Fero Industries, Inc. is a publicly traded holding company (OTC BB: FROI.OB). Fero's mission is to acquire healthcare related companies, products, and technologies that have large market potential, improve the quality of care, or have unmet needs.
Fero's initial focus is on diabetes. The Company has acquired the intellectual property and other exclusive world-wide rights related to the production, marketing, and distribution of Sucanon®, also known as Diab II, a treatment for Type II diabetes, and Pharmaroth SA de CV, a company incorporated in Mexico which markets and distributes Sucanon® in Mexico and Latin America.
Sucanon® is a member of a class of diabetic medications called insulin sensitizers. Insulin sensitizers lower blood sugar by increasing the muscle, fat and liver's sensitivity to insulin. Insulin sensitizers are blood sugar normalizing or euglycemic drugs that help return the blood sugar to the normal range without the risk of low blood sugars. Fero's strategy is to extend its product offering by acquiring other products in the bioceutical market place.
Sucanon® has undergone clinical trials in China and Brazil. Sucanon® is approved and is sold as an Over-The-Counter ("OTC") herbal remedy for Type II diabetes in Mexico and as an Rx pharmaceutical in Peru. Application for United States FDA approval of Sucanon® has not been made. As such, it is not offered for sale nor approved for sale in the United States at this time. The Company will consider applying for FDA approval in the near future.
Mission Fero Industries, Inc. will acquire companies, products, and technologies that have large market potential, improve the quality of care, or have unmet needs.
Fero Industries, Inc. is a publicly traded (OTC BB: FROI.OB) holding company focused on the medical device, biotechnology, pharmaceutical, nutraceutical, and healthcare IT industries. Fero's mission is to create and enhance shareholder value via a growth-by-acquisition strategy by acquiring synergistic companies, products, and technologies that have large market potential, improve the quality of care, or have unmet needs.
The current economic situation has provided many companies with an excellent opportunity to grow via acquisition.
Fero has initiated its strategy by acquiring the intellectual property and other rights related to the production, marketing, and distribution of Sucanon®, also known as Diab II, a treatment for Type II diabetes and Pharmaroth SA de CV, a company incorporated in Mexico which markets and distributes Sucanon® in Mexico and Latin America.
With this acquisition completed, Fero's strategy is to expand its product offering by acquiring other products in the nutraceutical market place.
Fero's growth-by-acquisition strategy is critical to its current operations. Growing an existing business using strategies to increase sales and improve operations (i.e., organic growth) should be a constant, on-going goal of any business.
The benefits of growing through acquisition include:
- Acquisitions can produce desired growth results much quicker than traditional organic growth strategies.
- Effective means of developing a competitive advantage by acquiring companies to address existing weaknesses or needs.
- Proven method of rapidly growing sales and income by acquiring new customers.
- Strategic acquisitions can be an effective means to diversify your customer base and/or enter new markets to reduce reliance on any one customer or industry.
- Acquisitions can be accomplished on a leveraged basis with financing to produce a return-on-investment superior to traditional organic growth results.
- Acquiring a business can be an excellent way to develop a competitive advantage.
- Acquiring a niche competitor providing a related service that your business doesn't currently offer can provide an immediate competitive advantage.
- Acquisition of another business can be an effective means of quickly increasing revenue and income while strategically adding customers to diversify your customer base.
In summary, the combination of the following key parameters differentiates Fero from other companies on the market:
- To maximize benefits to shareholders, our corporate focus is devoted to the acquisition of synergistic companies, products, and technologies which brings value added revenue and market opportunities.
- Fero has an experienced Management Team and Advisory Board directing all activities.
- A pipeline of potential acquisition candidates.
- Well-implemented strategy of acquiring candidates which have large market potential and significant.
- Highly flexible organization and low fixed overheads due to our innovative outsourcing strategy.
- Highly professional approach characterized by swift, responsive and well thought out decision-making and ability to redirect business efforts quickly and at low cost, to maximize partnering activities.
In 2000, according to the World Health Organization, at least 171 million people worldwide suffer from diabetes, or 2.8% of the population.
The incidence of diabetes mellitus in Mexico will have risen 40% by the year 2012, killing over 100,000 Mexicans during that year, according to Jose Angel Cordova Villalobos, Health Secretary, Mexico.
Only 68 percent of U.S. diabetics are diagnosed, according to the American Diabetes Association, an advocacy group based in Alexandria, Virginia. Some 5.7 million Americans don't know they have the disease, the association said.
What is Diabetes?:
Diabetes is a condition in which a person has a high blood sugar (glucose) level, either because the body do not produce enough insulin, or because body cells do not properly respond to the insulin that is produced. Insulin is a hormone produced in the pancreas which regulates glucose. Insulin enables body cells to absorb glucose and to convert it into turn into energy. If the body cells do not absorb the glucose, the glucose accumulates in the blood (hyperglycemia), leading to vascular, nerve, and other complications.
