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Never Heard of Intracellular Calcium Regulation?
Eagle Pharmaceuticals Thinks It Could Be Key to Some of the Most Pressing Medical Challenges of Our Time
David Pernock
President & COO
Eagle Pharmaceuticals, Inc.
(EGRX-(NASDAQ)
https://www.eagleus.com/
In-Site Communications, Inc.
Lisa M. Wilson (Investor Relations)
lwilson@insitecony.com
Interview conducted by:
CEOCFO Magazine
Published – June 8, 2020
CEOCFO: Mr. Pernock, what is the overall vision for Eagle Pharmaceuticals, Inc.?
Mr. Pernock: We want to help medicines do more for patients and we focus on two key areas: oncology and acute critical care. Our goal is to work with products to potentially give them an efficacy advantage, a safety advantage or a convenience advantage from which the healthcare provider can benefit.
CEOCFO: What do you look for in a product that you consider for Eagle?
Mr. Pernock: We look for products that our technical teams feel they can work with to enhance. For example, in one of our products we were able to reformulate it in such a way that, instead of using 12 to 13 vials of a competitive product, we did it with just one vial of our product. We also look for products where we can work with the chemicals to make it easier to administer. Oftentimes by doing that, we also find new uses for the product that may help serve unmet patient needs.
CEOCFO: Is it easier to work with the FDA on a product that is already in use when you are modifying, as compared to something brand new?
Mr. Pernock: Sometimes the steps we have to go through with the FDA on a repurposed drug are very similar to what you have to do with a new chemical entity. We still have to do the adequate control trials. We still have to do a lot of CMC (chemistry, manufacturing and control) work. The regulatory steps are very similar. But, in one way, it is easier because the safety and efficacy of the product are already established. Therefore, the body of work is not quite the same as with a new chemical entity, but many of the steps mirror each other.
CEOCFO: What are you working on now at Eagle?
Mr. Pernock: Right now, we are very focused on one of our products, RYANODEX® (dantrolene sodium), which is currently approved for the treatment of malignant hyperthermia. We have several really exciting projects in progress. Most recently, we announced positive laboratory test results in vitro with RYANODEX, related to COVID-19. We found in our studies that we were able to stop viral progression, which is very important. We are very excited about this opportunity, because there is a huge need with COVID-19 and we think the unique mode of action for RYANODEX could potentially make a big difference to patients. This is a top priority for us.
Also related to RYANODEX, we have a PDUFA (Prescription Drug User Fee Act) date of July 8, 2020, for an exciting opportunity related to exertional heat stroke (EHS). We are hopeful that this will be a positive outcome for us and RYANODEX will receive FDA approval for EHS.
Other developments related to RYANODEX include a recent announcement about our relationship with the University of Pennsylvania to continue the research we started with them in Alzheimer's disease. Eagle is also working with NorthShore University in Chicago to study the effects of RYANODEX on traumatic brain injury (TBI). In conjunction with the U.S. military, we have also done some work to explore the use of RYANODEX as an anti-nerve agent and in acute radiation syndrome. What makes all this possible is that RYANODEX has a positive impact on calcium regulation in cells. As you can see, we have many different, interesting first-in-class or best-in-class opportunities we are attributing to the unique characteristics of RYANODEX. We are very hopeful that it will be able to help patients across many different disease states and conditions.
CEOCFO: What does RYANODEX do? How does it react in the body? Is it unusual to have such a wide range of possibilities for one particular pharmaceutical?
Mr. Pernock: Very good question. In many of these conditions and injuries I just spoke about — whether it was due to exposure to a volatile gas in the case of someone under anesthesia in the operating room who develops malignant hyperthermia, or potentially someone who suffers from EHS, which is due to exercise and exposure to a hot environment, or due to a nerve agent attack, or potentially due to the COVID-19 virus, as examples — the root cause of all this is intracellular calcium dysregulation. Intracellular calcium dysregulation can lead to cell death and can have a very negative health impact on the cells in the body, including the brain and other major organs.
