Pain: The Last Frontier
MAKING A DIFFERENCE IN THE WORLD
RELIVRA - OUR FLAGSHIP PRODUCT, OUTPERFORMED EXISTING PAIN PRODUCTS IN MT.SINAI HOSPITAL HUMAN CLINICAL TRIALS
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VAS, mm
100
80
60
40
20
0
.
.
Relivra
Diclofenac
Lidocaine
Benzocaine
Ketoprofen
METHODOLOGY NOTES
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Data from the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), OpenSIGLE and ProQuest Dissertations and Theses, NIH Pubmed, and Relivra limited clinical trials were used for this chart.
In a world where pain is a widespread and complex health issue, we aspire to become a beacon of hope. At Nexa Bioscience we leverage cutting-edge methodologies and an advanced product pipeline to develop solutions that substantially improve patient outcomes across main areas of pain: orthopedics, post-injury rehabilitation, and maternity post-labor pain management. Our pipeline includes an exciting new candidate specifically aimed at treating Cutaneous Amyloidosis - an orphan disease lacking effective treatment options. We aim to provide accessible and affordable pain relief solutions, enhancing the quality of life for patients globally while addressing critical, unmet medical needs.
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LET'S CONQUER THE PAIN
and relieve patient suffering and enhance lives
WE HAVE THE SOLUTION
Pain is an enormous global health problem. Globally, it has been estimated that 1 in 5 adults suffer from pain and that another 1 in 10 adults are diagnosed with chronic pain each year. While pain affects all populations, it is not distributed equally across the globe and socio-economic spectrum. There are multiple reasons for regarding pain as a public health priority. The first and foremost is the staggering prevalence of pain. Because pain is a multivalent, dynamic, and ambiguous phenomenon, for hundreds of millions of people across the globe, excruciating pain is an inescapable reality of life. Relivra is an inexpensive, non-addictive solution ready to be deployed on a global scale.
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UNADRESSABLE PAIN
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OPIOID DEPENDANCY
Pain is one of the most misunderstood, under diagnosed, and under treated/untreated medical problems, particularly in women and minorities. However, the medical community has not placed the same emphasis on pain management for different conditions, genders and age groups such as women and seniors. Based upon analysis of 192 WHO members, over 234 million major surgical procedures are undertaken every year worldwide, and many receive inadequate pain relief after they come back home and in 20% of cases, the pain becomes chronic and increase risk of developing addiction or dependency from medication. Generally unaddressed, chronic pain can affect vulnerable people in ways that will follow them throughout their lives. Relivra prevent developing emotional and psychological scars from their pain that can taint future choices concerning their lives and health care.
Within individual health systems, Black and White patients received markedly different opioid doses. Opioid dependence and abuse have become a national nightmare in the last decade. The CDC estimates the total economic burden of prescription opioid misuse alone in the US is $78.5 billion/year including the costs of healthcare, lost productivity, addiction treatment and criminal justice involvement. 21-29% of patients prescribed opioids for chronic pain misuse them. 8-12% develop an opioid use disorder. 4-6 % who misuse prescription opioids transition to heroin. As mind-blowing as these numbers are, to a person who uses prescription pain medication for pain relief, opioids may seem like the path of quick recovery. Relivra could facilitate development of ethnically specific treatment to prevent and reduce overuse of opioid pain medications.
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MINORITIES AND GENDER DISPARITY
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IN ACCESS TO PAIN MANAGEMENT
AVAILABLE FORMULATIONS
ONLY MASK PAIN
Substantial pain prevalence is as high as 40% in community populations. There is consistent evidence that racial/ethnic minority individuals are overrepresented among those who experience such pain and whose pain management is inadequate. Racial/ethnic minorities consistently receive less adequate treatment for acute and chronic pain, even after controlling for age, gender, and pain intensity. Pain intensity differences appears to be a major contribution of minority individuals to pain management disparities. The major contribution by physicians to such disparities appears to reflect limited awareness of their own cultural beliefs and stereotypes regarding pain, minority individuals, and use of narcotic analgesics. Studies using data from the US NHNS have shown that individuals from racial/ethnic minorities are at increased risk of more serious or activity-limiting pain. Such patients with pain will benefit from Relivra deployment as a novel specific strategy to overcome potentially harmful mistreatment of minority patients.
