Better Health. Better Life.

M Pharmaceutical Inc. Announces Findings From Previous Lead Pilot Study Showing C-103, A Proprietary Reformulation Of Orlistat, Eliminates 98% Of Orlistat’s Gastrointestinal Adverse Effects

VANCOUVER, B.C., CANADA (August 11th, 2016) - M Pharmaceutical Inc. (CSE:MQ, OTCQB: MPHMF, FWB:T3F2 ), (the "Company" or “M Pharma”), today announced the existing data from the historical research and pilot study as it relates to the recently acquired Chelatexx technology, referred to as the Company’s C-103 project.  In this study, C-103 was over 98% effective in eliminating the GI adverse events associated with orlistat.

In total, M Pharma has reviewed three pilot studies related to company’s recently acquired patented Chelatexx technology, each of which provides strong validation for the development of the C-103 reformulation of orlistat.

C-103 is a novel formulation of orlistat, patented until 2030 in the United States. Orlistat is FDA-approved for weight management and sold by Roche as Xenical® (prescription) and by GlaxoSmithKline as alli® (over-the-counter).  Orlistat is the best-selling weight loss medication of all time with peak sales of over $900 million in 2007, but use is limited by socially unacceptable bowel-related side effects (fecal incontinence, oily spotting, and flatus with discharge), which lead to 90% of patients stopping treatment in the first month of use. C-103 is a patented, proprietary combination of orlistat, simethicone and activated charcoal, which is designed to maintain the efficacy of orlistat while minimizing its bowel-related side effects. The drugs are not systemically absorbed, and all are approved by the FDA for OTC usage and have strong safety profiles.

The lead pilot study, “Chelatexx Test Agent for Decreased GI Adverse Events compared to Orlistat API” (Active Pharmaceutical Ingredient), was conducted by Ronald J. Thompson MD (Principal Investigator) and James M. Thompson (Secondary Investigator) in Cincinnati, Ohio. Highlights from the Study include:

  • FDA research has documented that over 90% of orlistat users have experienced adverse events like fecal incontinence, oily spotting and flatus with discharge
  • That 90% rate was significantly reduced to less than 2% when accompanied with our Chelatexx Technology over the course of the Study.
  • In terms of overall efficacy, the test agent in this pilot study was over 98% effective in eliminating the GI adverse events associated with orlistat.

The primary study objective was to demonstrate the effectiveness of C-103 in reducing bowel-related side effects compared to orlistat taken alone. The methodology was a single center, open label, pilot proof-of-concept study conducted over four weeks with ten subjects. The test agent was taken three times daily with meals over the study duration. All dosage components of the test agent were used in accordance with their approved labeling and indications for use.

In terms of overall efficacy, C-103 was over 98% effective in eliminating the GI adverse events compared to orlistat alone. In terms of safety overall, there are few serious safety concerns associated with orlistat therapy, and the majority of adverse events were gastrointestinal in nature and non-serious.

“We have known for several years now that the Chelatexx technology has the potential to significantly reduce the adverse events commonly experienced by consumers of orlistat,” said Mr. Gary Thompson, President of M Pharmaceutical USA, Inc.

Mr. Thompson added: “The evidence is there in the summary data of all three studies. FDA research has documented that over 90% of orlistat users have experienced adverse events like fecal incontinence, oily spotting and flatus with discharge. That 90% rate was significantly reduced to less than 2% when accompanied with our Chelatexx technology. Our objective is to formulate these technologies, orlistat & Chelatexx, into one Sequential Release Duel Compartment Capsule that maintains the efficacy of orlistat, but without the messy adverse events.”

“Building on the M Pharmaacquisition of the Chelatexx drug technology and the establishment of M Pharmaceutical USA Inc., our leadership team and board of directors continue to focus our energies toward delivering weight loss solutions that people can use safely and effectively. We are encouraged by these findings and aim to make this drug technology available to the growing global market of almost 2 billion adults who can benefit from weight loss solutions like C-103,” noted M Pharma President & CEO, Mr. Brian Keane.

