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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
President & COO
Eagle Pharmaceuticals, Inc.
Lisa M. Wilson (Investor Relations)
Interview conducted by:
Lynn Fosse, Senior Editor
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-
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-
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-
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-
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-
Luckily, the FDA has set up a task force to enable products that treat COVID-
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-
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-
We also have a very interesting partnership with a company called Tyme Technologies, Inc., which has a product for pancreatic cancer in late-
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-
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-
We look for partners with specialized expertise or experience that we may not have and for people who value the same concept of patient-
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-
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-
Eagle Pharmaceuticals, Inc., Intracellular Calcium Regulation, Injectable Cancer Treatment, David Pernock, EGRX-
“Why pay attention to Eagle Pharmaceuticals? We are planning on completing five product launches in the next three years, all first-