India To Be A Biotech Hot Spot

The last 70 years have been transformational for the Indian biotech industry, mirroring the nation’s own rapidly advancing economy and rising global status. We have successfully leveraged recombinant DNA technology to deliver biopharmaceuticals, vaccines, genetically engineered crops and enzymes. In doing so, we have created a notable bio-economy valued at $35 billion. 

We have embraced cutting-edge technologies, built global scale manufacturing capacities, and benchmarked our systems and strategies to global best practices. Currently, India is among the top 12 biotechnology destinations in the world and ranks third in the Asia-Pacific region. While our immediate goal is to build a $100 billion bio-economy in India by 2025, in the next 30 years, India aspires to become a biotechnology hot spot reputed for its high-value, low-cost innovations in bio-therapeutics including personalised and precision medicine, advanced enzyme technologies, GM crops and bioinformatics.  

The success of India’s biotechnology industry can be traced to the pioneering spirit of entrepreneurs who leveraged a nascent technology and India’s cost-effective scientific talent pool to bring affordable innovations to the market. Its evolution over the decades mirrored the country’s growing confidence in life sciences. While the 1980s were the decade of enzymes, the next decade saw vaccines gaining prominence as a business segment. The emergence of genomics research companies in the 2000s was followed by Novel biologics and biosimilars making an impact from 2010 onwards.

I started Biocon as India’s first biotech enterprise in 1978 in a garage in Bengaluru to manufacture industrial enzymes for food and textile industries around the world. The initial years were tough as I encountered market scepticism, funding challenges, infrastructural hurdles, manpower issues and government apathy. I persevered because I believed biotechnology was the technology of the future with the potential to deliver transformational change.

By the mid-1980s, Biocon had evolved as the largest enzymes company of India pursuing an R&D-led biotech business. As few more biotechnology-based companies started coming up, it caught the attention of the government and, in 1986, the Department of Biotechnology (DBT) was established. I was privileged to be invited to be a part of the DBT’s Task Force, which helped articulate the regulatory framework for the industry. Recombinant technologies were at the fulcrum of regulations covering vaccines, genetically modified crops and biopharmaceuticals. 

Biocon’s stock market debut in 2004, as the first biotech company in India to go public, commanded a premium valuation. It led to the development of a biocluster in Bengaluru, attracting a number of large and small biotech companies. These included Strand Genomics, a bioinformatics company; Gangagen, a phage-based antibiotic company; Reametrix, a whole blood-based diagnostics instrumentation company; Syngene, which spearheaded research services; and Bio-IT companies like Genotypic Technology, BigTec and Molecular Connections. The cluster also spurred the growth of ancillary biotech companies. 

The disruptive power of Indian biotechnology innovation grabbed the attention of the world in the late 1990s when companies like Shantha Biotechnics, Bharat Biotech, and Serum Institute started producing and supplying vaccines at a fraction of the cost of western drug makers. Today, ‘1 in 3’ children globally are immunised with a ‘Made in India’ vaccine. 

Having built a strong base of indigenous R&D capabilities and excellent clinical trials and manufacturing infrastructure, the industry started developing biotech-based drugs or biologics. Taking the lead, Biocon introduced India’s indigenously developed recombinant human insulin using a proprietary fermentation technology in 2004 and, along with Wockhardt, was able to break the monopoly of innovators in insulins by offering indigenously manufactured affordable alternatives, thus enhancing access to this life-saving therapy. 

Over the years, Biocon has successfully launched two novel biologics and five biosimilar products aimed at cancer, diabetes and autoimmune diseases, making these advanced therapies available to a large patient population. Today, there are a select few companies such as Dr. Reddy’s Labs, Zydus Cadila, Intas Pharma, Reliance Life Sciences, Lupin, etc., which are active in the area of complex biologics/biosimilars. The biotechnology sector is evolving fast and it promises to transform healthcare, agriculture and environmental management, leading to the dawn of the ‘Biotechnology Age’. 

By 2030, the Indian bio-economy sector is expected to attain a size of $200 billion. I foresee the intelligent use of data to transform global health. India’s highly developed software skills offer a unique Bio-IT opportunity to mine, analyse and interpret data and create algorithms that can match therapies with the diagnosis. There is also considerable excitement over the promise of targeted genome editing technologies like CRISPR CAS9, which can potentially prevent several diseases, including some cancers, and prevent specific genetic anomalies from being passed on to future generations. 

I believe, by 2050, cancer will become manageable through advances in the field of immuno-oncology, which works by stimulating an immune response against malignant tumours, thus replacing the need for chemotherapy and radiotherapy. 

Biotechnology in agriculture and farming has the potential to address numerous challenges associated with food security in India. Just as the commercial cultivation of genetically modified cotton in India, starting 2002, helped convert the country from a net importer to a net exporter of cotton, selective propagation of genes that improve yields and are resistant to pests, flooding and drought, could make food cheaper, more nutritious and abundant. 

