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Asembia 2025 

Topic

Sales and Marketing

1rem

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Last November, President Clinton formally signed into law the Food and Drug Administration Modernization Act, sweeping bipartisan congressional legislation focused on reforming the agency's regulation of food, drugs, medical devices and cosmetics. Overall, the new law is considered a triumph by both the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization because it embraces many of the FDA legislative reform recommendations the industries had proposed to streamline the drug regulatory process.

Update from Washington: FDAMA

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

BeOne Medicines announced an agreement with Royalty Pharma to sell its rights on worldwide sales (excluding China) of Amen’s Imdelltra for upwards of $950 million. Terms of the agreement grant BeOne an upfront payment of $885 million, along with the option to sell its remaining royalties for upwards of $65 million within a twelve-month period.

Aaron Rosenberg, chief financial officer of BeOne, touched on the financial implications of the agreement, saying, “This agreement meaningfully accelerates value realization for BeOne, while preserving continued participation in the long-term potential of Imdelltra. A strong balance sheet is a hallmark of the most successful companies in our industry, and this transaction provides increased operational and strategic flexibility as we continue to execute our business strategy for the long term.”

The agreement will also provide BeOne a portion of royalties on annual net sales above $1.5 billion, while allowing BeOne to retain royalty and all other rights to additional assets included in its collaboration with Amgen. This includes xaluritmig a first-in-class STEAP1 x CD3 XmAb currently being studied in patients with metastatic castration-resistant prostate cancer (mCRPC).1

Imdelltra (tarlatamab) is a first-in-class immunotherapy, binding both DLL3 on tumor cells and CD3 on T cells, while activating T cells to kill DLL3-expressing cells. This generates the formation of a cytolytic synapse with lysis of the cancer cell. DLL3, a protein expressed on the surface of SCLC cells in most patients with SCLC. DLL3 is minimally expressed on healthy cells, making it a critical target for the treatment.

Imdelltra is currently involved in multiple studies.

DeLLphi-303, a Phase 1b study evaluating Imdelltra in combination with standard of care therapies in first-line ES-SCLC.

DeLLphi-304 is a randomized Phase 3 trial comparing Imdelltra monotherapy to standard of care chemotherapy in second-line treatment of ES-SCLC.

DeLLphi-306, a randomized placebo-controlled Phase 3 trial of Imdelltra follows concurrent chemoradiotherapy in limited-stage SCLC.

DeLLphi-308, a Phase 1b study evaluating subcutaneous Imdelltra in second line and or later ES-SCLC.

DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with Imdelltra in second-line ES-SCLC.

Following the announcement of the royalty purchase agreement, John V. Oyler, co-founder, chairman and CEO of BeOne briefly mentioned the implications the agreement will have for BeOne and its pipeline.

“Today’s announcement is testament to the value of our long-term collaboration with Amgen, the developer of Imdelltra, who recognized the potential of BeOne in advancing their oncology pipeline,” said John. “In the five years since entering into this collaboration, we have executed with purpose in advancing our mission to deliver multiple transformative medicines to more patients worldwide.”

BeOne Medicines Announces IMDELLTRA Royalty Purchase Agreement for up to $950 Million 

https://ir.beonemedicines.com/news/beone-medicines-announces-imdelltra-royalty-purchase-agreement-for-up-to-dollar950-million/b7f14787-2093-412f-8f72-243c6e59a41c

BeOne Medicines has entered into an agreement with Royalty Pharma to sell its rights to worldwide sales of Imdelltra, excluding China, for up to $950 million. The deal includes an upfront payment of $885 million and an option to sell remaining royalties for $65 million within a year. BeOne retains royalties on sales above $1.5 billion and rights to other assets in collaboration with Amgen. Imdelltra, a first-in-class immunotherapy targeting DLL3 in SCLC, is undergoing multiple clinical trials to evaluate its efficacy in various treatment settings.

BeOne Medicines entered a deal worth up to $950 million with Royalty Pharma  selling its rights to global sales royalties of Imdelltra, securing an $885 million upfront payment and potential additional royalties, while retaining rights to other pipeline assets and future high-sales milestones.

BeOne Medicines Announces $950 Million Royalty Purchase Agreement with Royalty Pharma for Imdelltra 

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiation therapy remain crucial, but their roles are evolving with the advent of novel systemic treatments. Multidisciplinary approaches are essential for optimizing care, emphasizing the importance of collaboration among oncologists, radiologists, and neurosurgeons to tailor interventions based on individual patient profiles and tumor characteristics.

This whitepaper presents a structured analysis of prior authorization outcomes for RA treatments requiring medical benefit coverage. It examines real-world access barriers from the perspective of payer decision patterns, documentation requirements, site of care, and plan type. Unlike claims-based studies or survey-based research, this analysis draws from actual prior authorization cases, providing a direct window into the real-world challenges faced by prescribers and patients alike.

