Drug Developers Look to Deuterated Drugs as Risk Managed Opportunity

Ease-of-Entry Tempered by Uncertain Patentability According to Greystone Research Associates

Interest in deuterated drugs – drugs in which carbon-hydrogen bonds have been replaced with carbon-deuterium (heavy hydrogen) bonds - has been increasing as drug companies seek to shorten the path to market by modifying existing APIs that have established clinical value. The ability of developers to employ formulation technology to substitute deuterium atoms into an existing drug molecule is seen as a way to lower drug development risk, although the need to establish specific therapeutic efficacy and safety still remain.


Recently, the number of articles about deuterated drugs has moved to a new level following FDA approval of Teva’s Austedo for the treatment of chorea associated with Huntington’s disease. One of the often-cited advantages of replacing hydrogen with deuterium is the effect that heavy hydrogen atoms can have on drug half-life. To the extent that the drug remains in the system longer there is the possibility that dosing frequency can be reduced.


Currently, there are about a dozen companies actively pursuing the deuterated drug market. The majority are smaller drug formulators and developers, often relying on partnerships for co-development and/or marketing and distribution. Patents are expected to play a major role in this segment, largely because the majority of deuterated drugs under development are approved APIs in undeuterated form. This dynamic has given rise to a significant level of defensive IP activity, in which companies patent deuterated APIs largely on speculation that the drug will prove to be efficacious and safe at some point in the future.


The potential for defensive acquisition and investment is also factoring into the response of existing API rights holders. In this scenario, a non-deuterated API patent holder may invest in a company in the deuterated drug space that is developing a deuterated version of the API, giving the investing company the ability to leverage the timing of an eventual FDA filing to minimize the negative competitive impact of a deuterated product version on existing product revenue.


There are currently about two dozen potentially important deuterated drugs in development. Many of these drugs are pursuing therapeutic targets in important markets that include neurotransmitter regulation, transmembrane conductance, protease inhibition, inflammation, mitochondrial function modulation and antineoplasticity.


The findings of a recent survey of the deuterated drug market are detailed in a new and comprehensive report researched and written by Greystone Research Associates. Deuterated Drugs: Products, Pipelines, Strategies, Therapeutics and Markets has been created to provide readers with information and data to assist them in understanding and effectively evaluating the market and competitive landscape for deuterated drugs. The report includes technology assessments, therapeutic target analysis, patent and product positioning strategies, therapeutic factors, near-term markets and market participant profiles.

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