Deal includes DTx-1252, a potential therapy for the neuromuscular disorder Charcot-Marie-Tooth disease type 1A (CMT1A), and two additional preclinical programs for other neuroscience indications

Novartis has announced that it has acquired DTx Pharma, a San-Diego based, preclinical stage biotechnology company focused on leveraging its proprietary FALCON platform to develop siRNA therapies for neuroscience indications.

DTx’s lead program, DTx-1252 targets the root cause of CMT1A—the overexpression of PMP22, a protein that causes the myelin sheath that supports and insulates nerves in the peripheral nervous system to function abnormally. DTx-1252, which was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), decreases the expression of this protein in Schwann cells, the target cell type for the development, maintenance, and function of peripheral nerves. The FALCON platform facilitates this targeted approach by conjugating siRNAs to naturally occurring fatty acids to improve the biodistribution and cellular uptake to tissues and cell types of interest.

Fiona Marshall, President of the Novartis Institutes for BioMedical Research (NIBR) said, “We look forward to continuing the development of DTx’s therapeutic programs and bringing new hope to patients with neuromuscular and other neurological disorders for which there have historically been few treatment options. We are also excited to bring DTx’s FALCON technology to Novartis and explore its potential to deliver drugs to extrahepatic tissues.”

In addition to DTx-1252, the deal also brings two additional preclinical programs for other neuroscience indications to Novartis and expands the Novartis siRNA toolkit, building on its capabilities in xRNA, one of the Novartis technology platforms.

Robert Baloh, Global Head of Neuroscience for NIBR said, “The growing arsenal of therapeutic platforms available to us continues to enable the development of novel, high-value medicines—particularly in cases where the underlying biology of disease is well defined. We look forward to continuing the development of DTx’s potential first-in-class medicine for CMT1A and are hopeful we can bring a therapeutic option to patients living with this debilitating neuromuscular condition.”

Under the terms of the agreement, Novartis will make an upfront payment of USD 500m and additional payments upon completion of pre-specified milestones.

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Australian biotech giant CSL yesterday named Paul McKenzie as the Chief Executive Officer (CEO) and Managing Director of the company, succeeding Paul Perreault.

McKenzie, who is currently CSL’s Chief Operating Officer (COO), will take over from Perreault in March next year. Perreault will stay with the company as a strategic adviser until September next year.

CSL makes most of its money paying people in the United States (US) for blood plasma, which it uses for treatments of rare diseases, but since the onset of the pandemic, it has experienced a slump in blood plasma donations.

McKenzie, who joined CSL in 2019, will step into the role of Chief Executive at a time when the company is experiencing a dip in profit due to lower blood plasma donations and sky-high inflation.

Edits by EP News Bureau

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Prime Minister Narendra Modi yesterday inaugurated the Biotech Startup Expo – 2022 in Delhi. He also launched Biotech products e-portal. Union Ministers Piyush Goyal, Dharmendra Pradhan, Dr Jitendra Singh, stakeholders of biotech sectors, experts, SMEs, investors were among those present on the occasion.

Speaking on the occasion, the PM said that India’s bio-economy has grown eight times in the last eight years. “We have grown from $10 billion to $80 billion. India is not too far from reaching the league of top-10 countries in Biotech’s global ecosystem,” he said. The PM also noted the contribution of Biotechnology Industry Research Assistance Council (BIRAC) in the development of the sector in the country. He said that today, when the country is taking new pledges during the Amrit Kaal, role of biotech industry is significant in the development of the country.

There are five big reasons why India is being considered a land of opportunities in the field of biotech — diverse population and diverse climatic zones, India’s talented human capital pool, increasing efforts for ease of doing business in India, increasing demand for bio-products in India and India’s Biotech Sector and its track record of success.

“In the last eight years, the number of startups in our country has increased from a few hundred to 70,000. These startups are made in about 60 different industries. In this also, more than 5,000 startups are associated with biotech. Every 14th startup in the bio technology sector and more than 1,100 such biotech startups emerged in the last year itself,” the PM informed. Further, talking about the shift of talent towards the sector, the PM said the number of investors in biotech sector has risen by nine times and biotech incubators and funding for them has increased by seven times. Number of biotech incubators have increased from six in 2014 to 75 now. Biotech products have increased form 10 products to more than 700 today,” he stated.

