Partner in Progress and a Unique Therapy for NMIBC Patients

January 2, 2025

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About Adstiladrin:

INDICATION

ADSTILADRIN is a treatment for adults who have all the following:

• High-risk non–muscle-invasive bladder cancer (NMIBC)
• Cancer that is not responding to Bacillus Calmette-Guérin (BCG) therapy
• Carcinoma in situ (CIS) with or without other high-grade tumors

IMPORTANT SAFETY INFORMATION

Who should not receive ADSTILADRIN?

Do not receive ADSTILADRIN if you have a sensitivity to interferon alfa or any of its components.

What is the most important information I should know about ADSTILADRIN?

Individuals who are immunosuppressed or immune-deficient should not prepare, administer, receive or come into contact with ADSTILADRIN.

What should I tell my healthcare provider?

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of ADSTILADRIN?

The most common side effects of ADSTILADRIN include:
Urinary discharge, fatigue, bladder spasm, urgency to urinate, and blood in your urine.

These are not all the possible side effects of ADSTILADRIN. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.

What other information should I know about using ADSTILADRIN?

For two days following treatment, voided urine should be disinfected for 15 minutes with an equal volume of bleach before flushing.

For more important information, call 1-888-337-7464.

Please see full Prescribing Information.

Transcript

Voice over:

This is Bladder Cancer Matters, the podcast for bladder cancer patients, caregivers, advocates, and medical and research professionals. It’s brought to you by the Bladder Cancer Advocacy Network, otherwise known as BCAN. BCAN works to increase public awareness about bladder cancer, advances bladder cancer research, and provides educational and support services for bladder cancer patients and their loved ones. To learn more, please visit BCAN.org.

Rick Bangs:

Hi, I am Rick Bangs, the host of Bladder Cancer Matters, a podcast for, by, and about the bladder cancer community. Today is the first in a series of podcasts that we’ll be doing in observance of BCAN’s 20th anniversary, which we’re celebrating all throughout 2025. In this anniversary year, BCAN is launching a Partners in Progress podcast series in which we’ll highlight the commitment of BCAN’s pharmaceutical company partners to creating better todays and more tomorrows for bladder cancer patients and families.

Today we’re featuring Ferring Pharmaceuticals as the January 2025 Partner in Progress. Ferring is a privately-owned-by-a pharma-company focusing on developing life-changing innovations that help patients live better lives. Grounded in a 70-year commitment to science and research, Ferring pursues therapies that help people build families stay healthy and fight disease. They develop life-changing therapies to address the unmet medical needs of patients diagnosed with bladder and other urologic cancers.

While we’ll be talking today about Ferring therapies, including Adstiladrin, which has the generic name, nadofaragene firadenovec, VNCG, it’s important to remember that different treatments have different results in patients and your results may vary.

Our guest on today’s podcast is Karishma Parikh, the head of Uro-oncology Marketing at Ferring Pharmaceuticals. With over 16 years of experience in the healthcare industry spanning multiple therapeutic areas, mostly in oncology, Karishma is a highly accomplished leader in pharmaceutical marketing and commercialization. She brings a proven track record of successfully launching therapies, driving business growth, and enhancing market positions. Recognized by MM&M as a leader within the annual 40 under 40 award. Karishma is known for her strategic vision and collaborative approach and has consistently exceeded expectations while advancing innovations that make a meaningful difference in patient care. Welcome to our podcast, Karishma.

Karishma Parikh:

Thanks so much, Rick. So happy to be here today.

Rick Bangs:

We’re happy to have you, as well. And so we’ve seen some major and exciting changes in bladder cancer treatment in recent years, including the FDA approval and availability of Ferring’s Adstiladrin. So from your perspective, what makes this recent movement particularly groundbreaking?

Karishma Parikh:

Yeah, it’s a great question and the recent advancements in bladder cancer treatment are really transformative, and the FDA approval and the full availability of Adstiladrin is a perfect example of how the field is evolving. And just so all the listeners know, Adstiladrin is a treatment for adult patients who have high-risk, non muscle-invasive bladder cancer that is not responding to BCG, and who also have carcinoma in situ, or CIS, with or without other high-grade papillary tumors.

