncology On May 15, 2012Biocon
On May 15, 2012, Biocon held a symposium on integrative research in oncology at their research center. Key speakers at the event included the director of the Koch Institute for Integrative Cancer Research, the president of R&D at Biocon, and professors from Harvard Medical School. Panel discussions were held on topics such as translational research with marketed oncology products and personalized cancer treatment approaches.
1) Alzumab, an antibody developed by Biocon Ltd to treat psoriasis, showed promising results in clinical trials, effectively treating a patient's psoriasis within 8 weeks.
2) Alzumab works through the Th17 immune pathway and has the potential to treat over 100 autoimmune diseases. It was launched in India to treat psoriasis in August 2013.
3) Biocon's development of Alzumab was a breakthrough for the company and Indian innovation, as it was developed through a decade-long process and may establish credibility for Indian clinical research.
Tobacco use, unhealthy diet, and physical inactivity increase the risk of heart attacks and strokes by leading to high blood pressure, high blood sugar, and high blood fats. These physical problems accelerate the narrowing and hardening of arteries. The document recommends preventing these risks through a healthy lifestyle of not smoking, eating a nutritious diet low in fat and salt, and exercising regularly. Maintaining these habits and seeing a doctor annually can significantly reduce the chances of heart attack and stroke.
What are the signs of stroke and what should you doBiocon
Strokes can occur suddenly and cause weakness or numbness on one side of the body, confusion, vision problems, or severe headaches. If someone shows stroke symptoms, call for emergency help immediately. Doctors use scans to diagnose the type of stroke and treat it with medicines to reduce symptoms and prevent future strokes. Rehabilitation after a stroke helps patients regain abilities and adjust to disabilities through exercises and therapies. Adopting a healthy lifestyle and strictly following medical treatment can help prevent additional strokes.
Este documento presenta los ganadores de los trabajos de Navidad realizados por los alumnos de la Asociación de Madres y Padres “San Vicente de Paul” del Colegio San José Infantil Primaria E.S.O Bachiller. Se enumeran los ganadores y segundos premios de cada categoría: Infantil, Primaria 1, Primaria 2 y E.S.O Bachiller.
Psoriasis is a chronic skin condition caused by genetic and environmental factors. It is characterized by red, scaly patches on the skin. While there is no way to prevent psoriasis, patients can help prevent flare ups by maintaining a healthy lifestyle and avoiding triggers. Treatments range from topical creams and drugs to phototherapy and biological treatments. Biological treatments are very effective but also expensive, while other traditional systems like homeopathy and ayurveda may also help if the treatment is genuine.
- Biocon delivered 23% year-over-year revenue growth in the first half of FY2013, driven by growth across business verticals like biopharmaceuticals and branded formulations.
- Net profit grew 8% to Rs. 169 Crores compared to the same period last year, despite a 54% increase in research and development spending and higher costs.
- Interim results from a Phase III trial of Biocon's biosimilar rh-Insulin in Europe showed comparable efficacy and safety to the innovator product.
The document provides an investor presentation for Biocon, an emerging global biopharmaceutical company. It discusses Biocon's vision, business structure, product portfolio including branded formulations in India where it has the number 1 or 2 market share for several drugs. The presentation outlines Biocon's research and development efforts including its pipeline of novel molecules and biologics in diabetes, oncology and immunology. Key pipeline programs discussed are Itolizumab in Phase 3 for rheumatoid arthritis, IN-105 for oral insulin, and partnerships for strategic alliances.
Canara Bank, Biocon Foundation and OTTET join hands to strengthen Healthcare ...Biocon
Canara Bank, Biocon Foundation, and OTTET have formed a public-private partnership to strengthen healthcare delivery in Odisha, India. Under this partnership, Biocon Foundation and OTTET will set up electronic diagnostic facilities and e-Health centers at primary health centers in Odisha managed by local entrepreneurs provided financial assistance from Canara Bank. This model aims to improve access to quality healthcare for rural communities by providing diagnostics, telemedicine consultations, and maintaining electronic health records.
Medgenics presented an overview of their Biopump technology for sustained protein delivery and their lead product candidates. The Biopump uses skin tissue to continuously produce and deliver therapeutic proteins from a patient's own skin for 6-36 months to treat chronic diseases like anemia, hepatitis, and hemophilia. Clinical trials have demonstrated sustained protein levels and disease treatment for this duration from a single treatment. Medgenics' experienced management team is advancing lead programs in Phase I/II trials while pursuing strategic partnerships for their disruptive platform technology addressing large markets exceeding $130 billion annually.