The PM said in order to transcend government-centric approach, the government is encouraging a culture of providing new enabling interfaces. Platforms like BIRAC are being strengthened and many other sectors are seeing this approach.

The PM emphasised, “Biotech sector is one of the most demand-driven sectors. The campaigns for ease of living in India over the years have opened up new possibilities for the biotech sector.”

Edits by EP News Bureau

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Kathua is, because of its resource richness with diversity as well as its geographical location, destined to be north India’s startup destination, Dr Jitendra Singh, Union Minister of State (MoS), Independent Charge (IC), Ministry of Science and Technology; MoS, IC, Ministry of Earth Science; MoS, Prime Minister’s Office (PMO) and Ministry of Personnel, Public Grievances and Pensions, Atomic Energy and Space, said recently while inaugurating north India’s first industrial biotech park at Ghatti, Kathua, Jammu, along with Manoj Sinha, Lieutenant Governor, Union Territory (UT), J&K.

Dr Singh said that this is the historic day for Kathua as its name is now listed among those developed regions of India where biotech parks have been established, attracting innovations and research not only from the country, but from the whole world.

He also said that the biotech park would act as hub for incubation of new ideas, and will act as a robust platform to support agri-entrepreneurs, startups, progressive farmers, scientists, scholars and students not only from Jammu & Kashmir and Ladakh, but also from nearby states of Punjab, Haryana and Himachal Pradesh.

Dr Singh said that the biotech park at Kathua has a potential to produce 25 startups in a year which will be among its great contributions to this region. He informed that with the unlocking of space technology in India under Prime Minister Narendra Modi, 60 startups have been established in only one-and-a-half year.

The minister stated that the facilities like herbal extraction, fermentation, analytical lab., distillation, micro-propagation and plant tissue culture would be available in the biotech park, besides the provision of technology incubation, training and skill development.

Dr Singh also said that the work on the two industrial biotech parks, one at Ghatti, Kathua, Jammu, and other in Handwara, Kashmir, jointly funded by the Department of Biotechnology (DBT) and Jammu and Kashmir Science, Technology and Innovation Council, was started in February 2019. The Council of Scientific and Indian Research-Indian Institute of Integrative Medicine (CSIR-IIIM) Jammu, has been entrusted with the responsibility of implementation of this project.

The union minister also informed that this biotech park will carry out research on biodiversity, medicinal and aromatic plants of Jammu and Kashmir and Ladakh, and it will also promote green category businesses.

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Dr Jitendra Singh, Union Minister of State (MoS) (IC), Ministry of Science and Technology; MoS (IC) Ministry of Earth Science; MoS, Prime Minister’s Office (PMO) and Ministry of Personnel, Public Grievances and Pensions has launched single national portal for biotech researchers and start-ups. The Portal “BioRRAP” will cater to all those seeking regulatory approval for biological research and development activity in the country, and thus aims for “Ease of Science as well as Ease of Business.”

Speaking during the launch of Biological Research Regulatory Approval Portal (BioRRAP), Dr Singh said, India is poised to become a global bio-manufacturing hub and will figure among the top five countries of the world by 2025.

Dr Singh said that the portal will also allow stakeholders to see the approvals accorded against a particular application through a unique BioRRAP ID. He described this unique portal of the Department of Biotechnology (DBT) as a step towards ‘Ease of Doing Science and Scientific research’ and ‘Ease of Start-ups’ in India. Biotechnology has fast emerged as an academic and livelihood avenue for youngsters in India. There are over 2,700 biotech start-ups and more than 2,500 biotech companies working at present in the country.

“This portal will strengthen inter-departmental synergies and bring accountability, transparency and efficacy in functioning of agencies regulating various aspects of biological research and issuing permission,” he added.

The minister further added that at present, there is no mechanism to track the requisite regulatory approval for a research proposal on a single portal and therefore, to provide more credibility and recognition to such biological researches, government of India has developed a web system under which each research, requiring regulatory oversight, will be identified by a unique ID called “BioRRAP ID.” He said that the portal will serve as a gateway and will help researcher to see stage of approval of their applications for regulatory clearances and to see preliminary information on all the research work being undertaken by the particular researcher and/or organisation.

