Novel Botanical Drug

Sandalwood Album Oil (SAO) is a complex mixture of small-molecular weight compounds, mostly sesquiterpenoids, derived from the distillation of the tree heartwood. The main components are two isomers, alpha- and beta-santalol which together comprise about 70% of the oil. Cultivated sandalwood trees, a hemi-parasitic species, take up to 15 years to mature and wild grown trees can take 50 years to reach an oil-bearing level of maturity.

SAO has been used for thousands of years in Asia as a traditional medicine. It’s been, applied topically for a range of skin conditions, as well as used orally for urinary tract infections and other systemic conditions.

SAO was extensively used in Western medicine as “Oleum santali” prior to the advent of antibiotics and was listed as such in both the US and British Pharmacopeias. Santalis is working towards re-establishing monograph specifications for Quintis’ pharma-grade SAO.

Quintis is the world’s only supplier of SAO that is acceptable to the US FDA for use in human clinical trials. The oil is produced under cGMP from sustainably-grown, commercially cultivated Santalum album trees and is fully compliant with international ISO specifications for the oil. Quintis leads the industry in responsible, ethical stewardship of the environment and has received numerous awards for its agricultural and manufacturing practices and maintains ISO 14,001 (environmental), 9,001 (Quality) and AS/NZ 4,801 (Health & Safety) standards across its operations.

In contrast, wild grown sandalwood from India is now either governmentally restricted or illegal to export, is considered a vulnerable species, and SAO from wild-grown trees is NOT allowed by FDA for use pivotal clinical trials or prescription drugs.

Today, SAO is an ideal candidate for development under FDA’s 2016 Botanical Drug Development Guidelines, due to its stability, batch consistency and ease of formulation.

Synthesis of the primary sandalwood oil components is difficult, expensive, and would not be supported under FDA botanical guidelines which focus on the use of defined mixtures as the drug substance, not the underlying active ingredient. Any single purified SAO component would need to be developed as a New Chemical Entity (NCE) and would be required to undergo costly and time-consuming preclinical and Phase 1 clinical development prior to entering advanced clinical trials.

In addition to the rigorous quality standards, Quintis’ supply control is a significant barrier to entry for potential competitors, due to the time required, difficulty and cost of sandalwood cultivation. This supply control minimizes the impact of intellectual property issues that typically preclude obtaining meaningful patent coverage for natural botanical substances.