Dr. Shankar Musunuri, Ph.D., MBA, is Chairman of the Board, CEO and Co-founder of Ocugen, Inc., discusses the Company’s lead clinical candidate (OCU300) that is currently in Phase 3 for patients with ocular graft versus host disease (oGVHD) and is the first and only therapeutic with orphan drug designation for oGVHD, and the Company’s second lead candidate (OCU310) which is also in Phase 3 for patients with dry eye disease.
Dr. Musunuri is a seasoned biotech veteran with more than 25 years of results-driven experience advancing and commercializing a diverse portfolio of products. Prior to co-founding Ocugen in 2013, Dr. Musunuri held leadership roles at numerous companies ranging from “Big Pharma” to novel start-up biotechs. Most recently, he founded Nuron Biotech, Inc., which he grew to a commercial company in less than three years, serving as President and CEO. Dr. Musunuri spent nearly fifteen years at Pfizer, where he gained extensive product launch and life-cycle management experience, playing a key role as Global Operations Team Leader for the most successful launch in vaccine history, Prevnar 13®. Prior to Pfizer, he was a group leader focused on Phase 3 clinical development at Amylin Pharmaceuticals. Dr. Musunuri obtained his PhD in Pharmaceutical Sciences from the University of Connecticut and an MBA from Duke University’s Fuqua School of Business. He is a recipient of the Distinguished Alumnus Award from the University of Connecticut’s School of Pharmacy and serves on the Advisory Board of Fuqua’s Center for Entrepreneurship and Innovation at Duke University.
Neal Howard: Welcome to Health Professional Radio. I’m your host Neal Howard, glad that you could join us on the program today. Our guest is Dr. Shankar Musunuri, he’s a PHd and MBA, the Chairman of the Board, CEO and co-founder of Ocugen Inc., a clinical stage biopharmaceutical company that’s focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Welcome to the program Doctor.
Dr. Shankar Musunuri: Thank you. Thank you for having me Neal.
Neal: Well I understand that you’re a seasoned biotech veteran. Give us a bit of your background.
Dr Musunuri: Yeah, you’re right. I’ve been in the industry for 25 years. I started my career in a biotech in San Diego called Amylin Pharmaceuticals. Moved to the East Coast then I joined a biotech company, became part of Wyeth, became part of Pfizer and an opportunity to really work at cross functional areas. I started in R&D to operations onto the business side. Then I became an entrepreneur. And so I think I had experience in developing, launching and managing lifecycle of many bio pharmaceuticals during those years.
Neal: So now you’re involved in Ocugen as a co-founder. chairman of the board, CEO. Being focused on some specific therapies for rare and underserved eye diseases, what would you say is I guess the top two underserved eye conditions that you’re focused on?
Dr Musunuri: I think our lead products, one of them is targeting ocular graft versus host disease and that’s a significant unmet medical need. This is the disease, the patients who go through donor cell, bone marrow transplants cancer patients. Within three to six months after the bone marrow transplant, they get manifestations at the lungs, liver … because it’s a disease, it’s really debilitating. Currently there are no approved therapies here in theU.S. or elsewhere too, so it’s an orphan disease. We are the first company to ever receive a proof of designation from the FDA for that. And the second one, the second leading product we have is for the dry eye disease. Once again, the dry eye is under sort of population. There are some therapies available which are approved and being used in the U.S. and elsewhere. However, there are major issues with the existing products. One of them is the current products take a long time to show the effect. Based on the clinical results that are produced, the trials for about three months to look at the endpoints. That means you have to continue to take them for many months, many weeks to show improvement. Therefore, currently there are about 16 million patients diagnosed in the U.S., about 30 million struggle from Dry Eye Disease, less than a million are getting treated. So patients are really looking for therapies which have a rapid onset preferably non-steroidal because steroidal products cannot be used for long term for safety reasons.
Neal: Do your products fall mainly in the prescription or the over-the-counter vein or a little bit of both?
Dr Musunuri: Actually, all our products are prescription products. We go through a new drug application path for our ocular GVHD and dry eye products. Then the back off our programs, we have under retinal diseases as well as inherited disease and they’re going to go through a path card it’s a new product still, Biological License Application path in the U.S.