Bioremediation techniques, which offer a cheaper alternative to conventional cleaning technologies, can be used to address the impending global crisis in the area of water and energy. Application of technologies like the ones being developed by Sea6 Energy, will help harness the potential of the oceans to provide solutions in energy, agriculture and feed, thus helping restore the ecological balance.

This article originally appeared in September 2, 2017 issue of Business World Magazine.

CRISPR: A Game Changing Technology for a More Equitable Future

Image Credit: Mopic/Alamy Stock Photo

2016 was a landmark year for the biotechnology industry as it was for the first time that the revolutionary CRISPR-Cas9 gene-editing technique was used in humans. With more human trials involving CRISPR-Cas9 scheduled to be conducted, I believe 2017 will be the year when the technology’s potential to treat human diseases could receive strong clinical validation.

CRISPR-Cas9, which provides scientists with a breakthrough tool to alter or replace the DNA of nearly any living organism with unprecedented precision, is one of the most promising scientific discoveries of the past century. This is why there was considerable excitement in the biotech world when news broke that scientists in China had injected cells modified with CRISPR technology into a patient suffering from an aggressive form of lung cancer. 

In the China trial, scientists used CRISPR technology to edit out genes that were preventing the lung cancer patient’s immune cells from attacking malignant cells. These modified immune cells were then injected back into the patient to help fight back the disease. The trial was seeking to primarily establish the safety of using CRISPR-based genetic modification to fight cancer. Beyond cancer, CRISPR holds the promise of therapeutic applications in tackling hitherto incurable genetic disorders such as haemophilia, muscular dystrophy, sickle-cell anemia and cystic fibrosis, as well as chronic conditions like Type 2 diabetes and Alzheimer’s disease.

The fact that CRISPR has been able to capture the popular imagination is evident from the fact that the four scientists who pioneered the development of the CRISPR gene-editing system were named runners-up for TIME magazine’s 2016 Person of the Year! They lost out to Donald Trump.

Faster, Cheaper & More Efficient

What makes CRISPR such a breakthrough innovation is the fact that it makes gene editing faster, easier, efficient and cheaper than previously available technologies. In time, CRISPR can open the door to affordable therapies that offer the right treatment for the right patient at the right time with the aim of minimizing side effects and maximizing positive outcomes.

Recently, researchers at the Salk Institute demonstrated that CRISPR could be used to partially restore vision in genetically blind rats. The Salk technique represents the first time scientists have managed to insert a new gene into a precise DNA location in adult cells that no longer divide, such as those of the eye, brain, pancreas or heart, offering new possibilities for therapeutic applications in these cells, the study, published in the journal Nature, said.

The rising popularity of CRISPR technology mirrors today’s medical paradigm that is rapidly evolving from treating symptoms to understanding disease at a cellular and genetic level to deliver personalised diagnostics and therapies.

Scientists are even looking at the possibility of using CRISPR technology to grow human organs in animals for transplantation, thus effectively tackling the problem of human donor shortages.

Studies are also ongoing to use CRISPR to manipulate mosquito genes so that they can no longer spread killer diseases like malaria and dengue. Research is also being conducted into the ecological and agricultural applications of CRISPR technology – from helping protect endangered species to developing pest-resistant crops that would help cut down use of toxic pesticides.

Huge Investor Interest

The huge potential of CRISPR has expectedly generated immense investor interest. In 2016 alone, the US witnessed the market debuts of three biotech companies focused on CRISPR technology. Editas Medicine and Intellia Therapeutics raised over USD100 million each through their market offerings earlier this year, according to Bloomberg; while Crispr Therapeutics generated USD56 million through its IPO in October. In fact, companies working on CRISPR technology have raised over USD600 million since 2013 in venture capital and the public markets, researchers at Montana State University had estimated in 2015.

In the US, the first human clinical trials to study the safety of a CRISPR-based cancer treatment are expected to be initiated in 2017. Interestingly, the trials are being funded by The Parker Institute, a new philanthropy created by tech billionaire Sean Parker to battle cancer.

 
Ensuring Affordable Access

While investments are welcome, the international medical research community needs to be cognizant of the fact that this breakthrough technology is not hijacked by purely commercial interests. The rush to profit from new biomedical discoveries based on CRISPR should not lead to the creation of restrictive patent regimes and monopolistic markets. It should not end up as a model that seeks to sustain super-normal profits by discriminating against patients on the basis of nationality, race and economic status.

The focus should firmly be on using CRISPR to develop therapies that fulfil unmet medical needs while ensuring they are affordable and thus accessible. The needs of poor patients and overall public health should not be sacrificed in favour of developing non-essential treatments for rich patients.

The game-changing CRISPR technology should lead to new paradigm where those needing life-saving medicines get it, at all times and in all places. 

Kiran Mazumdar - Shaw
Dec 19, 2016

Why FY14 was a Remarkable Year for Biocon

The fiscal year gone by has been one of the most exciting ones for Biocon. We delivered on our promise of affordable innovation, recorded robust top line and bottom line growth, augmented our capacities, optimized our product portfolio and introduced initiatives to achieve operational efficiencies.

