The Torrent Group, a diversified conglomerate, surpassed $20 billion (Rs 1.68 lakh crore) in market capitalization on Friday. This represents nearly a doubling of its market value, driven by robust growth across businesses, ranging from pharmaceuticals to energy.

 Torrent Group's m-cap stood at $10.8 billion (Rs 90,230 crore) on June 6, 2023.

On Friday, two listed companies of the group, Torrent Pharmaceuticals Limited and Torrent Power Limited gained 2.22 per cent and 2.59 per cent, respectively, setting a new milestone for the group's market capitalisation at $20.2 billion at the close of market hours, according to stock exchange data.

Steady growth in the group's market capitalisation mirrors robust financial performance, sustained growth trajectory and business expansions across verticals.At the core of its growth strategy is the business model driven by acquisitions.The group has already implemented a succession plan where the third generation of the founder late UN Mehta has assumed all prominent driving seats across businesses.Torrent Pharma has been an early mover into acquisitions when it acquired Elder Pharma in 2013, followed by a spree of acquisitions with latest being Curatio in 2022 to foray into the dermatology segment. The company's large and bold bets are paying off a decade later.Recently, the company inked a pact with Takeda Pharmaceuticals to commercialise its novel gastrointestinal drug Vonoprazan in India under the Torrent brand name of Kabvie for treatment of acid related disorders - Gastroesophageal Reflux Disease (GERD).Torrent Pharma reported a 33 per cent jump in the net profit at Rs 1,656 crore for the fiscal 2023-24 with a revenue growth of over 12 per cent at Rs 10,728 crore. The company earns about 50 per cent of its revenues from the domestic market.During the past year, Torrent Pharma's India business grew by 10 per cent, while on a MAT (moving annual turnover) basis, the company has outperformed the market across all focus therapies aided by strong new launch performance.Torrent Pharma has 20 brands in the top 500 brands in the Indian Pharmaceuticals Market (IPM), with 17 brands worth more than Rs 100 crore.Ranked 5th in the Indian Pharmaceuticals Market, Torrent is amongst the top 5 in the therapeutics segments of Cardiovascular (CV), Gastrointestinal (GI), Central Nervous System (CNS), Vitamins Minerals Nutritionals (VMN) and Cosmo-Dermatology. The company has a presence in 50 countries.The power arm of the group, Torrent Power reported a net profit of Rs 1,896 crore on the revenues of Rs 27,183 crore for fiscal 2023-24.The company has built 1,236 MW of renewable capacity with additional 3,041 MW capacities under development.It already has laid down a pipeline of projects in the renewable space.The company is investing in pumped-storage hydro (PSH) and the first project is likely to come up in the next five years.The company has also set ambitious plans for green hydrogen projects. The first pilot project on green hydrogen is being developed in Uttar Pradesh with the blending of green hydrogen with gas in the city gas distribution network in Gorakhpur.On the distribution front, Torrent Power distributes nearly 30 billion units to over 4.13 million customers across 12 cities.Read also: Torrent Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC

The platform, using a cell line and transposon-based technology in-licensed from Swiss biotech services company, ExcellGene, coupled with Syngene's clone selection and development processes, promises significant improvement in efficiency and precision.

The new platform accelerates enhanced protein production, enabling quicker preclinical and clinical development as well as product launches, thereby reducing time to market, the company claimed in a releae.

"By combining the cell line and transposon-based platform from ExcellGene with our proprietary processes, we are pushing the boundaries in cell line development. This innovative approach will not only accelerate development timelines but also enhance the overall reliability and efficiency of the process, delivering substantial benefits to our clients," said Sridevi Khambhampaty, Vice President, Biopharmaceutical Development, Syngene International.

"Syngene sees biologics as a key driver of future growth and we are committed to investing in cutting-edge technology to achieve reliability, precision and speed for clients. By combining Syngene's skills and experience with ExcellGene's best-in-class cell line development technology, we can expedite getting molecules to market for the people and patients who need them," said Alex Del Priore, Senior Vice President, Manufacturing Services, Syngene International.

"High yield manufacturing is a multifactorial exercise that starts with transfections and an optimised cell host. We are obviously delighted to partner with and to contribute to Syngene's process development and manufacturing capabilities. This will leverage our technology and our cells (CHOExpress) for the benefit of their extensive client base. At ExcellGene, we pride ourselves in having studied the profound challenges in DNA transfer to cultivated cells for decades and linked insights from such studies to their phenotypes and use in manufacturing. We are delighted that our work, combined with the talent and expertise of the Syngene team, will directly benefit patients around the world", said Maria J. and Florian M. Wurm, Cofounders and Managers, ExcellGene

The new platform streamlines clone selection and enhances operational productivity. It also supports a wide range of biomolecules including monoclonal antibodies, biosimilars, bispecifics, antibody-drug conjugates and other recombinant proteins. This versatility facilitates integration with both perfusion and fed-batch manufacturing processes.