The minister underlined that during pandemic, it was observed that there is need to link the applications submitted to various regulatory agencies for approval so as status of application may be seen at one place. Further, it was also felt that as a country, we should have repository of the research works being undertaken by our researchers working in public and private sector. This will not only help us in understanding our scientific strength and expertise, but also in formulation of enabling policies to garner the fruits of scientific research.

In his address, Dr Rajesh S Gokhale, Secretary, DBT, said, “BioRRAP has been developed that generates BioRRAP ID for all the research applications submitted on this portal and using this BioRRAP Id, further submission process to respective regulatory agencies has to be initiated based on the research application. He said, this portal is dedicated only for research-related activities, and not for product development.”

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Bangalore Bioinnovation Centre (BBC) and Cytiva have collaborated to work together to support the start-up ecosystem and academia in the field of biopharmaceuticals by providing a platform for skill development and industry-oriented training in the field of bioprocessing (upstream, downstream and analytical characterisation), the companies said in a joint statement.

As per Invest India’s survey, Indian biotechnology industry, estimated to reach $150 billion by 2025, expects to see the number of startups grow from above 4,000 to 10,000 by 2025. BBC is a world-class incubation centre with central instrumentation facility in a 10-acre campus with a total build-up area of 60,000 square feet, and is engaged in providing infrastructure support, skill development and assistance to start-up companies, ventures and projects in biopharmaceutical field to help conversion of innovative ideas and research into commercialisation. This collaboration aligns well in giving impetus to the innovation ecosystem by driving industry-academia linkages, and eventually, enhanced research, added the statement.

Talent is critical for all industries, but it is particularly critical for the biopharma industry given the complexity of the sector. According to the Cytiva Biopharma Resilience Index, the talent pool is the weakest link in the global biopharma industry. Sixty five per cent of the Indian respondents in the Biopharma Resilience Index say that sourcing talent in technology, manufacturing and R&D is a substantial challenge. Thus, the demand for collaboration is expected to be high, the statement concluded.

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DBT/Wellcome Trust India Alliance (India Alliance) has appointed Dr Jyotsna Dhawan as its CEO. She has taken over responsibilities from Dr Vasan Sambandamurthy with effect from 1st December, 2021 till further communication, as per a statement from DBT/India Alliance.

The statement informed that Dr Dhawan holds over 25 years of experience in research leadership at the Centre for Cellular and Molecular Biology, Hyderabad, where her group has focussed on muscle stem cells. She was involved in the establishment of DBT’s Institute for Stem Cell Science and Regenerative Medicine in Bengaluru in 2009. Dhawan’s research has focussed on molecular mechanisms by which dormancy or quiescence contributes to adult stem cell function and skeletal muscle repair.

She is the current (2019-2021) President of the Indian Society for Cell Biology and the Indian Society of Developmental Biologists (2017- 2020) and was elected as a Fellow of the Indian National Science Academy in 2019, the statement further mentioned.

Speaking on her appointment, Dr Dhawan said, “I am honoured and excited to join the prestigious DBT/Wellcome Trust India Alliance, a foundation that is at the forefront of transforming biomedical research in India. I look forward to working with the scientific community to strengthen the research ecosystem in India. We are at a critical juncture when the world is battling the COVID-19 pandemic and the public has very high expectations from science.”

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What is the current market scenario of biotechnology sector in India?

As per the India Brand Equity Foundation (IBEF), the biotechnology sector in India amounts to $63 billion (Rs 4,60,000 crores), and is expected to reach $150 billion (Rs 10,95,000 crores) by 2025, with a CAGR of 16.4 per cent. As one of the top 12 biotechnology locations, India currently contributes three-tofive per cent share of the global biotechnology sector, which is expected to grow up to 19 per cent by 2025.

Some of the drivers of this growth would be rapidly improving clinical capabilities, pegging India as a desirable destination for clinical trials, contract research and manufacturing drugs. Increased government expenditure is estimated to further boost the biotechnology industry’s growth. The demand for healthcare services in India will continue to rise as the country’s economy grows and people become more health-conscious. The outsourcing market size for CDMOs in India is roughly at Rs 20,000 crores and it is expected to grow to about Rs 40,000 crores in the next four-to-five years. The PLI schemes offered by the government is also expected to benefit domestic manufacturers as well as the country.