New Data Reveals What’s Behind Delays and Denials in RA Care 

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiotherapy remain crucial, but their roles are evolving with the advent of novel systemic therapies. Multidisciplinary approaches are essential for optimizing treatment plans, considering factors such as genetic mutations, patient performance status, and potential side effects. Ongoing research and clinical trials continue to refine these strategies.

Case study on how one mature/late stage biopharmaceutical brand leveraged SamaCare’s insights and intervention platform to decrease administrative related discontinuations of their drug and maintain market share during a biosimilar release. 

How One Brand Protected Market Share Amid Biosimilar Pressure

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Case study on how a neuro biologic brand leveraged SamaCare’s insights and interventions platform to decrease patient access friction and improve patient starts. 

How One Neuro Brand Cut Through Prior Auth Barriers

Valneva announced today that FDA suspended the license for Ixchiq in the U.S., citing four reports of serious adverse events (SAEs) related to chikungunya-like illness. Ixchiq’s suspension is effective immediately, requiring Valneva to cease shipping and selling of Ixchiq across the U.S.

Ixchiq initially received approval from the FDA under the accelerated approval pathway in November of 2023 for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years and older who are at increased risk of exposure to CHIKV. CBER’s cited serious safety concerns related to the vaccine, which the agency says appears to be causing chikungunya-like illnesses in vaccine recipients.

Ixchiq’s suspension follows a series of SAEs

On May 9 of this year, FDA issued a safety communication informing the public about FDA and CDC’s recommended pause of the use of Ixchiq in patients 60 years-or-older. Following the recommended pause, FDA conducted an updated benefit-risk assessment for the use of the vaccine in patients 60 years-or-older, along with patients aged 18-and-older.

CBER’s benefit-risk analysis yielded data reflecting how the vaccine doesn’t provide benefits outweighing risks, under most plausible scenarios. For these reasons, CBER believes the vaccine is unsafe, and that continuing administration to the public poses a danger to health.

On August 6, FDA removed its recommended pause on the use of Ixchiq in patients aged 60-and-older, citing an investigation of multiple SAEs predominantly occurring in older patients suffering from multiple underlying health conditions. One death due to encephalitis was attributed to the vaccine, along with an additional 20 reported SAEs all consistent with chikungunya-like illness, resulting in 21 hospitalizations and three deaths.

Thomas Lingelbach, Valneva’s chief executive officer, touched on FDA’s decision to suspend Ixchiq, saying, “As we determine potential next steps, and as the clear threat of chikungunya continues to escalate globally, Valneva remains fully committed to maintaining access to our vaccine as a global health tool for addressing and preventing outbreaks of this devastating illness. We aim to continue providing Ixchiq to all countries where the product is licensed and continue our efforts with our partners to accelerate vaccine access in low-and-middle-income chikungunya-endemic countries especially in response to any current or future chikungunya outbreaks, ensuring the vaccine reaches those most in need.”

What is the financial impact of the suspension?

Valneva is undergoing an evaluation of the potential financial impact of Ixchiq’s permanent withdrawal of licensing in the U.S. However, Valneva plans to refrain from modifying its revenue guidance. Reported sales of Ixchiq in the first half of 2025 contributed $10.2 million of Valneva’s $123 million in total sales.

Updated Warnings and precautions reflecting recorded adverse reactions

Addition of a new subsection “Post Marketing Experiences”

Valneva Announces FDA’s Decision to Suspend License of Chikungunya Vaccine IXCHIQ® in the U.S. 

https://www.globenewswire.com/news-release/2025/08/25/3138190/0/en/Valneva-Announces-FDA-s-Decision-to-Suspend-License-of-Chikungunya-Vaccine-IXCHIQ-in-the-U-S.html

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live) 

https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-update-safety-ixchiq-chikungunya-vaccine-live

The FDA has suspended the U.S. license for Valneva's chikungunya vaccine, Ixchiq, due to serious adverse events (SAEs) resembling chikungunya-like illness. Initially approved under the accelerated pathway, the vaccine's risks were found to outweigh its benefits, particularly in older patients. The suspension follows multiple SAEs, including hospitalizations and deaths. Valneva remains committed to providing the vaccine globally, especially in endemic regions. The financial impact of the suspension is under evaluation, but Valneva will not alter its revenue guidance. Label updates are required to reflect adverse reactions and post-marketing experiences.

The FDA suspended Valneva’s U.S. license for its chikungunya vaccine Ixchiq due to serious safety concerns, multiple hospitalizations, and deaths linked to chikungunya-like illness. 

Peggy Machak

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