India’s research and development (R&D) is being driven by its promising scientific acumen. The country’s research hubs like Centre for Cellular and Molecular Platform (C-CAMP), an initiative by the Department of Biotechnology, government of India, National Centre for Biological Sciences (NCBS), Indian Institute of Science (IISc) , Jawaharlal Nehru Centre for Advanced Scientific Research (JNCSAR), Centre for Cellular Molecular Biology (CCMB) among others are spearheading much of the innovation in drug development.
This year began with Biocon and Mylan announcing that the USFDA has accepted the biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers.
This development positions Biocon and Mylan among the first few companies to address the critical need of US patients for a high-quality biosimilar to treat certain HER2-positive breast cancers, in the near future.
Another development on the research front is the Institute of Bioinformatics and Applied Biotechnology (IBAB), Bengaluru and the Harvard South Asia Institute, Cambridge, MA collaborating to drive research on neurosciences. Through a B4 program, both IBAB and SAI are working to create a scientific research corridor to engage scientists from India and Harvard through exchange programs.
PricewaterhouseCoopers (PwC) in its Union budget 2017 expectations pointed out that tax benefits by way of weighted deductions should be granted for businesses or contract manufacturing R&D units through investment linked deductions as against profit linked deductions.
The research tax credits should be similar to those in some foreign jurisdictions said Dwaraknath E. N - Partner Direct Tax, PwC adding that the much-debated weighted deduction for companies engaged in R&D activity, should qualify for weighted deduction under section 35(2AB) even in respect of expenditure incurred outside the R&D unit. This is assuming that the said unit is appropriately approved by the Department of Scientific & Industrial Research (DSIR).
Global scene
Globally there is a dip in R&D activity. The key reason for fall in research activity, according to a Deloitte study is a rise in development costs and increasing political pressure over drug pricing for important medicine. The cost of research and time taken for new products to be launched are impacting advancements.
LegoChem Biosciences (LCB), has announced its research licensing agreement with Takeda Pharmaceuticals to evaluate the next-generation antibody drug conjugate (ADC) candidates. Through this agreement, Takeda will have access to LCB’s proprietary ADC technology, ConjuAll.
Utilizing a site-specific bio-conjugation method and a stable beta-glucuronide linker, ConjuAll enables the design of homogeneous plasma stable ADCs with the potential for improved payload delivery to cancer cells.
CytoDyn, a biotechnology company, has announced that it has filed a request for breakthrough therapy designation with the FDA for PRO 140 as a treatment for HIV-1 infection in treatment-experienced patients with virologic failure.
R&D activities in India
Rise in investments and collaborations are seeing Indian pharma and biotech companies augment their investments in research and development (R&D) by over 25 per cent. Most of the leading companies are in the midst of expanding presence in complex therapy segments like injectables, inhalers, dermatology, controlled-release substances and even branded bio-formulations and biosimilars.
With the government’s support, the R&D sector in India is all set to witness some robust growth in the coming years. The government is investing huge sums for setting up research centres specifically, noted industry consultants.
“Indian researchers cannot be ignored by the western world as we are a critical component of innovation in the global market,” said Prof. CNR Rao, National Research Professor Linus Pauling Research Professor & Honorary President Jawaharlal Nehru Centre for Advanced Scientific and chairperson Vision group on Nanotechnology in Karnataka.
The pharma sector hopes to see that innovation and research will play an important part in making 'Make in India' campaign launched by Prime Minister Narendra Modi a success. There is a need to maximize the capability of the India’s young scientific talent and capability for innovation through interdisciplinary research and next generation innovations noted the industry experts.
Insights on new molecule research
There is a spur in new molecule research and development. The Institute for Stem Cell Biology and Regenerative Medicine (inStem), Bengaluru has designed and tested a new drug delivery system to treat diseases resulting from chronic inflammation. The researchers used a cationic lipid-based delivery system which resulted in high treatment outcomes.
The inStem scientists have gained new insights about immune reactions caused by damaged cells leading to chronic inflammation resulting in osteoarthritis, rheumatoid arthritis, Crohn’s disease and fibrosis.
To enable technology innovators and entrepreneurs to pursue a promising technology idea, and establish and validate proof of concept (POC) for the idea, the Biotechnology Industry Research Assistance Council (BIRAC) under its Biotechnology Ignition Grant (BIG) scheme, has invited research proposals from potential entrepreneurs from biotechnology for igniting new ideas from biotechnology start-ups, entrepreneurs or academicians, scientists, researchers, PhDs, medical degree holders and biomedical engineering graduates. This is the 10th call for proposals from BIRAC since the BIG scheme was launched in 2012 has posted.
The Council for Scientific and Industrial Research-Centre for Cellular and Molecular Biology (CSIR-CCMB) has signed a memorandum of understandings (MoUs) with 4 start-up firms namely Oncosimis, Virupaksha Life Sciences, Theranosis and Bioartis, wherein all these firms will work in coordination with the CCMB scientists at iHUB to develop new drugs for cancer, diabetes, diagnostic method for cancer and kits for detecting marine diseases respectively.
Emerging concepts
Companies developing biosimilars for regulated markets or have portfolio of new chemical entities (NCEs) under development , are seen to get closer to conducting clinical trials. Further, such companies are scouting to pursue joint ventures and alliances to share investments, reports ICRA.
R&D in India is getting more innovative. There are many domestic companies which are already major outsourcing partners of global drug companies. They are likely to become a competitor of global pharma in not just manufacturing but R&D also noted Sujesh Shetty, India pharmaceuticals & life sciences leader, PwC in an earlier interaction with Pharmabiz.
Indian lifesciences industry feels that it would be the start-up and digital ecosystem in the country which is expected to give a fillip to the much-needed innovation. In 2017-2020, around $51billion worth of drugs are expected to go off patent in the US. This is where India with its quality science teams is set to capitalize with its capability to manufacture a substantial share of these drugs with research on novel products, said industry observers.
Impending issues
From funding access to poorly conceived concepts and lack of an ecosystem in the area of drug discovery and development are hampering growth of research.
Globally, there is an evolution in R&D progress and predominantly in drug discovery where companies are trying to ascertain the next model. Cost arbitrage emerges as a key factor in drug discovery and development. This is where academic and research institutions look to partner and chalk out ways to plough in funding for drug discovery and development,” noted an industry expert.
“We need to create an environment to foster innovation and research talent. In the case of Biocon, it is committed to reduce therapy costs of chronic diseases like diabetes, cancer and autoimmune. It has successfully developed and taken a range of novel biologics, biosimilars, differentiated Small Molecules and affordable Recombinant Human Insulin and Analogs from 'Lab to Market'. Some of its key brands are INSUGEN (rh-insulin), BASALOG (Glargine), CANMAb (Trastuzumab), BIOMAb-EGFR (Nimotuzumab) and ALZUMAb (Itolizumab), a ‘first in class’ anti-CD6 monoclonal antibody. It has a rich pipeline of biosimilars and novel biologics at various stages of development including Insulin Tregopil, a high potential oral insulin analog, said the Biocon chief.
“The ability to take risks and look for meaningful assignments will spur promising entrepreneurial culture. If India wants to become a knowledge economy it will need to ensure that industry look at universities for ideas, said Professor V. Kumaran, Department of Chemical Engineering, Indian Institute of Science (IISc) and Infosys Prize Laureate 2016, Engineering and Computer Science
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