On
his behalf, the award was received by the inventor, Dr. Mahesh Patel (Chief Scientific Officer - Drug
Discovery Research) during “Global Bio – India 2024” event held in New Delhi.
The award is in recognition of the highest level of innovation and research that led to successful
development of Nafithromycin (Miqnaf), which is the multi-drug resistant pathogen
active respiratory antibiotic for the treatment of Community-Acquired Bacterial Pneumonia.

Miqnaf(Nafithromycin) fulfils major unmet medical need as existing treatment based on
Azithromycin and Amoxicillin + Clavulanic acid have either developed resistance in contemporary
respiratory pathogens or lack the coverage of entire range of respiratory pathogens involved in Community-Acquired Bacterial Pneumonia.

As a result, many of these patients need to be
hospitalized due to limitations of current treatment options. With once-a-day, ultra-short, 3 daycourse of oral treatment, Miqnaf (Nafithromycin) would obviate the need of hospitalization for
many such patients.
Discovery and development of Nafithromycin at Wockhardt spanned over 12 years and involved
several Phase 1 and Phase 2 clinical studies which were conducted in USA and Europe.

Nafithromycin has successfully completed Phase III clinical trial in India and is awaiting DCGI
approval.
Globally, for the 1st time in 33 years, a new macrolide drug in the form of Miqnaf (Nafithromycin)
has been developed to treat millions of community respiratory infections through a convenient
home-based oral monotherapy.

Community Acquired Bacterial Pneumonia is one of the highest disease burden globally and in India,
responsible for high mortality, morbidity and hospitalization, particularly in children and older agepatients. India accounts for 23% of the global burden of pneumonia. The annual incidence of
Community-Acquired Bacterial Pneumonia in India is estimated to be 8-10 million infections. The
currently available drugs to treat Community acquired bacterial pneumonia majorly are
Azithromycin (>60% resistance) and Amoxicillin + Clavulanic which does not cover atypical
respiratory pathogens. Notably, atypical respiratory pathogens are implicated in >30% of
Community-Acquired Bacterial Pneumonia infections.

Read also: CDSCO Panel Approves Wockhardt's Protocol Amendment Proposal for antimicrobial drug Cefepime plus Zidebactam

In a release, Aurobindo Pharma highlighted that its revenue from operations also saw a significant boost, climbing to Rs 7,567 crore in the June quarter compared to Rs 6,851 crore in the corresponding quarter of the previous fiscal year. 

Commenting on the Company’s performance, Mr. K. Nithyananda Reddy, Vice-Chairman and Managing Director of the Company said: “We are pleased with our continued strong performance this quarter, with a significant top-line growth across all our business segments. Our profitability was sustained by improved gross margins and operational efficiencies, while ramping-up our recently commercialized plants. We are confident in our ability to achieve our growth targets for FY25.” 

US formulations (excluding Puerto Rico) revenue increased by 13.3% YoY to INR 3,555 Cr (USD 426 million). Europe formulations revenue increased by 7.9% YoY to INR 1,982 Cr (EUR 221 million)

Whereas, Growth Markets revenue increased by 49.2% YoY to INR 709 Cr (USD 85 million).

Read also: Aurobindo Pharma secures USFDA okay for generic version of Novo Nordisk Vagifem

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and  active pharmaceutical ingredients globally in over 150 countries.

The company has 29 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s     product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

Read also: Aurobindo Pharma arm buys Ace Lab for Rs 17.91 crore

At a press conference held, Madeleine Roach, Executive Vice President of Business Operations at Sanofi, highlighted the strategic significance of this expansion. She revealed that over the next two years, the GCC will expand to host up to approximately 2,600 employees, solidifying its position as the largest among Sanofi's four global hubs.

"We make quite a significant commitment. This is obviously a long term strategy. To set our deep footprint here, we are going to make a commitment of 400 million until 2030 (about Rs 3600 crore)," she said, adding that the centre currently has 1,000 employees. The official further said that the investments will primarily go into acquisition of talent and building new capabilities in order to run an operation of this scale, besides the state of the art facilities in Hyderabad. Established in 2019, the Hyderabad hub has grown exponentially from being a medical hub to now providing several best-in-class services for Sanofi's global functions and affiliates across the world, she said.

