The development of candidate molecules with the potential to treat multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and systemic inflammatory diseases is at the center of the collaboration signed by Sanofi and Denali Therapeutics, the last company due to receive $125 million upfront payment and future milestone payments that could exceed $1 billion.
The two lead molecules (DNL747 and DNL758) target the critical signaling protein RIPK1 in the TNF receptor pathway, which regulates inflammation and cell death.
Boehringer Ingelheimsigned a global collaboration with Epizyme to jointly research and develop novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets, i.e. enzymes within the helicase and histone acetyltransferase (HAT) families that when dysregulated have been linked to the development of cancers.The collaboration will focus on lung and other solid tumor cancers in patients with defined mutations, sub-populations that currently lack precision medicine treatments.
Epizyme will receive an upfront payment of $15 million and an additional $5 million in research funding in 2019; the company is also eligible to receive more than $280 million in additional payments for research, development, regulatory and commercial milestones.
A research collaboration has been signed between Embark Biotech and Novo Nordiskto discover novel treatments for obesity and its associated metabolic pathologies. Embark Biotech is a recent spin-out from the Center for Basic Metabolic Research at University of Copenhagen; its technological platform focuses on receptors that stimulate energy expenditure without triggering the sympathetic nervous system (the ‘fight-or-flight’ response). The aim of the collaboration is to develop novel drug candidates that help people with obesity lose weight by burning off excess energy instead of storing it as fat.
Eli Lilly and NextCurehave signed a multi-year collaboration for the discovery and development of immuno-oncology therapies based on NextCure’s proprietary FIND-IO™ platform. The two companies will each receive options to exclusively license antibodies resulting from the collaboration. Upon the terms of the agreement, NextCure will receive an upfront payment of $25 million; Lilly also made an additional $15 million equity investment in NextCure.
The FIND-IO™ platform aims to identify novel cell surface molecular interactions that drive functional immune responses in the tumor microenvironment and other disease sites. Established primary cell lines from immune lineages include T cells, NK cells, macrophages, myeloid-derived suppressor cells, dendritic cells, as well as cancer cells.
A new Functional Genomics Centre of excellence that will use CRISPR technology, big data and clinical insights to discover new targets and disease pathways in oncology is the goal of a collaboration signed between AstraZeneca and Cancer Research UK. The Centre will use CRISPR technology to study the biology of cancer in order to create biological modelsmore reflective of the human disease. It will be located at the Milner Therapeutics Institute at the University of Cambridge. According to the company, AstraZeneca and Cancer Research UK will have independent use of the Centre’s facilities.
A separate collaboration has been also signed by AZ with Innovative Genomics Institute (IGI) to use CRISPR to uncover genes and disease pathway mechanisms involved in DNA Damage Response (DDR), one of AstraZeneca’s four key platforms in oncology.
GlaxoSmithKlineannounced the definitive agreement to acquire the oncology-focused biopharmaceutical company Tesaro for an aggregate cash value of approximately $5.1 billion. Tesaro’s major marketed product, Zejula (niraparib), is an oral poly-ADP ribose polymerase (PARP) inhibitor currently approved for use in ovarian cancer. Clinical trials are ongoing to assess its use in “all-comers” patient populations, as a monotherapy and in combinations; it is currently under investigation also as a possible treatment in lung, breast and prostate cancer. Tesaro’s pipeline includes also antibodies directed against PD-1, TIM-3 and LAG-3 targets.
Janssen affiliate Cilag GmbH International entered a worldwide collaboration and license agreement with argenxBVBA and argenx SE focused on the investigational antibody cusatuzumab (ARGX-110) for use in blood cancers. The antibody targets CD70 immune receptors implicated in numerous cancers, including hematological malignancies. The first-in-class antibody is currently in Phase 1/2 clinical trials to evaluate its safety, tolerability and efficacy in the treatment of acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). According to the company, the deal has a total value of $ 300 million; a separate equity investment by Johnson & Johnson Innovation (JJDC) will be made in argenx SE.
Roche CEO and member of the Corporate Executive Committee, Daniel O’Day, will step down its role as of 31 December 2018. He will provide support to the company for a smooth transition until the end of February 2019, to then become the new Chairman of the Board and Chief Executive Officer of Gilead Sciences, effective March 1, 2019. O’Day has held the position in Roche since 2012, and prior to that led Roche Diagnostics.
The new CEO of Roche starting 1 January 2019 will be William (Bill) Anderson, currently CEO of Genentech; he will be based in Basel, report to Severin Schwan, Roche Group CEO and become a member of the Corporate Executive Committee.Bill Anderson joined the Group in 2006 as lead of the Immunology Business Unit in Genentech, to then took responsibility for Oncology Sales and Marketing. In 2013, he was appointed Head of Global Product Strategy based in Basel, and became CEO of Genentech in 2017. Bill Anderson holds Master of Science degrees in Management and Chemical Engineering from Massachusetts Institute of Technology.
