Latest news with #GlennSaldanha
Mint
2 days ago
- Business
- Mint
Sacrifices, trade-offs behind big win, says Glenmark's Saldanha
The road to drug discovery is long, arduous and littered with failure, but the payoff at the end makes it worth the trouble. It's a lesson that India's best pharmaceutical entrepreneurs knew all along. Yet, it took a Glenn Saldanha to prove it. 'We were always resilient in how we approached innovation. I think that's what finally rewarded us," Saldanha, chief executive officer and managing director of Glenmark Pharmaceuticals Ltd, told Mint in an exclusive interview. He was referring to one of the largest deals for an Indian biopharma firm after Glenmark's US-based unit Ichnos Glenmark Innovation (IGI) secured a $700-million exclusive licensing agreement with AbbVie for its blood cancer drug candidate last week. AbbVie will also pay as much as $1.23 billion as various milestones are completed, as well as tiered, double-digit royalties on net sales. ISB 2001, the investigational drug to treat multiple myeloma, is in phase-1 clinical trials and has shown promising data. In a trial with 35 patients who had exhausted all existing lines of therapy unsuccessfully, 79% showed a clinical response to it, and 30% were cancer-free. 'I hope this acts as a catalyst to expanding the innovation landscape in India…we've demonstrated that you can do it," said Saldanha. Last bet ISB 2001, developed on IGI's proprietary BEAT platform, was the firm's last bet. 'There was no plan B," said Saldanha. 'This was pretty much the end of the road. At this point, the technology had to demonstrate that it worked…or we don't know what we would have done as the next thing." The drug had been in discovery over the last five years, while the company had been working on the BEAT platform for about a decade. There were three other assets that the company stopped developing. ISB 2001 has received both the US FDA Orphan Drug and Fast Track designations, highlighting its Orphan Drug designation is given to drugs treating rare diseases, while a fast track designation intends to expedite the development and review of drugs for treating serious conditions and fill unmet medical needs. Following the licensing agreement, AbbVie will take over further development for phase-2 and phase-3 trials before it can file for regulatory approval. The process would typically take four to five years. The market size for multiple myeloma is estimated to grow to $50 billion by 2030. Should the drug hit the markets in 2030, taking into account the tiered double-digit royalties, Glenmark stands to earn an additional $2.02 billion in royalties until 2041, according to research by brokerage Nuvama. The deal validates several aspects of Glenmark, including the strength of IGI's BEAT platform, the potential for ISB 2001 to treat relapsed/refractory multiple myeloma, and its commercial viability following successful clinical trials, said an 11 July note by Motilal Oswal analysts. 'Moreover, AbbVie has established itself as a diversified biopharma leader, combining scientific innovation with strong commercial execution. In oncology, the company has built a robust presence anchored by two cornerstone therapies: Imbruvica, a BTK inhibitor, and Venclexta, a BCL-2 inhibitor. These medicines have transformed the treatment landscape for chronic lymphocytic leukemia and other B-cell malignancies, generating multi-billion-dollar revenues and reinforcing AbbVie's reputation as a pioneer in hematologic cancer," the note added. Huge sacrifices, trade-offs Saldanha has bet on innovation since he took the reins of the company in the late 90s. A few years after Glenmark was listed in 2000, it established its first R&D centre for novel biologics research in Switzerland. Over the years, the company did a number of licensing deals with novel assets. In 2019, it spun off its R&D entity under a new company, Ichnos Sciences, which built on its proprietary BEAT bispecific platform. The two announced the creation of Ichnos Glenmark Innovation (IGI) in 2024. The company's focus on innovation created a lot of frustration for investors and stakeholders, Saldanha said. '[We were] bordering on being called eccentric," he said. The company also had to sell its stake in its active pharmaceutical ingredient (API) division, Glenmark Life Sciences, to pare its debt in 2023, which was approximately ₹4,500-4,600 crore. Glenmark sold 75% stake in the unit to industrial conglomerate Nirma for ₹5,650 crore. The company has made 'huge sacrifices, huge trade-offs," said Saldanha. With the GLS sale, the company had a choice to decide 'which end of the value chain we play", said Saldanha. 'Whether we play on this API stable end of the value chain, and generate revenues like that, or we play on the high end of the value chain, which is innovation." But innovation is not a cost game, he said. 'It's all about being able to understand where the therapy is going and how to come up with solutions." What's next for Glenmark? IGI spends about $70 million annually on new drug research. With the upfront payment it receives, it will be self-funded for the next three to four years, said Saldanha. The company will also look at rewarding shareholders with dividends. Apart from that, there are no immediate investment plans, said Saldanha. 'At least for the next year or two, we won't do anything. We'll just continue regrouping and trying to figure out strategically where we can further add value," he said. The deal is a big event for the company, which 'basically resets the whole agenda for the company", he said. 'We have to really reset and rethink how we want to see the company over the next five to ten years." ISB 2001's early success has validated the BEAT platform. 'We think we've now got it right with the technology…the idea is how can we exploit that technology much more effectively to add more products and do more," said Saldanha. The unit has another asset called ISB 2301, which is in late pre-clinical development and will go to the clinic next year. This drug will target solid tumours, said Saldanha. IGI also has a couple of other early-stage programs. '...over the next three, four years, we will exploit the technology as effectively as possible."