Even over-the-counter pain relievers can pose dangers to patients' health. Taking OTC painkillers may seem like a good solution, but it is not. Over-the-counter meds like aspirin, ibuprofen and acetaminophen can have side effects. Acetaminophen can result in kidney damage. Ibuprofen can cause both kidney and stomach problems. Not only does taking meds for pain just mask the problem, it may cause yet another one. Using currently available pain medications do not get to the root of the problem. None of these medications are meant to be used long term as pain is not supposed to linger. Nerve signals alert to a problem that requires attention, from an infected area or traumatic injury to joint or overuse of a muscle or tendon. This is especially true of acute pain. Sensations of pain and stiffness discourage patients from using an injured body part while it is healing; once the condition resolves, pain should go away. Relivra is generally able to get to the source of pain, giving it a tremendous edge over existing formulations.
| PIPELINE HIGHLIGHTS
RELIVRA SNA - ORPHAN DRUG
We have developed a unique, transdermal formulation based on modified flavonoids, specifically designed to target the primary cause of Skin Nodular Amyloidosis (SNA). We have created a novel treatment that could inhibit the amyloid accumulation directly at the site of the skin nodules, presenting a lasting solution for a desease which currently has no treatmnet.
A NOVEL APPROACH TO TREAT AN ORPHAN DISEASE
RELIVRA PLUS
Relivra Plus is a breakthrough pain relief compound that has surpassed existing market options in several human clinical trials, demonstrating superior efficacy and safety. The pain relief cream is fully developed, tested, with a clear path to quick market entry and ready for immediate distribution, ensuring a rapid go-to-market strategy and revenue generation.
INNOVATIVE PAIN RELIEF WITH IMMEDIATE MARKET READINESS
| ABOUT US
We are focused on conquering pain, a critical unmet global need. We are committed to expanding patient access to important, cost-effective pain relief medicine and delivering significant savings to the global healthcare system. We apply our scientific expertise and proprietary technologies to develop and commercialize a blockbuster pain relief product that is designed to make a meaningful difference in the way people manage their pain. Beyond our central mission to develop pain medicine, we believe in championing approaches to treatment that account for the multitude of factors that affect outcomes for patients and communities.
Our core strength lies in our ability to excel in developing technologically complex product backed by our dedicated teams in formulations, process chemistry, and analytical development. Our approach to innovation builds on strong science combined with the drive to find solutions where the need is the greatest. We concentrate our efforts on a singular therapeutic area – pain, where we’ve proven our expertise, and where we feel we can have an even greater impact on diseases and how it is managed.
MEET SOME OF OUR EXPERTS
Professor Uryash is a visionary scientist, researcher, and an associate professor at Mount Sinai Hospital Biotech Institute in Miami He has been at the forefront of pain research for over a decade Experienced Scientist, Director Of Research Development,
Medical Science Communicator, Founder and Educator with a demonstrated history of working in the pharmaceutical industry He is
skilled in U S Food and Drug Administration (FDA processes, IP development medical technology biomaterials, and formulation).
Dr. Steven Presser, MD
Steven C. Presser, M.D. is an experienced Beverly Hills fertility doctor who has presented and published numerous research abstracts & peer-reviewed publications, given seminars and lectured crowds and clinicians alike and has frequented radio talk shows. His areas of research & publications include ectopic pregnancy, nutrition, lifestyle and reproductive health, oocyte freezing and fertility preservation, human embryo co-culture methods. He was the recipient of Mead Johnson Laboratories, Purvis Martin Award for excellence in research.
