In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース
By Lucie Ellis 06 Aug 2020
A selection of articles you might have missed from July 2020, including exclusive interviews with industry leaders and a review...
Bayer’s ambitious campaign to reposition itself as a global leader in two complementary fields – health and nutrition – will face its toughest test in the US, with its highly litigious approach to product liability and a tendency to target pharmaceuticals as the source of the health system’s affordability and access problems.
SEBASTIAN GUTH, BAYER PHARMACEUTICALS' PRESIDENT FOR THE AMERICAS
Leading the charge with a simple mantra “we do science well” is Bayer Pharmaceuticals’ president for the Americas, Sebastian Guth, a 45-year-old management PhD who took the position just a year ago after serving as the pharma unit’s global head of marketing. In the following conversation with In Vivo, Guth outlined his plans to execute two big product launches and multiple deals and new investments – all buttressed by a culture reset designed to open the organization to a new world of digital technology opportunities.
The US remains ground zero for the company in its bid to become a competitive leader in the crowded cancer space. Vitrakvi, a collaboration product with biotech start-up Loxo Oncology, is positioned for possible use against the NTRK-fusion mutation on more than two dozen different tumor sites.
Bayer AG’s biggest – and perhaps riskiest – bet is its determination to do what it takes to win in the crowded, high-cost field of cardiovascular drug development, where it is winding up a 13,000-patient clinical program on new treatments to address CVD complications associated with diabetes and chronic kidney disease. In the US, these co-morbidities are a key driver of mounting hospitalization and readmission costs, for which patients have few options.
(Q) In Vivo: Its’s been a little more than a year since you assumed the position as president of Bayer Pharmaceuticals for the Americas region - the US, Canada and Latin America. What have you accomplished so far in putting your imprint on the business?
(A) Sebastian Guth: My major focus has been on the US, globally Bayer’s most important single market. I took the time to consult widely – listening and learning. I spent the bulk of my time out in the field with my new colleagues meeting with physicians, patients, representatives of other institutions in the health sector, and our legislators in Washington. These wide-ranging discussions helped to narrow my priorities to three:
> accelerating our growth momentum, building on the significant product launches Bayer has executed over the past 12 months, including Vitrakvi (larotrectinib), a novel drug for a wide range of cancers with specific genetic features, and Nubeqa (darolutamide), for non-metastatic, castration-resistant prostate cancer;
> expanding our pipeline portfolio, evidenced by the decision to acquire the remaining stake in BlueRock Therapeutics, which is doing important work in engineered cell therapy for neurologic, cardiovascular and immunologic applications; and
> strengthening Bayer’s workplace culture to expand and diversify our talent base and promote productive relationships across the organization.
During the transition, I benefited from my role as a member of Bayer’s global Pharmaceutical Executive Committee. It is standard practice that the lead of the largest single market in the company has a seat on this committee. I find it invaluable as an opportunity to keep the rest of the global management team up to speed on the complexities of operating as an established local player in the US.
(Q) During your on-boarding exercise, were there areas that you felt required a reset or change in direction?
(A) I did not see the need for any radical transformation of the US business. Our focus remains one of becoming a competitive leader in oncology, a strategy we are implementing worldwide. In the US, I think we are at a critical juncture in achieving this goal, with two product launches in the past year and several other promising oncologic drugs in late-stage development.
We are also strongly committed to expand Bayer’s presence in the cardiovascular/cardiology segment, beyond our current, relatively narrow profile in pulmonary arterial hypertension. We are hopeful about a prospective US launch of finerenone, now in the largest global Phase III clinical program for patients living with chronic kidney disease who have type 2 diabetes, a major area of unmet medical need. Like oncology, we see cardio and its many co-morbidities as a world-class business for us, on a par with Bayer’s established therapeutic franchises like women’s health.
(Q) The women’s health segment poses substantial safety/efficacy and reputational challenges, particularly in the fertility and hormone space. Is Bayer still rigorously committed to this market as a revenue driver?
(A) Women’s health is not an adjacency for us; it remains one of Bayer’s key global growth businesses and a source of opportunities going forward. We launched a US advocacy campaign this year with the US actor and singer Lucy Hale on the choices she has made on contraception and why education about those choices is critical to female empowerment.
(Q) It is also true that several big pharma companies have abandoned cardiovascular therapy, seeing it as a crowded chronic disease segment prone to genericization, compounded by the high cost of large population-based clinical trials. What is the rationale for Bayer’s commitment here?
(A) As an industry, along with society in general, we have developed a blasé attitude toward cardiovascular disease (CVD). It belies the fact that the burden of cardiovascular disease is quite high and is destined to grow even more prominent as the US population ages. Specifically, we have our eye on sub-types of CVD like cardio-renal dysfunction, where many patients have limited effective treatments. Yet the statistics show that more than 40% of all patients with type 2 diabetes will also develop chronic kidney disease, leading ultimately to heart failure and other cardiovascular illnesses. The US spends $115bn annually managing chronic kidney disease, so finding new treatments could have a major impact on costly hospitalizations and other acute care services. Bayer is spending heavily on two clinical trials, FIGARO-DKD and FIDELIO-DKD, to investigate new options for diabetic and kidney patients with complications attributable to CVD.
