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Asembia 2025 

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Judith Sills, PharmD, is a member of The Degge Group, which specializes in risk management.

FDA has issued the industry a new charge-pay closer attention to risk management. Now that prescription drug user fees have helped the agency approve candidates more rapidly, FDA has returned to its basic mandate: assuring that marketed pharmaceuticals are safe. In the past, that meant clear labeling with adequate directions and warnings based on clinical trials. The agency now believes that product safety extends beyond warning labels and wants to ensure that prescriptions are used safely as well. As a result, it is asking the pharma industry to demonstrate products' safety before approval and to further control their use after

The New Era of Risk Management

AbbVie Pedro Valencia ADCs

PE: How is AbbVie using novel cancer biomarkers to develop potential first-in-class ADCs for the treatment of advanced solid tumors?

We're constantly looking for biomarkers that can help us to do two key things. The first is to tackle cancer cells. and spare normal cells. We’re looking for specific antigens that are over-expressing tumor cells, and you see limited expression in normal cells. We want to make sure that target that’s over-expressed is critical for the survival of the cancer cell. Once you block it, you can actually drive a cancer cell death. That’s what we're looking for. In that perspective, c-Met is one of those biomarkers that is over expressing multiple tumor types such as lung, colorectal, gastric, and other GA tumors. We as an industry have tried to tackle c-Met in the past but have been unsuccessful. It would actually be successful to tackle what we call met, which is a gene inside the cell.

There’s this thing called met amplification, where the cancer cell produces multiple copies of the gene, and around 30% of patients have it. We can actually tackle that with small molecules. But once the gene becomes a protein and gets over-expressed in the cell, that over-expression is something we haven’t been able to target. For example, we know that on lung cancer, c-Met over-expression is about 25% to 50% in colorectal cancer, and it could be anywhere from 30% to 70% depending how you measure it, so it’s quite prevalent.

With ADCs, we’re trying to tackle c-Met over-expression on the surface of cancer cells. That was novel, and we can do it through ADCs. 706 has a target called SEZ6, and it’s a target that is over expressed in neuroendocrine cells or neuroendocrine neoplasms. When you think about it, multiple tumor types kind of have a subset of cells that are neuroendocrine driven. Small cell lung cancer is one of the few that has everything driven by neuroendocrine cells. The beauty of SEZ6 is over-expressing those cells and limited expression in normal cells. So, we can tackle it with an ADC and drive the results that we're seeing today.

PE: ADCs have redefined the treatment of cancer in recent years. Can you please discuss the promise of this emerging class and what the future may hold?

At the end of the day, ADCs work like a trojan horse. You have a good antibody that cancer cells are happy to receive, but once you hook into the cancer cell receptor, you deliver the payload, which is pretty much chemotherapy. It’s actually a highly potent version of the regular chemotherapy cancer patients are given on a regular basis. So, from that perspective, our goal is to replace chemotherapy. Our grand goal with ADCs is to replace good old, decades old chemotherapy that is really toxic for some patients. That’s how we see the redefinition of cancer treatment in the future with ADCs. So, what do we see in the future? Well, if you think about it, chemotherapy is being given in combination with other agents. In the future, we see ADCs being given in combination with chemotherapy. There will be one with other agents such as immuno-oncology agents. So, if you combine the ADC and the PD1s, you can start seeing that synergy come together and kind of start really dreaming about cures for the patients. All in all, we're super excited about ADCs replacing chemotherapy. 

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer. 

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

Understanding Drug Launches and the Forces that Dictate Pricing

Jason O’Neill, author of 'The Secrets of Successful Drug Launches' and former Dendreon CEO, discusses the current state of the pharma industry and the factors that are impacting its growth potential.

The Secrets of Successful Drug Launches: Understanding Drug Launches and the Forces that Dictate Pricing

Servier announced it has entered a definitive agreement with Kaerus Bioscience, acquiring its potential Fragile X syndrome (FSX) treatment KER-0193. The agreement displays Servier’s commitment to building a neurology franchise through expansion of its pipeline. Under terms of the agreement, Kaerus will receive an upfront payment for KER-0193 and will be eligible for development and commercial earn-out payments reaching upwards of $450 million.

