India is recognised as a favoured destination for research and development of intellectual property. It is among the top five emerging pharma markets globally. Now the government must create a healthy environment for research, especially with respect to funding by venture capitalists, private equities etc. It should encourage industry-academia collaboration in low-cost research. This will not only bring the industry and academia closer, but will also result in the creation of an efficient talent pool and give a fillip to low-cost research, which will ultimately benefit the industry, Dr Manu Chaudhary, Joint Managing Director, Venus Remedies Ltd and Director, Research, Venus
Medicine Research Centre tells Nandita Vijay in an email interview.
How would you describe the pharma sector research scene in India?
India is slowly gaining recognition as a preferred destination for research and creation of intellectual property. Indian pharmaceutical companies have been investing a considerable part of their total revenue in R&D projects to stay ahead of the competition. Statistics show that investments in R&D in India have grown from Rs 347 crore (US $52.5 million) in 2000 to Rs 4,276 crore (US $646.5 million) in 2010. Out of this, domestic companies account for nearly 80 per cent, while the remaining 20 per cent investment comes from foreign companies. It is mainly due to the result of pharma outsourcing to the Indian market that the pharmaceutical sector has grown at a CAGR of 62 per cent over an eight-year period.
R&D is the key to survival because the business world runs on the survival of the fittest. In a rising cut-throat competitive environment with ever-rising pressure on margins of generic products, a shift to research is the only option to keep up the growth momentum. However, the current regulatory framework is a matter of concern for a majority of the Indian pharma companies. Besides, slowdown in clinical R&D and patent processes and delayed regulatory approvals are forcing many Indian pharma companies to think of shifting their operations to South-East Asia.
The government must create a healthy environment for research, especially with respect to funding by venture capitalists, private equities etc. It should encourage industry-academia collaboration in low-cost research. This will not only bring the industry and academia closer, but will also result in the creation of an efficient talent pool and give a fillip to low-cost research, which will ultimately benefit the industry.
What are the visible trends?
Today, India is recognised as a favoured destination for research and development of intellectual property. It is among the top five emerging pharma markets globally. The Indian pharmaceutical industry has been growing consistently at an estimated compound annual growth rate (CAGR) of 13-14 per cent for the past five years. According to a report by McKinsey & Company, Indian pharmaceutical sector will be a US $55-billion market by 2020.
The industry has been witnessing a paradigm shift in the attitude of people towards healthcare. The alarming rise in cases of antimicrobial resistance, cancer, lifestyle diseases and so on has created awareness among the masses about the need for novel, efficacious and cost-effective solutions. The trend in the Indian pharma sector is shifting from process patent-based research to innovative solution-finding research. But the acceptance of this research globally will take time. Global players have already started exploring opportunities in India through outsourcing of research-based capabilities and licensing for setting up a common platform for developing novel drugs/therapies.
What are the challenges for research in the country?
Despite the growth in the Indian pharmaceutical market, the pharma industry still faces a number of challenges, which includes funding for new technologies/drug development, non-availability of government funding to hospitals for clinical research and regulatory complications. The cost of research and developing new products is becoming more and more challenge day by day due to rise in input costs and regulatory hurdles. It takes 8-10 years and an average investment of $800-1,000 million to successfully develop a new chemical entity.
Furthermore, the approach at the academia level needs to be changed as far as industry-academia collaborations for low-cost solutions to the industry are concerned. Skill development courses must be introduced to improve the calibre of academic and industrial scientists. In the pharma sector, nothing can be launched without human clinical trials, but some of the new laws imposed on the industry with an intent to streamline the process have proved to be impetuous decisions. Awareness among various stakeholders, government support to research and a conducive and healthy environment for research are the need of the hour.
What are the Venus current efforts in oncology research and new product launches?
We are among the top-class manufacturers of oncology products which follows EU-GMP norms for all its activities. The company is contributing significantly to the oncology segment across the globe through its wide array of key products, which include Docetaxel, Paclitaxel, Gemcitabine, Oxaliplatin, Bortezomib and Pemetrexed. Besides, the Venus research wing, the Venus Medicine Research Centre (VMRC), is putting in a lot of effort to come up with revolutionary drugs to reduce the side-effects relating to cancer therapies, including Taxedol (a ready-to-use single vial injectable), VRP1620 (a cancer detection therapy) and VRP007(a targeted therapy for cancer treatment). VRP1620 and VRP007 are in different stages of development but under patent protection.
