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Consumer Healthcare

The development pathway of plant-derived medicinal products all have similar origins, and much of the initial work is the same regardless if the product is intended for use as a cosmeceutical, nutraceutical, or prescription-only botanical drug.  Additionally, products that are initially developed for the consumer and personal healthcare market may subsequently be investigated as a prescription-only botanical drug after filing of an IND with the shorter, less onerous route to market.  Phynova is developing a number of products in the consumer healthcare sector.  The products are all plants extracts from medicinal plants, and will be targeted at various markets worldwide.

(Amended from: Schmidt et al., 2007. Revisiting the ancient concept of botanical therapeutics. Nature Chemical Biology, 3(7): 360-366.)

Traditional Herbal Medicinal Products
The European market for herbal supplements and herbal medicines is currently estimated to be worth US$ 7.4 billion. However, under the new EU Traditional Herbal Medicinal Product Directive (THMPD), Directive 2004/24/EC, by April 2011 many of these products will no longer be able to be sold.  After April 2011, no industrially produced herbal product may remain on the market unless it has been registered or licensed. 

Registration of THMPs has many advantages, foremost is the ability to add label-claims to the product.  Previously, herbal product manufacturers could only list the ingredients/plant name from which the product was made, thereby being reliant upon consumer awareness as to the indication it was intended to treat.  Through the THMPD, these products will be sold alongside traditional over-the-counter (OTC) medicines and will be able to make similar indication and efficacy claims. 

Phynova has identified a significant opportunity to launch a range of registered traditional Chinese herbal products that will not only help fill the gap that will be created in the market by the removal of most TCM products in 2011, but also offer an appealing alternative to the few registered Western herbs that have currently been registered.  TCM is arguably the oldest and most famous traditional herbal medicine system in the world, and with the ability to add label claims to THMPs, the marketing opportunities are considerable.

Phynova is developing products across a number of OTC indications including colds and flu; stress, fatigue, joint care, pain relief, diarrhoea, and women’s health.  These THMP products are being developed primarily for the European market.

Relivergen™
Relivergen™ is a herbal extract aimed at promoting and improving liver health.  The liver is a vital organ and an intrinsic part of the body's detoxification, metabolism and digestion processes. There is currently no way to compensate for the absence of liver functions.  Poor diet, excessive alcohol, and a number of other factors and diseases can place a high level of stress on the liver and may result in fatty liver disease, steatohepatitis, cirrhosis, and even hepatocellular carcinoma.

Relivergen™ is a patented formulation consisting of a number of plant extracts selected for their detoxifying activity on the liver.  Clinical studies have shown that it effectively lowers the levels of liver enzymes associated with liver inflammation, often a precursor to many of the abovementioned diseases.  Phynova is looking to commercialise Relivergen™ in the USA, Asia, and some European countries.