New Indian Express
5 days ago
- Business
- New Indian Express
Glenmark-AbbVie deal: A turning point in Indian drug innovation
Glenmark Pharma's licensing pact for its investigational cancer drug ISB 2001 is not just a deal --it's a turning point in Indian pharma/biotech innovation. It reinforces the notion that India-based innovation can command global terms on par with leading biotech nations. Ichnos Glenmark Innovation (IGI), a wholly owned innovation arm of India's research-led generic drug maker, based in Switzerland, entered into this landmark global licensing agreement with US pharmaceutical major AbbVie. ISB 2001, currently in Phase 1 trials for relapsed or refractory multiple myeloma, is a first-in-class trispecific antibody developed using IGI's proprietary BEAT platform, targeting BCMA, CD38, and CD3. As part of the agreement, IGI will receive a $700 million upfront payment, with potential milestone payments totaling up to $1.225 billion, and tiered double-digit royalties on net sales. AbbVie secures exclusive rights to develop, manufacture, and commercialize ISB 2001 across North America, Europe, Japan, and Greater China, while Glenmark retains rights in emerging markets and India. A reset moment for Indian pharma innovation The $700 million upfront payment is unprecedented for a domestic biotech player and signals a major shift in how global markets value Indian R&D capabilities. Early Phase 1 data on ISB 2001 showed a 79–83% overall response rate and strong tolerability in heavily pretreated patients --remarkable results at this stage for a novel oncology agent. The deal also transforms IGI's funding model. According to Glenmark Chairman Glenn Saldanha, IGI will soon be self-funded, reducing dependence on parent capital. This frees up Glenmark to reinvest in R&D or explore shareholder-friendly initiatives. Prior to this deal, the company was net-debt; it is now net-cash. Following the announcement, Glenmark shares surged nearly 10%, hitting a 52-week high. Analysts believe this elevates Glenmark from a generics-focused player to a serious contender in biologics and innovation-led pharma.
Mint
5 days ago
- Business
- Mint
Glenmark unit clinches $700mn licensing deal for its cancer drug
A unit of Glenmark Pharmaceuticals Ltd is licensing its under-development blood cancer drug to Chicago-based AbbVie Inc. for $700 million, marking the biggest outlicensing deal for any Indian drugmaker. AbbVie will also pay as much as $1.23 billion as various milestones are completed. Ichnos Glenmark Innovation (IGI), a US-based unit of Glenmark, is conducting phase-1 clinical trials for ISB 2001, a so-called investigational asset to treat multiple myeloma, a type of blood cancer. As part of the deal, AbbVie will get to make and sell it in North America, Europe, Japan, and Greater China, while Glenmark retains rights for India and emerging markets. 'This asset is world-class; you don't come across a world-class asset too often, which can actually change the landscape for patients, and the value of the deal is purely because of the quality of the data," Glenn Saldanha, MD and CEO of Glenmark told reporters in Mumbai. The market for multiple myeloma treatment is projected to grow to about $33 billion by 2030, according to estimates by Bloomberg Intelligence. ISB 2001 targets cases where many patients don't respond to current treatments, or their cancer returns. It's a "tri-specific" antibody that targets three different markers on cancer cells at once; this helps it fight cancer even when other therapies have failed, including those that use a patient's own T-cells. Both the FDA Orphan Drug and Fast Track designations have been given to ISB 2001, highlighting its potential. Early trial results are promising. 'This is a landmark for India…it basically puts India on the world map in my view," Saldanha said. 'This is among the top three to five deals that we know of in the last two years that have been cut out globally, for bispecific antibodies," Saldanha said. In 2025, Pfizer licensed 3SBio's bispecific asset for $1.25 billion upfront, with potential up to $6 billion, and Bristol Myers Squibb licensed BioNTech's asset for $1.5 billion upfront, with a total potential of $11.1 billion. Following the licensing agreement, AbbVie will take over further development for phase-2 and phase-3 trials before they can file for regulatory approval. The process would typically take four to five years. Glenmark shares closed 5.54% higher on Thursday. The deal was announced after the close of the day's trading. 'It has been a huge journey for me personally and for Glenmark," said Saldanha. The company established its first R&D centre for novel biologics research in Switzerland in 2006, and did a number of licensing deals in the early years. It spun off its R&D entity in 2019 under a new company, Ichnos Sciences, which built on its proprietary BEAT bispecific platform. The two announced the creation of Ichnos Glenmark Innovation (IGI) in 2024. 'Multispecifics including trispecific antibodies represent a new frontier in immuno-oncology with the potential to deliver deeper, more durable responses by engaging multiple targets simultaneously," Roopal Thakkar, MD, executive vice-president, research and development and chief scientific officer, AbbVie, said in a statement. Currently, there are no trispecific antibodies commercialized, said Saldanha, but several pharma companies are trying to develop them. 'We are among the pioneers, the early guys to develop a trispecific antibody, and validate it in humans to show that it has a great safety profile, as well as efficacy," said Saldanha. IGI will continue developing multi-specific antibodies. It has another asset - ISB 2301 - which is in the discovery stages for application in solid tumors, as well as other assets in development. 