  

We successfully commercialized two world-class, low-cost monoclonal antibodies, an outcome of our innovation model– ALZUMAb™ and CANMAB™ , in India in FY14.

Our novel, ‘first-in-class’ biologic drug for chronic plaque psoriasis, ALZUMAb™, was made available to patients in August 2013. It is the first biological drug for psoriasis to be researched, developed and manufactured in India. ALZUMAb™ has received an enthusiastic response from both physicians and patients as it is an affordable treatment option that promises patients a better quality of life. This unique product offers an effective biologic treatment solution to 1-2% of the Indian population who suffer from psoriasis.

Biocon followed this up with CANMAb™, the world’s lowest priced trastuzumab. The launch of CANMAb™ in India represents an important milestone. It demonstrates that Biocon’s decade-long experience and expertise in developing biologics has equipped the company with the necessary clinical development and manufacturing skills to deliver high quality, world-class products.   

Creating IP, Adding Value

With these two launches, Biocon has again proved to the world that as far as scientific talent is concerned Indians are second to none.

Moreover, these two launches have lent credibility to our strategy of building a rich pipeline of innovative programs that has today made Biocon one of the highest R&D spenders in this country.

I believe that the only way we can create exponential and enduring value for Biocon’s stakeholders is through innovation and intellectual wealth and I am happy to say we are doing just that.

Here, I would like to draw attention to the fact that Biocon has been able to deliver on its promise of affordable innovation despite the current hostile environment towards pharma innovation in India.

Surmounting Challenges

Uncertainty over clinical trials is just one of the several challenges that Biocon faced in FY14. But in keeping with the company’s ethos, we addressed them with a sense of dedication and determination.

The clinical trials environment in India has become extremely challenging because of the irrational stand taken by courts on the issue and the government’s knee-jerk policy-making to mollify the judiciary.

If the situation is not rectified, it can have an irretrievable impact on India's ability to partake in new drug development and end up denying patients here the benefits from the latest advances in medical science.

To address the increasing product commoditization in the small molecules business and improve profitability, Biocon had embarked on its strategy of moving up the value chain to forward integrate into building a robust pipeline of generic formulations, including ANDAs for the US market. This pipeline of difficult-to-make, technology-intensive molecules will be the growth driver for the small molecules business in the next few years. It will also make Biocon among the few companies in the world with a strong portfolio of small molecule generics as well as generic biologics.

In FY14, the domestic pharma industry saw growth slow down to 6% due to the combined impact of economic slowdown, intense competition, and issues related to drug price controls. However, leveraging the strengths of its business model with a focus on specialty pharma, Biocon was able to outpace the industry, growing its India business revenue at 13%, over double the pace of the industry growth.

Financial Highlights

Besides, the India branded formulations business, other principal revenue drivers like insulin exports and research services also helped Biocon’s revenue jump 16% in FY14. Our profit for the previous year was boosted by an exceptional income related to the dissolution of our global partnership with Pfizer. Excluding the exceptional income recognized last year, profit for FY14 grew 28%.

Good demand from emerging markets for our insulin exports led to a 15% growth in Biopharma sales for the year. To meet increasing demand, Biocon had enhanced its insulin manufacturing capacity in Bangalore in FY14.

Given Syngene’s growing stature as a pharma outsourcing partner of global repute, it was no surprise then that our research services business reported stellar growth of 28% in FY14.

Syngene, which has marquee clients like BMS and Abbott, got a strong endorsement of its capabilities this year after Baxter established its Global Research Center at Syngene in Bangalore.

Other Highlights

In FY14, Biocon strengthened its focus on research partnerships with two important collaborations.

Biocon entered into a pact with Quark Pharmaceuticals to develop novel therapeutics for treating serious ophthalmic conditions like glaucoma.

It also tied up with Advaxis for developing a novel cancer immunotherapy to treat HPV-associated cervical cancer in women.

As a leading bio-pharma enterprise Biocon embarked on establishing Biocon Academy, a Centre of Excellence for Advanced learning in Biosciences. The Academy will train engineering and biotech graduates to enhance their employability and strengthen the talent pipeline for the benefit of the country’s bio-pharma sector. The first batch of 30 students who underwent 16 weeks of rigorous learning and skill development will be ready for placements in May. As an extension of its Corporate Social responsibility Biocon is offering 75% of the course fee as scholarship to all the students.

For its flagship program, the Academy has collaborated with Keck Graduate Institute, California.

Biocon was ranked No 6 amongst the Top Ten Global Best Employers as a mark of recognition for its Clarity of vision, CSR initiatives and Quality of research, by the 'Science' Magazine in 2013. It had debuted on the list in 2012 at No. 19.

We stay committed to pursue our innovation led business strategy and build superior value for Biocon and its stakeholders.