Claude Bertrand, executive vice president of R&D at Servier, spoke on the definitive agreement, saying, "KER-0193 is Servier's first asset acquisition in neurology and so marks a significant milestone in our 2030 strategy, reinforcing our long-term commitment to establishing a leading neurology franchise focused on rare diseases. It reflects our determination to build a differentiated pipeline of innovative therapies for patients with underserved needs. We are particularly excited to advance KER-0193 as we believe it holds meaningful promise for patients living with Fragile X syndrome, a condition for which no approved treatment options exist today."

KER-0193 was developed by Kaerus Bioscience as a potential SFX treatment (the most common genetic cause of autism spectrum disorder). Kaerus Bioscience successfully completed its Phase 1 clinical study of KER-0193 in healthy participants back in March of this year, confirming the treatments safety and tolerance with excellent pharmacokinetics. Additionally, KER-0193 was granted both Orphan Drug Designation and Rare Pediatric Drug Designations for the treatment of FXS by FDA.

KER-0193 is an orally bioavailable small molecule modulator of BK channels specifically addressing the abnormal function of BK channels linked to genetic causes of FXS.

 In its preclinical studies, KER-0193 displayed broad therapeutic-like abilities in improving syndrome-relevant behavioral, sensory, and cognitive deficits. 

Preparation for its launch of a Phase II clinical trial, with a target year of 2026 for the treatment of FXS patients in both the U.S. and Europe, is part of Servier’s development strategy.

Dr. Robert Ring, chief executive officer of Kaerus Bioscience, commented on the partnership with Serveir and what it means for KER-0193, saying, "We strongly believe in the therapeutic potential of KER-0193 in Fragile X syndrome. Servier's firm commitment to neurology and global capabilities make it the ideal partner to further develop KER-0193 for patients worldwide."

Servier is an independent international pharmaceutical company governed by a nonprofit organization and is committed to creating meaningful social impacts for its patients, along with providing contributions to building a sustainable world. The company’s governance model ensures independence while also support long term innovation with 100% of profits being reinvested into its development cycle.

Michèle Ollier, Venture Partner and co-founder of Medicxi, touched on Kaerus’ founding philosophies and its expectations for KER-0193’s development, saying, "Kaerus Bioscience was created by Medicxi to advance a clear product vision to develop a potential first-in-disease therapy for Fragile X syndrome. We are extremely proud of the cutting-edge scientific progress achieved by the Kaerus team under Dr Ring's leadership and are excited that this deal with Servier will accelerate the development of KER-0193, bringing us closer to ensuring this innovative new therapeutic can reach those patients who are most in need."

Servier acquires potential treatment for Fragile X syndrome, the most common genetic cause of autism spectrum disorder 

https://www.prnewswire.com/news-releases/servier-acquires-potential-treatment-for-fragile-x-syndrome-the-most-common-genetic-cause-of-autism-spectrum-disorder-302548854.html

Servier has acquired KER-0193, a potential treatment for Fragile X syndrome (FXS), from Kaerus Bioscience, marking its first neurology asset acquisition. This move aligns with Servier's strategy to establish a leading neurology franchise focused on rare diseases. KER-0193, an orally bioavailable small molecule modulator of BK channels, has shown promise in preclinical studies and completed a Phase 1 clinical trial. It has received Orphan Drug and Rare Pediatric Drug Designations from the FDA. Servier plans to initiate a Phase II trial by 2026.

Servier's acquisition of KER-0193 marks a pivotal step in developing innovative treatments for Fragile X syndrome, enhancing its neurology pipeline.

Servier Enters $450 million Definitive License Agreement with Kaerus Bioscience for KER-0193 

It’s arguable that one of the most pharma successful stories from the past few years is the rise and adoption of GLP-1 medications, especially for use with weight-loss. However, as the years continue to pass, more companies are entering the space and competition is getting tighter. Cheryl Reicin spoke with 

about the market and how drug makers and investors are looking to the future.

