Cardiovascular Disease Drug Market Offers Compelling Potential for First Movers, Innovators in the Space

NEW YORK, Aug. 3, 2021 /PRNewswire/ -- One of the most pervasive diseases in first-world countries, heart disease is the leading cause of death for men and women of most racial and ethnic groups in the United States, with one person dying every 36 seconds from cardiovascular disease. According to the Centers for Disease Control and Prevention (CDC), high blood pressure, or hypertension, is a key risk factor for both heart disease and stroke, and nearly half of all adults in the United States, or 108 million, have hypertension — yet only about 24% of those have their condition under control. Many don't even know they have it. The urgency of finding effective treatments for this life-threatening disease can't be understated, with many companies, including Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile), with its patented DehydraTECH(TM) drug delivery, joining the effort to offer safe, effective and affordable treatments. Hypertension and related conditions are also points of focus for other drug-making juggernauts such as Pfizer Inc. (NYSE: PFE), Merck & Company Inc. (NYSE: MRK), Novartis AG (NYSE: NVS) and AstraZeneca PLC (NASDAQ: AZN).

• High blood pressure is a life-threatening disease that can be managed with effective treatment.
• Lexaria is a first mover in developing potential treatment base on its DehydraTECH technology.
• The company has focused its ongoing R&D into three key segments, including pharmaceuticals and the treatment of heart disease.
• Recent human clinical study using DehydraTECH technology demonstrated rapid, sustained drop in blood pressure along with excellent tolerability.

Click here to view the custom infographic of the Lexaria Bioscience editorial.

Hypertension Running Wild

Controlling blood pressure is essential to health. High blood pressure is a primary or contributing cause of death in almost 500,000 deaths a year, and hypertension can double the risk of a heart attack and quadruple the chance of having a stroke, plus raise the likelihood of heart failure, vision loss, renal disease, dementia, peripheral artery disease, and more. And it's not just an "old-person" problem; nearly one in four adults aged 20 to 44 have high blood pressure. In addition, high blood pressure costs the United States about $131 billion each year.

The good news? The disease can be managed — and even cured —  with effective treatment. With that in mind, it's no surprise that the global anti-hypertensive drugs market is expected to grow from $24.17 billion in 2020 to $27.81 billion in 2025. Even with current hypertension drugs available, only 24% of the 108 million people in the U.S. with high blood pressure have their condition under control. It's a market ripe for innovation.

Increasing Onset, Bioavailability, Potency

Lexaria Bioscience Corp. (NASDAQ: LEXX) may be on the forefront of some of the exciting innovation in the space. The Kelowna, British Columbia-based company has developed and patented its DehydraTECH technology, a drug-delivery platform for increasing the speed of onset, bioavailability and drug potency. The mechanics involve combining an active pharmaceutical ingredient (API) with fatty acid oil and then applying the mix to carrier particles, which can even be common ingredients such as tapioca starch or gum arabic. Next, a patented dehydration synthesis procedure is performed, and the product is rendered as powder or liquid for use in the desired final form factor, such as a pill, tablet, chewable or oil.

Lexaria has been working with National Research Council of Canada, the biggest R&D organization in the country, since 2017 on defining the qualities of DehydraTECH. Among other things, Nuclear Magnetic Resonance molecular characterization suggests DehydraTECH does not change the chemical structure of an API it delivers, which is critical in reliance on original API safety data in developing novel delivery methods without starting from scratch regarding the FDA process. This keeps the door open to a faster path to market.

Ultimately what this means is DehydraTECH could make lower doses of some substances more effective while even reducing side effects. The company has focused its ongoing R&D into three key segments, including pharmaceuticals and the treatment of heart disease.

Early Results Show Extreme Promise

Just last month, Lexaria announced that a human clinical study using DehydraTECH technology demonstrated a rapid and sustained drop in blood pressure along with excellent tolerability. "We are very encouraged by these early results in our 2021 hypertension program," said Lexaria CEO Chris Bunka. "Lexaria's technology enabled a rapid and sustained drop in blood pressure, especially systolic pressure and particularly in stage 2 hypertensive volunteers."

Initial results show that blood pressure was reduced across both male and female volunteers and was most pronounced in the first 10–50 minutes of the study treatment, reinforcing pre-existing findings demonstrating that DehydraTECH delivers superior performance over generic controls. Dr. Phil Ainslie, the lead investigator on the study, commented that "these early results are extremely promising in this at-risk hypertensive population and provide a fundamental support for expansion into more prolonged repeat dosing and future longer term clinical trials.

