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Ten Years of Celgene Australia

Celgene is celebrating the tenth anniversary of its establishment in Australia this week. Pharma in Focus spoke to George Varkanis (Vice President and Managing Director ANZ) and global CEO Mark Alles about how the company sees Australia ten years on and its plans for the future.

“It’s been a fantastic journey,” says Varkanis. “We often talk about having the opportunity to start something from scratch. Essentially, this has been the story of Celgene around the globe in all of our affiliates [from] when the company decided ten or so years ago to go global, and it’s just a great opportunity to build an affiliate, to build an organisation globally but to build an affiliate and to go through those early days.”

At the time, Revlimid® (lenalidomide) was the company’s sole product in Australia and even it had yet to travel all the way to market.

“We’ve built from there,” Varkanis says.

“In Australia, several years in, Revlimid was reimbursed. Soon thereafter, Vidaza® (azacitidine) was also reimbursed. We had Pomalyst® (pomalidomide) reimbursed late last year, so they’re our three key brands.

“Obviously thalidomide is still a product that we have on the market here. There’s a couple of other products that are registered but not yet reimbursed and we’re working through that.”

Among those products is Otezla (apremilast), rejected for PBS listing last year.

Celgene’s recent struggles with the PBAC – it had three major submissions rejected last year – naturally raises the question of whether Australia is a particularly tough environment for companies seeking to have drugs reimbursed.

Reimbursement environment

Says Mark Alles “We’ve become very, very expert at working with market-based healthcare systems all round the world. I don’t think that I would put Australia into an especially difficult category.

“What I would say is that, like a lot of markets around the world, the system is fairly unique but we respect the system, we work through it, we partner, we negotiate, and we understand fully the responsibility that we have to bring innovative, life saving, life extending, life improving new therapies to market and to work with the respective governments, including the Australian government through its systems, on how to create the right balance between innovation and the recognition that innovation comes at a cost and that innovation needs to be negotiated based on local market considerations.”

Alles says he would rank Australia “in the developed markets of the world with a very rigorous system, one that is fairly predictable, one where we understand the rules of the road”. But he has a message none-the-less: “The Australian market or other single-payer systems like Australia around the world, could create more certainty and predictability in terms of how the system will work year in and year out and from budget cycle to budget cycle. That creates a sustainable partnership between industries like the pharmaceutical industry and Celgene and how it sees itself for the long term in a country like Australia.”

Varkanis adds that, based on local experience, “the process largely works.”

“In our experience, generally it’s been a good experience. Do we have prices at perhaps at the lower end of global price bands? Yes, but that, as Mark said, that is about understanding the markets that you work in. As long as there’s that consistency, that transparency and you know what you’re working with, it’s OK.

“Are there things that we could tweak in the process? Sure, but I think it comes down to believing in your product, believing in the data and then you work through the processes that you have in front of you.

“We have, as I said, a couple of products that are registered. They’re not reimbursed. They may never get reimbursed because we can’t agree on the data or the assumptions or whatever it may be.

I think industry and government perhaps could work more to find a middle ground because it’s never going to be black or white and I think that’s an area where, particularly for some of the rarer diseases, it shouldn’t be so clear cut and I think there’s room for dialogue to benefit patients.

Although not willing to name particular products, Varkanis says: “We’ve got one product that we haven’t even submitted and we probably won’t submit because the comparator is a low cost generic and you cannot sell this product at generic prices. It’s a rarer disease. It’s on phase II data. It’s got a lot of complexities to the package so I think in those instances a dialogue needs to happen and I think the rule book maybe kind of needs to be a bit more flexible.

Rare diseases

“Around the world where there are these more difficult negotiations around rare disease categories or where the system is structured for the mass markets, the bigger markets, and the bigger cost items, it does create some complexity that causes the industry to make different choices,” says Alles.

“But again, I don’t know that that is only in Australia. It may be somewhat different in terms of the exact process but I think the rarer the disease, the more complex the disease, sometimes the more challenging the environment but as George points out, we’ve had a great ten-year run here. We are very excited about the future of Celgene in Australia and we’ve learned to work with the system, I think, quite well.”