CorMedix Inc. (AMEX:CRMD) is a pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease.
The Ayurvedic Pharmacopoeia of India is the official book of standards for single drugs and formulations in Ayurveda. It was established in 1962 and provides standards for identity, purity, strength and quality to ensure uniformity of finished formulations. It has published 8 volumes describing over 500 single drugs and 635 compound formulations. The Pharmacopoeia Laboratory for Indian Medicines was established in 2010 to analyze samples and provide reference standards to help regulate quality in Ayurvedic medicines.
Innovative Science Affordable Medicine - JP Morgan_Biocon Health Conference J...Biocon
Biocon is an emerging global biopharmaceutical company focused on developing affordable products for patients worldwide. It presented on its research and product pipeline at the JP Morgan Healthcare Conference. It has a risk-balanced approach developing generics, biosimilars, novel molecules, and branded formulations. It is leveraging emerging markets which offer high growth opportunities, with 50% of its current revenues coming from emerging markets. Its product pipeline includes several biosimilars including insulin analogs, monoclonal antibodies, and novel molecules like Itolizumab which is in Phase III trials in India for the treatment of psoriasis.
This document discusses the rise of biopharmaceuticals and monoclonal antibodies. It notes key milestones in the pharmaceutical industry including the discovery of insulin in the 1920s and the development of genetic engineering in the 1970s. The document highlights that biological therapeutics now lead the pharmaceutical industry, with the top 5 drugs being biopharmaceuticals and 50% of the top 100 drugs being biopharmaceuticals. It also discusses the complexities of developing biopharmaceuticals and monoclonal antibodies due to their large molecular size and dependence on living systems for production. The challenges of developing biosimilars that are similar but not identical to original biologics are also outlined.
The document provides tips for quitting tobacco use. It recommends making a plan to quit on a specific date and getting support. Withdrawal symptoms like cravings can occur for weeks after quitting. Nicotine replacements can help with cravings. Tips include avoiding places one used tobacco, keeping busy, and remembering the health benefits of quitting like reduced risk of heart attack and improved circulation and taste. It encourages trying again if the first attempt at quitting fails.
Q4 & FY13 Post Earnings Conference Call April 26, 2013Biocon
The document is a transcript of Biocon's Q4 & FY13 earnings conference call. Key points include:
- Group sales grew 18% to Rs. 2,428 Crores, with strong growth in Research Services (36% to Rs. 557 Crores) and Healthcare (34% to Rs. 348 Crores).
- Group net profit grew over 50% to Rs. 509 Crores due to exceptional income from re-licensing generic insulin analogs to Mylan.
- Biocon extended its partnership with Mylan for generic insulin analogs, which significantly reduces Biocon's development costs and changes the profit sharing structure.
- The reading of Q4 numbers was impacted by exceptional income and
Understanding heart attacks and strokes - by World Health OrganizationBiocon
Heart attacks and strokes are major killers worldwide that are often preventable. A heart attack occurs when blood flow to the heart is blocked, damaging heart muscle, while a stroke happens when blood flow to the brain is interrupted. Both are usually caused by a buildup of fatty deposits in arteries from smoking, an unhealthy diet, and lack of exercise over many years. Taking steps to address risk factors like maintaining a healthy lifestyle can help prevent these conditions.
Integrative Research In Oncology On May 15, 2012Biocon
On May 15, 2012, Biocon held a symposium on integrative research in oncology at their research center. Key speakers at the event included the director of the Koch Institute for Integrative Cancer Research, the president of R&D at Biocon, and professors from Harvard Medical School. Panel discussions were held on topics such as translational research with marketed oncology products and personalized cancer treatment approaches.
1) Alzumab, an antibody developed by Biocon Ltd to treat psoriasis, showed promising results in clinical trials, effectively treating a patient's psoriasis within 8 weeks.
2) Alzumab works through the Th17 immune pathway and has the potential to treat over 100 autoimmune diseases. It was launched in India to treat psoriasis in August 2013.
3) Biocon's development of Alzumab was a breakthrough for the company and Indian innovation, as it was developed through a decade-long process and may establish credibility for Indian clinical research.
Tobacco use, unhealthy diet, and physical inactivity increase the risk of heart attacks and strokes by leading to high blood pressure, high blood sugar, and high blood fats. These physical problems accelerate the narrowing and hardening of arteries. The document recommends preventing these risks through a healthy lifestyle of not smoking, eating a nutritious diet low in fat and salt, and exercising regularly. Maintaining these habits and seeing a doctor annually can significantly reduce the chances of heart attack and stroke.