Platform Diversification

Lexaria's vision and focus is on several core business segments for DehydraTECH, including heart disease and hypertension, reduced-risk noncombusted nicotine and improved antiviral drug delivery, to name a few. Multiple successes on different fronts have been reported recently, including work in the antiviral program where DehydraTECH has been used to process compounds from leading drugs used for antiviral drugs for SARS-CoV-2/COVID-19 and HIV/AIDS. This is critical work not only for hopefully treating COVID-19 today but also in order to be better prepared when the next pandemic inevitably comes (think bird flu, swine flu, MERS, SARS, etc.).

The scalability to address a diverse group of market opportunities lends color to the potential of DehydraTECH. Consider the antivirals market that is in the spotlight right now because of the COVID-19 pandemic and the circulating delta variant is estimated at $52.1 billion and forecast to reach $66.7 billion by 2025. But DehydraTECH is so versatile, there are many other potential applications. Lexaria sees opportunities in human hormones (e.g., testosterone and estrogen replacement, a $21.9 billion market); oral mucosal nicotine (global smokeless tobacco products market valued at $13.6 billion in 2018), vitamin D3 ($1.1 billion market); PDE5 inhibitors ($4.4 billion market in 2014); and non-steroidal anti-inflammatories ($15.6 billion market in 2019).

Cardiovascular Disease Market Only Getting Bigger

Lexaria is only tapping into a slice of the $92.4 billion cardiovascular drug market that generates billions of dollars in profits every year for drug makers. Majors dominate this lucrative market expected to rise to $107.77 billion in 2025, fueled by a return to normal healthcare practices in a post-pandemic economy.

Pfizer Inc. (NYSE: PFE), one of the largest pharmaceutical companies in the world, notes that despite advances in care and treatment, cardiovascular disease (CVD) remains the number-one cause of death worldwide, with the prevalence only expected to increase. Pfizer is committed to harnessing its legacy and expertise as it aims to address gaps in CVD treatment through the development of new medicines that can meaningfully reduce CV risk for patients. Originally manufactured by Pfizer, NORVASC(R) has been available for more than 25 years and is prescribed to treat  high blood pressure (hypertension), certain types of chest pain (angina), and blocked arteries of the heart (coronary artery disease).

Merck & Company Inc. (NYSE: MRK) announced earlier this year that the FDA had granted approval to its (and Germany-based partner Bayer's) heart-failure drug, Verquvo (vericiguat). The company noted that patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. Many of those, perhaps even more than half, are hospitalized within a month of discharge due to a worsening event, and approximately one in five dice within two years. The approval of VERQUVO provides doctors, health-care professionals, and patients with a new option to current available therapies.

Novartis AG (NYSE: NVS), like most other majors, is highly diversified, with its top-20 products generating $16 billion in sales during the first half of 2021. Entresto, its drug to reduce the risk of cardiovascular death and hospitalization for heart failure in certain patients, was its biggest gainer during Q2, with sales surging 53% from the year prior quarter to $886 million during the quarter. Novartis is committed to reimagining medicine and using innovative science and technology to address some of society's most challenging healthcare issues.

AstraZeneca PLC (NASDAQ: AZN) announced in April that its proprietary sodium-glucose cotransporter 2 (SGLT2) inhibitor, Farxiga, has been approved for use in the United States. In phase 3 trials, the drug demonstrated unprecedented reduction in the risk of the composite of worsening of renal function, end-stage kidney disease and cardiovascular or renal death. Chronic kidney disease is often associated with a heightened risk of heart disease or stroke, and the company called the approval of Farxiga, one of the most significant advancements in the treatment  of chronic kidney disease in more than 20 years.

Heart disease is the most indiscriminate killer in the United States. Every year it is a leading cause of death for men, women and people of most racial and ethnic groups. About one in every four deaths is caused by heart disease, equating to roughly 655,000 Americans each year. It's clear that drug sales are booming trying to combat it, but any innovation to make these medicines (many of which have ugly side effects) better will almost certainly be welcomed with open arms.

For more information about Lexaria Bioscience Corp., please visit Lexaria Bioscience Corp.

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