So, as we think about this for decades, the innovation in the space has been relatively stagnant and the standard of care has often revolved around interventions like radical cystectomy. And Rick, as you know, while some of this is effective for some, the approach comes with significant challenges, limited patient choice, invasive procedures, and really lengthy recovery times. All that can impact a patient’s quality of life. And I think what makes this new era groundbreaking is how the scientific breakthroughs are addressing these long-standing challenges that patients have been having to face, and therapies like Adstiladrin not only provide patients with this new hope, but also offer this alternative to cystectomy really paving the way for bladder preservation. And this allows the dialogue shift to happen in this disease state that was really not tailored for the 2-way conversations between physicians and patients for so long.

So it really is this exciting time and we’re seeing a focus on combining this efficacy with the preservation of a patient’s wellbeing. And it’s something that’s just really been long overdue in this field. And I, along with the rest of the Ferring team are really happy to be at the forefront of that.

Rick Bangs:

And we are glad to see those improvements because when I was diagnosed in 2006 it was, as you point out, stagnant for years. So this is completely different [inaudible 00:04:58] than that I was offered. I want to talk about Adstiladrin. So can you share the backstory, when did Ferring begin working in the bladder cancer space, and what motivated the company to focus on this particular area?

Karishma Parikh:

Yeah, it’s interesting. So Ferring actually has a really strong background in urology, which many patients really may not know about this, but we’re not new to uro-oncology. And with Adstiladrin and the approval of Adstiladrin, we really partnered with their urologists and uro-oncologists to harness this innovative science really early on when there really weren’t that many options, and when the terms like BCG-resistance disease started getting greater acceptance in the field, and we recognized really early then that there was a tremendous unmet need for patients diagnosed with BCG-unresponsive NMIBC, and we partnered together with the experts to really bring this product to market for the population that was so underserved, and Ferring having played this key pivotal role in the early clinical development of the Adstiladrin.

I don’t know if you know this or not, but it’s the 14th gene therapy that was ever approved by the FDA. It’s one of 14, which is pretty outstanding knowing how many drugs the FDA has approved in its lifetime. And we’re the first and only gene therapy approved in this space in the non-muscle-invasive bladder cancer space. So I think Ferring with its longstanding presence in the uro-oncology space, we’re really excited and looking forward to what Adstiladrin will provide to patients, but really what the future will hold for the space and for the company.

Rick Bangs:

Yeah, I’m glad you pointed it out, because, pointed out that it’s a gene therapy because we’re used to chemotherapy, we’re used to surgery, radiation, we’re used to immunotherapy now, but this is a whole new category for us in the bladder cancer space.

Karishma Parikh:

Yeah, and we’ll talk about it a little bit more I’m sure later. But the interesting thing about being a gene therapy is that this doesn’t change your genes, right? It really works with your overall immune system, which I know can be a little frightening for patients, but it does not change any aspect of the genes for a patient.

Rick Bangs:

Okay, yeah, just like radiation doesn’t make you radioactive. So I think that’s important to know. All right, so I want to talk about you. What inspired you to join Ferring and how does your personal journey align with Ferring’s mission in oncology and bladder cancer?

Karishma Parikh:

Oh, gosh. So I’ve been working in the healthcare space in some capacity over the past 16 years, and a lot of that really has been in oncology and hematology, and like everyone has their reasons of why they want to work in oncology. And mine really was for my dad. My dad is a cancer survivor, and early on I’ve always known that I wanted to do something in this space and I wanted to continue bringing therapies to market that can save lives, so everyone really has a chance to be with their loved ones for just a little bit longer. So when I think about my personal and my professional work, I really try to choose meaningful work that impacts the lives of those that need care and those that are seeking solutions.