Emmanuel Frenehard, Executive Vice President and Chief Digital Officer, Sanofi said the ambition is to be the first biopharma company powered by Artificial Intelligence (AI) at scale. "From discovery to treatment, we are using AI ethically and safely to get to market faster with our drugs as there's plenty of unmet needs. We intend to onboard talent at the Hyderabad hub to embrace the power of AI across our value chain to harness the pace of scientific discovery, improve our productivity and place better decision intelligence in the hands of our people," he said.A senior official of the Pharma giant said 50 per cent of the Hyderabad centre's staff hold PhDs and Masters in Pharmaceutical Sciences, about 10 per cent are freshers from colleges such as National Institute of Pharmaceutical Education And Research (NIPER), and 20 per cent are tech people from IITs and other institutes.Telangana Minister for Industries D Sridhar Babu inaugurated the facility at HiTECH City here alongside Arunish Chawla, Secretary, Department of Pharmaceuticals and Thierry Berthelot, Consul General of France in Bangalore, a press release from Sanofi said

Read also: Sanofi Healthcare Gets CDSCO Panel Nod to Import and Market Belumosudil Tablets

The US Food and Drug Administration (FDA) has approved a post-approval supplement to the Biologics License Application for Susvimo, reflecting component-level updates made to the ocular implant and refill needle. Roche will work to make Susvimo available in the US to retina specialists and their patients with nAMD in the coming weeks.

“We are pleased to reintroduce Susvimo, a unique therapeutic approach shown to provide an effective alternative to regular eye injections by preserving vision with two refills per year in Phase III study patients with neovascular age-related macular degeneration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements.”

Susvimo provides continuous delivery of a customised formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require multiple eye injections per year.

The Susvimo implant is surgically inserted into the eye during a one-time, outpatient procedure and is refilled once every six months using a specifically designed needle, which introduces a customised formulation of ranibizumab directly into the device. Susvimo was approved by the FDA in 2021.

The following year, Roche voluntarily recalled the ocular implant, insertion tool and initial fill kit in the US following test results that showed some implants did not perform to Roche’s standards. Roche has since updated the Susvimo implant and refill needle, and testing confirmed that they now meet these performance standards. Manufacturing process improvements were also implemented.

Read also: Roche Vabysmo prefilled syringe bags USFDA nod for three causes of vision loss

In September 2022, Pfizer and its German partner BioNTech initiated legal action against Moderna, seeking the invalidation of two patents held by Moderna. In response, Moderna swiftly countered, alleging infringement of its patents just days later.

The competing lawsuits over the companies' two vaccines, which helped save millions of lives and made the companies billions of dollars, are just one strand of ongoing litigation around the world focusing on messenger RNA (mRNA) technology.Moderna had argued Pfizer and BioNTech copied mRNA advances it had pioneered and patented well before the COVID-19 pandemic began in late 2019.U.S.-based Moderna was seeking damages for alleged infringement of its patents by Pfizer and BioNTech's Comirnaty shot on sales since March 2022.Pfizer made $11.2 billion in sales from Comirnaty last year, while Moderna earned $6.7 billion from its vaccine Spikevax, illustrating the potentially huge sums at stake.Pfizer and BioNTech, however, asked the High Court to revoke Moderna's patents, arguing that Moderna's developments of mRNA technology were obvious improvements on previous work.According to Reuters, the High Court ruled on Tuesday that one of Moderna's two patents relating to mRNA technology was invalid, but that another similar patent was valid and that Pfizer and BioNTech's Comirnaty vaccine had infringed it.LIKELY APPEALSAll three companies said they disagreed with the parts of the court's decision on which they lost, and it is expected that all parties will seek permission to appeal.Pfizer and BioNTech said in a statement: "These proceedings have no bearing on the safety and efficacy profile of our vaccine, as established by regulators worldwide."Irrespective of the outcome of this legal matter, we will continue to manufacture and supply the Pfizer-BioNTech COVID-19 vaccine in line with our agreements and established supply schedules."A spokesperson for Moderna said the company was pleased the court "recognized the innovation of Moderna scientists by confirming the validity and infringement" of one of its patents.Pfizer, BioNTech and Moderna are also involved in parallel proceedings in Germany, the Netherlands, Belgium and the United States, much of which has been put on hold, as well as at the European Patent Office.The London ruling comes at a time of financial strain for Moderna, whose shares have plummeted by more than 70% since the peak of the pandemic as demand and sales for Spikevax have fallen. Shares of Pfizer, meanwhile, are down about 29% since mid-2021.Read also: COVID vaccine: Moderna wins patent case in Europe against Pfizer, BioNTech

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.

Read also: Johnson & Johnson concludes acquisition of Shockwave Medical

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.

Read also: Pfizer Gets CDSCO Panel Nod To study anti-cancer drug Lorlatinib