• Four drug candidates in the pipeline
• Potential sales of Alzheimer’s drugs run to billions
• Hyalolex heading for clinical trials

India Globalization Capital, Inc. (NYSE MKT: IGC) is racing ahead with its preparation of medical trials for four drug candidates that treat a variety of debilitating conditions. At the head of the line is Hyalolex, aimed at reducing the buildup of amyloid β-peptide (Aβ) plaques on neurons in the brain, a process that causes the crippling cognitive complaint known as Alzheimer’s disease.

Alzheimer’s afflicts more than five million Americans, and, so far, no effective cure for this form of dementia has been found. However, the FDA has approved five medications to treat its symptoms. IGC is hoping to make Hyalolex the sixth. The drug works through a molecular pathway that allows low doses of THC to bind to Aβ plaques and so prevent them from aggregating on neurons. IGC has entered into a definitive license agreement (http://dtn.fm/7Xsmp) with the University of South Florida (USF), which makes IGC the exclusive licensee of the USF-developed technology that is the subject of a U.S. patent filing entitled “THC as a Potential Therapeutic Agent for Alzheimer’s Disease.” If approved, Hyalolex could go some way to reducing the costs of treating Alzheimer’s, estimated to reach $259 billion in 2017. It should also bring IGC’s market cap in line with peer valuations that range in the hundreds of millions.

Alzheimer’s has the unwelcome distinction of being number five on the list of America’s five most deleterious diseases, after heart disease, cancer, chronic lower respiratory conditions and strokes, according to the Centers for Disease Control and Prevention (CDC). Every minute, someone new develops the condition, which takes its toll not just on those afflicted but on caregivers. The Alzheimer’s Association says that ‘35% of caregivers for people with Alzheimer’s or another dementia report that their health has gotten worse due to care responsibilities, compared to 19% of caregivers for older people without dementia”. The economic cost is also staggering and, if no cure or palliative is found soon, is expected to exceed $1 trillion by 2050.

With such high stakes, IGC’s pioneering therapy has become vitally important. Its mechanism of action uses the psychotropic component of cannabis, Δ9-tetrahydrocannabinol (THC), to inhibit the enzyme acetylcholinesterase (AChE) and prevent the aggregation of AChE-induced amyloid β-peptide (Aβ), which is the key pathological marker of Alzheimer’s disease.

Current treatments authorized for sale to the public by the U.S. Food and Drug Administration (FDA) for Alzheimer’s include donepezil, approved in 1996; galantamine (2001); rivastigmine (2000); memantine (2003); and a combination of donepezil and memantine, approved in 2014. Sales of donepezil (Aricept) reached $3.5 billion in 2009, the year before its generics were allowed market entry. Sales of rivastigmine (Exelon) have been in the hundreds of millions, exceeding $1.0 billion in 2011, and sales of memantine (Namenda) continue annually above $1.0 billion. According to Mordor Intelligence, “the global Alzheimer’s’ disease market… due to drug patent expirations in 2017 and many generics entering the market… is expected to see a declination… by the year 2017. (On the other hand), the market is anticipated to grow driven by… last-stage pipeline drugs”. They might have added “like Hyalolex.”

IGC’s pipeline also includes Natrinol, a natural substitute for Marinol, or synthetic THC, aimed at relieving nausea and vomiting while increasing appetite in patients with AIDS and cancer; Caesafin, which uses combination therapy to alleviate seizures in dogs and cats; and Serosapse, which addresses several end-points in Parkinson’s disease, including rapid eye movement (REM) sleep disorder, anxiety and dyskinesia.

For more information, visit the company’s website at www.IGCInc.us

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