What we believe RYANODEX does is helps return the calcium levels in the cell to homeostasis, which means a more normal level. What we are seeing in many of the different studies we are doing is the preservation of neuron function, which is very important. In the case of COVID-19, for example, we saw that we essentially stopped the progression of the virus in a lab test. We are looking at all of these different disease states because we think, fundamentally, calcium dysregulation plays a role in each and every one of them. Therefore, yes, it is unusual to have so many different potential uses for one product, but restoring calcium balance within cells is a really interesting approach that has widespread effects, and we are very excited to advance all of these indications. We think we can make a big difference for patients.
CEOCFO: When did you realize that it might be an appropriate or a good possibility for COVID? There are so many different approaches and so many different people jumping into COVID; how do you get the attention, whether from the medical, scientific or even investment community?
Mr. Pernock: Essentially, we have been in training, learning for years the role calcium plays in cells in the body. We knew, from published literature, that calcium seemed to play a role in the progression of viral replication. Put very simply, viruses need calcium to grow and sustain themselves, and when they are strong and growing they are replicating very quickly. The hypothesis was that if we did an in vitro test, we might be able to show we could actually stop the progression of the virus by maintaining normal calcium levels in the cells, so we did a very well-controlled study at a lab and we were very pleased with the results. We shared those results with some leading virologists and other outside experts, and everyone was equally impressed with what they saw in a test tube. Now the big question is, can we duplicate that in humans?
Luckily, the FDA has set up a task force to enable products that treat COVID-19 to get through the system a little more quickly, the Coronavirus Treatment Acceleration Program (CTAP). In parallel with that, we have been working with Hackensack University Medical Center to be prepared to implement that study as soon as we get the green light. There are many moving parts, but we are getting great cooperation. With the tragedy, size and scope of COVID-19, it is really encouraging to see everyone in the industry jumping in to help. There are a lot of companies working on vaccines, while there are others working on diagnostic testing or other potential treatments. There will not be one single answer to the COVID-19 crisis, because it's very complicated. What makes Eagle different in our approach is our concept of stopping viral replication by restoring calcium balance in cells. We think this may be part of the answer.
CEOCFO: Why injectable treatments? Why that direction, in general?
Mr. Pernock: We have a lot of technical expertise in sterile injectable products, oriented mostly toward hospital use. It gives us a unique niche in the marketplace that other companies either do not have the technical capabilities to do, or they view it as too difficult to do. We like to think of ourselves as being very good problem-solvers who do not give up easily; we like to take on difficult assignments. This gives us an advantage in the marketplace and leverages the full tactical capabilities within our company.
CEOCFO: Do you have products on the market today? What is your business model?
Mr. Pernock: In the oncology marketplace we have a very successful brand, BENDEKA® (bendamustine HCl) injection. It is a widely used cancer product. Before our product came to the marketplace, bendamustine had to be infused either for 30 or 60 minutes, but our product, BENDEKA, can be infused over just 10 minutes — so it is a much shorter infusion time. This makes it easier for the caregiver and for the patient receiving the product. We have a partnership with another company, and they converted well over 90 percent of the market they had with their product to our brand, BENDEKA. It was a very successful business model for us and one of which we are very proud because of the positive impact it has on patients.
Also in the world of oncology, we have tentative approval for a branded pemetrexed generic product called PEMFEXY™. We recently announced an agreement with Eli Lilly and Company to enter the marketplace in February of 2022 ahead of other generic competition. It is a very exciting opportunity for us, and in that particular situation, we have a ready-to-use product. Again, it is much easier for the healthcare professional to administer the treatment, so we expect it to be a successful product for us. We also have a fulvestrant product in our development pipeline called EA-114, which will be an alternative to AstraZeneca's product. It is widely used in the treatment of breast cancer. As you know, breast cancer is all too common, and in this particular case, EA-114 is for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer patients. Our belief, which is backed by scientific literature, is that the more you can block the estrogen receptor sites, the better chance you have of halting the progression of the disease. This is the main goal when treating breast cancer patients. We have been working very diligently over the past couple of years to develop a proprietary, novel formulation. We are getting very close to where we think we need to be, and we look forward to working with the FDA on that initiative.