Israel Vierma, MBA
A former marketing director of Johnson and Johnson, Israel Vierma is an expert in the sales of Advanced Medical Products. His career is based upon a platform of expert market knowledge, leadership skills and commercial experience with several of the world’s leading medical product providers. He has an MBA and dual engineering degree, with solid clinical knowledge and the ability to manage dynamic business development initiatives delivering innovative strategies, building teams that grow revenue and market share.
Dr. Ari Lamet, MD
Dr. Ari Lamet, MD, Director of The Broward Center For Gastrointestinal Disorders, is a distinguished expert and board-certified Gastroenterologist, with a specialized focus on the treatment of inflammatory bowel disease and ulcerative colitis. Dr. Lamet has authored or co-authored numerous articles and serves as a professor at Nova Southeastern University College of Medical Sciences. Dr. Lamet's innovative approach and extensive experience have positioned him as a leading authority in the field, making him an invaluable asset to our advisory board. His commitment to patient care and his relentless pursuit of novel therapeutic strategies underscore his dedication to improving the lives of those affected by these debilitating diseases.
Dr. Etan Marks, MD
Dr. Etan A. Marks, MD, Partner in Advanced Dermatology Surgery Center of South Florida is a distinguished pathologist with board certification in Dermatopathology, bringing a wealth of expertise to out advisory board. Dr. Marks has published over 20 articles in peer-reviewed journals, successfully managed multiple clinical trials and contributed to the development of regulatory skin oncology guidelines. His profound knowledge in diagnosing skin malignancies and extensive expertise in cellular and molecular techniques is important for promoting innovative treatments of Orphan Skin Diseases.
DIFFERENT AND SUPERIOR
Topical pain-relieving industry has boomed in recent years as one of the markets that holds enormous growth potential. A large number of advanced materials with unique physicochemical properties are currently being used in the cosmetics formulations in order to aid active ingredients for their delivery through the skin barriers. Nevertheless, these advanced systems have not made their way to pain treatment topical applications despite their demonstrated potential in targeted-oriented drug delivery and remarkable features such as better stability, site-specificity, prolonged action, enhanced skin penetration, and high drug-loading capability.
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Relivra® is a first known formula on the topical pain-treatment market using advanced physicochemical features and customizable carrier.
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Relivra® provides absorption and penetration of its active moieties within epidermal layers in a remarkable way of achieving selectable burst or sustained release.
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Advanced features of Relivra® formulation provide for superior biocompatibility, stability, site-specificity, prolonged action, and high drug-loading capability, while eliminating toxicity risks.
Skin delivery systems developed to improve the physicochemical properties of therapeutic compounds. Gel-Emulsions are one of these drug delivering systems formulated using water and lipids as main ingredients. However, the oxidative tendency of emulsions is often overlooked. Oxidation impacts the overall stability and safety of these formulations. Introducing unstable emulsions into biological systems further promotes oxidation in tissues. Products of these reactions then continue to pose serious harm to cells and damage to biological systems.
Peer review has become the foundation of the medical publication system because it effectively subjects company's work to the scrutiny of other experts in the field. Thus, it encourages authors to strive to produce high quality research that will advance the field. Peer review also supports and maintains integrity and authenticity in the advancement of science. Peer review is a central part of the publication process for medical journals. The medical community considers it to be the best way of ensuring that published research is trustworthy and that any medical treatments that it advocates are safe and effective for people. A scientific hypothesis or statement is generally not accepted by the academic community unless it has been published in a peer-reviewed journal. Relivra is proud to be scheduled to publish its latest results of clinical trials in industry's most reputable publications.
PEER REVIEWED PUBLICATIONS
CLINICAL TRIALS
Clinical trials are a crucial part of the development process for our new medical formulation. They provide professionals and regulators with valuable insights into the safety, efficacy, and potential benefits or risks of our novel treatments. We carefully analyze results of these trials to determine what the findings mean for clinical application and to plan the next steps in our product development.