What really drew me to Ferring was just how unique this company really is. It’s a family-owned company that really prides itself on ensuring that we keep people first. This company has a broad portfolio of products where we help people build families, help them stay healthy and really fight diseases to live longer in the way that they specifically want to, which I think is so critical when thinking about just from a cultural company perspective and the meaningful work that they do.

And when we think about the uro-oncology franchise here at the team, when we talk about the work that we do, it’s really always tied back to the most important aspect of that. And that’s really the patients and the families that desperately need these solutions when we’re thinking about their cancer care. And that’s really what our North Star is.

Rick Bangs:

Excellent. Excellent. And family-owned which is pretty unusual in the pharmaceutical industry.

Karishma Parikh:

Exactly. And the family definitely takes a lot of pride, especially when it comes to uro-oncology being one of the newer business units and there’s a lot of pride just knowing that we’re helping as many patients as we can.

Rick Bangs:

It makes a difference when you get up in the morning.

Karishma Parikh:

Mm-hmm.

Rick Bangs:

Okay. So talk to me about the segments of bladder cancer that Ferring addresses with its treatments and beyond Adstiladrin, are there other agents in your pipeline or areas of focus, some of them in clinical trial? Where are we?

Karishma Parikh:

Yeah, it’s a great question, Rick. I talked a lot about where we are currently with Adstiladrin as a monotherapy in the non-muscle-invasive bladder cancer space, but we also do have several ongoing clinical trials that are exploring the use of Adstiladrin as a monotherapy, but then also in combination with chemotherapy or an immune checkpoint inhibitor in this high-risk space. We’re also looking at the intermediate risk NMIBC space as well as low-grade upper tract urothelial cancer. So definitely a lot that we’re doing around Adstiladrin and really ensuring that we can find different use cases should it work in these different segments for bladder cancer. However, outside of that, we’re always looking to expand our pipeline with in-house agents, acquisitions, and potential partnerships, and we have a great team in-house that really focuses on that.

Rick Bangs:

Okay, excellent. That’s a pretty broad swath, but lots of needs in those spaces, so that’s great. And upper tract, I want to point that out.

Karishma Parikh:

And upper tract, correct, yep.

Rick Bangs:

Yeah, because there’s another one that’s underserved. All right. So what does Adstiladrin bring to the table for a bladder cancer patient? How does it stand out from other treatments? And you can talk about benefits and safety or approach.

Karishma Parikh:

So I had mentioned that Adstiladrin is a really unique product with an advanced mechanism of action. So the way it really works inside the body, it’s targeted. And like I had mentioned, it does not change the genes like other gene therapies that patients hear about and it does not impact the overall immune system. Instead, it works with the immune system and it really only fights the cancer that’s within the bladder. This is not a chemotherapy, something that a lot of patients are pretty much used to going through when they think about a first-line treatment. And it’s not combined with any other product like BCG, so it works as non-therapy, and that’s really how it helps to fight the cancer.

When we think about does a product work or not, it’s effective. We’ve established this in our clinical trial and, in fact, we actually have the longest follow-up of a clinical study for any product in this space. And we have data out to five years of people who received at least one dose. 96% of these patients did not progress to muscle-invasive bladder cancer, and over half of these patients were estimated to keep their bladder, which is really important as you think about bladder preservation. But I think more importantly that there were no new side effects that were reported out to five years, which is something that I know a lot of patients are concerned about when they’re thinking about being on certain therapies.

And it’s also really well tolerated. So most of the common side effects were urinary discharge, fatigue, bladder spasms, maybe urgency to urinate and blood in the urine. But in our clinical trial, these side effects were mild and it really went away after just two days. So it’s really a well tolerated product, too.

But I think more importantly, from a patient perspective, convenience is something that we hear often, time and time again, whether from the patients or from our clinicians, and Adstiladrin is quarterly dose. That means you only have to come in to the practice once every three months to get Adstiladrin and which is directly through a catheter into your bladder. Patients can stay with their urologist for this. They don’t have to worry about switching physicians for any reason. They stay with their urologist, with their trusted care team that they’ve been going to for. Adstiladrin itself.

