Innovation is the mainstay of drug development, and it is particularly important to overcome challenges in improving global health outcomes. A recent analysis by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which represents the research-based pharmaceutical companies and associations on a global basis, examines the role of “incremental innovation” in serving that role. The report was issued late last month concurrent to the Nineteenth Session of the World Intellectual Property Organization (WIPO) Standing Committee on the Law of Patents. WIPO is an United Nations agency focused on the use of intellectual property as a means of stimulating innovation. The report emphasizes the importance of incremental innovation in improving medicines, explaining its scientific rationale, its medical value, and the economic incentives needed for its development.
“Evidence-based discussions are key to advancing global health,” says IFPMA Director General Eduardo Pisani, in a Feb. 25, 2012 IFPMA report. “This publication provides facts and tangible examples to illustrate how biopharmaceutical innovation benefits patients and dispel the misperception that incremental medicines are trivial.”
Innovation may be classified as revolutionary, radical, and incremental, according to the IFPMA report. In the context of drug development, a revolutionary innovation would be discovery of a new biological or metabolic pathway. Revolutionary innovation is defined as conceptual advances, such as new scientific theories or principles, which form the basis for subsequent research. A radical innovation puts these principles into practice. A “first-in-class” drug, meaning the first drug in a new drug class is an example of a radical innovation, notes the IFPMA report. Incremental innovation involves exploring and improving radical products. Incremental innovation advances medicines by expanding therapeutic classes, increasing the number of available dosing options, discovering new physiological interactions of known medicines, and improving other properties of existing medicines, according to the report.
“There are countless examples of the significant public health impact of incremental innovation,” said Pisani in the release. “R&D efforts based on existing medicines have led to wide-ranging therapeutic improvements, such as a new use for an antifungal medicine’s metabolite to treat Chagas disease, a neglected tropical disease affecting nearly 10 million people. Improved health outcomes have also been achieved by reducing the antimalarial dosing of ASAQ from eight to two tablets daily. A case study cited in the report highlights an improved treatment of hepatitis C, which has boosted cure rates from 38% to 54%.”
ASAQ, which stands for Adapted, Simple, Accessible, Quality, is the project name given to a collaboration between Sanofi and Drugs for Neglected Diseases initiative (DNDi) to develop a new and more easily administered combination of two antimalaria drugs, artesunate and amodiaquine. The project yielded a new fixed combination drug that reduced dosing from eight tablets to two tablets daily. According to the IFPMA report, more than 150 million ASAQ treatments have been distributed in more than 33 countries.
In another example of incremental innovation, Eisai and DNDi partnered to further explore the effects of the antifungal medicine ravuconazole against the pathogen that causes Chagas disease, a neglected tropical disease. Once administered to patients, ravuconazole naturally metabolizes other compounds or prodrugs, one of which E1224, is being evaluated to treat Chagas disease. With its partnership with Eisai, DNDi is executing clinical trials to determine the safety and efficacy of the prodrug E1224, and Eisai is supplying the drug for the clinical trials and related scientific expertise.