Read also: Syngene biologics manufacturing facility to be operational for US, European customers from mid year

A parallel line extension application and type 2 variation application have also been submitted to the European Medicines Agency (EMA) for expanded pediatric use in Europe, where the product is marketed as REZOLSTA.

If the applications are approved, PREZCOBIX/REZOLSTA could be administered to adults and pediatric patients at least 6 years of age, weighing at least 25kg. A new co-formulated tablet containing a weight-adjusted pediatric dose (darunavir 675 mg/cobicistat 150 mg) has been developed to aid administration for younger children. The new pediatric tablets are scored to facilitate breaking for ease of swallowing.

“We are proud of this latest step in our years of work to ensure that some of the youngest people living with HIV have access to different treatment regimens that can work for them,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines and Global Public Health R&D at Johnson & Johnson. “If approved, this medicine could offer healthcare providers a new treatment option that ensures weight-appropriate dosing to better meet the needs of young people living with HIV.”

The applications to the FDA and EMA are supported by data from a clinical study sponsored by Janssen Research & Development, LLC, that evaluated the pharmacokinetics of the new combination tablet and established that it is bioequivalent to darunavir and cobicistat when dosed as single agents (NCT04718805). The efficacy, safety and tolerability of cobicistat-boosted darunavir for the treatment of younger children with HIV-1 was established in a Phase 2/3 clinical trial conducted by Gilead Sciences (NCT02016924).

Based on these data, Janssen Products, LP, a division of Johnson & Johnson, is seeking an expanded indication to allow the use of PREZCOBIX/REZOLSTA in treatment-naïve and treatment-experienced pediatric patients aged 6 years and older, weighing at least 25 kg, and who have no viral resistance mutations associated with darunavir.

PREZCOBIX/REZOLSTA is a two-drug fixed-dose combination tablet containing darunavir, an HIV-1 protease inhibitor, and cobicistat, a CYP3A inhibitor that serves as a PK enhancer or “booster.” The booster enables once-daily dosing and optimal therapeutic levels of darunavir.

This product is currently indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults and adolescent patients weighing at least 40 kg with no darunavir resistance-associated mutations.

Darunavir as a single agent is marketed by Janssen Products, LP as PREZISTA in the United States, and cobicistat, developed by Gilead Sciences, Inc., is marketed as TYBOST. The fixed-dose combination PREZCOBIX/REZOLSTA is a collaboration between Janssen R&D Ireland and Gilead Sciences, Inc.

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Landos' lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist (a member of the NOD-like receptor family), which is currently in Phase 2 for the treatment of moderate to severe UC (NEXUS study; NCT05785715). NLRX1 regulates immunometabolism and inflammation, and its activation may address inflammatory bowel disease (IBD) pathogenesis. With a dual mechanism of action that is anti-inflammatory and facilitates epithelial repair, NX-13 has the potential to offer a novel approach to the treatment of UC and CD.

"Many people living with IBD are not able to achieve or maintain remission and continue to experience debilitating symptoms," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "The addition of NX-13 complements our portfolio in immunology and strengthens our collective efforts to transform standard of care. I want to commend the Landos team for their efforts in advancing our shared mission of developing medicines for those who need it most."

AbbVie has acquired Landos at a price of $20.42 per share, plus one non-tradable contingent value right per share with a value of up to $11.14 per share, subject to the achievement of a clinical development milestone. Landos' common stock will cease to trade on the NASDAQ stock exchange prior to market open on May 24, 2024.

NEXUS is a Phase 2 proof-of-concept clinical trial evaluating NX-13 in patients with moderate to severe UC. NEXUS is a randomized, multicenter, double-blind, placebo-controlled, multiple dose, 12-week induction study evaluating 80 patients with moderate to severe UC with a long-term extension (LTE) period. All subjects will be randomized to receive either 250 mg or 750 mg immediate release NX-13, or placebo. The primary objective of the trial will be to evaluate clinical efficacy, safety and pharmacokinetics of oral NX-13 versus placebo (NCT05785715 ClinicalTrials.gov).

