Market

The Reformulated Drug Market

Blockbuster Territory

About 1/3rd of Blockbuster drugs (Drugs with annual sales over $1B) are reformulations of earlier versions of the same drug. There is an increasing trend in reformulating or re-purposing older drugs which are sub-optimal.  This is because of the considerably lower cost & time of development and a much lower risk, when compared to novel drugs.

While there are several drug delivery technologies, none have the promise and versatility of Nano drug delivery systems. NanoSystems are cutting edge drug delivery systems that potentially can improve a large proportion of the currently approved drugs which are sub-optimal because of poor water solubility and/or poor absorption into the body.

Despite a large-number of sub-optimal drugs, only 13 Nanodrugs have been approved thus far, thereby presenting a significant opportunity to reformulate them as Nanodrugs and generate superior clinical benefits of existing versions. Since, Pharmaceutical markets are data-driven markets, such clinically superior Nanodrugs present an opportunity to redefine the market shares of most small molecule drugs – A significant market opportunity in a trillion dollar global pharma market.

In addition to reformulation and re-purposing already approved drugs, we expect several NanoCanabinoids to be developed over the next few years with many having blockbuster potential. One of our key mandates is to be leading players in the field and to safely deliver NanoCanabinoids as an alternative to many traditional medicines such as opiates, which are currently considered over prescribed and potentially life-threatening.

The most noteworthy and successful nanoformulation thus far is  TriCor, which is a Nano reformulation of Fenofibrate. Approved as a cholesterol lowering drug, but its blood levels vary depending on whether taken with or without food, this limited its market potential to less than $200 million in annual sales. Making a nanoformulation eliminated  food variability and made TriCor into a >$1 Billion drug.

Case Study – Elan Pharma: Elan was the leading nanoformulation company and successfully re-formulated the majority of the 13 approved nano-products approved by the US FDA. Elan sold its delivery business to Alkermis for $980 Million in 2011.

NewGen’s  15+ successful nanoformulations thus far, plus an ability to reformulate several more, especially Cannabinoids, establish the potential of NewGen’s MNP platform and creates a solid investment opportunity to participate in the upside presented by Nanomedicine and Cannabinoids.

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