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Executive Summary
Lohocla Research Corporation is a research, pre-clinical and early-stage clinical trials organization
developing medications to treat chronic pain and addictions.
Kindolor can effectively supplant drugs like Neurontin and Lyrica®
Business Summary
Lohocla Research Corporation established itself in Colorado in 2000 with funding from its founder and
NIH-SBIR grant support. Lohocla continues to be
privately held and its activities are currently supported by an NIH
medications-development grant for treatment of alcohol addiction (“Nezavist”) from the National
Institute on Alcohol Abuse and Alcoholism (NIAAA) ($5 million), and a UH3 jointly from the National
Institute on Drug Abuse (NIDA) and the National Institute of Neurological Disorders And Stroke (NINDS). The
NIDA/NINDS award is $15 million over five years. The purpose of the NIDA/NINDS award is to bring the
Company’s pain- and opiate-sparing medication, “Kindolor” to and through Phase 1 Trials with humans.
Solution, Technology, Product
Kindolor is a drug designed by Lohocla Research Corporation to specifically and simultaneously target three
of the main mechanisms for conducting and amplifying pain signals from the periphery to the CNS. Kindolor is
an effective, non-addicting, and safe alternative to opiates for treatment of chronic pain. Kindolor
inhibits targets that become overactive during the development of chronic pain syndromes. Voltage sensitive
sodium channels (Nav1.7 and Nav1.8) that are located on sensory neurons and NMDA receptors in peripheral sensory terminals (nociceptors) and
in sensory ganglia are upregulated, leading to peripheral sensitization to stimuli that usually do not
produce pain. Kindolor, by inhibiting these peripheral NMDA receptors and voltage sensitive sodium channels,
blocks the conduction and amplification of chronic pain signals. By acting in the periphery, Kindolor
possesses little CNS activity, thereby avoiding incoordination and sedation as well as addiction. However,
Kindolor can effectively potentiate centrally (CNS)-acting analgesics for controlling chronic pain. It can
also be given in combination with opiates to reduce the dose of opiates 3-5 fold (via a synergistic effect),
thus reducing opiate side effects, addiction potential, tolerance, and mortality.
Market
As a stand-alone product, Kindolor can effectively supplant drugs like Neurontin and Lyrica®
that are used to treat chronic pain. Neurontin® has become a means for amplifying the “highs”
experienced with opiates and benzodiazepines and may well become a controlled substance (already Schedule 5
in Kentucky). Lyrica is also classified currently as Schedule 5, inducing a potential for abuse. Both
Neurontin and Lyrica have substantial side effects. 64 million prescriptions were written for Neurontin in
2016 and sales of Lyrica (brand name drug) in 2017 were $5.1 billion. Concerns regarding abuse, low
efficacy, and side effects make the gabapentinoids an attractive target for competition. The positioning of
Kindolor as a combination therapy to reduce opioid use and addiction is also a viable option even though the
DEA has imposed quotas on prescribing such combinations. It should be noted that current combinations of
oxycodone or hydrocodone with acetaminophen are no more effective than the opioid alone, but the use of
Kindolor in combination with opiates may generate a new paradigm.
Marketing Strategy
Partnering with, or licensing to, a large pharmaceutical company with excellent manufacturing, marketing,
sales, and distribution capacities. Lilly and Pfizer are examples of companies who have lost or will
lose patent protection for their drugs used to treat chronic pain.
Value Proposition
Global painful diabetic neuropathy (PDN) drug sales currently amount to $4.8 billion and are projected to
attain $8.9 billion by 2026. Lyrica (patent ending in 2018) accounts for the largest market share in
2017. Pfizer’s revenue from Lyrica in 2017 was $5.1 billion, and it is estimated that 30-35 percent of these
sales were for treatment of neuropathic pain, particularly that arising from PDN ($1.5 billion). Projections
of growth for Lyrica are bleak because of entry of generic versions of pregabalin (Lyrica) into the market.
However, the generics will be saddled with current evidence for abuse potential of pregabalin and mortality
when combined with large doses of opiates. A novel medication, significantly more effective than Lyrica,
with no measurable abuse potential and fewer side effects should be able to capture the PDN market share
currently held by Lyrica. Entry into other chronic pain markets (e.g., osteoarthritis, fibromyalgia)
impacted by Lyrica offers additional revenue opportunities. The current discounted cost of a month’s
supply of Lyrica is ≈$414. We estimate that commercial production of Kindolor would result in pricing
in the range of $250 for a one-month supply.
Business Model
Lohocla prides itself on conceptualizing novel approaches (molecules) for solving difficult medical
problems such as chronic pain and addiction. Lohocla completes proof-of-concept pre-clinical studies and
Phase 1, with the assistance of NIH grant funding and
early stage investors. Lohocla then seeks partners or a licensee to sponsor the post-IND Phase 2 clinical
trials and take the product to market. Currently, there are public companies with failed Phase II studies
that need new candidates for their pipelines. If working with a partner lacking sales and distribution
capacity, Lohocla and its partner will seek to engage with pharma companies that have these capacities as
well as established expertise in the chronic pain market segment (e.g., Lilly, Pfizer, Purdue).
Partnerships and Collaborations
Lohocla is a proactive biotechnology company that is actively looking for new diagnostic and therapeutic
products to better the lives of individuals around the world. We are always interested in joint-venture
and partnership opportunities that will help us to help others. We encourage you to contact
us if you’re interested in collaborating.