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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Please Note: FinancialBuzz.com is not a financial advisory or advisor, investment advisor or broker-dealer and do not undertake any activities that would require such registration. The information provided on http://www.FinancialBuzz.com (the 'Site') is either original financial news or paid advertisements provided [exclusively] by our affiliates (sponsored content), FinancialBuzz.com, a financial news media and marketing firm enters into media buys or service agreements with the companies which are the subject to the articles posted on the Site or other editorials for advertising such companies. We are not an independent news media provider and therefore do not represent or warrant that the information posted on the Site is accurate, unbiased or complete. FinancialBuzz.com receives fees for producing and presenting high quality and sophisticated content on FinancialBuzz.com along with other financial news PR media services. FinancialBuzz.com does not offer any personal opinions, recommendations or bias commentary as we purely incorporate public market information along with financial and corporate news. FinancialBuzz.com only aggregates or regurgitates financial or corporate news through our unique financial newswire and media platform. For Breathtec Biomedical Inc. financial news dissemination and PR services, FinancialBuzz.com expects to be compensated five thousand dollars by the company. Our fees may be either a flat cash sum or negotiated number of securities of the companies featured on this editorial or site, or a combination thereof. The securities are commonly paid in segments, of which a portion is received upon engagement and the balance is paid on or near the conclusion of the engagement. FinancialBuzz.com will always disclose any compensation in securities or cash payments for financial news PR advertising. FinancialBuzz.com does not undertake to update any of the information on the editorial or Site or continue to post information about any companies the information contained herein is not intended to be used as the basis for investment decisions and should not be considered as investment advice or a recommendation. The information contained herein is not an offer or solicitation to buy, hold or sell any security. FinancialBuzz.com, members and affiliates are not responsible for any gains or losses that result from the opinions expressed on this editorial or Site, company profiles, quotations or in other materials or presentations that it publishes electronically or in print. Investors accept full responsibility for any and all of their investment decisions based on their own independent research and evaluation of their own investment goals, risk tolerance, and financial condition. FinancialBuzz.com. By accessing this editorial and website and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy, as may be amended from time to time. None of the content issued by FinancialBuzz.com constitutes a recommendation for any investor to purchase, hold or sell any particular security, pursue a particular investment strategy or that any security is suitable for any investor. This publication is provided by FinancialBuzz.com. Each investor is solely responsible for determining whether a particular security or investment strategy is suitable based on their objectives, other securities holdings, financial situation needs, and tax status. You agree to consult with your investment advisor, tax and legal consultant before making any investment decisions. We make no representations as to the completeness, accuracy or timeless of the material provided. All materials are subject to change without notice. Information is obtained from sources believed to be reliable, but its accuracy and completeness are not guaranteed. For our full disclaimer, disclosure and Terms of Use, please visit: http://www.financialbuzz.com .
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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)
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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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FinancialBuzz.com, a leading financial news informational web portal designed to provide the latest trends in Market News, Investing News, Personal Finance, Politics, Entertainment, in-depth broadcasts on Stock News, Market Analysis and Company Interviews. A pioneer in the financially driven digital space, video production and integration of social media, FinancialBuzz.com creates 100% unique original content. FinancialBuzz.com also provides financial news PR dissemination, branding, marketing and advertising for third parties for corporate news and original content through our unique media platform that includes Newswire Delivery, Digital Advertising, Social Media Relations, Video Production, Broadcasting, and Financial Publications.
Please Note: FinancialBuzz.com is not a financial advisory or advisor, investment advisor or broker-dealer and do not undertake any activities that would require such registration. The information provided on http://www.FinancialBuzz.com (the 'Site') is either original financial news or paid advertisements provided [exclusively] by our affiliates (sponsored content), FinancialBuzz.com, a financial news media and marketing firm enters into media buys or service agreements with the companies which are the subject to the articles posted on the Site or other editorials for advertising such companies. We are not an independent news media provider and therefore do not represent or warrant that the information posted on the Site is accurate, unbiased or complete. FinancialBuzz.com receives fees for producing and presenting high quality and sophisticated content on FinancialBuzz.com along with other financial news PR media services. FinancialBuzz.com does not offer any personal opinions, recommendations or bias commentary as we purely incorporate public market information along with financial and corporate news. FinancialBuzz.com only aggregates or regurgitates financial or corporate news through our unique financial newswire and media platform. For Breathtec Biomedical Inc. financial news dissemination and PR services, FinancialBuzz.com expects to be compensated five thousand dollars by the company. Our fees may be either a flat cash sum or negotiated number of securities of the companies featured on this editorial or site, or a combination thereof. The securities are commonly paid in segments, of which a portion is received upon engagement and the balance is paid on or near the conclusion of the engagement. FinancialBuzz.com will always disclose any compensation in securities or cash payments for financial news PR advertising. FinancialBuzz.com does not undertake to update any of the information on the editorial or Site or continue to post information about any companies the information contained herein is not intended to be used as the basis for investment decisions and should not be considered as investment advice or a recommendation. The information contained herein is not an offer or solicitation to buy, hold or sell any security. FinancialBuzz.com, members and affiliates are not responsible for any gains or losses that result from the opinions expressed on this editorial or Site, company profiles, quotations or in other materials or presentations that it publishes electronically or in print. Investors accept full responsibility for any and all of their investment decisions based on their own independent research and evaluation of their own investment goals, risk tolerance, and financial condition. FinancialBuzz.com. By accessing this editorial and website and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy, as may be amended from time to time. None of the content issued by FinancialBuzz.com constitutes a recommendation for any investor to purchase, hold or sell any particular security, pursue a particular investment strategy or that any security is suitable for any investor. This publication is provided by FinancialBuzz.com. Each investor is solely responsible for determining whether a particular security or investment strategy is suitable based on their objectives, other securities holdings, financial situation needs, and tax status. You agree to consult with your investment advisor, tax and legal consultant before making any investment decisions. We make no representations as to the completeness, accuracy or timeless of the material provided. All materials are subject to change without notice. Information is obtained from sources believed to be reliable, but its accuracy and completeness are not guaranteed. For our full disclaimer, disclosure and Terms of Use, please visit: http://www.financialbuzz.com .
For further information: Media Contact: [email protected] +1-877-601-1879
URL: http://www.FinancialBuzz.com
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