“Whether it’s Australia or single-payer countries with government-backed reimbursement around the world, the rare disease category is a common issue because these are people with high mortality and morbidity burden and so there’s a disproportionate impact on the healthcare system albeit these are very few patients to have to deal with,” the Celgene CEO adds. “I think that’s where the dialogue has to come in.”

He says there may be a need for a different funding mechanism where rare diseases are concerned and that using the same set of rules as applied to drugs for more common illnesses is insufficient.

“We’re very open to a lot of novel structures on the basis of new innovation that sets a new standard in outcomes and benefits, where then the question is, what is the budget impact? We’re very open to that, country by country including in Australia. We’re happy to create that dialogue about a forward-looking approach to reimbursement.

The future in Australia and Australia’s role

Celgene is a company recognised around the world as a leader in blood cancers and has more in that pipeline but is branching out into other therapeutic areas as well.

Further, Alles places particular emphasis on the special relationship that he says Celgene enjoys with Australian researchers and research institutes.

“Some of the most important academic relationships that we have in the world are between Celgene and key investigators and research centres including the Peter Mac here in Melbourne so when we think about cancer research there’s a long history of collaboration between Celgene and some of the most important haematologists in the world right here in town,” he says.

“We recognise that over time there is going to be the up and down of the local relationship with respect to how the system is working and how the budgets allow for additional research to happen but we have a long term view that Celgene’s success in the world will depend on a very intimate relationship with Australia’s market so we look to build on our last ten years with a least another 12 to 25 years of success in Australia.

“As far into the future as I can see, we’re going to have a meaningful footprint in this market from a research and commercial point of view.”

The above story was adapted, with permission, from a Pharma in Focus article posted 7th April 2016.

Light the Night, Leukaemia Foundation

Celgene is proud to again be the key partner of the Leukaemia Foundation’s annual Light the Night.

More than 60,000 people are living with leukaemia, lymphoma, myeloma or a related blood disorder, and another 35 people are diagnosed every day.

Thankfully, the Leukaemia Foundation is committed to fighting this terrible statistic as part of a quest for a blood cancer free future. Light the Night events raise funds and hope to support Australian families affected by blood cancer.

Join us at one of the walks across the country on Friday October 7, 2016 to brighten the lives of families affected by leukaemia, lymphoma and myeloma.

Find out how to take part

Over the past decade, many new and effective treatment options for multiple myeloma have been introduced, allowing more patients today to effectively manage their disease and get back to living life on their own terms. Many are doing things that challenge conventional perceptions of what myeloma patients can do. These myeloma patients are making history and overcoming their disease to achieve major goals in their lives. We wanted to highlight some of the inspirational stories that we’ve recently heard.

Stan Wagner

Stan Wagner

Four years after being diagnosed with myeloma and three years after going into remission, Stan Wagner continues to go for monthly blood tests but, for the most part, doesn’t think about his myeloma much. He’s focused on giving back instead.

When he learned that a friend wanted to climb Mt. Kilimanjaro for a larger purpose besides herself, Wagner brought the idea to the Multiple Myeloma Research Foundation and helped develop the Moving Mountains for Multiple Myeloma fundraising event. Wagner decided to participate himself and trained by going on day hikes in upstate New York. In January 2016, Wagner made the 8-day hike through high elevations and low temperatures to the highest freestanding mountain in the world.

“Being a myeloma patient doing things like this shows that myeloma is not the end of the world,” Wagner said. “Hopefully, I can inspire other myeloma patients to get out of their shells and to keep doing what they want to.”

Mark Herkert

Mark Herkert

Although Mark Herkert has never been in remission since being diagnosed with myeloma five years ago, his treatment has allowed him to become healthy enough to complete a 5K run to support the Multiple Myeloma Opportunities for Research & Education organization, becoming a top fundraiser for the event.

