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As the market for specialty and generic products continues to become more competitive and pricing pressures increase, the 505(b)(2) pathway may allow companies more options to diversify their portfolios.

505(b)(2): A Pathway to Competitiveness Through Innovation for Specialty and Generic Companies

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

Growth and innovation require confident decision-making. While large corporations inherently recognize risks, strategic progress hinges on making deliberate choices and embracing necessary trade-offs.

For more than a century, Novo Nordisk has been driving change to improve the lives and health of people living with serious, chronic diseases. Our evolution from a diabetes-focused company to one encompassing multiple therapy areas has enabled us to provide vital treatments to millions of patients and significantly expand our business.

While internal discussions around risk management are important, an overly cautious approach can lead to stagnation. A strategy without clear direction and conviction lacks the power to drive meaningful change.

Here are five essential steps to create, implement, and animate a robust and enduring strategy throughout an organization.

While expressing a desire for revenue growth is common, understanding the “why” behind that intention is crucial. Delving deeper to uncover underlying reasons (asking “why” multiple times) allows an organization to define specific objectives—whether related to a patient ambition, defined patient outcomes, or entering new therapy areas.

Start with a candid assessment of your company’s current standing. This unbiased diagnostic helps ensure you find the right balance between maintaining what is working well and what needs to be changed, while being clear about what you still do not know. Clarity around the current and projected future health of your organization informs your strategic intent and highlights necessary trade-offs.

For example, if embracing data and digitalization is deemed essential to success moving forward, you could decide it is not a core strength and partner externally to maximize your balance between effort and value. Or you could prioritize being experts in your data and invest in the people and technology you need to drive the change in-house. Either choice could be correct, but clarity in intent ensures focused, coherent efforts across the value chain.

A successful strategy begins with a well-defined foundation that articulates your strategic intent. This foundation then guides decision-making, defines priorities, and aligns leadership, creating a disciplined and actionable path forward. Establishing a clear decision-making hierarchy and roadmap for strategy management will create the momentum needed for success. A compelling strategy, supported by a detailed implementation plan, transforms ideas into impactful results that drive sustainable growth.

Prepare your workforce at every level to carry the strategy forward. Success depends on engaging teams, equipping them with the necessary skills, and fostering a culture of adaptability and commitment.

Organizations must ensure that employees have the skills and resources needed to bring the strategy to life. Investing in training, mentorships, and cross-functional collaboration will help teams embrace new initiatives and execute with confidence. Appointing strategy “champions,” those who provided input along the way, throughout the organization can be a powerful tool to mitigate perceptions of an overly top-down approach, facilitating effective execution.

And as each strategic initiative presents unique challenges, providing targeted support ensures that teams can execute effectively in new and evolving environments.

A well-structured execution plan, aligned to clear ambitions, is key to making sure your strategic roadmap is implemented as intended.

4. Communicate your strategy holistically

A successful strategy must engage and align the entire organization with a broader vision. Notably, that does not necessarily mean every employee will directly relate to every aspect. There are parts of the business that are critical for subsets of customers or patients but are capable of running themselves and do not require an enterprise-wide effort to achieve success or simply do not meet the criteria of being an enterprise-wide strategic priority. There may be other parts of the business that have a strong legacy but are simply not value drivers moving forward. Either way, the strategy needs to be just that—one that clarifies the priorities and trade-offs required for success moving forward. A strategy that neatly illustrates where every part of your current and future business fits is typically not really a strategy, but a mere description of your business.

For example, when Novo Nordisk pivoted commercial focus toward emerging GLP-1RA therapies, we visualized this to the broader organization in a way that made it crystal clear the potential these therapies held, while also redefining the roles of certain other therapy areas to refocus effort in these areas appropriately. This approach resulted in a clear plan of action with sharpened therapy area plans and aligned execution. Creating these defined “swim lanes” at the highest level was one of our keys to success.

A successful strategy thrives on unwavering commitment from leaders, fostering trust and alignment throughout the organization.