Read also: USFDA grants full approval for Abbvie Elahere for certain ovarian cancer patients

It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.

“For healthcare teams treating patients with serious Gram-negative bacterial infections, the prospect of running out of effective treatment options is a daunting but very real threat,” said Yehuda Carmeli, Head, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Israel, and an investigator in the REVISIT study. “The approval of EMBLAVEO is welcome news for the infectious disease community and provides new hope to critically ill patients affected by antimicrobial resistance.”

Antimicrobial resistance (AMR) – when bacteria, viruses, fungi, and parasites change and find ways to resist the effects of antimicrobial drugs – is recognized as one of the biggest threats to global health. If AMR continues to rise unchecked, minor infections could become life-threatening, and many routine medical procedures such as caesarean sections and hip replacements could become too risky to perform. Multidrug-resistant Gram-negative bacteria are of particular concern due to the high rates of morbidity and mortality they cause. Metallo-β-lactamases (MBLs) are a type of enzyme produced by certain bacteria that can result in resistance to antibiotics, and MBL-producing Gram-negative bacteria are on the rise globally. Developing new treatments for infections caused by Gram-negative bacteria has been prioritized by the World Health Organization (WHO) as a critical area of focus due to their increasing spread.

“The European Medicines Agency’s accelerated review of EMBLAVEO reflects the urgent need for new treatments to address the threat of antimicrobial resistance,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With this approval, Pfizer is proud to take another step forward in its commitment to developing and bringing breakthrough health solutions to patients impacted by serious infectious diseases around the world.”

This approval is based on results from the previously reported Phase 3 program comprising the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies evaluating the efficacy, safety, and tolerability of EMBLAVEO in treating serious bacterial infections due to Gram-negative bacteria, including MBL-producing multidrug-resistant pathogens for which there are limited or no treatment options. Data support that EMBLAVEO is effective and well-tolerated, with no new safety findings and a similar safety profile to aztreonam alone.

The marketing authorization of EMBLAVEO is valid in all 27 European Union (EU) member states, as well as in Iceland, Liechtenstein, and Norway. Marketing authorization applications for EMBLAVEO are planned for submission in other countries.

EMBLAVEO combines aztreonam, a monobactam β-lactam, with avibactam, a recent broad-spectrum β-lactamase inhibitor. MBLs are a class of β-lactamase enzymes that are not inhibited by current β-lactamase inhibitors and hydrolyze nearly all β-lactam antibiotics, with an exception being monobactams such as aztreonam. However, monobactams are degraded by other β-lactamases that are frequently co-produced with MBLs, limiting the clinical usefulness of aztreonam monotherapy.

The combination of aztreonam with avibactam restores aztreonam’s activity against bacteria that co-produce MBLs and other β-lactamases and provides a well-tolerated and effective treatment option against multidrug-resistant Gram-negative bacteria. These multidrug-resistant Gram-negative bacteria include MBL-producing Enterobacterales, which have been highlighted as a critical priority pathogen by the WHO, and S. maltophilia. EMBLAVEO is the β-lactam/β-lactamase inhibitor combination for treating serious bacterial infections in adult patients caused by multidrug-resistant Gram-negative bacteria, including MBL-producing bacteria, approved for use in the EU.

EMBLAVEO was jointly developed with AbbVie. Pfizer holds the global rights to commercialize this therapy outside of the U.S. and Canada, where the rights are held by AbbVie. Development of EMBLAVEO was also supported by public-private partnerships between Pfizer and the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under OTA number HHSO100201500029C; and through the EU’s Innovative Medicines Initiative(IMI) – a partnership between the EU and the European pharmaceutical industry – under a project called COMBACTE-CARE (Combatting Bacterial Resistance in Europe – Carbapenem Resistance). The COMBACTE-CARE consortium is a unique public-private collaboration that unites the knowledge and capabilities of leading drug-resistant bacterial infection experts and is supported by the COMBACTE pan-European clinical and laboratory networks.

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Data from the commerce ministry indicates that pharmaceutical exports in March saw a particularly significant surge, increasing by 12.73 percent to USD 2.8 billion.

In 2022-23, the exports stood at USD 25.4 billion.