Since that first race, Herkert has gone on to run the Lavaman Waikoloa Triathlon and the 2015 New York City Marathon, raising more than $70,000 for myeloma research through all his efforts to date. Next year, he plans to follow the footsteps of myeloma patients like Wagner by participating in the MMRF Mt. Kilimanjaro Trek.

“I felt like maybe this is what I was meant to do,” Herkert said. “I am contributing and getting in great shape at the same time. My goal is to encourage others to be part of the solution and to show others with myeloma that the sky can truly be the limit.” 

Alex Clark

Alex Clark

Being in and out remissions several times since being diagnosed with myeloma in 2011 hasn’t stopped Alex Clark from spending time outdoors, including camping and mountain climbing. When his disease went into remission for the first time, he took a road trip to Oregon, spending six weeks hiking, backpacking and mountain climbing in the wilderness. During that first trip, he logged over 300 miles and scaled five big summits.

More recently, Clark spent a rainy February weekend camping in Wisconsin’s Northwoods on the edge of Lake Superior. Clark said that he finds peace being in nature and has come to recognize that he is strong enough to overcome whatever happens next in his journey.

“I have a tattoo on my arm that says ‘don’t panic,” Clark said. “I try to think about that phrase a lot. Things are never as bad as they seem, as long as you don’t panic and keep doing the things that you enjoy.”

 

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As Multiple Myeloma Awareness Month comes around again, the myeloma community has good reason to celebrate the past decade, which has brought new treatment options for today and a better understanding of how to treat this disease in the future.

A patient who is diagnosed with myeloma has an about 47 percent chance of living five years or longer, which is up from 31 percent twelve years earlier. Meanwhile, although people are being diagnosed with myeloma at an increasing rate each year, their survival chances are improving.

“The progress has been quite dramatic,” Dr. Paul G. Richardson of the Dana-Farber Cancer Institute Hematology Oncology department said. “Although we may have seen similar improvements in other cancers, the difference with myeloma has really been the volume of new treatment options that have been approved in the past decade and their impact on outcomes as reflected by the improvements we have seen in survival.”

Between 2006 and 2015, the U.S. Food and Drug Administration approved 13 new therapies for the treatment of myeloma, which is especially remarkable considering myeloma accounts for less than 2 percent of new cancer cases in the United States each year. During the same period, the FDA approved 20 treatments for lung cancer, which accounts for 13 percent of all new cancer cases, and 12 for breast cancer, which accounts for 12 percent.

Multiple Myeloma: A Decade of Progress infographic

These new myeloma therapies have already helped patients live longer lives, and the best may be yet to come as doctors explore how to use them most effectively. According to data released during the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO), researchers believe that by 2022 at least half of myeloma patients will live 6 years after being diagnosed, which is 140 percent longer than was expected in 2001.

While immunotherapies are certainly exciting because of their new approaches, we should not underestimate the therapies approved over the past decade.

Over the past decade, researchers have improved our understanding of the immune system’s role in myeloma, which may transform the way we treat this cancer in the future. For instance, one study of 74 myeloma patients who live for 10 years or longer found that their immune systems may be better equipped to recognize and attack harmful entities—such as cancer cells—than others.

Over the next decade, immunotherapies, which leverage our body’s immune system to bring cancer under control, may help further extend the lives of myeloma patients. These approaches include antibody-based therapies, chimeric antigen receptor (CAR) T-cells and checkpoint inhibitors.

“While immunotherapies are certainly exciting because of their new approaches, we should not underestimate the therapies approved over the past decade,” Richardson said. “There’s going to be great value in combining the next generation of myeloma therapies with those we have today.”

To learn more about how myeloma treatments are allowing patients to continue living active lifestyles, read our “Patients Not Letting Myeloma Hold Them Back” story.

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For a long time, Élodie Laurent loved nothing more than baking for the people who visited her French café. But that joy was taken away by something out of her control—psoriasis.

She has the obvious physical symptoms of the disease, including the red, scaly patches on her face and arms. But a closer look into her day-to-day life reveals the emotional and psychological toll that this immune-inflammatory disease has taken on her: she is self-conscious about her appearance, imagines her disease to be much worse than it is and actively avoids family and friends. Having been forced to give up her job as a pastry chef, she lives a solitary and isolated existence in London.