Frequent changes in strategy should serve as a warning sign; a strong strategy should be durable yet adaptable to evolving dynamics, triggers and milestones, and the outcome of pre-defined scenarios. Life is unpredictable, though, and therefore, an organization should regularly pressure test its strategy to evaluate necessary strategic, operational, or execution-related adjustments.

Effective strategy development and implementation requires both conviction and adaptability. By clarifying strategic intent, equipping teams for execution, communicating effectively, and remaining flexible, organizations can bring enterprise-level strategies to life and achieve lasting impact.

David Kamenir is Vice President, US Enterprise Strategy and Business Development, at Novo Nordisk

Five steps for organizations in bringing enterprise-level strategies to life.

Bridging the Gap:  A Large Pharma Blueprint

Tardive dyskinesia (TD) is an involuntary movement disorder that is associated with the use of antipsychotic medications. Due to the social stigma surrounding mental health issues, people suffering from the condition often struggle with acknowledging the symptoms and getting properly diagnosed.

A new campaign from Neurocrine Biosciences hopes to reduce the stigma attached to TD by sharing stories of people with the condition who sought treatment.

 Musician and mental health advocate Carnie Wilson is the face of the campaign, which is named ConnectING with Carnie.

In a press release, Wilson said, “Mental health is a topic close to my heart, and I'm grateful for the opportunity to partner with Neurocrine Biosciences to spread hope and positivity by sharing stories, connecting with individuals in the mental health community and encouraging those experiencing uncontrollable movements to speak with their healthcare provider about appropriate treatment. I've seen the difference that seeking support and treatment can make, and I want people who may be struggling with tardive dyskinesia to know they do not need to suffer in silence."

Neurocrine Biosciences is also using the campaign to promote is drug Ingrezza, a treatment for adults with TD.

In the same press release, Neurocrine Bioscience’s chief commercial officer Eric Benevich said, “We are moved by Carnie's passion to be a guiding voice for people impacted by TD, recognizing that even mild uncontrolled movements can significantly impact everyday activities, personal well-being, and interactions with others. Our goal for ConnectING with Carnie is to reduce stigma, increase understanding and encourage individuals with involuntary movements to consult a healthcare provider for appropriate diagnosis and treatment options, such as Ingrezza."

Neurocrine also recently released the results of a survey looking into impact of early and routine screening for TD.

 The survey, conducted by The Harris Poll, found that the majority of people living with TD said they should’ve been screened for the condition earlier and that their HCPs should’ve discussed treatment options for the condition earlier as well.

In a press release issued alongside the survey, Neurocrine Biosciences chief medical officer Eiry W. Roberts, MD, said, “These findings highlight the significant daily challenges faced by people living with tardive dyskinesia. This underscores the importance of regular screening to detect the condition early, ensuring patients can receive appropriate treatment for their involuntary movements, which often cause functional impairment, emotional distress and social difficulties."

Roberts also said, “Regular screening for tardive dyskinesia among patients on antipsychotic therapy is crucial for early detection and management, ultimately leading to better outcomes for patients, their families and care partners.”

In the same press release, Josie Cooper, executive director of the Movement Disorders Policy Coalition, added, “The involuntary movements of tardive dyskinesia can profoundly affect individuals physically, socially and emotionally. Tardive dyskinesia can often go undiagnosed, but with proactive and routine screening, we can ensure those affected receive the care and support they need to help manage the condition. That's why we are working on a national and state level to improve access to care and resources for those experiencing uncontrolled movements."

Neurocrine Biosciences and Carnie Wilson Team Up to Launch ConnectING with Carnie™ Awareness Campaign for People with Tardive Dyskinesia. 

. May 6, 2025. https://www.prnewswire.com/news-releases/neurocrine-biosciences-and-carnie-wilson-team-up-to-launch-connecting-with-carnie-awareness-campaign-for-people-with-tardive-dyskinesia-302446443.html

Neurocrine Biosciences Announces New Survey Revealing Need for Routine Screening and Earlier Diagnosis for People Living with Tardive Dyskinesia. 