Neal: Do these two main conditions, do they occur later in life, earlier or could it pop up at any time and develop in anyone male or female, young or old?
Dr Musunuri: That’s a very good question. I think ocular GVHD as I mentioned, it happens in the cancer patients and it is picked up the age when they go through donor cell bone marrow transplants, up to 60 percent of the patients can get the disease, the attack of the donor cells on the host cell immune system. So again, I mean if you look at the prevalence rates, up to 60 percent then by 2020 when we expect to launch this product, we expect there’ll be over 60,000 patients suffering from the disease in the U.S. alone. And the dry eye disease, it’s a good question you asked. It’s again, many patients get it and again as you age, obviously age has an effect. And again, I mean maybe you’ll see more dry eye conditions in women than male than the age. And also with the digital … environmental effects and seasonal, there are many factors which contribute to dry eye disease. That’s why the prevalence rates are so high. In the U.S. as well as elsewhere. I mean U.S. alone as I mentioned before, 30 million patients actually believe to have dry eye disease and 10 million actually are diagnosed.
Neal: Is it more important the cause of the dry eye or the dry eye disease or that it exists in the first place? Are there different levels of it? Can you treat it with an over-the-counter as opposed to a prescription or is a prescription always the best to alleviate the problem?
Dr Musunuri: That’s a very good question. Yeah, I think the prescription obviously is the best way to treat dry eye disease. Over the counter products, as you know, some of them do some clinical trials but they’re not as rigorous as products going into a new drug application path doing controlled Phase 3 clinical trials. And also, typically the over the counter drugs, if you look into the marketplace, it’s not about just giving a relief when you put the drops in your eye. It’s also working on those underlying conditions and looking at the pathology of the disease. And for example, in the dry eye case, I mean you have patients suffering from dry eye. They got inflammation on the surface of the eye and they also have discomfort, some level of pain and you need to treat those conditions with the appropriate drug, with the appropriate mechanism… which work on those factors. I mean if you take any over-the-counter medications, you may get a shock and relief, they may not be working on the actually underlying pathology of the disease to treat you better.
Neal: Now you say you’ve got a release for 2020. When do you think you’ll have an FDA clearance for say OCU300 for OGVHD?
Dr Musunuri: OCU300 for OGVHD, it’s going to phase three clinical trials expecting top line results from these trials by the end of next year, 2019. And then we do the NDA with FDA. Typically the process, because being an orphan drug designation, we may be on the fast track. Therefore we’re expecting to launch the product in the second half of 2020. That means it’ll take about six to nine months for FDA … NDA filing to get us the approval.
Neal: Well where can our listeners go and learn more about Ocugen and some of the treatments that you working on there?
Dr Musunuri: Yeah. Some of the biological programs in the back of the, we do have the groundbreaking gene therapy platform technology we licensed from the chief in science … from Harvard Medical School. This is a modified gene therapy, this is based on … for genes so these genes regulate many other genes in the retina that are responsible for development, metabolism and functions. So the way this is distinct from traditional gene therapies, international gene therapies when you have a retinal disease, you replace that gene with a functional gene and it fixes the disease. In this case, this is a modifier not only the direct mutations caused by this … You can replace the traditional vector delivery. You can also actually target many other mutations because … genes like an artery … they can bring homeostasis to the retina and they can control the disease progression and in many cases it can even reverse the disease. So this is a difference, that means each …. for targeted gene therapy products can go after multiple inherited retinal signal diseases compared to traditional gene therapy.
Neal: Where can our listeners go online and learn some more?
Dr Musunuri: Yeah. You can learn more on going to www.ocugen.com, our website.
Neal: Doctor Musunuri, it has been a pleasure. Thank you so much for joining us here on the program today and congratulations on your success and continued success there at Ocugen Inc. Thank you so much.
Dr Musunuri: Thank you for having me again, I appreciate it.
Neal: You’ve been listening to Health Professional Radio, I’m your host Neal Howard. Transcripts and audio of this program are available at hpr.fm and at healthprofessionalradio.com.au. You can also subscribe to this podcast on iTunes, listen in and download at SoundCloud and be sure and visit our Affiliate Page at hpr.fm and healthprofessionalradio.com.au.