Although Élodie is a fictional character—the protagonist of the new short film Millefeuille (A Thousand Leaves)—her story is inspired by psoriasis and psoriatic arthritis patients around the world. The movie was produced following extensive research in this space to raise awareness of the sometimes hidden burden of psoriasis.

Millefeuille movie

IN MILLEFEUILLE (A THOUSAND LEAVES), (LEFT) INITIALLY RESISTS THE WARMTH OF HOLLY’S FRIENDSHIP BECAUSE OF THE EMOTIONAL EFFECTS OF HER PSORIASIS.

Typically, when filmmakers set out to educate on a topic close to their hearts, they lean toward a documentary style. But here, they instead set out to make a short drama, aiming to attract a wider audience and a patient community who may have given up hope that life with psoriasis could be different.

“It’s been a really fascinating process doing this,” the film’s director Alistair Clayton said. “It’s not something I’ve seen done before.”

Millefeuille movie

To learn more about Elodie’s condition, read “The Reality Behind Millefeuille.”

Over 100 million people worldwide—including some 14 million Europeans—have psoriasis. Beyond skin effects, up to 30 percent of people living with psoriasis are likely to develop psoriatic arthritis, which can lead to painful swollen joints and a loss of physical functioning. The toll of the disease is often hidden from the public; patients like Élodie wear sleeves and hats to strategically cover their skin lesions and hide from friends and family when their psoriasis flares. Hard-to-manage symptoms like itching can often become hugely burdensome for some patients as we see in the film.

Millefeuille is an accurate portrayal of the experiences that commonly affect those living with psoriasis,” said Nikhil Yawalkar, a dermatologist at the University Hospital Bern in Switzerland who served as a consultant on the film. “Many people with psoriasis isolate themselves because of such a deep sense of shame, embarrassment and low self-esteem, and Élodie’s experience is reflective of this.”

Indeed, 88 percent of psoriasis patients said their condition affected their emotional well-being according to surveys conducted by the National Psoriasis Foundation between 2003 and 2011. Most psoriasis patients said they experienced anger, frustration and helplessness due to their disease.

Millefeuille movie

THROUGH HOLLY’S UNDERSTANDING AND ACCEPTANCE OF HER DISEASE, ELODIE REKINDLES HER PASSION FOR BAKING AND LIFE.

But the film also portrays the hope that remains for people living with psoriasis. When Élodie befriends Holly, an outgoing young neighbor, she finds understanding and acceptance and discovers that Holly is a ‘millefeuille’ herself—deep, sweet, with many layers. Holly helps Élodie rediscover her passion for baking and place in the world.

“We’re delighted to see a story that shows us the value of looking beyond the disease and seeing the person.”

 

“It’s fabulous to see psoriasis getting this type of creative exposure,” Christine Janus, CEO of the International Alliance of Dermatology Patient Organisations, said. “Most people love cinema and a good story, and we’re delighted to see a story that shows us the value of looking beyond the disease and seeing the person.”

World Cancer Day 2016 marks the launch of a three-year campaign dedicated to exploring how everyone can play a part in reducing the global burden of cancer. This “We can. I can.” campaign focuses on several messages, including “We can work together for increased impact.” Nowhere is this message truer than in the work being done in cancer clinical trials today.

Clinical trials have introduced new treatments that have improved the lives of millions. However, only 3 percent of cancer patients participate in clinical trials today, and dropout rates can be as high as 30 percent. To ensure that clinical trials remain as efficient, informative and effective as possible, patient advocates are becoming essential conduits to understanding and improving the patient experience.

“It’s important to have the patient voice and perspective throughout the process,” Joel Beetsch, vice president of patient advocacy at Celgene, said. “Over the past year, we’ve made a large effort to work with patient groups to find ways to improve the experience of clinical trials for patients and, as a result, make the process more effective.”

