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CEOCFO Magazine, PO Box 340
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Lynn Fosse, Senior Editor
Steve Alexander, Associate Editor
Bud Wayne, Marketing
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Christy Rivers -
Jeffrey A. Meckler
Vice Chair & Chief Executive Officer
Intec Pharma Inc.
Interview conducted by:
Lynn Fosse, Senior Editor
Published – December 21, 2020
CEOCFO: Mr. Meckler, what is the focus today at Intec Pharma Inc? What is the status on your Accordion Pill®?
Mr. Meckler: Thank you, Lynn. Our mission at Intec is to create value by leveraging the potential of our Accordion Pill® (AP) platform. Our growth strategy is to advance a mix of internally-
Despite not meeting the primary endpoint in our Phase 3 ACCORDANCE study of AP-
We continue to advance our collaboration with Merck and were particularly pleased with the recent decision by Merck to proceed into a new research collaboration program with us. In addition, we also recently announced a new cannabinoid research collaboration with GW Pharma.
We also continue to make progress on our internally-
There are also additional discussions with other potential pharmaceutical partners for the development of new custom-
CEOCFO: How do you go further into the results to see what you need to do next?
Mr. Meckler: The clinical trial data readout was in late July 2019. We spent the latter part of the summer going through the data, gaining an understanding of what the data demonstrated and where we could optimize performance. The key learnings from the trial are that our technology was safe and we delivered the drug with a steadier pharmacokinetic (PK) profile than the immediate release formulations on the market today. Safety data from both the Data Monitoring Committee and the Phase 3 open label extension study provided us with the first validation of the long-
What we believe we did not do is use a trial design that allowed for the delivery of enough drug to the patients in the higher dosage cohort of the immediate release arm of the study. Patients who were in the higher end of the dosing regimen were not getting enough drug in the AP arm, given that the AP arm was limited to 1500 mg of levodopa. Some of this is attributable to the novelty of the AP and FDA’s inexperience with the safety profile of the long-
CEOCFO: How are you looking to branch out today? Would you give us some specifics?
Mr. Meckler: Our research and manufacturing teams continue to drive innovation as we expand our capabilities and build out our portfolio of potential applications. In addition to the variety of film technologies and release mechanisms we have developed to date, including those we created for partners, we continue to innovate and are working on next generation AP technologies that will increase gastric retention time (i.e., a 24-
Key to advancing these innovations and attracting new partners is our ongoing work on commercial scale manufacturing with our partner LTS. Together, we built a commercial scale manufacturing facility and conducted preliminary validation work using our AOP CD/LD platform. This manufacturing facility stands at the ready for the Parkinson’s program and conceivably, for other programs that may advance to a commercial scale.
CEOCFO: Why the choice of LTS Lohmann Therapy-
Mr. Meckler: That is great question! There are a variety of parameters that led us to LTS Lohmann. First and foremost is their position as one of the world’s leading manufacturers of transdermal drug delivery products. They have a large business in drug-
Another reason we selected LTS was its proximity to Israel. Being in Germany, LTS is only one-
CEOCFO: What did you learn from the Novartis partnership?
Mr. Meckler: A lot! With big pharma companies, we learned that decision processes are not always linear. What I mean by that is going from point A to point B is not always a straight line. Novartis gave us a very difficult assignment, probably one of the most technically difficult the company has had. We successfully achieved their stringent PK parameters, both in vitro and in humans. Our team was very excited to advance the program as we saw a real opportunity to improve the therapeutic benefit of the compound. We delivered them the data in mid-
Another lesson for us is that we need to adapt our business model for their processes and take a broader shots-
CEOCFO: Would you tell us a bit more about your programs regarding cannabinoid? What is your idea and thinking in this area?
Mr. Meckler: First of all, we are not a pot stock company or medical marijuana company. There are many cannabinoid companies taking semi-
Cannabinoids are very oily and are poorly soluble in the human body. The combination of the slower rate of rise with sustained and consistent plasma levels is expected to lead to an improved therapeutic effect and reduce the adverse events that are correlated with rate of rise and peak THC plasma levels. Also, given the known analgesic properties of cannabinoids, we are enthusiastic about the potential for these programs and believe our AP-
We completed an initial PK study with AP-
On positive data from this program, we would look for a partner to license the asset and advance the development and commercialization of our AP cannabinoids. Here, we look to work with a partner who is aligned with our goals to pursue legitimate medical indications through the FDA regulatory process. We believe the work we are doing now is forming the foundation for success with this type of collaboration.