'ISB 2001 exemplifies the potential of our BEAT protein platform to generate effective multispecifics that may overcome resistance and improve outcomes in hard-to-treat cancers," Cyril Konto, president and CEO of IGI, said in a statement. 'We will continue to develop assets, take them to a certain level, and continue development on our own or with a partner at a later stage," said Saldanha. The journey is to move up the value chain, as Glenmark will continue to build on high-value assets, said Saldanha. It will remain focused on its core segments of dermatology, respiratory and oncology in the global markets. Saldanha said the company has no plans at the moment for the upfront payment as well as milestone payments that it will receive. 'IGI spends about $70 million a year in terms of the research that they are doing; so, they are funded at least for the next three to four years out of this upfront payment. Additionally, some of the amount will get dividend back to Glenmark," said Saldanha.
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Business Standard
6 days ago
- Business
- Business Standard
Glenmark arm IGI licenses cancer drug to AbbVie for upfront $700 million
In what can be called a landmark deal for Indian pharma and research, IGI Therapeutics SA, a wholly owned subsidiary of New York-based Ichnos Glenmark Innovation Inc. (IGI), signed an exclusive licensing agreement with US-based AbbVie for its oncology and autoimmune diseases asset ISB 2001. The deal includes an upfront payment of $700 million (₹6,000 crore) and milestone-based payments of up to $1.2 billion (close to ₹10,000 crore). ISB 2001, an investigational asset, has been developed using IGI's proprietary BEAT protein platform for oncology and autoimmune diseases. The US Food and Drug Administration granted ISB 2001 orphan drug designation in July 2023 and fast-track designation in May 2025 for the treatment of relapsed or refractory myeloma patients. The Phase-1 trial in human studies is underway, and dose escalations are currently being tested. The company believes that due to its mechanism of action, ISB 2001 could potentially be a viable therapeutic option for various autoimmune indications. Glenmark shares have risen 38 per cent in the last three months and, on Thursday, touched a fresh all-time high of ₹1,919 apiece. IGI is a wholly owned subsidiary of Mumbai-headquartered Glenmark. Speaking to reporters, Chairman and Managing Director Glenn Saldanha said, 'This deal puts India on the world map. There is no parallel to ₹6,000 crore upfront payment.' He added that the deal ranks among the top out-licensing deals in the antibody space globally. Notable recent deals include 3SBio Inc. and Pfizer's $6 billion licensing deal for global rights (excluding China) to develop, manufacture, and commercialize 3SBio's bispecific antibody SSGJ-707. This deal involved an upfront payment of $1.2 billion to 3SBio. Roopal Thakkar, MD, Executive Vice-President, Research and Development, and Chief Scientific Officer at AbbVie, said, 'Multispecifics, including trispecific antibodies, represent a new frontier in immuno-oncology with the potential to deliver deeper, more durable responses by engaging multiple targets simultaneously.' Glenmark expects the molecule to transform the multiple myeloma space, which could become a $50 billion market by 2030. The asset may take another 4-5 years to be commercialized if timelines are met. ISB 2001's competitors include Pfizer and J&J's already launched drugs for multiple myeloma. Looking ahead, IGI is likely to pursue an IPO, but nothing is immediately on the cards, Saldanha said. The research arm is self-funded for at least the next three to four years, as it uses $70 million annually. Saldanha also mentioned that the ₹6,000 crore would definitely be used to fund IGI's pipeline of investigational assets, with some amount to be paid as a dividend to Glenmark shareholders. Glenmark had a net debt of ₹400 crore before the deal, and Saldanha stated they would now be net-cash. Saldanha has fought a long battle to pursue his ambitions around innovation and has already tasted success with several key partnerships forged with players like Almirall and Astria for innovation assets. Glenmark has had its tryst with managing R&D spending, debt, and cash flows over the years. In 2019, Glenmark spun off its research unit into a separate subsidiary to de-risk its investments, reduce debt, and improve focus on the core business. Earlier, cash flows from the base business were deployed in the high-risk innovation programme, which many analysts had felt was a drag on shareholder value. Motilal Oswal analyst Tushar Manudhane noted recently that Glenmark is on track to optimise R&D spending on its innovation assets. From 8 per cent (₹800 crore) of total sales in FY19, the company reduced innovation R&D spend to 4.5 per cent (₹600 crore) in FY24, and further to 3.5 per cent of sales in 9MFY25, Manudhane said. IGI had entered into an exclusive global licensing agreement for another innovation asset, ISB 880 in autoimmune diseases, with Spanish firm Almirall in December 2021. Glenmark received $320 million for upfront payment, development, regulatory, and sales milestone payments, plus tiered royalties on global sales. In another major deal, IGI entered an exclusive global licensing agreement for ISB 830 and its follow-on ISB 830-X8 (monoclonal antibody for atopic dermatitis) with Astria Therapeutics in October 2023. In January 2025, Astria announced the initiation of a Phase-1 clinical trial of STAR0310, a potential best-in-class OX40 antagonist for the treatment of Atopic Dermatitis. Glenmark received €20.8 million for the upfront payment, plus development, regulatory, and sales milestone payments, and tiered royalties on global sales.