The global intellectual property matters for Pfizer’s proposed adalimumab biosimilar has been solved with the signature of licensing agreements with AbbVie, which granted Pfizer a non-exclusive patent license for the use and sale of the product in many countries around the world.All litigation pending between the parties will be withdrawn. The financial details of the agreements have been kept confidential. According to the company, in US the license period will begin on November 20, 2023, while in Europe the launch of the new biosimilar may occur after its approval by the European Medicines Agency.
The Indian pharmaceutical market is booming. This on the one hand thanks to production costs that are significantly lower than those of the United States and Europe (almost half), on the other hand for the government’s moves to encourage it. The Indian pharmaceutical industry responds to over 50% of the global demand for various vaccines, 40% of the demand for generics in the United States and 25% of all drugs in the United Kingdom. The India brand equity foundation produced in July 2018 a dedicated report for this growing market.
India, the advantages
Cost-effectiveness of production is the first element to analyse if we look at the Indian market and think about the advantages of this country. In fact, the low labor and R&D costs increase the efficiency of Indian pharmaceutical companies. India’s production cost is about 33% lower than that of the United States. Due to lower treatment costs, India is also emerging as a primary destination for medical tourism. If this is coupled with the ability of the country to produce high quality medicines at low prices, it is easy to understand what a great business opportunity for the domestic industry is. Secondly, India focuses on several economic drivers: on the one hand the economic growth of the country to improve the accessibility of drugs, on the other the increase in the penetration of health insurance. Finally, with increasing penetration of pharmacies, especially in rural India, over-the-counter drugs will be readily available to more people. Furthermore, India intends to continue to diversify its portfolio, which currently weighs 10% on global pharmaceutical production. The country has more than 60,000 generic brands in 60 therapeutic categories and produces more than 500 different APIs. Last but not least, government support for growth (Box 1). “Pharma Vision 2020” was presented to make India a global leader in end-to-end drug production.
Generic Indian pharmaceutical market
India is the largest provider of generic drugs globally. In particular, the Indian pharmaceutical industry provides answers to 40% of generic demand in the United States. The government plans to allocate 70 million dollars to local actors for the development of biosimilars. Furthermore, the domestic market is expected to reach $ 27.9 billion in 2020 and $ 40 billion by 2030.
Active pharmaceutical ingredients
National API consumption is expected to reach $ 18.8 billion by 2022 (fiscal year). In April 2018, a high-level task force was established to create a roadmap to increase national production of APIs. In fact, India currently imports over 60% of APIs from other countries.
Market size
The Indian pharmaceutical market was valued at $ 33 billion in 2017. Based on the growing annual turnover, anti-infective, cardiac and gastrointestinal drugs are the ones with the largest market share. The pharmaceutical industry in the country is expected to expand in the coming years to reach 55 billion in 2020 (CAGR of 22.4% in the period 2015-20). India’s pharmaceutical exports are estimated at 17.27 billion dollars in 2017-18 and are expected to reach 20 billion dollars by 2020. The main export destination for Indian pharmaceuticals is the United States. In 2017, 38% of the exports of products formulated by India were in the United States, followed by 20% by Sub-Saharan Africa (Figure). In 2018, 31% of India’s total drug exports went to the United States. Indian companies received 304 approvals shortened by the FDA in 2017. The country accounts for about 30% (in volume) and about 10% (value) in the US generic market. The Indian biotechnology industry is expected to grow at an average rate of about 30% per year and reach $ 100 billion by 2025. Biopharma, including vaccines, therapy and diagnostics, is the largest sub-sector and contributes almost 62% of total revenue ($ 1.89 billion).
Indian export in 2017
Investments
The Indian pharmaceutical industry has received foreign direct investments worth USD 15.72 billion between April 2000 and March 2018. In 2017, the Indian pharmaceutical sector saw 46 merger and acquisition operations (M&A) worth a total of 1.47 billion dollars. Over the past three years, the pharmaceuticals segment has accounted for over 70% of the merger and acquisition operations of the entire country.
Contract Research and Manufacturing Services (CRAMS)
That is a fragmented market with more than 1,000 players. CRAMS industry is estimated to reach US$ 18 billion in 2018 and expected to witness a strong growth at a CAGR of 18-20 per cent between 2013-18.
Clinical trial
India is among the leaders in the clinical trials market. Because of a genetically diverse population and the availability of qualified doctors, India has the potential to attract huge investments in this field. Data show that from 2009 to 2015, 3043 clinical trials were performed in India. Furthermore, in June 2017, the Clinical Trials Registry – India registered 8,950 clinical trials.