Biotechnology sector is recognised as the key driver for contributing to India’s $5 trillion economy target by 2024. In what ways do you think this goal can be achieved? What role can Windlas Biotech play in this?
It is true that biotechnology sector holds the potential for providing innovative, low-cost and improved solutions for the existing gaps and challenges in sectors like health, environment, energy and industrial processes. The COVID-19 pandemic has accelerated the acceptance of many breakthrough technologies in research as well as in manufacturing. For instance, during the global pandemic, India cemented its position as an important hub for COVID-19 vaccine R&D. At one point, there were at least half-a-dozen Indian vaccine makers in different stages of vaccine development.

Globally, the biggest push has come in the field of Nucleic acid therapeutics. Many messenger RNA, anti-sense oligonucleotides have been approved and others are in advanced stages of development. While a lot of this action is within the innovator biopharma ecosystem in the west, Indian generic companies are ushering in advances in bioinformatics, protein synthesis, isolation, characterisation and large-scale manufacturing that will ultimately be required to make these breakthrough medicines viable on commercial scale. Windlas Biotech, as a CDMO, is investing in creating fill-finish capacity for injectable products which will help marketing companies launch their brands of different products.

Additionally, the Biotechnology Industry Research Assistance Council (BIRAC), a public sector enterprise set up by the Department of Biotechnology (DBT), Government of India, plays a pivotal role in the development of a bio-economy in India. Through its funds, BIRAC supports all stages of product development right from proof-of-concept demonstration to product commercialisation. Entrepreneurs, start-ups, companies and academic institutions can benefit from the schemes to work on research ideas that have translational potential.

Give us a brief about the CDMO sector in India current opportunities and challenges, and how COVID-19 pandemic has impacted this sector in India when compared globally.

The pandemic has opened doors of opportunities for accelerated vaccine development, drug repurposing to manage COVID-19 symptoms, novel and rapid diagnostics. We’ve seen an array of scientific advances in the last one year.

However, a majority of Indian biotech and pharmaceutical businesses are still focussing on the generic drug market and are not necessarily involved in New Chemical Entity (NCE) research. However, the ecosystem’s capabilities are ripe for value creation in the contract research, development and manufacturing services market. Due to the pandemic, reduced time span from concept to prototype to trial, the whole NCE world (innovator pharma/biotech companies) is recognising the value of collaborating with agile and scientifically-competent enterprises in India to hasten drug development.

For Indian CDMOs like us, this means that we can put our existing resources and facilities to work on a higher-value-added project and make a difference. When looking at the overall savings in terms of developmental timeline contraction and the ripple effect on total capital at risk on a specific NCE proposal, these partnerships are extremely synergistic. Even in the generic market, CDMOs have proven their worth to clients by quickly ramping up manufacturing volumes and averting stock-outs for essential products that witnessed a sudden spike in demand owing to the pandemic.

How has Windlas Biotech leveraged the opportunities in the CDMO sector? Tell us about your achievements so far.
Though a recently listed company, we’ve always had a strong track record on research, development, manufacturing and distribution of pharmaceutical products in India and several other emerging markets. Windlas Biotech works with large multinationals and Indian pharma companies to rapidly bring new products to market.

We primarily focus on three areas: improving existing molecules to lessen patient pill burden and hence enhance medication compliance; using innovative drug delivery technologies to boost medicine bioavailability or to deliver the drug directly to the location, hence improving the therapy’s safety profile; and reducing therapy cost for more improved accessibility and affordability.

We knew early on in the outbreak that scientists would require rapid prototyping and clinical trial skills to bring new concepts to market. We collaborated with Oncotelic, a biotechnology business based in the US, to develop and market an integrated drug and device therapy against respiratory illnesses and COVID-19. The therapy is known as ‘PulmoHeal,’ prepared from a plant extract of the indigenous herb Artemisia.