There are many types of diabetes the most common of which are:
- Type I Diabetes (previously called insulin-dependent diabetes mellitus (IDDM) or juvenile-onset diabetes): results from the body's failure to produce insulin, and presently requires the person to inject insulin.
- Type II Diabetes (previously called non-insulin-dependent diabetes mellitus (NIDDM) or maturity-onset diabetes): results from insulin resistance, a condition in which cells fail to use insulin properly, sometimes combined with an absolute insulin deficiency.
The disease mechanisms in Type II diabetes are not wholly known, but some experts suggest that it may involve the following three stages in most patients:
- The first stage in Type II diabetes is the condition called insulin resistance; although insulin can attach normally to receptors on liver and muscle cells, certain mechanisms prevent insulin from moving glucose (blood sugar) into these cells where it can be used. Most Type II diabetics produce variable, even normal or high, amounts of insulin, and in the beginning this amount is usually sufficient to overcome such resistance.
- Over time, the pancreas becomes unable to produce enough insulin to overcome resistance. In Type II diabetes the initial effect of this stage is usually an abnormal rise in blood sugar right after a meal (called postprandial hyperglycemia). This effect is now believed to be particularly damaging to the body.
- Eventually, the cycle of elevated glucose further impairs and possibly destroys beta cells, thereby stopping insulin production completely and causing full-blown diabetes. This is made evident by fasting hyperglycemia, in which elevated glucose levels are present most of the time.
All forms of diabetes have been treatable since insulin became medically available in 1921. Type II diabetes can be controlled with tablets, but it is a chronic condition that usually cannot be cured.
Diabetes without proper treatments can cause many complications. Acute complications include hypoglycemia, diabetic ketoacidosis, or non-ketotic hyperosmolar coma. Serious long-term complications include cardiovascular disease, chronic renal failure, and retinal damage.
Sucanon®...Diabetes is not curable but is treatable...enjoy life™
The increase in the total population of diabetics, may raise total U.S. sales of insulin and oral type 2 diabetes therapies to $24.4 billion, from $10.3 billion in 2008.
What is Sucanon®
Sucanon® is one of only several drugs approved in the world, belonging to a class of diabetic medications called insulin sensitizers. Insulin sensitizers lower blood sugar by increasing the muscle, fat and liver's sensitivity to insulin. Insulin sensitizers are blood sugar normalizing or euglycemic drugs that help return the blood sugar to the normal range without the risk of low blood sugars.
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1. Insulin binding to receptors and entering the cell, (which is impeded in NIDDM patients), is essential for the uptake of glucose 2. Sucanon® increases the binding of insulin to its receptors 3. Sucanon® increases the internalization of insulin 4. As a result, Sucanon® increases the intracellular level of insulin, which then increases the uptake of glucose.
Sucanon® is a medication that helps the body make better use of its own insulin, the hormone that controls blood sugar levels. Type II Diabetics produce insulin, but their cells gradually lose the ability to absorb and use insulin, to get sugar out of the blood stream. Sucanon® transports sugar out of the blood stream and into cells where it can be burned. Sucanon® particularly helps muscle cells use insulin and thus draw sugar out of the blood stream.
Sucanon® increases sensitivity to insulin which leads to decreased blood sugar levels and a reduction of a wide range of Type II Diabetes symptoms, including: weight gain, fatigue, excess thirst and excess urination. The reduction in blood sugar levels also reduces the possibility of peripheral nerve damage; the damage caused to peripheral nerves by chronic high blood sugar can ultimately lead to impotence in men and amputation of limbs in both men and women.
Clinical Trial Summary:
Clinical trials on Sucanon® were performed in China. After submission of a New Drug Application ("NDA") Sucanon® was approved by the Chinese Food and Drug Administration ("FDA"). Subsequent clinical trials were also performed on Sucanon® in Brazil. The Brazilian study showed that equivalent clinical activity occurs in a non-Asian population.
Sucanon® clinical trials (see Clinical Results for more detailed information on trial results) were shown to reduce the problems and symptoms of Type II Diabetes:
High blood sugar: Clinical studies have shown that Sucanon® reduces blood sugar readings by about 25% - 30% and brings high blood sugar back into the normal range (non-fasting blood sugar is above 200 mg/dL (milligrams per deciliter) or fasting blood sugar is above 126 mg/dL).
Fatigue: Clinical studies have shown that Sucanon® reduces fatigue. Fatigue is a frequent symptom of Type II Diabetes or a pre-diabetic condition called Impaired Glucose Tolerance.
Weight gain: Clinical studies have shown that people who have taken Sucanon® report weight loss along with increased energy. Very often, people who are diabetic or pre-diabetic gain weight because their insulin-resistance is leading to sugar being converted into fat instead of being burned to produce energy.
Excess thirst and urination: Clinical studies have shown that Sucanon® reduces excess thirst and excess urination. Higher-than-normal levels of blood sugar instigate thirst, which in turn leads to increased frequency of urination.