The top five export markets, for the sector during the last fiscal, are the US, the UK, the Netherlands, the United Kingdom, South Africa and Brazil.The US accounts for over 31 per cent of India's total pharma exports, followed by the UK and Netherlands (about 3 per cent each).In 2023-24, the outbound shipments also entered new geographies like Montenegro, South Sudan, Chad, Comoros, Brunei, Latvia, Ireland, Chad, Sweden, Haiti and Ethiopia.An industry expert said that increasing market opportunities and healthy demand in countries like the US are helping exports to record healthy growth rates month after month.Read also: Alembic Pharma Gets CDSCO Panel Nod to Study FDC Carbidopa, Levodopa ER Capsule for export purpose onlyExperts have said that India's pharmaceutical business may exceed USD 130 billion by 2030, supported by expanding market opportunities and heightened demand in the overseas markets. The business stood at over USD 50 billion for the 2022-23.On average, India exports pharma products worth USD 2-3 billion every month.Read also: CDSCO Introduces Online Application System to issue Neutral Code for manufacturing Medical Devices for exportIndia's pharmaceutical industry is the third largest by volume and the 13th largest by value in the world, producing more than 60,000 generic drugs across 60 therapeutic categories.The government has rolled out two production-linked incentive (PLI) schemes to promote domestic manufacturing of key pharmaceutical ingredients and generic medicines

Read also: India to demand faster USFDA inspections of pharma firms at Trade Policy Forum meet

The trials are carried out by Bharat Biotech in close collaboration with Biofabri.
Trials to evaluate the safety and immunogenicity of MTBVAC have started with a
pivotal safety, immunogenicity and efficacy trial planned to start in 2025.

After more than three decades of research, Esteban Rodriguez, CEO of Biofabri
says, "It is a giant step to test in adults and adolescents in the country where
28% of the world’s TB cases accumulate and concludes that more effort and
funding is needed to combat TB, which remains one of the world’s leading
infectious causes of death, especially in India."

Dr. Krishna Ella, Executive Chairman Bharat Biotech added, “Our quest for a
more effective vaccine against Tuberculosis received a big boost, with
clinical trials in India. Our goal to develop TB vaccines to prevent disease in adults
and adolescents has taken a big step. We are honoured to partner with
BioFabri, Dr. Esteban Rodriguez and Dr. Carlos Martin in this noble effort to
reinvent TB vaccines.”

As per the release, the MTBVAC vaccine has passed several milestones before entering clinical
trials in India. The first is that after the recent completion of a Phase2 dose finding trial, a
double-blind, controlled Phase3 clinical trial in newborns has started in 2023,
comparing the vaccine with the current BCG vaccine. 7,000 newborns from South
Africa, 60 from Madagascar and 60 from Senegal will be vaccinated. To date,
more than 1,900 babies have been vaccinated. The aim is to assess the immunogenicity and efficacy of MTBVAC which is
administered intradermally to infants on the first day of life.

Vaccination began at a time of setback in the global fight against TB. Health
restrictions imposed during the COVID-19 pandemic led to an increase in
infections and a decrease in diagnosis and treatment. As a result, annual TB
deaths have risen to over 1.6 million.

This Phase3 neonatal project, partially funded by the European Union through its
EDCTP (European & Development Countries Clinical Trial Partnership)
programme, is being coordinated by Biofabri, as part of a consortium that also
includes the University of Zaragoza (Unizar), TuBerculosis Vaccine Initiative
(TBVI), The University of Cape Town (UCT)/SATVI, Wits VIDA Health Consortium
(WHC), Stellenbosch University (SUN-FAMCRU), Enhancing Care Foundation
(ECF), Center de Recherche Biomedicale Espoir Pour La Santé (CRB-EPLS,
Senegal) and Institut Pasteur de Madagascar (IPM).

"Another important milestone is that after completing a dose escalation trial in HIV
uninfected adults, a Phase2 study in HIV infected adults has started in 2024 to
determine whether MTBVAC is safe in this population. This ongoing trial at 16
sites in South Africa – involving the vaccination of 276 adults – is evaluating safety and immunogenicity in HIV-negative and HIV-positive adults and adolescents
vaccinated with MTBVAC," the release stated.

A Phase2b efficacy study in adolescents and adults is planned to start in the
second half of 2024 in Sub-Saharan Africa.

The studies in adolescents and adults in Sub-Saharan African are led by the
American institution IAVI. The Phase2 HIV safety study is carried out by HIV
Vaccine Trials Network (HVTN) and is funded by the Division of AIDS (DAIDS),
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes
of Health (NIH), Department of Health and Human Services (DHHS). The
Phase2b efficacy study will be carried out by IAVI and will be funded by BMGF
and Open Philanthropy.