What are the signs of stroke and what should you doBiocon
Strokes can occur suddenly and cause weakness or numbness on one side of the body, confusion, vision problems, or severe headaches. If someone shows stroke symptoms, call for emergency help immediately. Doctors use scans to diagnose the type of stroke and treat it with medicines to reduce symptoms and prevent future strokes. Rehabilitation after a stroke helps patients regain abilities and adjust to disabilities through exercises and therapies. Adopting a healthy lifestyle and strictly following medical treatment can help prevent additional strokes.
Este documento presenta los ganadores de los trabajos de Navidad realizados por los alumnos de la Asociación de Madres y Padres “San Vicente de Paul” del Colegio San José Infantil Primaria E.S.O Bachiller. Se enumeran los ganadores y segundos premios de cada categoría: Infantil, Primaria 1, Primaria 2 y E.S.O Bachiller.
Psoriasis is a chronic skin condition caused by genetic and environmental factors. It is characterized by red, scaly patches on the skin. While there is no way to prevent psoriasis, patients can help prevent flare ups by maintaining a healthy lifestyle and avoiding triggers. Treatments range from topical creams and drugs to phototherapy and biological treatments. Biological treatments are very effective but also expensive, while other traditional systems like homeopathy and ayurveda may also help if the treatment is genuine.
- Biocon delivered 23% year-over-year revenue growth in the first half of FY2013, driven by growth across business verticals like biopharmaceuticals and branded formulations.
- Net profit grew 8% to Rs. 169 Crores compared to the same period last year, despite a 54% increase in research and development spending and higher costs.
- Interim results from a Phase III trial of Biocon's biosimilar rh-Insulin in Europe showed comparable efficacy and safety to the innovator product.
The document provides an investor presentation for Biocon, an emerging global biopharmaceutical company. It discusses Biocon's vision, business structure, product portfolio including branded formulations in India where it has the number 1 or 2 market share for several drugs. The presentation outlines Biocon's research and development efforts including its pipeline of novel molecules and biologics in diabetes, oncology and immunology. Key pipeline programs discussed are Itolizumab in Phase 3 for rheumatoid arthritis, IN-105 for oral insulin, and partnerships for strategic alliances.
Canara Bank, Biocon Foundation and OTTET join hands to strengthen Healthcare ...Biocon
Canara Bank, Biocon Foundation, and OTTET have formed a public-private partnership to strengthen healthcare delivery in Odisha, India. Under this partnership, Biocon Foundation and OTTET will set up electronic diagnostic facilities and e-Health centers at primary health centers in Odisha managed by local entrepreneurs provided financial assistance from Canara Bank. This model aims to improve access to quality healthcare for rural communities by providing diagnostics, telemedicine consultations, and maintaining electronic health records.
India's first Int'l Conference on Best Practices in Pharma Microbiology Biocon
This is the first time that Pharmig, an international Pharmaceutical Microbiology think tank based out of the UK is organizing a conference on the "Best Practices in Pharma Microbiology" for the first time in India. You can register
by sending an email to maxine@pharmig.org.uk. For booking a seat for the conference, please visit: http://bit.ly/1J4gtLh
Q1FY14: Biocon Delivers a Healthy Growth of 22% driven by strong traction in ...Biocon
Biocon delivered 22% revenue growth in Q1 FY14 driven by strong performance in its biopharma business. Revenues were ₹723 crores with EBITDA of ₹175 crores and PAT of ₹94 crores. The company's insulin business continues to grow due to an increased geographic footprint in emerging markets. Research services also grew at 26% due to increased demand for integrated services. Biocon plans to launch its second novel biologic, Alzumab, for the treatment of psoriasis in India in the current fiscal year.
The document provides an investor presentation for Biocon from September 2011. It summarizes Biocon as an emerging global biopharmaceutical company focused on developing affordable therapies. It discusses Biocon's business structure, product portfolio across areas like diabetes, oncology and biosimilars. The presentation outlines Biocon's research and development pipeline including oral insulin and monoclonal antibody programs. It also describes Biocon's strategic partnerships with companies like Pfizer, Mylan, Amylin and others. Financial highlights show Biocon's revenues growing over 2008-2011 time period with contributions from areas like research services, branded formulations and biosimilars.
- Biocon is an emerging global biopharmaceutical company focused on developing affordable biologic drugs and biosimilars.
- It has several growth segments including small molecules, biosimilars, novel biologics, and research services.
