Psoriasis Treatments with Next Generation Vitamin D Analogs
`The Wisconsin Alumni Research Foundation (WARF) is seeking commercial partners interested in
`developing novel compounds for the treatment of psoriasis.
`
`Overview
`According to the National Institutes of Health, approximately 7.5 million
`people in the United States have psoriasis, an incurable and painful skin
`disorder in which affected individuals develop thick, scaly areas on their
`skin. This disease ranges from minor localized patches on the skin to
`debilitating full body coverage.
`
`Psoriasis occurs when the immune system sends out faulty signals that
`cause skin cells to grow too fast. Many treatments, including topical
`products, systemic medications and phototherapy, are available to control
`the symptoms of psoriasis, but these treatments may cause adverse side
`effects or may not be effective in many individuals.
`
`Analogs of the hormonally active form of vitamin D, known as calcitriol or
`1,25 dihydroxyvitamin D , have been recognized for years as a promising
`3
`focus for the development of psoriasis therapies. Calcitriol encourages skin
`cells to stop proliferating and start differentiating, reducing their growth rate to near normal levels. In addition,
`calcitriol acts on the immune system to reduce itching and inflammation.
`
`While promising for the treatment of mild cases, the concentrations of calcitriol required for effective
`treatment of severe psoriasis can be toxic. The hormone mobilizes calcium from bones and increases
`intestinal absorption of dietary calcium. Effective therapeutic concentrations can lead to hypercalcemia; a
`condition characterized by elevated blood calcium levels, alterations in mental status, muscle weakness and
`calcification of soft tissues and organs such as the heart and kidneys. Therefore, a need exists for non-
`calcemic compounds that provide desirable therapeutic effects without causing dose-limiting hypercalcemia.
`
`A Novel Treatment: Non-calcemic analogs of calcitriol
`
`Researchers at the University of Wisconsin are designing non-calcemic analogs of calcitriol. These analogs
`may provide the solution to the dose limitations of calcitriol by offering a wider dose range and lower potential
`for causing hypercalcemia and its complications. They show significant ability to slow the growth of skin cells
`at concentrations that do not cause bone calcium mobilization, intestinal calcium transport or increase blood
`calcium to dangerous levels.
`
`WARF maintains a robust and growing portfolio of low and non-calcemic analogs of calcitriol. Intellectual
`
`Medac Exhibit 2082
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
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`property rights and special development incentives for commercialization in the psoriasis space are currently
`available.
`
`Business Opportunity
`Through 2006, the prevalence of psoriasis was estimated to be 17 million people worldwide.
`Datamonitor reports $1.95 billion in sales of psoriasis treatments in 2005.
`By 2015 the market for psoriasis treatments will exceed $2.3 billion in the U.S., $832 million in the E.U.
`and $354 million in Japan.
`An increasing demand exists for safer therapeutics that control symptoms with greater efficacy, longer
`duration and improved quality of life.
`Providers view vitamin D analog treatments as first line options versus steroids due to safety concerns
`and also over biologic treatments as payers carefully scrutinize risk-benefit and cost-benefit ratios.
`Next generation vitamin D treatments are needed to replace older products with narrow therapeutic
`indexes.
`Applications
`Mild psoriasis
`Severe psoriasis
`Key Benefits
`A proven biologically active compound that slows the growth of skin cells with minimal potential for raising
`calcium levels.
`May enable less frequent dosing and increase in size of treatment areas.
`Early preclinical screening studies completed; later stage preclinical and clinical GLP evaluations may be
`available.
`Offers a fresh therapeutic approach for gaining access to the growing psoriasis and skin therapy market.
`Innovative licensing and/or development terms available.
`Stage of Development
`The analogs offered in this portfolio have been subjected to in vitro/in vivo models for evaluations of receptor
`binding, cell proliferation, cellular differentiation, calcium mobilization and blood calcium levels. In some
`cases, Good Laboratory Practice (GLP)-rated preclinical and clinical data may be available for evaluation.
`
`Please contact our office for updates as study data sets may be evolving with compounds under
`development.
`
`Additional Information
`For more information about the inventor, see Hector DeLuca.
`
`Contact Information
`Please contact our licensing team at licensing@warf.org or 608.263.2500 to explore and discuss innovative
`development pathways that are available to qualified development interests.
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`Copyright © 2016 WARF. All rights reserved.
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