High cholesterol and triglyceride levels: Clinical studies have shown that Sucanon® reduces the levels of cholesterol and triglycerides. People who are diabetic or pre-diabetic often have elevated cholesterol and triglyceride levels. Elevated cholesterol and triglycerides significantly increase the risk of heart disease.
Side effects: Clinical studies have shown that Sucanon® showed no side effects. This sets Sucanon® apart from many other anti-diabetic products, which can have effects on digestion, the liver, or the heart.
Toxicity: Clinical studies have shown that Sucanon® toxicity was undistinguishable from the placebo. In addition, Sucanon® showed no carcinogenicity, mutagenicity, and teratogenicity in mice.
The clinical benefits of Sucanon were convincingly demonstrated in a double-blind, randomized, placebo- & Glibenclamide controlled, multi-center, efficacy and safety study in 370 adult patients with Type II diabetes. DIAB IIT" was administered as tablets, one in the morning and one in the evening. The duration of the study was 6 months; four months treatment, preceded by one month screening evaluation, and followed by one month post-treatment follow-up. Glibenclamide is a commonly prescribed sulfonylurea, its benefits and limitations have been well known to diabetologists for over a decade. The parameters of response to therapy included an evaluation of the changes in clinical signs and symptoms of diabetes, an alteration in the blood and urine measurements of glucose metabolism, and an alteration in blood lipid levels.
The results indicated that the parameters of disease activity in patients receiving either Glibenclamide or Sucanon responded in a highly relevant clinical manner and that the differences from baseline measurements were statistically highly significant (p values <0.01). The lack of response in the group of patients who were randomized to receive placebo was also unequivocal, where the effect of administration was clinically small or non-existent, and the baseline to treatment difference was statistically insignificant (p value >0.05). An extract of the data is summarized in the following graphs and tables.
Changes in glucose abnormalities in 370 Type II diabetic patients in 3 treatment groups of the randomized, double-blind, controlled study (before treatment and at the end of treatment analyses)
Results from table 1 expressed as "Percent Improvement" (baseline to end of treatment)
Response to therapy was documented not only by a loss of, or a reduction in, disease related symptoms which included polyuria, polvdipsia, polyphagia, and fatigue, but also by the improvement in objective parameters of disease, namely, a reduction to normal or near normal levels in the elevated fasting blood glucose, and urinary sugar, and a normalization of the 100 g - oral glucose tolerance test. The objective results are given in table 1 above where the mean and standard deviations for these Values are listed, as well as the calculated "t" and "p" values. Given that the coefficient of variance of baseline values for the three treatment groups is small, and the patient number per group relatively large (n = 123), a between treatment group comparison is not unreasonable. These calculations (not shown) reveal that the improvements associated with therapy for both the Glibenclamide group of patients and the Sucanon™ group of patients were hoth better than placebo for all objective parameters measured, to a level that was statistically significant (p Values <0.05 to <0.01 respectively. This was not surprising from the t values listed in table 1. The difference in reduction of fasting blood glucose between the latter treatment groups was not statistically significant (p value >.0.05).
Sucanon associated improvements in blood lipid levels
Pre-clinical in vivo and in vitro studies have identified that intravenous and oral Sucanon™ is pharmacodynamically active in diabetic rats, and out-performed all biguanides and sulfonylureas tested in those models. When added to rat muscle cells, its critical influence commences in seconds as it up-regulates insulin receptors, in a manner not yet understood, With the resultant increase in insulin endocytosis, uptake of glucose and L-leucine effects which last more than an hour.
In single-dose rat studies, peak response in lowering blood glucose takes 2 to 4 hours to occur, and the effect is lost by about 10 hours. Multiple oral dosing in rats (48 davs) and up to 4 months in man, shows no loss of activitv. Clear-cut pharmacological dose-response features were documented. Sucanon™ is also superior to other hypoglycemic agents in these models.
The therapeutic index is so large (10,000 in mice) that its margin of safety must be unique in the armamentarium of drugs for the treatment of diabetes. Carcinogenicity, mutagenicity, and teratogenicity toxicities were not found in mice. Chronic dosing in dogs and rats at 2000 times the therapeutic dose was free of any toxicity.
Sucanon® Regulatory Approvals:
Sucanon® has been approved for prescription sale in Peru and has been approved as an over-the-counter (non-prescription) product in Mexico. Application for United States FDA regulatory approval has not yet been made. Thus, doctors cannot prescribe nor purchase Sucanon® in the United States. However, Type II diabetics can buy Sucanon® for their own use and have it delivered to them from Mexico under the U.S. FDA's "personal importation" guidelines. A similar program exists for Type II diabetics in Canada who wish to buy Sucanon® for their own use.
FROI goes dark: http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=8994190
| Market Value1 || $1,200,600 || a/o Dec 10, 2011 |
| Shares Outstanding || 149,350,000 || a/o Dec 10, 2011 |
| Float || N/A |
| Authorized Shares || N/A |
| Par Value || 0.0010 |
AMENDED ARTICLES OF INCORPORATION
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