How, according to you, can governments support CDMOs better?
Under the Aatmanirbhar Bharat programme, the Indian government has taken a number of steps to make the country’s healthcare sector self-sufficient. For instance, the government stated last year that it will offer production linked incentives (PLIs) ranging from five per cent to 20 per cent to encourage the domestic manufacturing of essential Active Pharmaceutical Ingredients (APIs).

The government has been setting up mechanisms to take in account feedback and concerns of the industry. Two regulations have been changed where (a) the marketing firm has been given the same level of responsibility for product quality as the manufacturing firm and (b) through the revision of Schedule M, the new GMP guideline applicable under the Drugs and Cosmetics Act was brought in line with the global best practices. Both these regulations are expected to have significant impact on the quality of drugs and minimise the presence of sub-standard drugs in the market.

I believe that enforcement of these laws is crucial, and companies need to be proactive in upgrading their human systems, practices and infrastructure to fully reap the global opportunities now opening for us. Moreover, the government must encourage more international players to invest in R&D-driven pharma companies and CDMOs.

Going forward, what should be the focus to make the Indian biotechnology/CDMO sector Aatmanirbhar?
India is the leading exporter of OTCs and generics to the United States, with a market share of over 40 per cent. With over 3,000 pharmaceutical businesses and over 10,500 production facilities, the country is the world’s third-largest seller of pharmaceuticals. However, when it comes to generating a novel medicine molecule, the country trails far behind. As a result, it’s even more critical to bring all of the parties together-Indian pharma companies, CROs, and CDMOs – and to foster collaboration between industry and academic institutions. All of these players will be able to continue to develop, expand and strengthen their own experiences and push for an Atmanirbhar India.

What are the trends and patterns which will continue in the post-COVID world in the CDMO sector?
One of the major trends to follow would be investment in new facilities and new technologies – prompted by increasing quality standards as well as demand. So, as said before, the market has the potential to grow and the major stimulus for that would be innovation and greater access to larger section of the population. Newer technologies with new delivery systems like mRNA, and high potency products are areas of demand, such trends are expected to carry on. Lastly, the fact that collaborations among large pharma companies and CDMOs worked well during pandemic, is a testament that such partnerships could be explored for increasing access in other high-priority areas in a post-COVID-19 world as well.

akanki.sharma@expressindia.com
journoakanki@gmail.com

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India and Colombia exchanged views on possible scientific cooperation in the biotechnology sector as the latter showed willingness for a tie-up in the areas of vaccines, biosimilars and medical devices.

A high-level delegation from Colombia led by Marta Lucia Ramirez de Rincón, Vice-President and Minister, Foreign Affairs, visited the Department of Biotechnology (DBT) and held a meeting with the Indian delegation led by Dr Renu Swarup, Secretary, DBT.

Calling health and biotechnology sectors major priority areas of shared interest, Rincón said she looked forward to cooperation towards building a sustainable biotechnology ecosystem.

There was a mutual exchange of views on possible areas of scientific cooperation in the biotechnology sector, the Science and Technology ministry said in a statement.

“To formalise the cooperation, a Letter of Intent is proposed to be executed between the Ministry of Science and Technology on the Indian side and Ministry of Science, Technology and Innovation on the Colombian side,” the ministry said.

Dr Swarup said, “Indian Biotechnology industry is aimed at reaching a $150 billion bio-economy by 2025. Look forward to bilateral cooperation in areas of mutual scientific interest.”

Fernando Ruiz Gomez, Minister of Health and Social Protection, Colombia, mentioned that India is renowned as a global vaccine manufacturing hub and expressed willingness for cooperation in the areas of vaccines, biosimilars and medical devices.

Appreciating the accomplishments of India over the past few decades in the S&T sector, Sergio Cristancho, Vice Minister of Science, Technology and Innovation, Colombia, said that they hoped to replicate Indian models of knowledge generation and innovation and looked forward to developing sustainable collaborative initiatives.

Dr Swarup said she hoped that through this visit the bilateral partnership, could be taken to the next level in in areas of mutual scientific interest.

Remarking that biotechnology is one of the most emerging sectors and that the Indian biotechnology industry is aimed at reaching a $150 billion bio-economy by 2025, Dr Swarup expressed hope of working together in achieving the target.