About M Pharmaceutical Inc.
Formed in early 2015, M Pharmaceutical Inc. is a clinical-stage company developing innovative technologies for obesity and weight management.  In addition to its recent acquisition of C-103, a reformulation of Orlistat from Chelatexx, LLC, the Company will focus on the development of its Trimeo capsules, temporary controllable pseudobezoars for non-invasive gastric volume reduction for the treatment of obesity, for which it has exclusive rights. 

M Pharmatrades on the Canadian Securities Exchange (CSE) under the ticker symbol “MQ” as well as on the OTCQB as “MPHMF” and FWB (Frankfurt Stock Exchange) as “T3F2.”

For more information contact:
Investor Relations
Phone: +1 604 428 0511          
info@m-pharma.ca
www.m-pharma.ca

Notice regarding Forward Looking Statements: This news release contains forward-looking statements. The use of any of the words "anticipate", "continue", "estimate", "expect", "may", "will", "project", "should", "believe" and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because the Company can give no assurance that they will prove to be correct. This news release includes forward-looking statements with respect to the commercialization of the rights to the company’s biomedical & drug technologies.  Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. These statements speak only as of the date of this news release. Actual results could differ materially from those currently anticipated due to a number of factors and risks including various risk factors discussed in the Company's disclosure documents which can be found under the Company's profile on www.sedar.com and the Company’s filings to the CSE at www.cnsx.ca.  Such risk factors may cause the inability of the Company to successfully commercialize any of its biomedical technologies.

Notice regarding investigational devices: C-103 and Trimeo are investigational drugs or devices and are not currently available outside of approved clinical trials.  Claims regarding the safety and efficacy of these devices have not been evaluated by Health Canada, the U.S. Food and Drug Administration, or any other international regulatory body.  

VANCOUVER, B.C., CANADA (August 11th, 2016) - M Pharmaceutical Inc. (CSE:MQ, OTCQB: MPHMF, FWB:T3F2 ), (the "Company" or “M Pharma”), today announced the existing data from the historical research and pilot study as it relates to the recently acquired Chelatexx technology, referred to as the Company’s C-103 project.  In this study, C-103 was over 98% effective in eliminating the GI adverse events associated with orlistat.

 

In total, M Pharma has reviewed three pilot studies related to company’s recently acquired patented Chelatexx technology, each of which provides strong validation for the development of the C-103 reformulation of orlistat.

 

C-103 is a novel formulation of orlistat, patented until 2030 in the United States. Orlistat is FDA-approved for weight management and sold by Roche as Xenical® (prescription) and by GlaxoSmithKline as alli® (over-the-counter).  Orlistat is the best-selling weight loss medication of all time with peak sales of over $900 million in 2007, but use is limited by socially unacceptable bowel-related side effects (fecal incontinence, oily spotting, and flatus with discharge), which lead to 90% of patients stopping treatment in the first month of use. C-103 is a patented, proprietary combination of orlistat, simethicone and activated charcoal, which is designed to maintain the efficacy of orlistat while minimizing its bowel-related side effects. The drugs are not systemically absorbed, and all are approved by the FDA for OTC usage and have strong safety profiles.

 

The lead pilot study, “Chelatexx Test Agent for Decreased GI Adverse Events compared to Orlistat API” (Active Pharmaceutical Ingredient), was conducted by Ronald J. Thompson MD (Principal Investigator) and James M. Thompson (Secondary Investigator) in Cincinnati, Ohio. Highlights from the Study include:

 

·         FDA research has documented that over 90% of orlistat users have experienced adverse events like fecal incontinence, oily spotting and flatus with discharge

·         That 90% rate was significantly reduced to less than 2% when accompanied with our Chelatexx Technology over the course of the Study.

·         In terms of overall efficacy, the test agent in this pilot study was over 98% effective in eliminating the GI adverse events associated with orlistat.

The primary study objective was to demonstrate the effectiveness of C-103 in reducing bowel-related side effects compared to orlistat taken alone. The methodology was a single center, open label, pilot proof-of-concept study conducted over four weeks with ten subjects. The test agent was taken three times daily with meals over the study duration. All dosage components of the test agent were used in accordance with their approved labeling and indications for use.

 

In terms of overall efficacy, C-103 was over 98% effective in eliminating the GI adverse events compared to orlistat alone. In terms of safety overall, there are few serious safety concerns associated with orlistat therapy, and the majority of adverse events were gastrointestinal in nature and non-serious.

