Increase in investments and collaborations are seeing Indian pharma and biotech companies up 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.
Expenditure on R&D is unlikely to decrease, in view of pharma and biotechnology industry’s growing focus in the regulated regions with a focus on complex molecules and therapy segments, according to an ICRA report.
This ensues Union government insisting pharmaceutical companies to increase investment in R&D to emerge as a hub of innovation in low cost health products and services.
According to Union minister for micro, small and medium enterprises, Kalraj Mishra, innovation and research will play an important part in making 'Make In India' campaign launched by Prime Minister Narendra Modi a success. More over innovation and research are necessary to produce goods with zero defect and zero effect on environment.
“We need to maximize the capability of our young scientific talent and capability for innovation through interdisciplinary research and next generation innovations for which the Government has taken number of steps in this direction, added Minister Mishra.
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.
Companies are exploring new markets for innovative assets to add value to their pipeline according to Frost & Sullivan.
Pharma majors like Lupin, Glenmark, Biocon, Dr Reddy’s Labs, Torrent, Cadilla, Zydus to Sun Pharma Advance Research Co (SPARC), Panacea Biotec and Micro Labs to name a few are on track to work towards developing novel molecules. For instance , Glenmark the research-led global integrated pharmaceutical company introduced Teneligliptin which is a new third generation oral anti-diabetic agent for the management of type-2 diabetes mellitus. Globally gliptins is emerging as the preferred line of treatment for managing type-2 diabetes. Teneligliptin has been highly effective in decreasing postprandial glucose levels, amount of glucose in the blood after meals, as well as fasting blood glucose levels, with a once-a-day administration. It introduced this molecule under two brands:- Ziten and Zita Plus at a breakthrough price of Rs. 19.90 per tablet per day treatment. Thus the launch of these two products will lower the daily cost of treatment for a Diabetes patient on gliptin therapy by approximately 55%. Most gliptins are priced at around Rs. 45 per day treatment. This translates into a saving of approximately Rs. 9,000 per year for diabetes patients with the introduction of Teneligliptin.
The recent Lupin acquisition of Gavis Pharmaceuticals LLC and Novel Laboratories Inc. broadens the former’s pipeline in dermatology, controlled substance products and other high-value and niche generics. Gavis brings to Lupin a highly skilled US-based R&D organization which would complement Lupin’s Coral Springs, Florida, inhalation R&D center.
R&D from a drug discovery perspective:
According to Kiran Mazumdar-Shaw, chairperson, Vision Group on Biotechnology and chairman-managing director, Biocon, our business backed by a combination of product sales and monetization of R&D assets through licensing. Our biosimilars strategy is playing out well with five programmes in phase 3 clinical development. Between April to June this year, we successfully licensed an oncology biosimilar Trastuzumab in key emerging markets. Our insulin business is boosted with the launch of insulin glargine in Mexico and Colombia. Our focus on key branded formulations has begun to translate into better earnings.
“In the past decade genomics-based research has seen a perpetual growth globally while the adoption in the domestic market is still nascent. Advanced sequencing technologies such as Next-Generation Sequencing (NGS) facilitated the generation of huge volumes of sequencing data, at significantly low costs, thereby enabling many researchers to investigate human diseases/disorders at a molecular level. Identification of genetic markers and single nucleotide polymorphisms (SNPs) combined with cutting-edge computational biology have helped in establishing causal links between genes and diseases. Traditional clinical research is estimated to have only 7%-10% success rate from phase 1 to approval leading to inefficiencies in resources (time and cost) spent. Genomics-based research enables more targeted research approach through patient stratification and identification of relevant biomarkers, noted Sam Santhosh, CEO, MedGenome.
But Dr Sundeep Dugar, CEO, Sphaera Pharma Singapore begs to differs and stated “Unfortunately, drug discovery and development in India has not made the advances it could have. It needs resources to flourish. In the absence of support of entrepreneurs and young and small biotechs it will be hard for drug discovery and development to find its path. Both government and private enterprises have to figure out how to assess the risks involved and get involved but staying away from drug discovery cannot be the option.”
Visible trends
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.
Advances in R&D
MedGenome is a pioneer in genomics-based research in India. It develops an insight into diseases at the genetic and molecular level. “Towards this, we partner with academic and commercial research organizations to deliver genomics-based research solutions. Our proprietary cancer analytics platform, OncoMD, is an integral part of our genomics solutions. The extensive experience with clinical genomics in India provides us with insights into population-specific genetic variations feeding into our research solution development process. Our two state-of-the-art sequencing labs in Bengaluru and Kochi are equipped with all the technology platforms like NGS, Sanger, Micro Arrays and Q-PCR. We are one of the first in India to offer investigational tests like Whole Genome, Whole Exome and Mitochondrial Genome for research collaborations. We are the only lab in India to have HiSeq 4000 currently,” said Sam Santhosh.
“There has been an ongoing evolution globally in R&D and particularly drug discovery where companies are trying to figure out the next model. Cost arbitrage has been played out to the hilt, but simply reducing cost cannot be the answer for tackling issues and solving problems associated with drug discovery and development. So academic and research institutions are getting involved, pharma companies are inking alliances to figure out how to fund drug discovery and development. While this is happening globally including China and US, in India it is pretty dormant,” pointed out Dr Dugar.
Sphaera focuses on alliances to successfully advance projects to the clinic. “Our alliance with THSTI and Wellcome Trust for multi drug resistant TB is an example of the discovery and development of a NCE for a novel therapeutic approach for a disease that has a significant burden in India. We are still away from calling it a complete success, but what we have achieved should encourage others innovators and funders that this can be done in India. As we bridge expertise, experience and resources we are finding that the model is providing a structure that is allowing projects to move through the translational space into the clinic. It is slow, but sure and steady. Our investors have taken a long term view to help us create this model and we can now say that it is working, he added.
Inclination of fresh biotech-pharmacy graduates/PG for R&D
“We need to create an environment to foster innovation and research talent, said Shaw.
Persistence and perseverance are needed to develop a safe and efficacious drug for treatment of patients. The objective should be to ignite and spark for research and create a path towards gainful employment. however, we notice a gap between on how young scientists think about drug discovery and development.
There is need for a more comprehensive approach. In this context, we need to take a cue from the US to adapt and incorporate initiatives. In India, young biotech and pharmacy graduates and post graduates have a constant exposure via conferences, alliances between industry and academia, But in the US it offers a dedicated industry training programme. For instance the University of California at Davis brings together leaders from the academia and pharma companies to address students and interact with them. There is also a curriculum for a Master's programme in pharmaceutical chemistry with an emphasis in not just academics, but with a goal to expose student to the needs of the pharma world as it applies to drug discovery and development, said Dr Dugar.
Issues bogging R&D
Access to funding, poorly conceived concepts are seen to be key challenges. Unfortunately in the area of drug discovery and development considerable issues are there and a lot needs to done to create an ecosystem, noted Dugar.
Future of R&D
India is on the right track of innovation. There is scientific talent and a pool of start-up entrepreneurs. The government is providing ample funding resources for research to take-off, said Shaw.
There is potential for India but unless all interested parties are willing to participate no research can take place. In the case of drug discovery, venture capitalists and private equity are not receptive to this segment of R&D. Therefore from a funding perspective for drug discovery and development much work needs to be done, said Dr Dugar.