- Biocon partners with other companies for drug development and commercialization to leverage its capabilities and for global access.
- In 9M FY13, Biocon saw revenue growth of 23% and EBITDA growth driven by performance across business segments.
The document provides results and highlights from Biocon for fiscal year 2012. It discusses Biocon's 16% revenue growth to Rs. 2,148 crores and EBITDA and PAT margins of 27% and 16% respectively. It outlines Biocon's research and development efforts including positive results from a phase 3 clinical trial of Itolizumab for psoriasis. It also discusses Biocon's partnerships with Mylan for biosimilar monoclonal antibodies and its biosimilars portfolio including insulin products in clinical trials. The financial highlights section shows Q4 and full year 2012 results.
1) The Chairman discussed Biocon's focus on developing affordable biopharmaceuticals to make healthcare more accessible globally through five growth verticals.
2) These verticals include small molecules, biosimilars, branded formulations, novel molecules, and integrated research services. Biosimilars and insulin formulations are seen as major growth opportunities.
3) Biocon is augmenting manufacturing, R&D, and marketing capabilities to pursue strong sustainable growth through a new facility in Malaysia and an R&D center in Bangalore. Clinical trials show promise for biosimilar molecules in development.
The Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of generic demand in the US, and 25% of medicine in the UK. It is dominated by small and medium enterprises, though the largest 250 companies control 70% of the Indian market. India has gained prominence as the pharmacy of the world and biggest generic supplier due to its innovatively engineered generic drugs and active pharmaceutical ingredients. It accounts for around 30% of the $70-80 billion US generics market by volume and 10% by value.
There are several methods for delivering insulin to diabetics, including syringes, insulin pens, insulin pumps, and inhaled insulin. Insulin pumps mimic the pancreas by providing a continuous basal insulin dose throughout the day and additional bolus doses when meals are eaten. The number of diabetic patients in India is increasing and insulin delivery systems represent a growing market opportunity in the country.
This document discusses biosimilars and their manufacturing and regulation. It defines biosimilars as biological products that are similar but not identical to already approved biologics. Their manufacturing involves analyzing the reference product and replicating its structure through living cell cultures. Biosimilars undergo clinical trials to demonstrate similarity in safety and efficacy. Regulatory approval requires demonstrating comparability to the reference product. Issues include potential differences in efficacy and immunogenicity compared to the reference product.
The document discusses the importance of pharmacovigilance for biotherapeutic medicines. It notes that biotherapeutics are more complex and difficult to characterize than traditional small molecule drugs due to their large size and biological production processes. This underscores the importance of specific traceability for biotherapeutics in pharmacovigilance activities. The document recommends that the WHO work to develop global naming recommendations for biotherapeutics to facilitate accurate tracking and tracing of products and linkage of adverse events to the appropriate product. It also discusses new EU legislation requiring identification of biotherapeutics by brand name and batch number in adverse event reporting.
This document provides an overview of biosimilars including their definition, categories, development principles, and regulatory approval process. Biosimilars are biological products that are highly similar to an existing approved biologic reference product. They are developed through a stepwise comparative process to demonstrate similarity in terms of safety, purity and potency. Some key points covered include:
- Biosimilars are large protein therapeutics derived from living organisms unlike traditional small molecule drugs.
- They include categories like hormones, monoclonal antibodies, and recombinant proteins.
- Their development follows principles of extensive characterization studies comparing them to the reference product.
- In India, biosimilars require approval through the regulatory pathway overseen by authorities
This document summarizes guidelines for biosimilars in India. It begins by defining biosimilars as biologic compounds that are similar but not identical to reference biopharmaceuticals. It then discusses several biosimilar drugs used in cancer treatment such as G-CSF, interferons, and epoetins. While biosimilars have similar mechanisms of action, differences in manufacturing can result in differences in properties. The document concludes by outlining Indian regulatory guidelines for biosimilar approval and the importance of post-marketing safety monitoring to evaluate potential differences from reference drugs.
This document discusses biosimilars, which are biologic medications that are similar but not identical to an original biologic reference medication. It provides background on biosimilars and regulatory guidelines around them. Specifically, it notes that biosimilars take 6-9 years to develop compared to 3 years for generics, and that they require clinical trials to demonstrate safety and efficacy compared to the reference medication. The document also discusses biosimilar guidelines in India and examples of biosimilars used in cancer treatment, noting some differences between biosimilar versions of medications like G-CSF and interferons.
1) The document discusses the concept of biosimilars, including their definition as biological products that are similar but not identical to an approved biologic in terms of quality, safety and efficacy.