 

“We have known for several years now that the Chelatexx technology has the potential to significantly reduce the adverse events commonly experienced by consumers of orlistat,” said Mr. Gary Thompson, President of M Pharmaceutical USA, Inc.

 

Mr. Thompson added: “The evidence is there in the summary data of all three studies. FDA research has documented that over 90% of orlistat users have experienced adverse events like fecal incontinence, oily spotting and flatus with discharge. That 90% rate was significantly reduced to less than 2% when accompanied with our Chelatexx technology. Our objective is to formulate these technologies, orlistat & Chelatexx, into one Sequential Release Duel Compartment Capsule that maintains the efficacy of orlistat, but without the messy adverse events.”

 

“Building on the M Pharma acquisition of the Chelatexx drug technology and the establishment of M Pharmaceutical USA Inc., our leadership team and board of directors continue to focus our energies toward delivering weight loss solutions that people can use safely and effectively. We are encouraged by these findings and aim to make this drug technology available to the growing global market of almost 2 billion adults who can benefit from weight loss solutions like C-103,” noted M Pharma President & CEO, Mr. Brian Keane.

 

About M Pharmaceutical Inc.

Formed in early 2015, M Pharmaceutical Inc. is a clinical-stage company developing innovative technologies for obesity and weight management.  In addition to its recent acquisition of C-103, a reformulation of Orlistat from Chelatexx, LLC, the Company will focus on the development of its Trimeo capsules, temporary controllable pseudobezoars for non-invasive gastric volume reduction for the treatment of obesity, for which it has exclusive rights. 

 

M Pharmatrades on the Canadian Securities Exchange (CSE) under the ticker symbol “MQ” as well as on the OTCQB as “MPHMF” and FWB (Frankfurt Stock Exchange) as “T3F2.”

   

For more information contact:

Investor Relations

Phone: +1 604 428 0511          

info@m-pharma.ca

www.m-pharma.ca

 

Notice regarding Forward Looking Statements: This news release contains forward-looking statements. The use of any of the words "anticipate", "continue", "estimate", "expect", "may", "will", "project", "should", "believe" and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because the Company can give no assurance that they will prove to be correct. This news release includes forward-looking statements with respect to the commercialization of the rights to the company’s biomedical & drug technologies.  Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. These statements speak only as of the date of this news release. Actual results could differ materially from those currently anticipated due to a number of factors and risks including various risk factors discussed in the Company's disclosure documents which can be found under the Company's profile on www.sedar.com and the Company’s filings to the CSE at www.cnsx.ca.  Such risk factors may cause the inability of the Company to successfully commercialize any of its biomedical technologies.

 

Notice regarding investigational devices: C-103 and Trimeo are investigational drugs or devices and are not currently available outside of approved clinical trials.  Claims regarding the safety and efficacy of these devices have not been evaluated by Health Canada, the U.S. Food and Drug Administration, or any other international regulatory body.  

Drug Treatment Portfolio

Obesity, Weight Management Treatment

C-103 is a novel reformulation of orlistat, patented until 2030 in the U.S.  Orlistat is FDA-approved for weight management and sold by Roche as Xenical® (prescription) and by GlaxoSmithKline as alli® (over-the-counter).  Proven safe and effective in over 100 clinical trials, orlistat is the best-selling weight loss medication of all time with peak sales over $900 million in 2007.  The C-103 reformulation addresses adverse events reported by over 90% of orlistat users. These adverse events have led to the decline in Orlistat sales to approximately $200 million in recent years. 

C-103 is intended to maintain the efficacy of orlistat while minimizing its socially unacceptable adverse events. Unlike other weight loss drugs:

  • Orlistat is not an amphetamine
  • Orlistat does not affect the central nervous system
  • Orlistat is not systemically absorbed
  • Orlistat is the only FDA-approved OTC weight loss drug because of its safety
  • Orlistat is the only FDA-approved weight loss drug for adolescent patients (age 12-18)

Infertility Treatment

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ToConceive is a women’s health treatment supported by a FDA 510K clearance and is protected by four USPTO patents. ToConceive’s proven ability to increase a woman’s natural production of transudate results in significantly higher success rates for couples trying to conceive, without the added expense, or stress, associated with assisted reproduction treatments.