Pharmaceutical Executive: How is the GLP-1 boom impacting deal flow, valuations, and partnership terms?

 Lily and Novo Nordisk are flush with cash and have been racing to have many shots on goal for the next generation of GLP-1 drugs. While the GLP-1 drugs initially propelled both of these companies into the number 1 and number 2 market cap position of big pharmas, both companies were well aware that one trick ponies don’t last forever in this industry and have been investing not only in the next generation of the GLP 1 drugs but in other therapeutic areas also. These developments also coincide with the patent cliff , where many blockbuster drugs will be coming off patents soon, creating the impetus behind other big pharmas seeking new therapeutic opportunities, the cash situation for Lily and Novo and the patent cliff concerns has caused big pharma to be competitive and generous with valuations but this has been tempered because the real competition to partnership, licensing and M&A for bio pharma companies are traditionally capital provided by venture capitalists and other private investors and the public markets. These sources of funding have been particularly difficult to access post COVID pandemic.

While early-stage companies are starved for cash and big pharma are starved for new product, options-to-buy have come back into vogue. This allows big pharmas to cast a wide net for potential drugs while keeping the research and development (R&D) budgets off the balance sheet. While option agreements provide needed capital and can be non-dilutive to small companies, generally if the clinical results are successful and the option to buy is exercised, the pre-determined acquisition prices will be lower than it would have been if the company had funded the R&D with capital from third party investors.

This subsector of the industry is dynamic and changes rapidly and will continue to do so. The recent announcements have focused on Lily’s new oral GLP-1 and other companies are also gunning for the best oral applications. At the same time, Novo Nordisk has announced massive layoffs, and its market value is down $490 B since its peak in 2024 while still reaping in enormous revenue.

PE: What role are cross-border transactions and foreign investments playing in capturing market opportunities?


 R&D is a cross border global game—great innovation and science wherever it is conducted is valuable. When it comes to production and supply, demand for GLP-1s materially outpaces supply, and cross-border transactions and foreign investments play a critical role in scaling production and expanding market access. Novo Holdings’ acquisition of CDMO Catalent to boost production of Ozempic and Wegovy, as well as AstraZeneca’s $50 billion investment in a new US manufacturing facility, are examples. Global and cross border deals with big pharma or regional players allow smaller companies access to market faster. Also, there is a race to access Chinese innovation which is quicker and cheaper than innovation in North American and elsewhere. The political, tariff, intellectual property protection vulnerability and other concerns that accompany partnering with China allows for an interesting and uncertain future but with that comes opportunity for those willing to take calculated risks. They also keep lawyers busy!

PE: How can smaller companies differentiate themselves in the GLP-1 market?


While Lily, Novo Nordisk, Astra Zeneca and others are conducting internal research for the next gen GLP-1s, they are in a war to be and remain at the cutting edge of this drug class. Smaller companies with innovative improvements such as those that provide oral delivery, lower dosing frequencies, broader metabolic benefits, new indications, lesser muscle loss, improved gastrointestinal tolerability and other lessor side effects and /or lower cost alternatives are most attractive, and several are garnering significant valuation premiums. Also, innovations for targeted subsectors of the current market are desirable as a way of increasing market access. Unique models for self-pay may become more important as side effects diminish and the drugs become more of lifestyle aid.

PE: What are the key deal considerations for GLP-1 companies?


The big pharma companies are entering into deals with multiple companies to address the same or similar problems. A big risk for a small company that is granting exclusivity to a big pharma is that exclusivity is likely not to be reciprocal––especially in the fast-evolving GLP-1 market. Smaller companies must focus on monetary compensation or claw back rights if a big pharma is no longer prioritizing its technology. Negotiating the right incentives and protections can be critical.