2) It provides an overview of the regulatory approval pathways for biosimilars in the European Union, United States, and India, which generally require demonstrating biosimilarity through comparative clinical and non-clinical studies.
3) The production of biologics is more complex than small molecule drugs due to biologics' larger size, more complex structures, instability, and potential microheterogeneity.
The document discusses Pfizer's plans to create the world's premier biopharmaceutical company through acquiring Wyeth. The acquisition will strengthen Pfizer's leadership in key areas like biologics and vaccines, expand its portfolio of growth drivers, and enhance its scientific and manufacturing capabilities. It analyzes how the acquisition advances Pfizer's strategic objectives such as becoming a leader in biologics, entering the vaccines market, and expanding in emerging markets. Charts show how the combined company will have a more diversified portfolio of therapies and platforms.
This document outlines Pfizer's plans to acquire Wyeth to create the world's premier biopharmaceutical company. The acquisition will diversify Pfizer's portfolio and strengthen its leadership in key therapeutic areas and geographies. Pfizer expects the deal to advance its strategic priorities and deliver $2 billion in cost savings by 2011 on top of $4 billion in synergies from the transaction. The all-cash-and-stock deal is valued at $68 billion and will be funded through cash, debt, and Pfizer stock.
The document discusses various techniques for formulating and delivering biological products, including lyophilization, spray drying, and vacuum drying. It notes that biologicals are delicate, complex macromolecules that require specialized formulation and processing to maintain stability compared to conventional small molecule drugs. The challenges include physical and chemical instability due to weak non-covalent interactions, as well as susceptibility to degradation from temperature, moisture, oxidation, and other environmental factors. Proper formulation design is needed to protect biological activity and structure during production, packaging, storage and delivery.
Biocon - Key updates and events
1. Biopharma posts robust revenue growth: 15% YoY
2. Statins: Strong growth in Q2; robust sales of Simvastatin and Pravastatin
3. Focus on improving operational efficiencies to augment capacities
4. Our biosimilar co-marketing Insulins partner, Pfizer has launched in the Indian markets.
Biocon is India's largest biopharmaceutical company, established in 1978. It has grown from an enzyme manufacturing unit to a fully integrated biopharmaceutical enterprise. Biocon has shown strong financial performance over the years, with increasing profits and revenues. However, it has also faced some ethical criticisms over unapproved clinical trials that led to deaths and not following proper procedures. While Biocon's work in biotechnology is innovative, it must focus on conducting all activities ethically to ensure patient safety and trust in its products.
Biocon provides an investor presentation summarizing its business operations and financial performance. It discusses its focus on developing biosimilars and biologics through research and development efforts. However, it notes that forward-looking statements in the presentation are subject to risks and uncertainties. The presentation provides an overview of Biocon's business segments and product portfolio, and highlights its financial results for the first quarter of the 2014 fiscal year which showed growth across key metrics.
Biosimilars are biological drugs that are similar to already approved biologic reference drugs. They are produced through biotechnology methods involving genetic engineering. While biosimilars hold promise to increase access to biologic treatments, they differ from traditional generics in important ways due to the complex nature of biologics. Biosimilars must undergo rigorous testing and demonstration of similarity to the reference product to ensure similar safety and efficacy profiles. Regulatory frameworks for approving biosimilars have been established by the EMA and FDA, with guidelines outlining requirements for comprehensive characterization, clinical trials, and pharmacovigilance to ensure patient safety.
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This document announces job openings for several positions at a location in Bangalore, India. It provides requirements for Fill Finish Production, Insulin Production, Engineering & Maintenance, and Instrumentation roles. All positions require experience in a pharmaceutical or healthcare setting and working in shifts. Candidates should bring documentation to an interview at a hotel in Indore, Madhya Pradesh.
Walk-in Drive at Aurangabad, Maharashtra on Oct 23, 2016Biocon
Walk-in drive at Aurangabad for positions in Fill finish Production, Fill finish Packing, Engineering & Maintenance, Instrumentation, Insulin Production and Packing inspection.
Date: Oct 23, Sunday (9AM-2PM)
Venue: The Salt, MGM-Sports Club & Stadium, Behind MGM Hospital, N-6 CIDCO, MGM Campus, Aurangabad, 431003
#Job #Recruitment #Biotechnology #Hiring
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The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
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This document provides information about a walk-in interview being held by Biocon Limited in Hyderabad for various positions at their API, Biosimilars, and Injectable facilities in Bangalore. The walk-in will take place on May 22nd, 2016 from 9:00AM to 2:00PM at the Hotel Sree Krishnaa Grand in Hyderabad. Candidates should bring the required documents and register online. A number of positions are listed along with their required qualifications and experience.
