At Novartis, fighting COVID-19 on two fronts

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Thomas Kendris wears several different hats at pharmaceutical giant Novartis. He’s the president of East Hanover-based Novartis Corp., and as such is the U.S. country head. Kendris also chairs the company’s country leadership team, which consists of all the country and business heads. And he is the global head of litigation, a role he retained after past stints as general counsel of several Novartis units, including its vaccines business during the H1N1 epidemic.

NJBIZ talked to Kendris about what it’s like to lead a company that is not only dealing with the disruption caused by the COVID-19 pandemic, but is also racing to find a way to end, or at least ease, the physical and economic pain. Toward that end, the company created a $20 million global fund to support communities affected by the pandemic. In this country, the Novartis U.S. Foundation established a $5 million Community Response Fund, for immediate response and recovery efforts related to the outbreak.

In addition, the company donated 130 million doses of hydroxychloroquine, of which it is a major supplier, to a variety of institutions. Kendris discussed that and other aspects of the Novartis response in the interview, which has been edited for length and clarity.

NJBIZ: The HCQ donation, is that for research, or is that designed to be a treatment for the pandemic?

Thomas Kendris: It’s for both. In the U.S., we had 30 million doses on hand, and we agreed to give that to HHS [U.S. Department of Health and Human Services]. FEMA [Federal Emergency Management Agency] has it now, and they’re distributing it where it can be used pursuant to the FDA [U.S. Food and Drug Administration] authorization. They took over the distribution of those 30 million doses in the U.S., which we gave them right away, several weeks ago. But we’ve also committed to giving them more as we manufacture it going forward.

NJBIZ: And can you add anything to the discussion that’s now taking place about the efficacy of hydroxychloroquine in fighting COVID-19? What’s your view of how useful it is?

TK: Well, first let me mention [that] we are working really well with HHS, and FEMA, and we’ve given them the 30 million [doses] and we’ve agreed to give them more in May and July as we manufacture more. But we’ve also tried to make some available to other countries that need it, and we certainly have enough for all of the clinical trials that are going on around the world. There are lots of them. So, we’ve got a global task force that is making sure that we can get hydroxychloroquine to any group that’s conducting a clinical trial.

Look, it’s indicated for anti-malaria, lupus and rheumatoid arthritis, so it’s been on the market for a long time. It’s a well-known compound. The reports about its efficacy in COVID-19 are early. There’s limited data, open to interpretation. But that’s why we need to study it, and that’s why we’ve made sure that not only are we giving to the governments so that they can give it to doctors who need to prescribe it to patients, but we’re also making it available to these clinical studies because it’s important that we generate high-quality data in this new disease.

There’s preliminary evidence. There was a small study in China; there was a very encouraging French study. And it does have strong anti-viral properties in the lab. But we need the clinical studies of patients to best inform doctors how to use HCQ.

It is frustrating to have to wait for the results of the larger studies. But it’s really important to get this high-quality data back so we know how it can be used, where it’s most efficacious, where it can be safely used. And by where, I mean in what patients.

NJBIZ: Right.

TK: It may be riskier in some patients than in others. And a large, well-powered clinical trial will elucidate all of that—make it safer to use and more efficacious in the people it may help.

NJBIZ: I assume you’re working on other things as well. Could you talk about what you’re doing along those lines—is there anything you can tell me about the kind of research you’re doing and its status?

TK: That’s a really good question—on point. Because HCQ has gotten a lot of publicity, but there are a lot of other key research initiatives that we’re involved in.

We’ve joined two cross-industry initiatives: the COVID-19 Therapeutics Accelerator, backed by the Bill & Melinda Gates Foundation, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative. We’re engaged with both of them in research, but we’re also doing our own studies of two compounds.

One is Jakavi. We have a partner there–Incyte. This is a drug that is used in cancer. And we’ve announced plans with Incyte to initiate a Phase 3 trial to evaluate Jakavi in patients who are experiencing the cytokine storm that is associated with patients with COVID-19. Jakavi is very well established as what is known as a “JAK-inhibitor.” It’s been shown to reduce the levels of inflammatory cytokines in patients who have what that drug is indicated for, which is myelofibrosis. But in COVID-19 patients, Jakavi may be able to mitigate the effects of a type of severe reaction, the cytokine storm, that can result from the coronavirus infections—that contributes to the respiratory compromise that leads patients to really bad outcomes.

We think the Jakavi clinical trial is just as important as the HCQ clinical trials.

And then, in a similar theory, we have a compound called Ilaris, and we are planning to study that in trials for similar activity against COVID-19. It also is an anti-inflammatory, not in cancer, but it would also be directed at that cytokine storm.

So, we think that between Ilaris and Jakavi and HCQ, we have three candidate treatments.

And then these research initiatives with the Gates Foundation and with the Innovative Medicines Initiative, are also important.

Those are the main research initiatives that we’ve begun. HCQ, Ilaris and Jakavi, in terms of products –three things – already approved drugs that are now being tested for use in COVID-19.

We have our research hub in Cambridge, Mass. They’re primarily working with the Gates Foundation and IMI on these cross-industry research initiatives, where they’re basically hunting for other compounds that might be useful in COVID-19.

NJBIZ: Sounds like a lot. When we talk to economists, people who are thinking about the economy and opening it back up again, what we hear all the time – and I know you hear it too – is that we can’t really get back to a full recovery unless there are treatments and vaccines available. I’m curious how confident or optimistic you are that that’s something we could see in a year? Eighteen months? Is that really what it’s going to take?

