More Drugs in Development Than Previously Reported
There are more drugs in development for potential treatment or prevention of Zika virus infections than those identified in WHO’s Product Landscape list published on March 3, 2016. According to data currently available in pipeline databases, there are at least 28 product candidates now under investigation by 26 organizations worldwide, compared to the 18 active programs included in the World Health Organization’s report. Time lag in public announcements by prospective developers of their intent to initiate new Zika research only partially accounts for differences in landscape surveys. A week-by-week tally of new drugs entering the pipeline in 2016 shows that information about 21 prospective Zika products was added to at least one of four major pipeline databases before February 29th—as is illustrated in a timeline graph (Figure 1)
This new report also includes a table summarizing data about each prospective Zika drug, based on product records found in a federated search of Adis R&D Insight, Citeline Pharmaprojects, IMS R&D Focus, and Thomson Reuters Cortellis. Each of these databases specializes in monitoring drug development worldwide in all therapeutic areas, providing product-specific pharmaceutical competitive intelligence for thousands of diseases. They systematically survey a broad spectrum of sources to identify new products and to update entries for those previously added to their online directories. The scope of their ongoing surveillance includes not only press releases in the public domain, but also company and government Web sites, research results disclosed in presentations at scientific meetings, relevant articles published in medical journals, clinical trial registries, investment analysts’ reports, industry newsletters, patent applications, and company annual reports, as well as SEC filings and presentations to investors. As a result, it’s not surprising that more prospective drug products for Zika could be identified in these databases than were included in the WHO publication. The updated list compiled by PharmaIntelligence includes 18 prophylactic vaccines and 10 post-infection therapeutics under investigation. Five of the vaccines are being developed by organizations not cited in the previous report, and four more originate from companies mentioned only in the footnote to the WHO table.
At the same time, a comparison of the two surveys will also show that five products identified in WHO’s landscape are omitted in the newer list, because their association with Zika could not be validated from information currently provided in the pipeline databases. Although records for each product were, indeed, available in these sources, none cited Zika as a new addition to the drug’s research program. This does not mean that data assembled by WHO is inaccurate. Discrepancies such as these are often due to differences in sources used as a basis for information presented. For example, even in a search confined to pipeline databases, no single source included more than 18 of the cumulative total of 28 Zika products found by accessing all four. Comparisons of lists and of statistics such as these underscore the benefits of checking multiple authorities for an aggregated and broader view of the landscape before in-depth analysis can begin. Numbers don’t always tell the whole story. Further details about inclusion and exclusion parameters set when compiling the PharmaIntelligence Updated List are provided in the full report (available for downloading free of charge).
Although relatively little is currently known about Zika virus pathogenesis, it’s widely recognized that knowledge obtained from previous studies of viruses in the same family, the flaviviruses, is likely to help accelerate development of new drugs specifically designed to treat or prevent Zika infection. Accordingly, our tabular summary includes information about each developing organization’s prior experience in investigating other antiviral candidates, especially those products focusing on Dengue and/or West Nile fever.
To supplement data compiled in the Zika landscape table, the PharmaIntelligence report concludes with a Funnel Chart of drugs in the pipeline for Dengue or West Nile fever that have progressed beyond preclinical development. The chart also identifies organizations actively involved in clinical research for these product candidates. Other product attributes are flagged in icons for each drug, such as Product Type and/or MOA, as well as Route of Administration.
It’s important to remember that all prospective products currently under investigation for preventing or treating Zika virus infection are, at the very least, several months away from progression to the clinical trial phase — successful completion of which is a prerequisite before any authorization to market can be granted. Optimistic predictions of unusually fast transition from preclinical to human testing can’t be re-interpreted into firm forecasts of vaccine availability in the near future. Despite major advances in biotechnology, drug development is a lengthy (and very expensive) process, typically requiring years of work to ensure that products are reasonably safe and effective.
Monitoring changes and additions during this progression from lab to launch is essential to provide an accurate view of the Zika drug landscape. Nonetheless, the attached Infodesk PharmaIntelligence report will update what’s been published previously and, we hope, provide a broader basis for gauging the current status of research in this area.
COMMENTS