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Biocon Walk In at Vishakhapatnam
Venue: -
Integral Institute of Advanced Management (IIAM)
Plot Not 10, Sector 7, MVP Colony, Visakhapatnam - 530 017.
Landmark: Near to CBI Office
Date: Sunday, 22nd May 2016. Time: 9:00AM- 02:00PM
Biocon organizing walk-in interviews at Don Bosco College, Margao, GoaBiocon
Biocon Limited is India's premier biopharma company focused on delivering affordable healthcare globally. It has evolved into an emerging global enterprise serving over 100 partners and customers in 100+ countries. Biocon is ranked #6 among the top 20 global biotech employers by Science Magazine in 2013.
Biocon is looking for experienced professionals for their injectable facilities in Bangalore. Positions include Junior Executive/Executive/Senior Executive/Assistant Manager in Production, Junior Executive/Executive/Senior Executive in Engineering & Maintenance, and Executive/Senior Executive in Validation & Compliance. Candidates should bring documents including photos, CVs, educational and work experience certificates to the walk-in on December 13, 2015 in Margao
Biocon Walkin Interviews Hyderabad 29th November 2015Biocon
All available positions are Bangalore based. This document contains details of the Walkin Interviews scheduled to be held in Hyderabad on the 29th of November, Sunday.Refer this document for available positions and mandatory documents including venue details. Interested candidates can register themselves by clicking here: http://bit.ly/1lNUQGG
New Candidate Registration & Application Process: Navigation from Biocon.comBiocon
To apply for a job at Biocon Ltd., candidates must first create a profile by registering with a username and password. They can then search for suitable jobs, select one, and complete the application in the applicant cockpit. Alternatively, candidates can log in if they already have a profile and search for jobs or continue building their profile before applying. The registration and application process is designed to help candidates create a profile and apply for jobs on the corporate website.
Biocon Bio Waste Disposal Company Statement Biocon
This is the official company statement regarding the trucks carrying waste from Biocon to Terra Firma for disposal as per Pollution Control Board Norms
This document provides details about the available positions for the Biocon Walk In Interviews scheduled to be held on the 28th of June, 2015. Candidates who are unable to attend the Walk In Interviews, are required to register
themselves on the careers page: http://bit.ly/1TRkJ53
Biocon provides an investor presentation summarizing its business segments and financial performance. It operates in small molecules, biosimilars, branded formulations, research services, and novel molecules. Revenues have grown from $318 million in FY10 to $487 million in FY14. In Q1 FY15, revenues were $124 million. Biosimilars and research services represent key growth opportunities, while it continues developing a pipeline of novel molecules.
Indeed, we have changed the paradigm. Take a look at how we performed in the past year and what were the major developments of the past year. Also, gain an understanding of how we intend to take Biocon to the next level.
Biocon is India's premier biopharma company focused on delivering affordable healthcare globally. It has facilities in Bangalore looking to hire skilled professionals. Positions include production roles in MAbs, fill finish, fermentation, insulin and GPP requiring diplomas or degrees in engineering, chemistry or biotechnology with relevant experience. Other roles include instrumentation, R&D and engineering/maintenance. Candidates should bring documents to a walk-in on November 9th between 9am-4pm or apply online.
World Polio Day is observed annually on October 24th to commemorate the birth of Dr. Jonas Salk, who developed the first polio vaccine. Polio is a highly infectious disease that primarily affects children under 5 and can cause paralysis. The number of polio cases has declined over 99% since 1988 due to a global effort to eradicate the disease through vaccination. India was once considered highly polio-affected but has been polio-free for two years due to a robust vaccination program. However, the risk of polio persists until Pakistan and Bangladesh are also polio-free.
This document discusses avoiding heart attacks and strokes by protecting oneself. It describes several heart conditions including heart failure, which occurs when the heart cannot pump enough blood due to damage from prior heart attacks or other causes. Congenital heart disease refers to defects present at birth, while rheumatic heart disease results from untreated strep throat and damages heart valves over time. Preventing rheumatic fever through prompt antibiotic treatment of strep throat is the best way to avoid rheumatic heart disease.
What are the signs of a heart attack and what should you doBiocon
Heart attacks and strokes can strike suddenly and be fatal if assistance is not sought immediately. The document outlines signs of heart attacks and strokes and advises that if any signs are detected, emergency medical help should be contacted without delay. Treatment options are described that may help restore blood flow and minimize damage, but quick action is critical to survival. Lifestyle changes after the event can also help prevent future attacks.