TK: I can tell you that I was in our vaccines company with Vas Narasimhan, our CEO, and with Eric Althoff, who was on the phone with us. We acquired Chiron in 2005, and it had, among other things, a vaccines business. So, we had our vaccines business during the H1N1 pandemic. We developed a vaccine for that.

We have since spun off our vaccines business, so we are not doing the vaccines research.

I am confident that the industry is going to find a vaccine for the COVID-19 virus. As you pointed out, the only question is how long it is going to take. And I think 18 months, in my view, is the outlier—it’s a long period. And that time period has already started. They’ve been trying, they’ve been at this, for a few months now.

It’s hard to say, but I would say that a year from now, less than 18 months from now, we should have a vaccine. But this is a little different—my experience, and I was global general counsel of our vaccines business, so I wasn’t as involved in other activities at that time, as Vas was, who at that time was involved in both our commercial business and our clinical research. But I don’t recall there being as much research on treatments outside of vaccines during H1N1.

NJBIZ: In general, is there anything else that Novartis is doing that folks should know about?

TK: Our Sandoz division – our generics company – which made the donation of HCQ, was actually the first company to commit to keeping a stable set of prices for the basket of essential medicines that might help in the treatment of COVID-19. It’s a broad group of medicines that are used in the ICU.

And we’ve also made donations in the Novartis U.S. Foundation—we’ve supported the Commons Project, which is actually an app. It’s called COVIDcheck, which is a free public digital health service. It’s under development with global, national, state and local public health authorities.

We’ve also made grants already to Americares and Direct Relief. They’re both organizations in the U.S., safety net clinics to help patients and hospitals.

And we’ve made donations to hospitals in the state of New Jersey. We supplied the state of New Jersey PPEs—a thousand masks, 10,000 pairs of gloves, 10,000 caps, 1,200 gowns and coveralls. Our PPE is supplied by donations to New Jersey and to other states where requests have been made. So, for example, requests for ventilators from New York City, and we gave two ventilators to Cornell Medical Center.

The other thing that I wanted to get across—our response as a company. We’re really focused on protecting our people. And we’re focused on getting our medicines to patients.

Our manufacturing folks have really been incredible in keeping our sites open. For example, right around the corner here, in Morris Plains, we continue to make Kymriah, a cancer drug for acute lymphoblastic leukemia. These folks are continuing to come in. They’re viewed as essential workers by Gov. Murphy, and they’re really committed to making Kymriah for patients, usually, in that case, children. And it’s a unique drug—it’s made patient by patient, it’s not an assembly line of pills. The patient’s blood is taken, it’s sent to Morris Plains, they work on it, the immune system is triggered to fight the cancer, and it’s reinfused back into the patient. It takes about 23 days for this process to happen. And it’s very efficacious. And we’ve kept that operation going.

And we’ve kept other operations going. Our supply chain; our clinical trials, largely we’ve been able to keep going, and manufacturing in other places. HCQ, for example, is manufactured in Wilson, N.C., and they’re going to be making more of it in May and in July.

While we’re focused on the pandemic, and protecting our people and getting medicine to patients, we’re also starting to think about the process of getting back to work. We want to do it carefully, thoughtfully, and safely. We really appreciate the opportunity of working with Gov. Murphy and the governors of the other states – Massachusetts, New York – we have employees in all those states.

NJBIZ: And how are you doing? Are you going to the office every day? Working remotely? How has the disruption changed your day-to-day activities?

TK: Early on, weeks ago, we wrestled with the question, like every company did, about whether to close sites, to work from home, how to continue to keep our products, our medicines available to patients. Around March 13 we requested our associates to work from home, except for those who couldn’t do their jobs at home, so essentially researchers who had to be in the lab to do their work, or people at manufacturing sites.

We’ve done everything we can to help the people who work from home, and I have been working from home. … We’ve all gotten better at using a variety of virtual tools, to have phone conferences.

And we are all doing as much as we can for our associates. For example, we have a lot of associates who have children who are not in school now, and we’ve been making some resources available to them. For example, Coursera – it’s a way to access almost 4,000 courses from universities and industries in multiple languages. And we’re also making courses available from the Khan Academy. We can provide this to our people so that their children can continue to study and work from home and our associates can work from home with them.

We have also made childcare assistance available in the form of access to special childcare facilities or reimbursement for personal childcare arrangements.

And we’ve done some other things in regard to our Energize for Life initiative, which includes a lot of programs to improve employees’ health and wellbeing. For example, we’ve made an app available to them called Tignum X. Tignum is a company that specializes in nutrition, movement, mindset and recoveries. And we’ve been working with Tignum for a long time. …

We’ve kept working with them. And it’s an even more important relationship now … as you’ve pointed out, during this period when we have to get used to working at home and you have to put in different personal strategies for being able to do that. Taking breaks, going for walks, not sitting in one place for 12 hours as I did for the first 10 days [of the quarantine]. And the Tignum relationship helps our folks to be able to work together and collaborate together in new ways.

I don’t know whether, going into this, I would have thought that our systems would have been able to hold up with everybody working from home, but in an amazing way, they have. We have been doing an awful lot of virtual meetings with our IT systems that I might not have thought were possible three or four months ago.

We’ve been quite successful—I think we have over 80,000 associates logging on successfully from their homes in order to do their job every day. And the system has not failed.

NJBIZ: So, the business is doing well now, you haven’t had to do any cost reductions or layoffs?

TK: No, we have not. We’re making our medicines available, it’s working out.

We’re focused on protecting those people who are going into an office or to a manufacturing site. They’re practicing social distancing, wear masks, and we are continuing to make that protection better and better as we learn more about this. But we’re still having those folks go in and they are getting those medicines ready.

I have to say, it’s been amazing. I think our people have really stepped up.