Over the past year, we’ve made a large effort to work with patient groups to find ways to improve the experience of clinical trials for patients and, as a result, make the process more effective.

Beetsch has been helping to identify best practices for engaging patient groups in trials through a public-private partnership called the Clinical Trials Transformation Initiative (CTTI). Recently, the CTTI recently published the results of a survey in the Public Library of Science One that found individuals from industry, academic institutions and patient groups view the barriers to and benefits of partnering with patient groups differently. After analyzing these perspectives, the CTTI has developed recommendations for a more holistic approach to engaging patient groups in clinical trials than traditional efforts.

“Historically, the industry has only looked to patient advocacy groups for help with trial recruitment,” Beetsch said, “But patient advocacy groups can provide a valuable perspective throughout the process.”

For instance, Beetsch helped spearhead a program in which patient advocacy groups reviewed Celgene’s informed consent forms, which explain the goals, potential benefits and possible risks of a trial to patients. The advocates pointed out that the forms didn’t explain how the study would fit into patients’ lives. When and where would the patient need to show up for appointments? How long would those appointments last? While it seems obvious in retrospect, explaining the nuts and bolts of committing to a trial upfront might reduce dropout rates.

Another major reason patients drop out of clinical trials is distress. Since 32 percent of cancer patients experience some form of emotional distress, this obstacle can be exceptionally challenging in cancer trials.

Cancer Moonshot 2020To help patients cope with the distress and stay in studies longer, the Cancer Support Community with support from Celgene’s Impact Innovation Award program is adapting its Cancer Support Source for use in clinical trials. The program will give clinical researchers a simple yet accurate 36-item distress-screening tool. Once distress is recognized, the system provides doctors and patients with resources and recommendations for addressing it.

These steps to improve the patient experience will be essential as we continue to explore the next-generation of combination immunotherapies through the Cancer Moonshot 2020 initiative—the ultimate in the “We can. I can.” attitude of working together to improve outcomes.

Under this initiative, an alliance of multiple stakeholders across the cancer care ecosystem has come together to enroll 20,000 cancer patients for clinical trials by 2020. Celgene is one of the companies supporting this initiative as it prepares to launch.

“We’re still in the very early stages of the Cancer Moonshot 2020, but Celgene is very much dedicated to working with patient advocates and other partners in this initiative,” said Beetsch. “We’re hoping it will really open the eyes of cancer patients to the patient-centric experience that today’s clinical trials offer.”

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Athletic, 6-foot-5-inches and in his 30s, Alex Clark is not the typical cancer patient. Clark is living with multiple myeloma and is eager to share his thoughts on how myeloma patients can spread awareness of this rare disease, the invisible mechanics of cancer culture and what is troublesome about the healthcare system today.

How long ago were you diagnosed with multiple myeloma? How has your life changed since then?

In late 2011, after ignoring symptoms of myeloma for about 10 months or so, I finally dragged myself into the emergency room. I was an overactive 26-year-old who thought that he was invincible. Some friends and I had climbed Mt. Baker in Washington about a month before I collapsed in the ER. When I got home from that trip, my body felt like it was crumbling to pieces. By the time I was finally diagnosed, I had lost 60 lbs, my heart rate was dangerously high, and my kidneys had failed. I avoided doctors almost to my death. But I’ve been lucky enough to come out on top. I’m the same person, I’ve just learned to slow down and be more present to what’s going on in my body. I place a higher value on subtle beauty.

Alex Clark

Multiple myeloma patient Alex Clark continues to enjoy camping and being outdoors despite living with a rare disease. Source: Alex Clark

Were you able to enjoy the outdoors again?

After treatment, I went into remission and the only thing that I wanted was to be outside, to be self-reliant. I road-tripped back to Oregon to reclaim my life and spent six weeks in the woods hiking, backpacking, camping, climbing peaks and talking to nature. That was the best medicine for me. Treatment keeps me living, but nature gives me life. Your perspective changes monumentally when you become a patient. You end up more self-focused and inward looking. The wild always reminds me of my insignificance. It provides an important perspective about how fragile our lives really are.

