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KidneyX Phase 2 Proposal

About Us

Supported by Visionary & Distinguished Nephrologists and Scientists

SYMPOSIUM AT THE INTERNATIONAL SOCIETY OF ARTIFICIAL INTERNAL ORGANS IN EDINBURGH, SCOTLAND. Aug 04, 1999

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Kibow® Biotech was established in 1997 by its scientific founder, Dr. Natarajan Ranganathan, and is currently located in Newtown Square, PA (a western suburb of Philadelphia). Although initially established as a drug development entity, due to technological, FDA regulatory hurdles and other challenges, Kibow® transitioned to a successful dietary supplement company. Yet the company has accomplished a pharmaceutical-like development and validation for their proprietary Probiotic/Prebiotic formulations for chronic kidney failure and general wellness purposes. Kibow® is best known for its animal (Azodyl®) and human (Renadyl™) probiotic dietary supplements for kidney failure, as well for its’ general immune and general wellness probiotic supplements, Kibow Flora™ and the multifiber product Kibow Fortis®. Guided by an outstanding group of internationally recognized scientific advisory board members, Kibow® has provided affordable breakthrough dietary supplement products for patients who might otherwise have limited access to kidney transplants, dialysis, or cost-prohibitive drugs.

Kibow® has mostly financed itself – initially with Founders/Family/Friends and subsequently from highly competitive SBIR phase I and II fast-track dual back to back grant awards from NIDDK-NIH and Qualifying Therapeutic Discovery Project (QTDP) Programs. Additionally, the company also obtained a USAID grant funding allocated to India but used exclusively for the US R&D operations and product development on a conditional basis. The company’s breakthrough happened with its substantial licensing income plus royalties derived (since July 2006) from Vetoquinol SA (VETO, a publicly-traded European veterinary company in France). By 2018, end-market sales for Vetoqiunol’s veterinary product, AZODYL®, reached $10 million in the USA and Canada.

Our Mission

The highly specific probiotic strains and chosen prebiotic ingredients in Renadyl™ are “Generally Recognized as Safe (GRAS) by US FDA.” Hence US FDA approval is not required for Renadyl™, Kibow Flora®, and Kibow Fortis® marketed as dietary or health supplement products. The company has also performed three distinctly different human observational clinical trials on its flagship product Renadyl™, to demonstrate the safety and efficacy of the product. All data and clinical findings have been published in peer-reviewed clinical/ medical journals (https://kibowbiotech.com/rd/and https://kibowbiotech.com/journal-publications/).

Renadyl™ - Human Product

Since April 1st, 2010, Kibow® Biotech’s human product Renadyl™ has been marketed directly via the Company’s global e-commerce site (https://kibowbiotech.com/our-products/and on Amazon. The various products are classified as dietary supplements intended to help promote healthy kidney function, improve immune/intestinal health and general wellness, strictly adhering to US FDA and FTC* guidelines. At present, Kibow® has engaged aggressively in its core activity of selling scientifically developed and clinically tested probiotic and prebiotic formulations via Amazon and our e-commerce on-line web store and other social and digital media advertising sources. 

Natarajan Ranganathan

Kibow® has also established an exclusive license agreement with Centaur Pharmaceutical for marketing Renadyl™ in India and several other non or semi-regulated countries where it has already established active distribution and marketing of its current portfolio of products. Centaur Pharmaceuticals Pvt. Limited., with over 3000 employees and 600 distributors, is in Mumbai, India. In 1978, Centaur Pharmaceuticals commenced pharmaceutical manufacturing operations in Mumbai and has now evolved into a vertically integrated pharmaceutical company. Centaur has a strong matrix of capabilities across the pharmaceutical value chain, including API, formulations, Contract Research and Manufacturing Services, Clinical Research, R&D, regulatory, and marketing (https://www.centaurpharma.com/about-us/).

Kibow® has mostly financed itself – initially with Founders/Family/Friends and subsequently from highly competitive SBIR phase I and II fast-track dual back to back grant awards from NIDDK-NIH and Qualifying Therapeutic Discovery Project (QTDP) Programs. Additionally, the company also obtained a USAID grant funding allocated to India but used exclusively for the US R&D operations and product development on a conditional basis. The company’s breakthrough happened with its substantial licensing income plus royalties derived (since July 2006) from Vetoquinol SA (VETO, a publicly-traded European veterinary company in France). By 2018, end-market sales for Vetoqiunol’s veterinary product, AZODYL®, reached $10 million in the USA and Canada.

Kibow® Biotech’s R&D, marketing, and administrative teams currently consist of 14 full-time and two part-time employees. The raw materials and the final products are contract-manufactured in USFDA/GMP approved facilities located in Madison, WI, and ADH Health at Congers, NY, respectively. Hence, Kibow® is proud to proclaim that all their product ingredients and flagship products are made in the USA. Kibow® Biotech’s dietary supplement company has been steadily growing year after year with increasing revenues and profitability. The company’s kidney health supplement is poised to generate closer to $30M with about 50% gross margin in the next three to five years. Although the kidney health supplement Renadyl™ has been developed with Pharma-like validation over two decades, the potential use of these products is limited by the US FDA/FTC regulations, as no healthcare or disease treatment claims can be made.

Additionally, these products, as dietary supplements, are not qualified to garner medical reimbursement. Given these limitations and a desire to reach and help more Chronic Kidney Patients, Kibow® is divesting to get an IND Approval for the currently marketed Renadyl™. However, the company will also perform additional R&D for a new generation of products. This is mainly to address the additional needs of patients with CKD: A.) 40% of CKD patients suffer from gout and B.) many hemodialysis and peritoneal dialysis patients suffer from C-Diff infections related to hospital infection and frequent readmission processes. The company will also devote substantial R&D with this proposed new generation of products. 

The right time and sudden awareness have just begun towards addressing the long-neglected and costly kidney disease in the USA and as well worldwide. 

Change is the law of life in all aspects, whether it is personal or professional, and as well, business strategy matters. Those who look only to the past or present are certain to miss the future opportunities. Hence, timing is most certainly one of the critical elements of operating a profitable business– especially when launching a new enterprise or product, or the repositioning of a company in the marketplace. Generally, in personal or professional life, one can precisely control the timing on several matters or aspects. However, achieving the right timing in a business endeavor is not something that can happen easily or quickly. What one can do, however, is make a concerted effort to anticipate when it might arrive – and be ready to take full advantage of it the moment it does. After twenty-two years of successful business operations as a kidney health dietary supplement company, the timing has finally come for Kibow®. Hence Kibow® is transitioning to a pharmaceutical drug, ultimately reaching out, accomplishing, and achieving the multi-billion-dollar business potential with its novel and breakthrough “Enteric Dialysis®” platform technology. This improved revolutionary generation of product formulation is a continuation of its two decades of pharma like clinically validated platform technology. The founder and his team – i.e., current employees, the scientific advisors, and board of directors strongly support this transition process, and the entire Kibow® team strongly believes this can be accomplished by Jan 2023.

 
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