(Q) You spent six years as Bayer Pharmaceutical’s chief marketing officer, based in Berlin. Given that introducing a new medicine to the market is an increasingly fraught exercise for big pharma, what makes for a successful launch?
(A) There are three principal ingredients. The first is the quality of the science behind the product. The science must stand on its own. It’s a necessity to significantly impact either the length or quality of life in the target population – and preferably both. Second, you must have an impeccable access proposition, in which those measurable attributes of the product are secured at an appropriate cost to individual patients and society too. Third, and very important, is an ongoing commitment to life cycle management of the asset, particularly in investigating the utility of additional indications beyond the original approved label. Another element is the added value that comes from the partnerships Bayer has secured with other big pharma and biotech players. Some of our most successful franchises were introduced with partners like Johnson & Johnson and Regeneron, where we had a common interest in investing in some of the biggest new ideas in science. We have added to our store of human capital through the listening and learning we’ve done in our day-to-day interactions with these other companies, who often bring a fresh perspective to what we do. For us, it’s a core reason that these partnerships have been so successful.
(Q) What are the elements of a good partnership for Bayer?
(A) Every tie-up comes about for reasons that are unique; a rulebook approach is not useful now that the overall climate for drug development is so fast-paced and competitive. Bayer will collaborate with small companies as well as our peers. Loxo Oncology, a six-year-old biotech, is a good example. Vitrakvi, our first tumor agnostic precision cancer drug, is the result of that collaboration. And it is telling that we opted to collaborate rather than take the acquisition route. But experience told us that a well-structured collaboration deal brings flexibility and a big dose of creativity that can be shared by both parties, with additional value to patients and society. We’ve certainly had that with Loxo. The example shows that insisting on full 100% control through an M&A is not the only way to achieve our strategic and revenue growth objectives.
(Q) How dedicated is Bayer to creating links with academia?
(A) Bayer has made a substantial bet on partnerships with academic institutions, especially here in the US. We have an active incubator lab at the University of California San Francisco campus at Mission Bay, with 11 start-up companies on site. We have a similar incubator unit in Cambridge, MA, where we operate a research partnership with the Broad Institute and its sponsors, including Harvard and MIT as well five teaching hospitals. In addition, investment at our Berkeley, CA, operations and manufacturing facility has been bolstered with a new $150m stake in cell culture technology platforms. Bayer’s new global head of business development and licensing, Marianne De Backer, will also be based in the Bay Area, giving the state of California a pole position as the company adds more heft to its innovation ecosystem.
(Q) I’ve been asking your recent predecessors the same question – is Bayer Pharmaceuticals, a formidable global player itself, ready to crack the top 10 of biopharma companies active in the US market? Is there a plan to move beyond status as marketer of the oldest existing drug therapy – aspirin – and become a leading source of innovation for US patients?
(A) Within my geographic remit, Bayer ranks as one of the top foreign-based drug producers in Latin America, while in the US Bayer has never cracked the top 10, in terms of sales. The considerable investment we are taking to upgrade our franchise in CVD indicates our desire to scale US operations significantly above where they are today. We would not be doing this if our commitment was weak or tentative. Being aggressive about this doesn’t mean we are going to end up in the top five US producers overnight. Inventing and making drugs requires being in it for the long game. Nevertheless, I have no doubt that Bayer’s presence in the US will continue to grow. The innovations we are introducing are distinctive because they will help resolve some of the biggest challenges facing the US health care system, with its desperate need for lower costs, more productivity and increased access for patients, especially for those with the biggest health needs.
(Q) Bayer’s size and global reach are compounded by its stake in other fields outside prescription pharmaceuticals. Does the company’s significant position in seeds, crop science and agricultural chemicals require you to work harder to gain the attention of senior management in ensuring the lead times necessary for drug innovation long can proceed without distractions?
(A) Our lines of business are complementary, focused on two broad areas – health and nutrition – that are critical to the world’s future. I am excited about the opportunities our combination of businesses gives us to be creative in solving some big, impactful problems. Do I see any distractions? No – we share with our seed and crops business a desire to innovate even if doing so poses a risk of failure. The commitment to “do science well” unites us. Bayer Pharmaceuticals’ LEAPS program, where we invest in breakthrough technologies with an intent to eventually cure rather than just treat, exemplifies this approach: we’ve signed five deals and made five investments in the last 12 months alone. That’s not evidence of a company that is drifting without a compass.
(Q) What do you think about Bayer’s reputation in the US?
(A) I know what I want that reputation to be. First, to be regarded for the quality of our science. And second, for being very transparent about our desire to apply that science to impact society, in a positive way. The third is to be viewed as a company with its eye on the future.
(Q) Is influencing the US policy environment a reputational priority for Bayer?
(A) We strongly support industry-wide efforts to advance the policy debate to build support for innovation in a market that in many ways determines the global future for our business. The innovations we create have a significant impact on society, so I think we have a duty to get out and help shape the debate. I have accepted a position on the board of the Biotechnology Innovation Organization (BIO) for precisely this purpose – it’s a role I take seriously. One concern I have is this debate must extend beyond our industry to include the rest of the health care sector. Simply put, health care costs are much more than the cost of a drug, which accounts for a little more than 10% on the dollar.