Earlier during the meeting, an overview of the spectrum of activities supported by DST and DBT in the lifesciences sector, the efforts by the Biotechnology Industry Research Assistance Council (BIRAC) in nurturing the biotechnology start-up and innovation ecosystem, was provided.

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We can agree on two things. Biocon is a superstar. And so is SII. 

Biocon is a poster child of biotech innovation in India. Decades of unwavering passion, commitment to a science that India has no skill in, and enduring financial patience, has brought it in the league of a big few, like Amgen. While it is nowhere near inventing new drugs, it is possibly halfway there. What’s important is that its science has received validation from regulatory agencies that matter. Its ability to manufacture new forms of insulin at global standards and scale is remarkable. This is one of the world’s oldest drugs but has remained a monopoly of two or three big companies for nearly a century. Biocon is busting that and how – with nearly three billion does already dispensed globally. 

Serum Institute of India (SII) is already the world’s largest manufacturer of vaccines and by some reports, accounts for nearly two-thirds of the world’s vaccine use. A private company, it kept a low profile, maintaining a tight focus on child immunisation the world over – working closely with GAVI, UNICEF and the health ministries of the world. Until Covid stuck, who outside the industry would have heard of SII? It perhaps is a household name today, or nearly getting there. What remains vastly unacknowledged is the serious global impact that one organisation can have on the health of the world. That SII has remained fiercely independent is perhaps the biggest contributor to affordability and accessibility of essential vaccines in the southern hemisphere. 

That two global superstars are coming together is a milestone event in the evolution of Indian biotech. What’s interesting about this alliance?

Let’s not invade each other’s spaces

SII has been working to get into biosimilars, novel antibodies and proteins on its own. It has not seen much progress despite having technical collaborations in these areas. Biocon is light years ahead, as we know. By taking a stake in the latter, SII gets a meaningful share of the value of a pipeline it aspired for but is late to the party. Similarly, for Biocon, vaccines would have been the logical expansion opportunity, given its scientific ability. It now gets access to a commercial portfolio and can bring immediate revenues.

A joint future pipeline

Biotechnology based sciences have many new frontiers that are opening to therapeutics and prophylactics – mRNA, CAR-T, fusion antibodies, novel conjugations, stem cells etc. – to name a few. There is merit in pooling together resources to explore this. Much of the raw materials used in biologically derived products are import intensive – media, bags, reagents. There is also merit in collaborating to indigenize this – as considerable global scale is available in both companies to back this. This “Atmanirbhar” theme is timely. 

Devil is in the details

• Will Biocon be successful in commercialising the 100 million doses per annum it has access to? Most of the developing world depends on GAVI, UNICEF and national level health bodies to make these available and SII already services these channels successfully. It will also service the Covid vaccine alliance once exports are allowed to open up. It leaves the private trade channels available for Biocon to participate in – where opportunity exists mostly in the US and Europe. The more modern polyvalent and pneumococcal vaccine should be considerable scope here, however lengthy regulatory hurdles will not be insignificant even for the joint might of these two companies. 
• No details of the proposed joint pipeline are available. One assumes that it may be a conceptual understanding presently. Who will invest how much, how will synergies be leveraged, which synergies will be leveraged – are currently unknown? Arguably the most exciting part of the collaboration remains a mystery

Managing perceptions and egos

Optically, without details of future pipeline and investments, it does appear that the alliance is a short-term fix to “revenue gaps” for Biocon. At the price of some “loss of control”. The companies should disclose more granular plans in the near term to prevent this perception from cementing. It’s also unclear why Biocon hasn’t taken a commensurate reciprocal stake in SII, which would have eased even remote “conflicts of interest” in future. Could that be a possible next step?

Both companies are professionally managed, founder driven organisations. They are run by flamboyant founders, who not only enjoy being in the limelight but are also known to speak their minds. Will they be able to strike the right relationship and governance that deals with issues objectively and proactively? The track record of Indian companies collaborating (other than outright M&A) is woefully inadequate to form a view. 

The success of this alliance may depend as much on Founder Chemistry as it does on the science of Biology. 

(Note: Chandru Chawla is Executive VP, Cipla and writes on management, leadership, environment conservation and human rights. The views expressed above are personal)

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