Time of India
02-06-2025
- Business
- Time of India
Glenmark's blood cancer drug ISB 2001 shows promising results in trial
Ichnos Glenmark Innovation, a clinical stage biotechnology company focused on oncology, has announced promising results for an innovative drug used for the treatment of relapsed or refractory multiple myeloma (RRMM), a rare form of blood cancer that affects plasma cells in bone marrow. Coded ISB 2001, the drug demonstrated an overall response rate (ORR) of 79% in a Phase 1 global study based on finding from patients who were administered a recommended dose. Patients who had exhausted other advanced treatments, such as CAR-T cell therapy and bi-specific antibodies, also showed encouraging results when given the drug. IGI is an alliance between the New York-based scientific research group Ichnos Sciences and Indian drug maker Glenmark. Senior haematologists say that the drug could potentially be an important candidate in the treatment of patients - who exhaust other therapy options due - to its unique mechanism of engaging the body's T cells (that are a vital part of the immune system) along with the attacking two sites on the tumour cell. Dr Shyam Rathi, consultant, clinical hematology, PD Hinduja Hospital & Medical Research Centre in Mumbai, said: 'It can definitely be a game changer in treatment of multiple myeloma which keeps relapsing thus exhausting treatment options quickly. This new drug looks very attractive because it targets two different sites on the cancer cell and it engages the body's own T-cells.' 'We have existing bi-specific antibodies where the target is only one antigen and they develop resistance very fast. However, ISB 2001 targets the two sites on the cancer cell and we expect some better results. It looks exciting in the future.' In lay terms, ISB 2001 binds to three sites on the cancer tumour. First, the ISB 2001 activates the CD-3 T-lymphocytes, which are the cells that have the natural attacking power against tumour cells. Next, it binds to two additional sites. The first is BCMA (a protein found on myeloma cells), which is the target for bi-specific antibodies but there is also CD38, which is the binding site of the widely prescribed drug called daratumumab, branded as Darzalex by Johnson & Johnson. Glenmark, which is pinning a lot of hopes on the new drug, is in advanced talks with multiple global Big Pharma companies for a licensing deal, Chairman and Managing Director Glenn Saldanha told analysts over an earnings call recently. 'The discussions are progressing really well, and we anticipate a positive outcome very quickly,' said Saldhana. He said a deal for ISB 2001 will 'really be transformational for Glenmark' and 'will overshadow anything else that we are doing in the near term.' 'You should see some visibility around a licensing deal pretty quickly.' Last year Ichnos and Glenmark entered into a partnership for discovery of cutting-edge therapies, specifically to treat blood related cancers and malignancies like multiple myeloma. The global market for multiple myeloma treatment is seeing a surge. The business for such drugs is expected to rise to $33 billion by 2030, up from $23.5 billion in 2023,according to Bloomberg Intelligence estimates. Hang Quach, professor of haematology at the University of Melbourne noted that the data presented on ISB 2001 highlighted the 'remarkable anti-myeloma activity of this first-in-class trispecific antibody-T cell engager in heavily pre-treated RRMM patients' including those who have exhausted other approved therapies. According to Quach, ISB 2001 has the potential 'to redefine the treatment landscape for multiple myeloma, offering new hope for patients with limited therapeutic options.' The drug demonstrated a favourable safety profile throughout the dose-escalation phase, with no dose-limiting toxicities (DLTs) reported.
