IP based drug with a short approval pathway, to address unmet needs of millions of patients worldwide.
Novadiol, Inc. is a C-Corporation that was incorporated in the State of Kansas on June 7, 2012. Its offices are located at 6425 Nieman Road, Shawnee Mission, KS 66203. Novadiol was formed to develop and globally market a vitamin D compound. G.P. Georges is the CEO and he has nearly 30 years of experience in the pharmaceutical industry. He is the owner of two successful companies: NephroTech Inc., a dialysis products firm, and NephroTech 1, LLC, a Calcium products firm.
The Problem We Solve
According to the National Kidney Foundation and the CDC, over 20 million US patients suffer from CKD just in the US. Over 4 MM of these patients have stage 3 or 4 CKD and suffer from SHPT. The incidence rates for SHPT in our other chosen markets are similar to those in the US. Hypovitaminosis D (Hypo-D), defined as 25OHD insufficiency/deficiency in the blood typically afflicts a third of the population in the US, EU, Australia and Japan. Thus just in Australia, the patient population is estimated at around 5.5 MM. Each of these markets represents significant opportunities even with low, conservative pricing. Currently patients take high daily doses of Vitamins D2 or D3 to treat Hypo-D, which show limited efficacy in raising 25OHD blood levels. Similarly in SHPT treatments, the current standard of care typically includes 1,25D analogues, which can cause imbalances in the calcium and phosphorus metabolism. Novadiol’s IP based product delivers a reliable, therapeutically effective increase in 25OHD without the side effects of the 1,25 analogues in SHPT or the variability of Vitamin D2 and D3 in Hypo D patients respectively. Cost effective, with a long duration of action, our therapy is a first-in-class for the SHPT/Hypo-D market aimed at delivering compliance and efficacy at a competitive, payer friendly price point, while generating significant profitability for our stakeholders.
Traction & Accomplishments
Novadiol is pursuing an IP based, 505(b)(2) NDA pathway in the USA. Our US NDA is expected to be filed in 2018-19 with approval and commercial launch in 2019-20. Because of the well researched, science based evidence of the clinical efficacy of our molecule Novadiol is in late stages in one of our other chosen markets. We are pursuing our CMC development with a leading CMO and we expect to file a NDA in this market in 2015. We expect to commercialize in this market in 2016 via partners. Our global development cost is expected to be $15 – $20 MM of which a substantial portion could be generated by out-licensing revenues from our late stage markets.
We are currently preparing our IND package in the U.S, and our Dossier in foreign jurisdictions.