We also have a very interesting partnership with a company called Tyme Technologies, Inc., which has a product for pancreatic cancer in late-stage clinical trials. We hope that this product is successful because we know that pancreatic cancer is a very difficult cancer to treat. We clearly need better options out there and we hope that this product will be that. If we are successful, we will have commercialization rights to this product, as well. In short, you can see on the oncology side of the business, if our pipeline is successful, it would consist of four major brands in the marketplace that represent challenging areas to treat (lung cancer, breast cancer and pancreatic cancer), and we are very proud of our efforts.
Then, on the acute care side of the business, RYANODEX is our key brand. We are currently approved for the treatment of malignant hyperthermia, which is a rare condition that can occur in operating rooms when a patient is exposed to the volatile gas of anesthesia, and due to genetic reasons, they may have a very negative reaction to the volatile gas where their body temperature rises rapidly, among other symptoms. This can happen with certain other medications as well. RYANODEX is very effective at reversing the impact of malignant hyperthermia, which can be life-threatening. This is why we are looking at the unique mechanism action of RYANODEX to develop other indications. In summary, we have a very wide and very rich pipeline of products, and some currently marketed products as well.
CEOCFO: What is the key to handling a large volume of partnerships, a large volume of trials or products, and what do you look for in a company when you partner with them?
Mr. Pernock: You create successful partnerships when you have a shared vision and value system with your partners. If all people involved really are patient-centric, then the rest flows from there. I focus on what is most important. We are very good at project management and process thinking. We clearly lay out the steps of what needs to be done by each partner and we have effective follow-up and excellent communication. We are in constant dialog with our key colleagues. They understand our priorities, and we understand theirs. We work toward solving problems together.
We look for partners with specialized expertise or experience that we may not have and for people who value the same concept of patient- and customer-centricity that we do. The rest is just good management, focusing on what is important and urgent and then developing a list together, deciding responsibilities and following up on it. So far, it is working very well. We have great partnerships with other companies, including our contract manufacturers and outside laboratories. We are very blessed that way.
CEOCFO: How have you adapted to the restrictions surrounding the COVID environment today?
Mr. Pernock: Adaptability during a time of change is critical, and now is an excellent example of how this comes to life. All of our employees are working from home. It is very important, when people are working from home, that you keep in constant contact because they enjoy having interaction with one another. We have weekly virtual town halls, for example, to keep employee engagement high and we often feature guest motivational speakers. We just had one yesterday, as a matter of fact, where we had a breast cancer survivor addressing our group. We also maintain frequent communication with our employees. We ask for suggestions and tips from them and we answer all of their questions. We are very open and transparent with our colleagues in many ways.
We do the same thing with all of our major partners, suppliers and so on. That is because it is important for people to know that we are focused on the positive things we can do and we may have products that can help patients with various hard-to-treat ailments (COVID-19, breast cancer, pancreatic cancer, etc.). We each have an important job to do, so helping our employees focus on the importance of their work, even as they are doing it from home, I think is critical. It is leadership that is partially communication, partially logistics and clear direction, and most important, connecting with people on an emotional level. At the end of the day, that is why we are in this business. We are driven by the idea of thinking that our work will help someone out there. It is an inspiring time for the company.
CEOCFO: Why pay attention to Eagle Pharmaceuticals right now?
Mr. Pernock: Why pay attention to Eagle Pharmaceuticals? We are planning on completing five product launches in the next three years, all first-in-class, best-in-class or first-to-market opportunities. That is a pretty profound statement. For the investment community, that is why they should be interested in following us. Other people should be interested in following us because when you have first-in-class, best-in-class opportunities, it means that we will be able to help patients who otherwise might not have a promising treatment option. We are very motivated by this.
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"Why pay attention to Eagle Pharmaceuticals? We are planning on completing five product launches in the next three years, all first-in-class, best-in-class or first-to-market opportunities. That is a pretty profound statement."
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