Do you think the people around you understand what you are going through?

Not really. I don’t think many people actually know what myeloma is. When I tell them I’m going to the Mayo Clinic for myeloma treatment, I usually just whittle my story down to “I have cancer.” The conversation can get longer and be more melancholy than most people can handle. The specifics of myeloma get cumbersome. Even I don’t fully understand what’s happening to me. Luckily, I have some amazing doctors on my team who understand this disease better than anyone ever has in the history of medicine.

Cancer is scary. Most people want to plug their ears and pretend it’s not there. So I’m trying to use my voice to call attention to it.

Do you think the patient voice is important in the fight against myeloma?

Cancer is scary, and most people want to plug their ears and pretend it’s not there. So yes, I feel like it’s important to use my voice to simultaneously spread a both a sense of urgency and a feeling of calm. We’re dealing with this. The more we talk about it, the quicker we can find solutions. Patients are so much more than numbers on a spreadsheet, but if you don’t speak up it’s easy to become a statistic.

Were there people who helped you in your fight with myeloma?

People like to tell me I’m so brave for fighting cancer. But to be honest, I don’t feel like I’ve done a single thing. I lie in bed and take medicine. The doctors and nurses who see the human effects of this disease on a daily basis, they’re brave beyond comprehension. I sometimes imagine myself lying in a hospital bed and my disease as this specter coming to attack me. But it slams into my army of nurses and doctors. Cancer has introduced me to some of the world’s most caring, brilliant, beautiful souls. I owe them my life.

Does every myeloma patient you know have access to great doctors like you?

I doubt it. I’m incredibly lucky. It blows me away that, as a society, we can still deny a person access to the system because of financial or logistic obstacles. If we truly have the best healthcare system in the world, why do we allow people to just disappear rather than treating them as a valuable resource? With every new case we learn more about myeloma and yet people still treat proper healthcare like a privilege reserved for those who deserve it. Healthcare is a human right. We all deserve it. The way people still debate this is insane.

Alex Clark on mountain

While climbing a mountain in 2011, Alex Clark experienced pains across his body that he now recognizes as the first symptoms of multiple myeloma. Source: Alex Clark

Are you optimistic about your future?

Of course! When I was first diagnosed in 2011 there were only a handful of treatments. But each year, I’ve seen more myeloma treatments being investigated and made available. And that gets me excited about the future. I don’t panic. I live my life and take solace in the fact that cancer is not a death sentence. In a lot of ways, for me, it was a blessing in disguise.

Download the Celgene Story

The Company’s commitment to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first.

From helping people obtain their medications to using cutting-edge scientific technology to discover new treatments, Celgene’s entrepreneurial spirit, teamwork-oriented culture and commitment to rare diseases create a unique platform for transforming patient outcomes. At every level, it is growing and evolving.

Passion, innovation and courage have been in the company’s genes since its founding. “Our journey to a successful company included unexpected road blocks, the courage of our people to convert those road blocks into opportunities and seize them, the vision to not only overcome obstacles but to transform them into novel approaches and progress,” former Chairman & CEO Sol J. Barer, PhD said. On those principles, Celgene has become a leader in delivering medicine to patients with unmet needs, by digging deeper to resolve unanswered scientific questions and working tirelessly to improve the lives of patients worldwide.

 

Whether it’s working to deliver innovative therapies to emerging markets that lack proper infrastructure or doggedly pursuing regulatory approvals to bring new options to treat rare diseases, Celgene employees are committed to putting patients first

 

 

Celgene is committed to conducting business based on integrity, ethics, sound decision making, respect for the environment and behaviours that reflect its corporate culture. They have expanded efforts with the aim of continuous improvement of environmental, social and economic performance. These efforts include new methods for patient support and advocacy, personnel interactions with corporate leadership and support for new programs in local communities.

The story of Celgene encompasses unexpected opportunities, the courage to seize those opportunities, and the vision to transform those opportunities into progress. Ultimately, Celgene hopes to turn some of the most formidable disease challenges of the 21st century into manageable conditions.