Also, as the GLP-1 boom continues to accelerate, dealmakers are navigating a complex set of considerations that go beyond clinical promise. Supply chain vulnerabilities are front and center: GLP-1 manufacturing is intricate, with many therapies relying on materials from many different and sometimes less stable regions. As a result, thorough supply chain due diligence is crucial in deals for GLP-1 companies.

Regulatory hurdles are another key factor. Strict aseptic manufacturing requirements for injection-based GLP-1s come with steep production costs. Dealmakers must also anticipate potential increased regulation that could further impact margins. Skyrocketing valuations for developers of early-stage GLP-1s without strong clinical backing also raise concerns about overpayment.

Competition in the GLP-1 market is intensifying as well. Biosimilars for first-generation GLP-1s like semaglutide are expected in Canada and Brazil by 2026. Compounding pharmacies also add pressure, making lifecycle management a critical deal consideration. Limited insurance coverage for GLP-1s and the resulting prevalence of self-pay channels in this market mean that dealmakers targeting GLP-1 companies must take into account their pricing strategies, distribution channels, and cost efficiency. Deals covering international markets also face unique challenges, including slower regulatory approvals and the absence of e-prescription infrastructure, which can complicate commercialization strategies.

The GLP-1 market is experiencing significant growth, driven by companies like Lily and Novo Nordisk, who are investing in next-generation drugs and other therapeutic areas. The competitive landscape is shaped by patent cliffs, venture capital challenges, and the resurgence of options-to-buy agreements. Cross-border transactions and foreign investments are crucial for scaling production and market access, with China emerging as a key player. Smaller companies can differentiate through innovative delivery methods and cost-effective alternatives. Key deal considerations include supply chain vulnerabilities, regulatory hurdles, and the intensifying competition from biosimilars and compounding pharmacies.

As the GLP market begins to settle, pharma companies and investors are looking to predict what comes next.

The Future of GLP-1 Investment: Q&A with Cheryl Reicin

What Diagnostic Areas are Investors Focusing On?

Pharmaceutical Executive: How have recent developments in genomic research transformed cancer care?

 There’s been a lot of change in diagnostics in general, but particularly in oncology over the last five years. It’s clear that next gen sequencing has created a new paradigm that has enabled us to come up with new tests and put them in clinical use. The way that the industry has transformed has gone from a model driven by volume (even if the test was painful) to a more responsible model that generates evidence in a way that ensure durable ongoing reimbursement for a test, having it released to the marketplace, and having it adopted by physicians.

 Diagnostics 2.0 is responsible launching of molecular diagnostic tests that focuses on strong, robust scientific evidence that demonstrates not just the clinical validity of a test, but that it has use for physicians. It changes the way that physicians practice. We’re very focused on physicians as our allies and the people we’re enabling to do their job the way they need to do it.

Diagnostics 2.0 is a focus on developing evidence very early on.

PE: What are the core tenets of diagnostics 2.0?

 The core are robust science supported by machine learning and AI technology. It is robustly completely clinical studies and ensuring that those studies are focused on the patient population for which the test is intended. It’s also about making sure that the data demonstrates clear patient and physician benefit in the treatment path and an ongoing commitment to generate evidence during the life of the test.

PE: What diagnostic areas are investors focusing on?

 There’s a few areas that investors have been focused on for several years. Some of them have come and gone. Early detection was getting a lot of focus, and it hasn’t gone away. It’s still getting a lot of attention from investors and companies. Today, however, in oncology, areas like prognostic and predictive diagnostic clinical tests that fit into the physician workflow and provide additional insights are clearly getting attention.

Another area is minimum residual disease (MRD), which is getting a lot of traction for a number of reasons. It’s very helpful for patients who have been treated, whether by therapy or surgery, and you’re looking for residual disease state or recurrence. This test can be used at multiple time points after the treatment. It’s an interesting new area and getting a lot of attention.

One thing we’re seeing is that the existence of MRD could be a potential endpoint in clinical studies because it’s proving to be a good indicator.

Marc Stapley, CEO of Verasyte, explains how investors are reacting to recent advancements in cancer care.

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Judith Sills, PharmD

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