In case of RELIVRA, the clinical trials were conducted on diverse patient populations, including those in women's health, orthopedics, and post-injury rehabilitation. This broad range of trials ensures that our results are applicable to a wide variety of patients, increasing the potential market for our products.
The results of our clinical trials have been very positive. Our unique formula, which combines peptide and polymeric matrix transdermal carrier with flavonoids, terpenes, siRNA, and FDA approved pain medication components, has shown significant efficacy in reducing pain and improving patient outcomes.
In addition to demonstrating efficacy, our clinical trials have also shown that our products are safe for use. The trials have not revealed any significant side effects or complications, further supporting the potential of our products in the market.
Moreover, our clinical trials have also revealed potential significant cost savings for insurers and providers. By facilitating faster rehabilitation, reducing readmission rates, and lowering opioid dependency, our products can help to significantly reduce healthcare costs.
In conclusion, the results of our clinical trials support the potential of our products in the market. With demonstrated efficacy, safety, and cost savings, we believe that our products represent a significant advancement in the field of pain management.
PIPELINE AND COMMERCIALIZATION
- 4 DISTINCT PRODUCTS
- 3 PLATFORMS
- 1 ORPHAN DISEASE APPLICATION
Successive Waves of Innovation Contribute to Sustained Growth
As a result of the “opioid crisis” in the USA various stringent regulations regarding the usage of opioids have been put in place resulting in a number of opioid pain drugs been pulled from the market. The blockbuster pain killers Oxycontin™ and Subsys™ are facing enormous regulatory scrutiny rapidly losing market share. As the baby boomers are aging, a number of patients with chronic pain is growing steadily and already reached over 100 million Americans. Opioids accounted for about $17 billion of the $36.1 billion United States market in 2017 and physicians are desperately looking for alternatives. The large market share held by opioids have unfortunately been accompanied by an epidemic of overdose deaths, with prescription opioid mortalities in the US now exceeding the number of people dying from heroin and cocaine combined. Opioids are also responsible for almost 500,000 emergency room hospital visits each year. In other words, the consequences of opioid use are a public health nightmare. Patients suffer because effective, non-addictive alternatives are not available. In its “war on opioids” major insurance payors are no longer covering most of the opioid pain medications effective January 2019, those leaving tens of millions of patients without any viable pain management solutions. Existing topical pain creams on the market are not nearly as effective as opioids and not perceived as a viable alternative to opioid medications.
Our pipeline is positioned to deliver both near-term and sustained growth in two waves: In the near-term, the OTC formulation launch through FY2024 will start bringing a steady revenue stream, representing best-in-class or first-in-class therapies. Looking to FY2025 and beyond, our R&D engine with internal research capabilities and external partnerships is expected to deliver a steady stream of next-generation pain therapies that will sustain our growth.
PIPELINE: PRODUCTS
PIPELINE: MANAGEMENT PLATFORMS
RELIVRA PLUS
01
A tailored solution for unaddressable pain, including women, seniors, and minorities, providing personalized pain relief for orthopedics, rehab, and women's health.
RELIVRA mRNA
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Harnessing mRNA + LNP technology to promote tissue regeneration and pain relief, especially beneficial for orthopedic and post-surgical rehabilitation.
RELIVRA POSTBIOTIC
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Embracing immune modulation and tissue regeneration for a holistic approach to pain relief.
RELIVRA ADVANCED EXCIPIENTS
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Enhancing stability and safety by optimizing excipients, mitigating risks to the supply chain.
RELIVRA ADC
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Merging pain-targeting antibodies with potent pain-relieving agents, offering a precise and effective approach to pain management.
RELIVRA PRP
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Utilizing a Precision Research Platform to optimize pain management based on individual genetic and biomarker profiles.
RELIVRA MICRO TRIALS
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Accelerating development through de-risked and incubated micro clinical trials, ensuring rapid optimization and validation.
R
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Enhancing stability and safety by optimizing excipients, mitigating risks to the supply chain.