And then, obviously when we think about reimbursement and coverage, you know, Ferring offers comprehensive resources to help really ensure that patients are able to afford Adstiladrin. We believe strongly here that everyone that can and wants access to Adstiladrin should be able to get the access to Adstiladrin.

So really all this really leads to the why we launched our new patient campaign with the slogan, “Stil doing it my way.” And hopefully once you all visit the website, you can see the play on words with, Adstiladrin and stil with the spelling, but this product really does empower people to continue living their life the way that they want to be living it. And it really showcases patient stories like Mike, who had been on Adstiladrin since the clinical trial, and he’s been on it for over six years and still remains cancer free. So really showcasing these patient stories through a patient campaign and showing all the benefits that this product has.

Rick Bangs:

So I heard lots of things there, but once a quarter, which is very different from a lot of other treatments. Side effects, low level of side effects that dissipate pretty rapidly, like a couple of days. That’s great. And the results sound very, very promising. 96% I think is what you said. And 50% with bladders after what, five years, so-

Karishma Parikh:

Correct, yeah.

Rick Bangs:

Awesome. I want to talk a little bit about patient engagement. How did you engage patients throughout your development of Adstiladrin? And can you elaborate on the role of patient involvement in clinical trials or survivorship studies that might’ve happened as a result?

Karishma Parikh:

Yeah, so patients are definitely at the heart of all of our clinical programming, and throughout our history, ever since we’ve started even researching about Adstiladrin and how we will bring it to market, we’ve worked really closely with patients and families in need. And it’s really important that the feedback that we receive from patients, we incorporate it, whether it’s for a trial design or for anything that we do once we’re out, that patient voice is so important. And in uro-oncology we’re working with patients currently to introduce plain language to help demystify the clinical development process, giving patients the ability to fully understand really what it means to be on a trial, to understand what all that trial design really means.

And we’re also working on building a patient coalition through advisory boards, patient councils, and really just any effort that we can to coalesce around patient advocacy efforts, especially working with you guys, in terms of spearheading what that means for us and the community in bladder cancer.

And then I had mentioned this, but we recently built out a patient marketing and advocacy function specifically at Ferring to focus on just this. And what we’ll do with that is to really ensure that we’re always thinking about patient first and caregiver first, and what we can do to continuously better support them as we’re thinking about, not only this product, but the future for uro-oncology here at Ferring. So yeah, we’re committed the patient voice and applying patient learnings to everything that we do from a strategic perspective and continued evolution for what we’ll continue bringing to the market.

Rick Bangs:

That’s wonderful, wonderful. Love to hear about this level of patient engagement. I want to come back to, and you mentioned this earlier, so costs of cancer treatments is often a concern. So can you talk about the typical out-of-pocket cost of Adstiladrin for insured and uninsured patients? And I think you mentioned, and I think we should talk about specific programs and how people would arrange to have some help managing those costs.

Karishma Parikh:

So this is definitely something, Rick, we hear quite often, “What am I going to pay?” Ferring has taken a really strong approach in ensuring that we work with our healthcare providers and our patients and our advocates to inform our approach on really patient assistance and access and ensuring that we can meet the diverse patient needs. And it’s really important for us as an industry to ensure that any patient, again, should they be eligible for Adstiladrin that they should be able to receive Adstiladrin. We have patient assistance programs that really make it accessible and affordable, an option for all patients. And so an example of that, for instance, is our patient assistance programs where we may be able to offer patients who need financial assistance to Adstiladrin, to receive it at little or no cost, or for patients that may have commercial insurance, we may be able to reduce their co-pay down to just $100 per dose. So programs like this are really important, and we stand behind these programs to ensure that patients, for them to have a therapy that can help preserve their bladder, they aren’t worried about the financial aspect of this.

And then, aside from that, we’re on the National Formulary at the VA, which Rick, as you know, and we hear from so many patient stories on BCAN, that so many of our veterans who have served our country are currently battling bladder cancer because of the toxic hazards that they had been exposed to. So just knowing that Adstiladrin is on the National Formulary for the VA is a big deal for them and for their clinicians that are looking to prescribe the product.