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Understanding User Needs and Satisfying ThemAggregage
https://www.productmanagementtoday.com/frs/26903918/understanding-user-needs-and-satisfying-them
We know we want to create products which our customers find to be valuable. Whether we label it as customer-centric or product-led depends on how long we've been doing product management. There are three challenges we face when doing this. The obvious challenge is figuring out what our users need; the non-obvious challenges are in creating a shared understanding of those needs and in sensing if what we're doing is meeting those needs.
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• Present the Onion Diagram, a tool for contextualizing task-level goals
• Illustrate how customer journey maps capture activity-level and task-level goals
• Demonstrate the best approach to selection and prioritization of user-goals to address
• Highlight the crucial benchmarks, observable changes, in ensuring fulfillment of customer needs
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2. DISCLAIMER
Certain statements in this release concerning our future growth prospects are
forward-looking statements, which are subject to a number of risks,
uncertainties and assumptions that could cause actual results to differ materially
from those contemplated in such forward-looking statements. Important factors
that could cause actual results to differ materially from our expectations
include, amongst others general economic and business conditions in India, 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 biotechnology and
pharmaceuticals industries, changes in political conditions in India and changes
in the foreign exchange control regulations in India. Neither our company, nor
our directors, nor any of their respective affiliates have any obligation to update
or otherwise revise any statements reflecting circumstances arising after this
date or to reflect the occurrence of underlying events, even if the underlying
assumptions do not come to fruition.
2
3. AGENDA
BIOCON SNAPSHOT
PRODUCTS (BRANDED FORMULATIONS)
RESEARCH & DEVELOPMENT
STRATEGIC ALLIANCES
FINANCIAL HIGHLIGHTS
3
5. VISION
Biocon is an emerging, global Bio-pharmaceutical enterprise,
focused on developing affordable products and services
for patients, partners and healthcare systems across the world.
Biocon is committed towards:
Reducing therapy costs of chronic diseases. (Diabetes, cancer & immune-mediated)
Research and marketing partnerships that provide global access.
Leveraging the India cost advantage to deliver high value, licensable R&D assets.
5
6. BUSINESS STRUCTURE & HOLDINGS
Biocon Research , India | 100%
R&D- Novel Molecules
Biocon Biopharmaceuticals | 100%
MAbs
61% | Promoters
Biocon , Malaysia | 100% PRODUCTS
~5 % | Employees & ESOP trust Biocon Overseas subsidiary
~34 % | Public Biocon SA, Switzerland | 100%
Overseas subsidiary
NeoBiocon, UAE | 50%
Overseas subsidiary
Syngene International, India | 100%
Custom research, drug discovery RESEARCH
Clinigene International, India | 100% SERVICES
Clinical development
6
7. PRODUCT PORTFOLIO: VERTICALS
New Molecules
New chemistry-
oriented molecules
Biologics
MAbs, IN-105,
Itolizumab
Other novel
Small Molecules biologics
Research Services
Statins, Fidaxomicin, Syngene
Immunosuppressants Clinigene
Insulin Other Bio-pharma
Insulin & analogs Orlistat & Other APIs
Branded
Formulations
Existing Portfolio Diabetology,
Nephrology, Oncotherapeutics,
Comprehensive Care, Cardiology,
Portfolio Expansion Areas
Immunotherapy 7
12. BIOCON’S INSULIN BUSINESS (INDIA)
MAT August 2011 YoY
Biocon’s ranking Biocon’s market share by
growth for value sales of
volume:
insulin:
#4 in the overall insulin space Market: 26% 40 IU Insulin: 11%
#3 in the 40 IU Insulin market Biocon: 46% Glargine vials: 62%
#1 in the Glargine vial market Novo Nordisk: 24%
Source: IMS Health – MAT, August 2011
10 players in
Biocon has the insulin
both OADs space
and insulins
60 of these are in the oral
anti-diabetics space
61 players operate in the
anti-diabetics market
12
13. INSUPen® ease LAUNCH
Designed for accuracy, efficiency, safety & economy.