We have already launched “Taxedol”, an innovative product which has been introduced for the first time in the market. Unlike Docetaxel 20mg/0.5 ml & 80mg/2 ml, our single-vial formulation concentrate of 120mg/3ml has this advantage that it requires a single dilution step in suitable infusion solutions prior to administration, thus offering a cost-effective solution to patients. Research has established that this novel technology is unique and will offer significant therapeutic advantage over all other similar and competing products in the market. The usual dose of Docetaxel is 75mg to 100 mg per square metre of body surface area. But that one dose comes to be around 120 mg for Indians whose average body surface area is 1.6 square metres. Hence we introduced this strength in the market, and it is giving us an edge over the single-vial formulations of its competitors.
What are the likely future efforts of the company in this space?
The company is conducting Phase III clinical trials for VRP1620, a New Chemical Entity (NCE), which is based on selective tumour targeting because tumor-infiltrating blood vessels deviate morphologically and biochemically from normal vessels. VRP1620 specifically increases tumour blood flow and this property has been utilised for confirmatory cancer detection. The studies done in Phase I and II clinical trials have established that VRP1620, a highly selective ETB receptor agonist, enhances breast tumour perfusion. This technology would prove to be a new ray of hope for early detection of breast cancer and other solid tumours. We are hopeful of introducing this product in the domestic market by the last quarter of this year.
VRP007 is in its initial phases of clinical development. It will take three-five years for VRP007 to come to the market. It will help in alleviating cancer through specific and selective targeting. The therapy holds its essence in its significant potential to conjugate a wide range of drugs (physiochemically different), thereby reducing the amount of the drug to be targeted as well as the cost. The drug can be effective in various types of cancers ranging from the most common one like breast cancer to the rarest ones. Due to targeted delivery of highly toxic cancer drugs, there is huge reduction in side-effects, one of the main causes of cancer-associated mortality.
What are the areas of collaborations for the company in oncology. Does this first overseas venture with Ukraine for an anti-cancer product still continue?
Yes, it is still on. We do have several collaborations with Indian and foreign MNCs for different territories and for CTD (common technical dossier) development for regulated markets. We are open to suitable collaborations for co-development or technology commercialisation of our R&D pipeline products, such as the VRP007 therapy. While we have a collaboration with University of Illinois, Chicago, US for cancer detection, we are also looking for CTD development of technologies going off-patented in regulated markets.
Where does India stand in oncology research and product development?
Cancer has seen a steep rise in India and it is estimated that the number of cancer deaths in India will increase to seven lakhs by 2015. In such a scenario, oncology drugs have become more crucial than ever before. The escalating prevalence of cancers of all kinds and the ever -rising unmet needs in the field of cancer treatment creates a great opportunity for pharma companies.
However, inadequate funds for research and lack of help from the government are the major reasons why India lags behind others when it comes to research on innovative drugs.
The cancer market of India is majorly taken over by Western companies as they are offering sophisticated diagnostic techniques, advanced technologies and easy-to-use and affordable versions of diagnostic and cancer treatment products. India, which has a population of 1.2 billion, is likely to suffer substantial human and economic costs accruing from increasing prevalence of cancer. More than one million cancer cases are diagnosed annually in India, and this number may reach five million over the next decade. However, there is always a ray of hope with the development of indigenous technologies, which will be available at a lower cost with better patient compliance.
What are the challenges faced by oncology companies in the country to sustain and succeed in research and manufacture?
Oncology is the most rapidly growing segment of treatment in the pharmaceutical market with immense scope for smart drug strategies to treat cancers. However, the industry faces many challenges when it comes to research and development. They include inadequate funding: Lack of funding for research as investor sentiment in India is not pro-research.
In the area of patient recruitment in clinical trials, some of the new laws imposed on industry with an intent to streamline the process proved to be impetuous decisions which have not only slowed down the process but sky rocketed the recruitment costs.
A longer R&D cycle in pharma sector in comparison to other industries: R&D in a pharmaceutical company requires consistent flow of money to complete the R&D cycle of a product, which is larger in comparison to that of other industries. It is a huge R&D challenge to come up with a technology for improved patient compliance without sufficient patent protection.
Environment for clinical trials is not conducive: It is high time that India came out with clear guidelines on clinical trials and provided necessary infrastructure to enable them.
To ensure life-saving, high-cost drugs to be provided to the poor strata of society is a big challenge for R&D in the pharmaceutical industry. The situation can be dealt with by generating awareness among various stakeholders, creating a conducive atmosphere for research in oncology and ensuring government support to R&D in terms of funding and incentives.