. May 5, 2025. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-new-survey-revealing-need-for-routine-screening-and-earlier-diagnosis-for-people-living-with-tardive-dyskinesia-302445385.html

ConnectING with Carnie promotes the importance of routine screening and treatment options for the involuntary movement condition.

Carnie Wilson Teams with Neurocrine Biosciences for TD Awareness Campaign

Video interview with Omar Hafez about IPAY 2028 and what it means for the industry

From Uncertainty to Opportunity: Navigating IPAY 2028

Omar Hafez, SVP of Market Access at Avalere Health, discusses the upcoming changes tied to the Initial Price Applicability Year (IPAY) 2028—the first year Medicare will include medical benefit drugs in its price negotiations. There are significant implications for therapeutic areas like oncology, immunology, and neurology, and this new pricing model could affect provider reimbursement and patient access. Hafez offers strategic insights for pharmaceutical manufacturers on how to prepare, including understanding the importance of real-world evidence and global pricing strategies.

How the 2028 Medicare drug price negotiations will reshape market access, provider reimbursement, and patient care

Phreesia and Kick Health recently released a study detailing the diversity of experiences that patients struggling with obesity have when interacting with the healthcare system.

 According to the study, the ways that these patients feel they are perceived by the industry and the ways that treatment options are presented to them can have a significant impact on how they develop their healthcare journey in relation to obesity.

The study surveyed a variety of patients with body mass indexes (BMI) from 27-29.9%, 30-30.9%, and BMIs of over 40%. The participants also included a variety of races, ethnicities, and socio-economic conditions in order to account for the full spectrum of patient experiences. The survey showed that as BMI increased, patients were more likely to show concern for their BMI in regard to how it impacted their health.

However, when it comes to interacting with the healthcare industry, the results showed that many of these patients aren’t necessarily looking for medications to decrease their BMI.

“Obesity medications like Novo Nordisk’s Wegovy™ and Eli Lilly’s Zepbound™ have gained popularity, but lifestyle changes remain the dominant choice for many patients,” the study says. “More than 80% of patients who expressed concern about their weight as it relates to their health had made lifestyle changes in the past. Of these patients, three-quarters (75%) of those with a BMI from 27 to 29.9, and about 65% of those with a BMI of 30 or greater, still relied on this method to manage their weight.”

Most importantly, the results suggest that when it comes to interacting with the healthcare industry, a significant number of respondents across the board said they had not discussed weight with their doctors. A variety of reasons were listed, such as patients feeling that they’d rather make lifestyles changes on their own or feeling uncomfortable discussing their weight with their doctors.

However, a significant number of respondents said that while they had had conversations with their doctors about their weight, they were the ones to initiate the conversations. However, these conversations were only likely to continue if the doctor brought up the topic first.

According to the study, “Only a minority of concerned patients reported that their doctors collaborated with them to develop a comprehensive weight-management plan, indicating room for improvement when it comes to tailoring personalized weight-management strategies. This opportunity is just one of many for healthcare providers to engage more effectively with their patients by customizing support for overweight and obese patients who view and relate to their weight in a variety of different ways.”

Patients with higher BMIs said they were more likely to seek out information about weight management. These sources, however, did not necessarily include their doctors. Patients discussed getting information from a variety of sources, such as advertisements, commercial weight-loss programs, and even social media platforms. The accuracy of these sources can vary significantly.

According to the study, “Trust in pharmaceutical ads ticked up significantly among people with a BMI of 40 or greater who were concerned about their weight. About half or more concerned patients reported seeing advertisements related to weight-management products or medications ‘all the time’ or ‘most of the time’ compared to about one in three of patients who were not concerned about their weight. Of the concerned patients, nearly six in 10 felt that these sources broadly represent the experiences of people who are overweight or obese.”

Closing the Gap: Tailoring Support for Patients with Obesity. 

. https://lifesciences.phreesia.com/reports/closing-the-gap-tailoring-support-for-patients-with-obesity/

A study detailing how patients struggling with obesity interact with the life sciences industry suggests that they don’t get weight loss information from their doctors.