And then, I think we’ve said this a couple of times, but at Ferring we really do, and it’s been our mission and our goal from the beginning, to make Adstiladrin accessible to patients and providers who need it, and really to facilitate that broad coverage as the therapy represents a really novel and efficacious option for these patients that don’t have many other options right now.

Rick Bangs:

And we certainly want patients to have access to treatments that are right for them. So I think this is really critical.

Karishma Parikh:

Exactly.

Rick Bangs:

So I just want to be clear if I’m one of these patients that needs some help, do I work through my doctor? Do I go to the Adstiladrin website, which you’re going to give us here at the end of the podcast, what’s the best way to seek that help?

Karishma Parikh:

Yep, great question. So it can be a number of ways. Talking to your healthcare provider and your nursing staff would be a great step should you want to ask for the information around this. We have support resources that we’ve provided with them so they can offer it to you. Going to www.adstiladrin.com is another great option where you can not only get all the clinical information about the product, but you can also receive all of the resources and read through some of these support programs that I had just mentioned, from the site as well.

Rick Bangs:

Okay, thank you. I think that’ll be very helpful. So Ferring has been partnering with BCAN and I’m interested in hearing more about this collaboration and any plans you may have for future partnering.

Karishma Parikh:

Yeah, we’re so excited about our partnership and collaboration with BCAN. BCAN is just such an instrumental part to the patient journey and just the wealth of information that BCAN has for the patients. It’s just phenomenal. And our relationship with BCAN is so strong and we’ll continue honing in on that as the years to come. So, we’ve been the presenting sponsor of the Walk to End Bladder Cancer for the past two years, and we will continue doing that as we see just as the communities are coming together and how influential that is, it’s just, it’s breathtaking going to these walks and seeing everyone come together. It brings tingles and just another layer of just the support that you guys provide to patients.

We also sponsor both BCAN Summits for patients and families as well as the supporting survivors and families program. We sponsor the state and federal advocacy efforts and Bladder Cancer Awareness Month activities that happens every year.

And we’re also sponsoring the Faces of Bladder Cancer, the survey that BCAN is putting out and supporting a program like this, the Partners in Progress program, which is exactly why we’re here today as the inaugural partner and part of this program.

So as we think about how we’ll continue evolving this, our sincerest desire is to be a trusted partner with BCAN and to help uncover the gaps in bladder cancer patient care that we all as a community are looking to do, and working collaboratively to find solutions that lead to these outcomes that we’re all looking for. One of the best examples, and we’ve just actually have been discussing this a lot more recently, is talking about the VA and how many patients are dealing with bladder cancer that go there, is our focus there and amending the PACT Act. And so that’s something that Ferring is partnering very closely with BCAN on currently as an initiative that we’ve started. So as I think about our future, our future with BCAN, and that partnership looks really bright, and we’ll continue working on ways to enhance our collaboration, not only with you, but to best support the bladder cancer patients and their loved ones that need it the most.

Rick Bangs:

Okay. So I just want to pause for a second and talk a little bit about the PACT Act. I believe it has to do with environmental considerations that might impact our veterans. So can you just explain a little bit about that?

Karishma Parikh:

Yeah, and that’s exactly what it is. And BCAN has been a force in trying to ensure that these environmental conditions are more broad and really trying to amend the PACT Act to include all sorts of different types of environmental situations that a veteran may have come across. So what Ferring is doing, we’re just hoping to help facilitate this by bringing coalitions together to help BCAN fight this when it comes to the legislation. So we’re doing what we can from an industry perspective to just aid in the efforts that BCAN has already started.

Rick Bangs:

Which should help our community get treatments that would otherwise maybe not be accessible to them.

Karishma Parikh:

Exactly. Yep.

Rick Bangs:

Awesome. All right, so I want you to look into your crystal ball and tell me what you think the future holds for bladder cancer care and give a little bit of the Ferring perspective. Where do you see the field evolving and how does Ferring plan to contribute?

