The statement comes following a landmark licensing deal between AbbVie and IGI Therapeutics SA, a wholly owned subsidiary of Ichnos Glenmark Innovation (IGI).
“Clearly, this is a huge moment for us. We’ve been working on this for 25 years in the innovation space, and I think ISB 2001 really is a world-class asset which can be transformational for patients,” Saldanha told CNBC-TV18 in an exclusive interview.
Under the agreement, Glenmark will receive $700 million upfront, with another $1.25 billion in potential milestone payments tied to clinical progress, regulatory approvals, and commercial milestones. If successful, the drug could also yield double-digit royalties, making it a long-term revenue stream. “This could pretty much be an annuity if the molecule makes it to market,” he said.
While ISB 2001 is still in Phase 1B and considered early-stage, Saldanha pointed out that clinical data from 40–50 patients has been encouraging. At ASCO, the drug showed a 79% overall response rate and complete remission in nearly 30% of patients who had exhausted all prior lines of therapy. “We have good clinical data… very good safety profile, good efficacy data,” he said.
The company expects AbbVie to now lead the development of the molecule, with a typical timeline of four to five years for commercialisation. “I can’t give you a specific one, but typically it’s about four to five years,” Saldanha said when asked about market launch expectations.
The $700 million upfront cash will be partially deployed to fuel IGI’s ongoing innovation pipeline, including its multi-specific antibody platform. The company currently spends around $70 million annually on R&D. A portion of the funds will also be considered for shareholder payouts, Saldanha said. “We’ll definitely consider increasing the payouts to shareholders… we’ll put it up to the board and get that approval.”
Despite sitting on a large cash reserve post-deal, Glenmark is not eyeing acquisitions in the near term. “For the next one year, we’re going to stay focused. I don’t think you’d see us doing anything on the M&A side,” he said.
Saldanha also noted that while funding conditions for biotech have been tight globally, the strength of ISB 2001’s data generated significant interest from multiple pharma companies. “Big pharma has always had deep pockets… we’re happy we concluded the deal with AbbVie as the final partner,” he said.
Below is the excerpt of the interview.
Q: Could you just go through the finer points of this big deal that has taken place for IGI, your innovation subsidiary?
Saldanha: Clearly, this is a huge moment for us. We’ve been working on this for 25 years in the innovation space, and I think ISB 2001 really is a world-class asset which can be transformational for patients.
From a partnering perspective, the way we’ve structured it is, we’ve partnered with AbbVie for the US, Canada, Europe, China, Japan—most of the developed markets—and Glenmark will commercialise this product eventually in India and all emerging markets. So, the two of us will make sure this asset is successful going forward.
IGI is 100% a subsidiary of Glenmark and has done a phenomenal job developing this asset and getting the phase 1 data. We have phenomenal data in patients from the phase 1 trial. In the recent presentation we made at ASCO, we had almost a 79% ORR and almost 30% of the patients had complete remission. These are patients who had gone through all prior lines of therapy in multiple myeloma, and then eventually came on to ISB 2001 and showed this response. So, very exciting times. We’re super excited about partnering with AbbVie—a great partner, with huge global capabilities and resources—to make ISB 2001 successful and bring it to market.
Q: Explain the financials to us. $700 million is what you would get upfront, $1.2 billion in terms of milestones, and the remaining would be royalties?
Saldanha: That’s correct. We get a $700 million payment upfront, and as soon as we get regulatory approvals, that money will be received by us. The $1.2 billion- milestones are spread across clinical development milestones—as the molecule progresses through clinics, we keep getting milestone payments. There are also regulatory milestones—when the molecule gets filed and approved in various markets, we get milestone payments—and then sales-linked milestones. Cumulatively, that number comes to $1.25 billion for the asset. Then, once it’s commercial, we get royalties on sales. As you know, with some of these innovative products, the life of the royalties is pretty long, so this could pretty much be an annuity if the molecule makes it to market.
Q: Let’s first understand where exactly this molecule stands. It’s currently in phase 1B. Explain that to us—how nascent is this molecule at this point?
Saldanha: So ISB 2001 is still at a relatively early stage. The good news is that we have patient data in about 40–50 patients. We have good clinical data that we presented at ASCO—very good safety profile, good efficacy data. But it’s still early-stage, so it has to go through a significant amount of clinical development as we go forward.
Q: So, AbbVie is now going to take over the entire development of this molecule. When do you think it will probably hit the market or show any kind of results?
Saldanha: AbbVie takes over all clinical development from here on. In terms of timeframe, I can’t give you a specific one, but typically, if you look at other assets in the space, they usually take about four to five years to get to commercialisation.
Q: So, 2030 would be a good target to probably expect something tangible coming in from the molecule, or commercial sales—if it is successful?
Saldanha: Again, I can’t specifically talk about ISB 2001, but typically it’s about four to five years to commercialisation.
Q: Let’s talk about how you’re going to use the funds now. The $700 million—roughly ₹6,000 crore of cash on Glenmark’s books. How exactly is this going to be utilised?
Saldanha: The way we’re looking at it is, IGI will continue development of various other assets they have. They have a great multi-specific antibody platform technology, which they will continue to exploit. They spend about $70 million a year, so that spend will continue. Clearly, a big part of this upfront will be allocated to their spends. The balance—some of it—will be dividend-ed out to Glenmark, and the rest will sit as cash on the books.
Q: Any plans of rewarding the shareholders of Glenmark, who waited very patiently for a possible R&D deal?
Saldanha: We’ll definitely consider increasing the payouts to shareholders. I think we’ll put it up to the board and get that approval.
Q: Now, this $1.2 billion in milestone payments—what is it contingent on? Any milestones you can share with us? And when can we probably expect them?
Saldanha: The milestones are all based on meeting certain events—like completion of a certain phase of clinical development, regulatory filing, or regulatory approval. They’re spread out, so it’s hard to say when exactly these will fructify.
Q: Now, the royalty payments—if the molecule is successful and comes to market—how long will they last? And given the size of the multiple myeloma market, how much do you think it can potentially garner?
Saldanha: The multiple myeloma market today is about $30 billion and is estimated to be around $50 billion by 2030 globally. So, the market size is very large. In terms of royalty payments, typically some of the novel drugs have a life of at least 15–20 years of exclusivity. So, the royalty payments can be significant as and when these drugs come to market.
Q: You’ve done this deal at a time when there is a lot of challenge in terms of funding—especially for biotech companies. How challenging was it in this environment?
Saldanha: Big pharma has always had deep pockets, and given the clinical data that we had, and the level of efficacy and safety that ISB 2001 demonstrated, we had a lot of interest around this asset. We’re happy we concluded the deal with AbbVie as the final partner.
Q: Can you tell us how many companies approached you—big pharma companies?
Saldanha: I think all that is history. Finally, we have AbbVie as a partner, and we’re excited to have them as the final partner.
Q: You’re going to have a significant amount of cash on books. A lot of companies are looking at acquisitions—we saw the Torrent-JB Chemicals deal recently. Will M&A be something you’d consider?
Saldanha: Well, for the next one year, we’re going to stay focused. I don’t think you’d see us doing anything on the M&A side.
Watch accompanying video for entire conversation.
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