Patients Getting Weight Loss Information from Advertising as Opposed to Doctors: New Study Suggests

Picture this: You're a marketing executive for a pharmaceutical company, and you've just been handed a challenging assignment. Your task? To breathe new life into a mature product that's facing increasing competition. It's a scenario many of us in the pharma industry have encountered.

In this article, we'll dive into strategies that can help you not just maintain, but grow your market share. We'll explore how to adapt to new competitive pressures and evolving customer needs, turning potential threats into opportunities for innovation and growth.

Prioritizing patients for sustainable success

With an established product, your existing customer base is your greatest asset. We can achieve continued success by prioritizing patients and addressing their entire healthcare journey. Take inspiration from Pfizer's "This is living with cancer" program.

 The program offered coordinated services with human care champions and an integrated digital tool to organize information, build communities, and track symptoms.

 Create partnerships with stakeholders to offer coordinated services that go beyond medication, fostering patient loyalty and improving overall health outcomes.

Evolving brand campaigns to inspire hope and action

Refreshing your brand's creative campaign can change the dialogue around the disease state and reignite interest in your product. Entresto's "Heart Failure meet Heart Success" campaign exemplifies this approach, empowering patients and HCPs to view heart failure not as a death sentence, but as a manageable condition with treatment options.

 Develop campaigns that focus on patient empowerment and reframe disease narratives, moving beyond product features to inspire hope and action.

Exploring new formulations to address patient needs

Improving the customer experience through new formulations can breathe new life into mature products. For example, a citrate-free version of ixekizumab was developed to reduce injection site pain, directly addressing a key patient concern.

 Invest in R&D to develop extended-release versions, combination therapies, or more convenient delivery methods that address unmet patient needs. These strategies may help extend market exclusivity.

Leveraging real-world data to demonstrate long-term value

In mature markets, extensive real-world data can be a powerful differentiator. Johnson & Johnson's use of real-world evidence for Invokana in diabetes management helped maintain its competitive edge against competitors and new entrants, while demonstrating better patient outcomes such as adherence and cost.

 Conduct post-market studies to gather economic and clinical data. Use this information to demonstrate long-term value to payers, providers, and patients.

Embracing digital ecosystem to streamline patient access

In today's digital age, innovative marketing approaches can set your product apart. Biohaven's launch of Nurtec showcases this strategy in action.5 They partnered with Cove telemedicine network, enabling website visitors to schedule evaluations and, if appropriate, receive prescriptions delivered to their homes or local pharmacies. This seamless digital experience, coupled with $0 copay cards, improved access to their solution - a tactic mature products can employ for renewed market relevance.

 Create integrated digital ecosystems that streamline patient access, enhance treatment journeys, and provide value-added services, setting your mature product apart in a crowded market.

By implementing these strategies, pharmaceutical companies can evolve their marketing approaches to protect and grow market share in competitive mature markets. The key lies in balancing the established reputation of the product with continuous innovation in both the product itself and the marketing strategies employed.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer_launches_novel_programs_to_put_important_support_services_at_the_fingertips_of_cancer_patients

https://investor.lilly.com/news-releases/news-release-details/lillys-taltzr-ixekizumab-now-available-new-citrate-free#:~:text=Lilly%27s%20Taltz%C2%AE%20(ixekizumab)%20Now,Experience%20%7C%20Eli%20Lilly%20and%20Company

https://www.jnj.com/media-center/press-releases/real-world-evidence-shows-oral-invokana-canagliflozin-results-in-greater-weight-loss-and-treatment-adherence-than-injectable-glp-1-receptor-agonists-in-type-2-diabetes-patients

https://www.fiercepharma.com/marketing/biohaven-accelerates-dtc-campaign-timing-for-migraine-med-nurtec-odt-launches-tv-digital

Strategies that can help  maintain and grow your market share. Plus how to adapt to new competitive pressures and evolving customer needs.

Mohit Jain

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