Karishma Parikh:

Yeah, so starting with the FDA approval of Adstiladrin and really the success of the launch and the number of patients that we’ve treated thus far, we’ve allowed and offered a new hope for these patients for a durable bladder preservation. So when we think about the future and from our conversations with physicians and patients, we know that Adstiladrin offers an optimized and seamless treatment experience, and we’re really pleased to be delivering on those expectations.

And we’re now looking towards that future where we have expanded our ability to meet the current unmet need now, in this high-risk NMIBC space, but also for the future for urothelial cancers in general.

So it’s one step towards realizing that the clinical trials that are underway with Adstiladrin and with these new trials that hope remains the same. We hope to see that same low treatment burden. We hope to see a great efficacy and managerial safety profile for patients across the spectrum, and we’ll continue partnering with our clinicians and patients and caregivers to ensure that we’re pulling through from what we can from a Ferring perspective and we’ll continue contributing to ensure that we can be there for the patients with these unmet needs and really be that partner.

Rick Bangs:

Excellent. So we’re going to keep our ear to the ground and you on call so that when you have something exciting to share, we’ll-

Karishma Parikh:

Yep. And you guys have my number so can call anytime.

Rick Bangs:

That’s excellent. Excellent. Okay. Any final thoughts you want to offer?

Karishma Parikh:

Rick, this has been awesome and again, thanks for allowing me to come on here and really share some of what brings so much excitement to my day-to-day. I wake up every day so happy knowing that we’re providing this hope for patients. We’ve been discussing managing this unmet high-risk NMIBC need and the challenge that patients and physicians both have, and really, from Ferring’s perspective, our mission to transform the treatment landscape has been driven by this deep commitment to improving outcomes for patients. And with Adstiladrin, we’ve taken a major step forward in establishing a new standard of care for BCG, unresponsive NMIBC patients really offering that optimized and seamless treatment experience that meets the needs of the patients and their caregivers.

And this achievement really wouldn’t have been possible without the close collaboration and support of the bladder cancer community. So for everyone listening from BCAN’s perspective, the urologists all coming together to really make strides for better outcomes for patients and their families. So honestly, I’m really looking forward to the future for not only this product, but for everything else that this company is going to put out for patients because it really is our number one mission to provide and fill in some of the gaps in the space.

Rick Bangs:

Excellent.

Karishma Parikh:

It’s been great and a pleasure speaking with you. I want to thank the audience for listening in on this podcast and really looking forward to seeing where we go.

Rick Bangs:

Excellent. Excellent. And Karishma, I want to thank you for introducing Ferring and your new agent, Adstiladrin, and for creating better todays and more tomorrows for bladder cancer patients and families by being one of BCAN’s partners in progress.

Karishma Parikh:

Thank you so much.

Rick Bangs:

If you’d more information on bladder cancer, please visit the BCAN website www.bcan.org. In case people wanted to get more information about Ferring or Adstiladrin, where can they go?

Karishma Parikh:

So if you’d like to learn more about Adstiladrin, please visit our website www.adstiladrin.com. Or reach out to your healthcare provider for any more information.

Rick Bangs:

Okay. And Adstiladrin is A-D-S-T-I-L-A-D-R-I-N. Adstiladrin. Just a reminder, if you’d more information about bladder cancer, you can contact the Bladder Cancer Advocacy Network at 1-888-901-2226. That’s all the time we have today. Be sure to Like, Comment, and Subscribe to this podcast so we have your feedback. Thank you for listening, and we’ll be back soon with another interesting episode of Bladder Cancer Matters. Thanks again, Karishma.

Karishma Parikh:

Thank you so much.

Automated voice:

Thank you for listening to Bladder Cancer Matters, a podcast by the Bladder Cancer Advocacy Network or BCAN. BCAN works to increase public awareness about bladder cancer, advanced bladder cancer research, and provide educational and support services for bladder cancer patients. For more information about this podcast and additional information about bladder cancer, please visit BCAN.org.