CEOCFO: How do you continually innovate the technology?
Mr. Meckler: This speaks to our roots of being a data driven company focused on improving human health. Our research and manufacturing teams continue to drive innovation as we expand our capabilities and build out our portfolio of potential applications. We have spent a lot of time analyzing the huge amount of data collected from our Phase 3 study, literally gigabytes of data, and we’ve learned a ton about release times and gastric retention in the process. In addition, every time we development a new product, there is an opportunity for innovation, product development and creation of new intellectual property. Novartis, for example, approached us to create a mechanism we had not done before and we were able to build a customized Accordion Pill. As a result, we developed new films and will apply for new patents on that. So, as you can see, we are constantly reviewing our data, exploring new approaches and refining our technology.
This year, our main focus on innovating the technology is on the development of a 24-
We are a drug delivery company not a drug discovery company. I often say, “We do not make the drugs you take; we make the drugs you take better.” We do that by how we deliver the drug into the stomach. For us, innovating on the platform means constantly applying and learning and reviewing data to evaluate how we can advance the application, release and retention of already existing drugs and drugs in development.
CEOCFO: How are you handling the COVID environment? What advice would you give CEOs in these times, both during COVID and with moving forward from a failed Phase III trial?
Mr. Meckler: It has certainly curtailed my travel, so I am home now all the time! Not sure how my wife feels about that! That said, our primary focus is to ensure that our employees are safe, motivated and engaged. Without question, the pandemic has definitely changed the way we are doing business. For starters, social distancing makes the collaborative R&D process more difficult. Whether it is with our internal R&D team, where we cannot bring everyone into the conference room due to social distancing rules, or with our partners and potential new partners, where we have to find new ways and formats to work together. The first challenge of dealing with the pandemic is learning how to be collaborative in a social distancing environment.
On a more macro view, I am proud to be part of an industry that is stepping up and innovating many ways to address the pandemic. This is not just in the realm of vaccines; it is across a large number of therapeutic approaches with literally hundreds of companies looking for ways to combat the disease. Some of these treatments we have had experience with and the level of effort is a testament to the capability of the industry to focus for the greater good of society.
As far as advice for other CEOs following on a failed Phase 3 trial, once again, I think it is all about being data driven. The real key is to look at the data and see what was learned. The pharmaceutical business is about learning and innovating from what is learned. This is a large part of why I love this business. I think you need to plan for failure and then celebrate success. All too often, we get so excited about the opportunities that maybe we lose sight of what can go wrong. It is important to keep positive but also to be realistic. I say this with regard to all constituents, whether it is your investors, your employees, your board of directors or your partners. Importantly, you need to be sure you have enough runway that if things go wrong, you have time to figure it out and adjust. Lastly, I would say, communicate, communicate, communicate. When you have a setback, people’s emotions and fears can take over. It is the CEO’s job to reassure them. “Here are the facts; here is what we are doing and why.” For us, we had a really tough decision in the second half of last year that led to a restructure and a reduction in staff. These are not just employees. They are colleagues and friends. Throughout the process, we kept everyone informed on our decision process and about the consideration, and we did it with a good deal of respect. All in all, it is really about keeping positive, realistic and being data driven.
CEOCFO: Why is Intec Pharma and your Accordion Pill Technology so important? Why should people pay attention?
Mr. Meckler: The Accordion Pill technology allows drugs to be delivered in a unique way that can improve the therapeutic benefit for patients in a variety of potential indications. It is this patient benefit that drives us to advance the AP platform. Driving Intec’s innovation is our commitment to the patient and to demonstrating how our AP technology can improve lives. At the end of the day, that’s the core of what we do and we think it is important for the patient, the scientific community and for investors as well.
While we are not working on drugs that address the COVID-
As I look back on the previous year, we took our losses. We analyzed the data and made decisions on how to move forward. Now, the company is in on solid footing. Between our cash and our equity line, we have runway through 2021 which allows us to focus on advancing our pipeline, expanding our partnerships, and creating value through these new opportunities.
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“Between our cash and our equity line, we have runway through 2021 which allows us to focus on advancing our pipeline, expanding our partnerships, and creating value through these new opportunities.” Jeffrey A. Meckler
“We do not make the drugs you take; we make the drugs you take better.” Jeffrey A. Meckler