Data Projects the NASH Market Will Eclipse USD 21 Billion by 2025

NEW YORK, August 3, 2018 /PRNewswire/ --

According to a report published by Allied Market Research, the global non-alcoholic steatohepatitis (NASH) market was valued at USD 1,179 Million in 2017 and is expected to reach USD 21,478 Million by 2025 while growing at a CAGR of 58.4% from 2021 to 2025. NASH is a common liver disease, often called as silent liver disease. It has no symptoms until its later stages, and therefore many patients are unaware of the disease. The research indicates that NASH is projected to lead the cause of liver transplantation in the U.S. in the coming years. Based on drug type, the NASH market is segmented as vitamin E & pioglitazone, obeticholic Acid (OCA), elafibranor, and selonsertib & cenicriviroc. Currently the vitamin E & pioglitazone segment dominates NASH market, due to efficacy. Breathtec Biomedical Inc. (OTC: BTHCF), Galectin Therapeutics Inc. (NASDAQ: GALT), DURECT Corporation (NASDAQ: DRRX), Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD), Conatus Pharmaceuticals Inc. (NASDAQ: CNAT)

Data provided by GlobalData projects that by 2026, the vast majority of global sales for NASH treatments will have come from drugs that are currently in the pipeline. Lakshmi Dharmarajan, Ph.D., Managing Healthcare Analyst for GlobalData, explains, "Currently, the NASH market has no approved therapies and is dependent on off-label agents that only offer sub-optimal safety and efficacy outcomes to patients. However, despite NASH drug developments being historically slow, several companies developing late-stage pipeline drugs for the disease have been actively employing strategies to identify biomarkers in recent years."

Breathtec Biomedical Inc. (OTCQB: BTHCF) is also listed on the Canadian Securities Exchange under the ticker (CSE: BTH). Yesterday, the Company announced breaking news that, "it will be opening a new drug development division and has signed a Letter of Intent ("LOI") to acquire 100% of the shares of Nash Pharmaceuticals Inc. ("Nash Pharma"). Nash Pharma is a clinical stage pharmaceutical development company focused on drug repurposing in the areas of non-alcoholic steatohepatitis (NASH), chronic kidney disease (CKD) and inflammatory bowel disease (IBD). Through its ongoing research programs, Nash Pharma has developed data that supports the advancement of up to 7 drug candidates into phase II trials.

Pursuant to the LOI, the Company will enter into a definitive agreement whereby the Company, prior to the closing of the transaction, will complete a consolidation of its securities on a 2-to-1 basis. This will result in the Company having 28,682,012 common shares, 6,005,833 outstanding warrants and 2,147,500 outstanding options. Further, the Company will acquire all of the issued and outstanding common shares of Nash Pharma in consideration for the issuance by the Company of 15,800,000 common shares of the Company and will issue an additional 14,800,000 warrants at a price equal to the exercise price of the Nash Pharma warrants.

Concurrent with the transaction, the Company anticipates that it will complete a private placement financing of its securities to arm's length parties for aggregate gross proceeds of up to CDN 1,000,000, at a price per security to be determined based on the context of the market, with such proceeds to be allocated towards funding development of the business division of Nash Pharma.

The Company is committed to and will continue to advance the research and development program for its FAIMS technology and will be providing an update to the market on its progress shortly."

Galectin Therapeutics Inc. (NASDAQ: GALT) is a biotechnology company focused on discovery and development. Galectin recently reported that the Company has received notice of issuance of U.S. Patent Number 9,968,631 titled "Method and Treatment of Pulmonary Fibrosis." The patent's principal claims cover method of use of GR-MD-02 as a means to treat pulmonary fibrosis. The patent is expected to provide broad protection for the use of GR-MD-02 for compositions, methods of using and methods of manufacturing compositions capable of treating pulmonary fibrosis. The patent coverage extends to 2032. "This patent protects our commercial ability to use GR-MD-02 to potentially treat pulmonary fibrosis and is yet another example of the widespread applicability of our galectin-3 inhibitor in treating fibrotic disease," said Dr. Harold H. Shlevin, Chief Executive Officer of Galectin Therapeutics. "Pharmaceutical companies may have an interest in this disease as there is a sizeable section of the population in need of treatment and well-defined regulatory pathways for approval of agents to treat pulmonary fibrosis."

DURECT Corporation (NASDAQ: DRRX) is a biopharmaceutical company actively developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR 928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT's Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury, hepatic and renal diseases such as nonalcoholic steatohepatitis (NASH) and Primary Sclerosing Cholangitis (PSC), and inflammatory skin conditions such as psoriasis and atopic dermatitis. DURECT recently announced that Indivior PLC (LON: INDV) has reported that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for PERSERIS™ (risperidone), which was formerly known as RBP-7000. As described by Indivior, PERSERIS is the first once-monthly subcutaneous risperidone-containing, long-acting injectable for the treatment of schizophrenia in adults. "We are pleased to see PERSERIS receive FDA approval as an innovative treatment option for patients suffering from the very difficult medical condition of schizophrenia," stated Jim Brown, President and Chief Executive Officer of DURECT Corporation.

Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) is a clinical-stage biopharmaceutical company focused on the development of Aramchol, a first in class, novel, once-daily, oral therapy for the treatment of NASH for variable populations. The Company recently announced top-line, 52-week results from the global Phase 2b ARREST study. In the ARREST study, patients underwent MRS and biopsy at baseline and week 52, which were centrally read, blinded to treatment allocation. The primary endpoint of the study was the change from baseline to end of study in liver triglycerides ratio as measured by MRS (Aramchol 600mg vs. placebo). Secondary endpoints, demonstrated through biopsy, included fibrosis improvement by at least one stage or more without worsening of NASH (defined by an increase of inflammation and or ballooning) and NASH resolution (defined by ballooning score 0 and inflammation score 0-1 at termination) without worsening of fibrosis. Other secondary endpoints included improvement (2 points or more) in NASH activity index, as measured by NAS or SAF, without worsening fibrosis and change in baseline to week 52/termination in ALT (U/L). "We are excited with the ARREST results that will enable Galmed to meet with the regulators as soon as possible and discuss the pivotal study design," said Allen Baharaff President and Chief Executive Officer of Galmed. "It is extremely gratifying that Aramchol's scientific rationale for disease modification of NASH is being translated into clinical coherent results."

Conatus Pharmaceuticals Inc. (NASDAQ: CNAT) is a biotechnology company focused on the development of novel medicines to treat liver disease. Conatus recently announced the completion of enrollment in ENCORE-PH, a Phase 2b clinical trial evaluating emricasan, the company's first-in-class, orally-active pan-caspase inhibitor. Top-line results from the ENCORE-PH clinical trial are expected in the fourth quarter of 2018. The ENCORE-PH clinical trial is designed to evaluate safety, dosing and efficacy of emricasan in NASH cirrhosis as an integral part of the company's initial registration strategy. The double-blind, placebo-controlled trial is being conducted at approximately 70 U.S. and EU clinical sites in approximately 240 patients with nonalcoholic steatohepatitis (NASH) who have compensated or early decompensated liver cirrhosis and severe portal hypertension confirmed by hepatic venous pressure gradient (HVPG) of ≥12 mmHg at baseline. "We were pleased to complete enrollment in the ENCORE-PH clinical trial on schedule," said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus.

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