When asked, SILEX Pharmacetical’s Anthony Mack notes that—like most pain killers—cannabis works for some, but not everyone.“Pain,” he notes, “is pretty subjective.” To render it less so is the mission of SILEX. “We are uncompromising in our focus to become the global pharmaceutical leader in pain management,” the website states. “We are committed to social, environmental, economic, and ethical responsibility. Dedicated to using international partnerships, we strive to deliver the next generation of trailblazing products that are responsible by design.”
DDNews: Please tell our readers about SCILEX Pharmaceuticals, Inc., how it originated and its experience to date.
Anthony Mack: We are focused on the development and commercialization of late-stage products for the treatment of pain. This is a timely endeavor since more than 100 million Americans currently suffer from chronic pain. Our company has a strong management team with experience marketing multiple pain products including Lidoderm® and OxyContin.
Our first investigational product is a 1.8 percent lidocaine patch and is a topical patch formulated for the treatment of the pain associated with post-herpetic neuralgia (PHN), a chronic, painful condition that may follow a shingles infection. The 1.8 percent lidocaine patch was designed to address potential challenges with existing PHN therapies.
The U.S. Food and Drug Administration concurred that our 1.8 percent lidocaine patch should be submitted under Section 505(b)(2). We filed a New Drug Application (NDA) in July 2015. Pending an FDA approval, the targeted launch date for the 1.8 percent lidocaine patch is Q3 2016.
DDNews: Why focus on pain?
Mack: There still is tremendous need for better treatments for pain and a lot of my prior professional experience and that of my team was in pain treatment, as I mentioned. We have handled large products such as OxyContin, Opana® ER and Lidoderm®. Another motivation for working with pain was the desire to focus on products that we can make better—try to improve their safety and efficacy. During my time with Endo Pharmaceuticals, I worked with their various patch products. While the technology of topical products has improved over the years, we are focused on bringing the latest technology to the market that provides responsible products to physicians and patients.
DDNews: How was the management team assembled? What is the background of each of the four leaders?
Mack: We wanted to select folks who not only had some experience in pain but also experience in launching and bringing products to market. Our team has extensive backgrounds in these areas. All of them—including our human resources, government affairs and communication directors—have at least 10 years or more in the business. All have experience launching several brands, including pain products. I worked with Novartis as a sales rep and rose all the way up to national sales director at EKR Therapeutics. I have also owned a transdermal R&D factory, ProSolus Pharmaceuticals, which I sold in May 2015.
William Pedranti, our chief operating officer, was at one time at Spectrum Pharmaceuticals. He has very good range of knowledge on raising capital and building teams. He understands the work it takes to build out a company. Bill Stewart, our vice president of market access and commercial development, has 30-plus years in industry. Market access is critical in the 21st century because payors drive the market. So understanding what those payors’ needs are is critical. Dean Ferrigno, our vice president of global finance, has critical knowledge in financing and accounting work, as well as a strong pharma background. Kip Vought came to us from Clinipace Worldwide; where he oversaw the clinical development of the 1.8 percent lidocaine patch. We offered him a position and he is now vice president of development. He oversees any product going through the development process. His role is critical as we start to add to our pipeline and communicate further with the FDA.
DDNews: How is SCILEX’ pain-management technology applied?
Mack: Our technology is applied as a topical patch. We strive to engineer our patch systems to efficiently deliver medicine through the skin. Our adhesive and pliable properties are designed to permit reliable skin contact throughout the dosing regimen.
DDNews: Cannabis is frequently championed as a pain medication. What is SCILEX’ viewpoint on this subject?
Mack:Under regulatory conditions, cannabis may work in similar ways to opioids. Pain is pretty subjective and not everybody reacts to any given type of opioid. It is all individual. As a pain company, we believe in the appropriate use of safe and effective treatments. So it is something a patient should discuss with their physician.
DDNews: Your first investigational product candidate, ZTlido™, is referred to as “a branded, fourth-generation transdermal lidocaine patch formulated for the pain associated with post-herpetic neuralgia, or PHN, a chronic, painful condition that may follow a shingles infection.” How does it differ from other medications used for shingles?
Mack: As with other topical lidocaine patches for PHN, it is not designed to be systemic. If you look at a lot of pain medications and ask clinicians, getting to a therapeutic dose may be impossible because of side effects. So having a topical patch could potentially give patients fewer side effects. For doctors, having products like topical patches instead of a systemic treatment may help someone be compliant with their medication.
The key to successful topical products is the ability to stay in contact with the skin. We hope that our technology will deliver a topical product that permits reliable skin contact.
DDNews: What other products are in the SCILEX pipeline and in what stage of development?
Mack: We are looking at other actives, but we don’t want to disclose the details. However, we are looking at other transdermal pain products as well as injectables. We are specifically looking at one non-opioid pain medication and are waiting to hear back from the FDA regarding the pathway. Once we hear back from them, we will make an announcement.
Overall, the transdermal drug delivery market is set to grow dramatically. Pain is the largest segment in the pipeline of transdermal drugs under development. High barriers to entry make this market attractive for branded drugs with novel delivery systems despite generics.
Anthony P. Mack, CEO, SCILEX Pharmaceuticals, Inc.
Anthony Mack has more than 20 years of experience in the pharmaceutical and finance industries. Prior to co-founding SCILEX Pharmaceuticals, Mr. Mack founded Miami’s ProSolus Pharmaceuticals, a 12,000-square-foot R&D and cGMP transdermal manufacturing facility. During his tenure with ProSolus, Mack has overseen agreements with U.S. and international pharmaceutical partners to develop five generic transdermal prescriptions. In 2014, ProSolus was awarded the Dade County Life Science Award. Mr Mack has held high-level management positions with Purdue Pharma, Endo Pharmaceuticals, Novartis, and EKR Therapeutics. He has led training, marketing, and commercial distribution for billion-dollar pain management products and has forged key strategic alliances. By serving on executive boards for SCILEX and ProSolus, Mack has utilized his skills and experience to implement policies relating to corporate governance and overall business strategy. Mack holds an MBA in Pharmaceutical and Healthcare Marketing from Saint Joseph’s University and a BS in Business Management from Charter Oak State College in Newington, CT.