• Launched in October, 2011
• Based on proprietary German
technology
• Reusable delivery device capable
of delivering both InsugenTM &
BasalogTM
• “One Call Does All” Support
helpline
Expected to add further impetus to branded formulations’ sales in H2FY12
13
15. HIGH POTENTIAL PRODUCT PIPELINE
Diabetes IN 105
Oncology /
Novel Molecules*
Inflammation / Itolizumab CIMAb
Auto immune
Oncology Nimotuzumab CIMAb
Oncology Anti-CD 20 Vaccinex
Targeted
Oncology Immunoconjugates IATRICa
Diabetes Peptide Hybrid Amylin
2 novel drugs in late-stage clinical trials
More molecules moving from labs to clinic
* Including molecules from collaborative programs 15
16. HIGH POTENTIAL PRODUCT PIPELINE
ItolizuMAb
Phase 3 study (TREAT-PLAQ) ongoing
Expected to be complete by Q4FY12
BVX-20
Phase 1 study is expected to start in Q1 of next year
Phybrid
Plan to submit an IND and commence phase 1 study by end
of 2011.
16
17. LEAD PROGRAM: ORAL INSULIN IN-105
Drug Highlights
Conjugated peptide
Lower immunogenicity and mitogenicity.
Comparable safety and good clearance profile.
Metabolically equivalent.
Monotherapy.
Combination therapy with metformin,
sulfonylurea, PPAR agonists, DPP4i.
Pre-meal insulin in combination with
basal insulins.
Proof of Concept : Stable tablet formulation.
Established oral delivery
17
18. IN-105 INDIA PHASE III RESULT SUMMARY
SECONDARY END POINTS
Efficacy – Secondary Endpoints
Statistically significant reduction in PPG during STM
Significant reduction in SMBG post prandial glucose excursion
Safety – Secondary Endpoints
No clinically significant hypoglycemia
Very low immunogenicity
No neutralizing antibodies detected
No effect on liver enzymes
No effect on lipid profiles
No effect on renal function
Efficacy – Primary Endpoint
Change in Hb1Ac for IN-105 not statistically significant X
due to higher than anticipated placebo effect 18
19. ANTI-CD6 MAb: T1h
Drug Highlights
Target CD6 o.4mg/kg once in 4 weeks
is a type 1 cell membrane glycoprotein belonging to the
scavenger receptor cysteine-rich (SRCR) super family group B.
CD6 is predominantly expressed by T cells &
a B cell subset. Day 1 Day 29
CD6 binds ALCAM (activated leukocyte cell adhesion molecule)
which is expressed on:
Activated T, cells, B cells & monocytes.
Skin fibroblasts, keratinocytes, rheumatoid arthritis synovium.
0.8mg/kg once in 4 weeks
Drug Development
Day 1 Day 57
Database lock for Phase 3 clinical trial in Psoriasis done.
Data analysis ongoing.
Planned Initiation of Phase 2 double blind trial
in RA in the 2nd half of this fiscal.
19
22. BIOSIMILARS PARTNERSHIP: PFIZER
Insulin and Insulin analogs
Combines Biocon's research and manufacturing
capabilities with Pfizer's global marketing prowess
Global agreement for commercialization of Biocon's biosimilar versions of
Insulin & Insulin Analogs: rh- Insulin, Glargine, Aspart, and Lispro.
Pfizer will have exclusive rights (with some exceptions) to commercialize
these products globally.
Biocon will be responsible for clinical development, manufacture, supply, &
regulatory approvals.
Upfront from Pfizer 100 USD mn
+ New manufacturing facility setup milestone payments 100 USD mn (in escrow a/c)
+ Development, regulatory & launch milestone payments 150 USD mn
+ Payments linked to supplies and sales.
22
23. GLOBAL INSULIN MARKET (2010)
Total 2010 Insulin Market USD ~15 bn ~ USD 20 bn in 2020
Lantus
22%
Novolog
32%
Humalog
8% Novomix
10% Levemir
14%
14% Rh Insulin
Growth forecast of ~6% per annum*
Sources: Biocon’s estimates complied from Industry reports *Factoring the advent of Biosimilar Insulins
23
24. BIOSIMILARS PARTNERSHIP: MYLAN
Monoclonal Antibodies (MAbs)
Combines Biocon's R&D and manufacturing prowess of
novel biologics/ bio-generics with Mylan’s regulatory &
commercialization capabilities in the US and Europe
Market size for product portfolio in 2010 : USD ~30 bn
.
Exclusive collaboration for development and commercialization of
complex biogenerics and biosimilars.
A basket of products with patents expiring between 2014-18. MAbs in particular.
Mylan and Biocon to share development and capital costs.
Mylan will have exclusive commercialization rights in the regulated markets;
profits to be shared
Biocon and Mylan to have co-exclusive commercialization rights in other markets.
24