This vaccine was developed in the laboratory of the University of
Zaragoza, which has been part of CIBERES since its creation, in collaboration
with Dr Brigitte Gicquel of the Pasteur Institute in Paris. The University of
Zaragoza has the Spanish biotechnology company BIOFABRI as an industrial
partner.

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OSE-230 is a first-in-class monoclonal antibody designed to activate ChemR23, a G-Protein Coupled Receptor (GPCR) target. Activation of ChemR23 may offer a novel mechanism for the resolution of chronic inflammation, modulating functions of both macrophages and neutrophils.

"This collaboration underscores our commitment to expanding our immunology portfolio with the ultimate goal of improving the standard of care for patients living with inflammatory diseases globally," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "By leveraging our expertise in immunology drug development, we look forward to advancing OSE-230, which offers a novel mechanism-of-action to treat chronic inflammation."

"We are very pleased to collaborate with AbbVie, a global leader in the development and commercialization of innovative medicines, to drive our OSE-230 program forward," said Nicolas Poirier, chief executive officer, OSE Immunotherapeutics. "This partnership represents a major milestone in our company's progress and recognizes the value of our innovative R&D capabilities. I would like to thank all our employees who helped us reach this milestone through dedication and hard work."

Under the terms of the agreement, AbbVie will receive an exclusive global license to develop, manufacture and commercialize OSE-230. OSE Immunotherapeutics will receive a $48 million upfront payment and will be eligible to receive up to an additional $665 million in clinical development, regulatory and commercial milestones. In addition, OSE Immunotherapeutics will be eligible to receive potential tiered royalties on global net sales of OSE-230.

The transaction is subject to the satisfaction of customary closing conditions, including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Read also: AbbVie, Tentarix collaborate to develop conditionally-active, multi-specific biologics for oncology, immunology

Tentacles are multi-functional, conditionally-active antibody-based biologics that are designed specifically to activate immune cells that can modulate disease pathways, while potentially mitigating safety concerns associated with non-specific targeting of other immune cells.

"Oncology and immunology are two of our key strategic growth areas where we are pursuing novel technologies that aim to deliver transformative therapies, which address unmet patient needs," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "This strategic partnership complements our ongoing efforts in developing novel biologics, potentially to expand our oncology and immunology portfolios with conditionally-active multi-specific molecules."

"We are excited to join forces with AbbVie to help accelerate cutting-edge, conditionally-active therapeutic programs towards clinical applications for patients in need," said Don Santel, interim chief executive officer, Tentarix Biotherapeutics. "This collaboration adds to our portfolio of internal and external pipeline programs and is a strong validation of our approach in understanding and targeting complex immune interactions that drive cancers and inflammatory diseases."

Under the terms of the agreements, Tentarix will receive upfront option payments, totaling $64 million from AbbVie, for the two programs. AbbVie will receive an exclusive option to fully acquire the programs following candidate nomination, for an additional undisclosed payment for each program.

Read also: AbbVie concludes acquisition of ImmunoGen

"Together with ImmunoGen, we have the potential to continue redefining the standard of care for those living with cancer," said Robert A. Michael, president and chief operating officer, AbbVie. "The addition of ImmunoGen's treatment for ovarian cancer will accelerate our ability to help patients today, expand our oncology pipeline and drive long-term revenue growth well into the next decade. I want to thank ImmunoGen for their efforts to advance science for patients and we look forward to welcoming our new colleagues to AbbVie."

ELAHERE (mirvetuximab soravtansine-gynx) is an antibody-drug conjugate (ADC) approved by the U.S. Food and Drug Administration (FDA) in ovarian cancer. The FDA granted accelerated approval for ELAHERE in folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) patients based on response data. Results from a confirmatory trial currently under review by the FDA show that ELAHERE is the first targeted agent to offer a survival benefit in PROC, with label expansion opportunities across larger segments of the ovarian cancer market.

ImmunoGen's follow-on pipeline of ADCs further builds on AbbVie's existing solid tumor pipeline of novel targeted therapies and next-generation immuno-oncology assets, which have the potential to create new treatment possibilities across multiple solid tumors and hematologic malignancies. Through focused R&D efforts, AbbVie has developed novel ADC technology and has unique strengths in antibody engineering, drug linker chemistry and toxin research. AbbVie and ImmunoGen's combined capabilities represent an opportunity to deliver potentially transformative ADC therapies to patients.

ImmunoGen's investigational Phase 1 asset, IMGN-151, is a next-generation FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications.

Pivekimab sunirine, currently in Phase 2, is an investigational anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN.

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