However, there is one area where we have a vulnerability – it’s the challenge of patient co-pays and co-insurance contributions that increasingly are forcing patients to abandon filling their prescriptions or to under-medicate during the course of treatment. The issue is too complex for us to solve it ourselves, so I think we have to work harder to address this with stakeholders across the industry.
(Q) Can you indicate what you see as the most exciting products in the current Bayer pipeline?
(A) Our pipeline is very deep, with about 50 compounds in various stages of development. As a prelude, the August launch of Nubeqa for prostate cancer has been well-received in the clinical community. We also feel confident about prospects for finerenone, which if approved will offer new hope for patients with chronic kidney disease (CKD). CKD is a looming public health threat and a key area of unmet medical need, as evidenced by the Executive Order on “Advancing American Kidney Health” signed by President Donald Trump on 10 July 2019. Assuming finerenone is approved, we intend to focus on the community of patients with type 2 diabetes and CKD. It’s a sizeable and diverse group, as an estimated 40% of all type 2 diabetics end up with some form of CKD. And the cost of treating this co-morbidity is staggering, accounting for a large segment of hospital readmissions – itself a metric of pervasive system-wide inefficiencies.
In addition, I take great pride in Bayer’s oncology pipeline. I have already mentioned Vitrakvi, one of the first in a wave of precision treatments that will change the way cancer is treated, bringing fresh hope to millions of patients with few options under the current drug armamentarium. I have a personal interest in advancing this transition. Two years ago, my father died after battling lung cancer, where, until the very end, he was treated the traditional way, focusing entirely on isolating the tumor at its site of origin. High-throughput, next-generation sequencing of his cancer etiology was introduced when it was too late to redirect his treatment to the underlying drivers of metastasis.
My father’s death convinced me it was time to change the way we look at cancer and treat it. Our launch of Vitrakvi in November 2018 gives Bayer a strong position in precision oncology, as it was the second FDA-approved drug (and the first in Europe with a tumor-agnostic label) to target the NTRK-fusion mutation that causes cancer cells to proliferate, using a common biomarker to identify different tumor types rather than just the tumor where the cancer originated. Building on this initial breakthrough, our researchers are looking at more than 24 different tumor sites where we’ve uncovered NTRK-fusion mutation as a key driver of disease. I am excited because of my genuine belief that the tumor-agnostic approach will help people like my father, now and in the future.
(Q) You’ve cited Bayer’s commitment to making big bets in science, where the risks are high and the payoff, assuming success, is long-term. How does that strategy look to you right now?
(A) This is the bookend to the pipeline – our LEAPS by Bayer initiative where we are investing in start-up companies that promise solutions to some of the most vexing challenges in medicine. The focus is on cell and gene therapies designed to deliver cures rather than incremental gains in treatment. With health care investment firms, such as Versant Ventures, we have founded and financed three new biopharma companies: Casebia Therapeutics, which is applying CRISPR/Cas technology to seek cures for severe genetic disorders; BlueRock Therapeutics, using stem cells to achieve cures for CNS and cardiovascular genetic dispositions; and most recently Century Therapeutics, a start-up developing allogeneic or off-the-shelf immune cell therapies for cancer.
In August, we agreed to take full ownership of BlueRock to help advance its development program on cell-based drugs to alleviate functional decline from Parkinson’s disease. In July, Bayer and Versant announced plans to join with Fujifilm Cellular Dynamics Inc. in a $250m stake in Century Therapeutics, a Philadelphia-based start-up specializing in creating allogeneic, off-the-shelf pluripotent stem cell lines against a range of incurable cancers, including hematologic and solid tumors. Century is an excellent complement to the work that BlueRock is doing with cell therapy, aiming to cure disorders in the CVD and CNS space. Each of these investments puts Bayer in the front line toward an eventual cure for these high-profile and challenging diseases. Century also gives us a presence in Philadelphia’s ecosystem of basic research -- companies like Spark Therapeutics Inc. also got their start in “Cellicon Valley.”
(Q) Summing up, how do you intend to measure yourself and the performance of Bayer US as we move into the first years of a new decade?
(A) First up is accelerating growth by building Bayer’s US pharmaceutical business to a greater scale. Our oncology franchise is critical to achieving this objective along with the expansion of the cardiovascular segment into new areas of unmet medical need. We also intend to preserve our world-leading presence in women’s health care and in radiology as well as pursuing some great niche franchise opportunities in hemophilia and multiple sclerosis. Second is expanding our pipeline through external collaborations with innovative centers of excellence – especially in academia and small biotech. As Bayer’s top pharmaceutical business representative in the US, I intend to keep reaching out to all the great science happening throughout the country, promoting Bayer’s reputation as a partner of choice.
Finally, I intend to keep working on creating a culture at Bayer US that encourages colleagues to do their best, and to feel proud to be part of what we are doing to fight disease and contribute to the innovative potential of medical science—in this country and throughout the world.
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