Natural Products: A New Golden Age in Drug Development?
This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.
We live in a time of miracles and wonders, where a return to nature holds the promise of a new golden age of drug development for the benefit of patients in the US and globally.
From the vast environmental biomes around the world to our own Microbiome, scientists are studying novel approaches to defend the body against growing public health threats like diabetes, heart disease and cancer and persistent tropical illnesses like malaria and tuberculosis.
Renewed study of natural products appears extraordinarily promising – so long as we maintain patent incentives needed for investment in their commercial development.
In the late 20th century, pharmaceutical companies largely scaled back on natural products development – repelled by legal uncertainties associated with bioprospecting, and attracted by the prospect of combinatorial chemistry, which enabled the creation of enormous collections of synthetic compounds from which drug candidates would then be identified through high-throughput screening. With diminishing returns from such drug discovery strategies, academic and commercial researchers now are using 21st century analytic tools to gain transformational insights into natural compounds from microbial, plant and animal sources. At the University of Michigan, scientists are researching the therapeutic potential of natural products with support from ever-expanding genomics capabilities, ‘big data’ bioinformatics, capabilities, mass spectrometry, X-ray crystallography, and other cutting edge tools.
As the Cole Porter classic goes, ‘Everything old is new again,’ and Novartis is developing a potentially important new antibiotic from the thiopeptides family, a rare soil microbe similar to the earliest antibiotics, e.g., Merck’s streptomycin and Pfizer’s penicillin. With antibiotic resistance spreading faster than our ability to introduce new compounds into the clinic, such new antibiotics are sorely needed. Among the relatively few new antibiotic drugs that were approved during the past decade are Cubist’s daptomycin and fidaxomicin, both were originally discovered in obscure soil-dwelling bacteria. And just in January of this year major scientific and popular publications broke the news on the novel antibiotic teixobactin and its astonishing activity against drug-resistant pathogens. Teixobactin was discovered in a soil sample from a field in Maine.
Microbial substances are not the only source of inspiration for modern drugs. Think of the Gila monster. The venom of this ill-tempered desert lizard provided the clue for a class of molecules which today help diabetics control their blood glucose without weight gain. Most recently a Harvard researcher isolated and synthesized Cortistatin, an anti-cancer molecule derived from deep-sea sponges, with demonstrated anti-cancer effectiveness in the mouse model. And we have barely scratched the surface, so to speak, of the vast biological diversity of global biomes crossing temperate, arid and ocean, and tropical regions.
While analytic methodologies facilitate new research insights from natural products, effective patent protection remains critical to attract continuing investment supporting continued taxonomic research, identification of potentially therapeutic molecules, and commercialization of new therapies and cures. Following the US Supreme Court’s invalidation of patents for the BRCA1/BRCA2 genes in Association for Molecular Pathology et al. v. Myriad Genetics et al. (2013), there is a need for greater clarity around patentability for the broad swathe of inventions relating to natural products development, beyond isolation of human genes.
Now more than ever, market incentives are essential to deliver on the promise of natural products development, while ensuring sustainable use and conservation of the world’s biological diversity. The legal certainty of patent exclusivity holds the key to successful commercialization of new and better therapies and cures.
About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues in the US and globally. She also is CEO and Managing Director of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India commercializing oncology peptides. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.