Treating H1N1: the innovation behind the science
Michaela White, Principal Consultant, Life Sciences, Asia Pacific, Thomson Reuters
October 2009
This article is featured in the October 2009 issue of PharmaAsia
The recent outbreak of the swine influenza virus (H1N1) has precipitated an immediate response from the international health community, governments and pharmaceutical industry alike. World attention has focused on identifying the most effective anti-influenza drugs currently available and developing the next generation drugs as the H1N1 virus will certainly continue to mutate. As stock prices of certain pharmaceutical companies such as Biota soar, we may ask who the originators, current manufacturers and patent holders of these life-saving drugs currently in use are.
Of the 22 drugs available for the treatment of influenza virus (source: Thomson Pharma), the Center for Disease Control (CDC) has recommended the use of Oseltamivir (brand name Tamiflu) or Zanamivir (brand name Relenza) for the treatment and/or prevention of infection with the H1N1 strain. Competitor drugs, M2 ion channel inhibitors Amantadine (Symadine, Symmetrel) and Rimantadine (FlumadDue), have not been recommended due to the increasing occurrence of mutations in the viral M2 ion channel protein and resulting drug resistance.
So what are some of the comparative differences between Oseltamivir and Zanamivir? A SWOT analysis of these two drugs on Thomson Pharma, the pharmaceutical pipeline intelligence database of Thomson Reuters, reveals a competitive advantage of Oseltamivir over Zanamivir: method of delivery. Oseltamivir offers easier oral dosage as compared to the inhalation delivery required for Zanamivir. However, Zanamivir has first-in-class status and reimbursement strategies are in place for a significant portion of the US and Japan, as well as for high risk groups in the UK.
To date, there are, 291 drugs related to the therapy area 'Influenza Virus Infection'. Using the visualization tools of Thomson Pharma, we are able to view the current pharmaceutical pipeline for this therapy area (Fig.1). Many of these drugs are either still in the discovery phase or classified as no development reported for the past 12 months. However, there have been promising drugs emerging in the pipeline such as Daiichi Sankyo/Biota's CS-8958, which in April 2009 reported positive Phase II results.
Figure 1: Number of drugs in the pharmaceutical pipeline for 'Influenza Virus Infection'
Source: Thomson Pharma
The current dominant marketers and primary patent holders for Zanamivir and Oseltamivir are Biota/GSK and Gilead Science/Roche respectively. Patents cover product, process, formulation, component of combination and delivery devices. Zanamivir patents will expire in 2013 after which we can expect to see moderately heavy generic competition. Thus far there have been no paragraph IV challenges for Zanamivir. However, companies such as Cipla and Hetero, two Indian-based drug manufacturers, are showing evidence of scaling up or developing API manufacturing capabilities (source: Newport Premium).
Oseltamivir patents are set to expire in 2016. Although currently facing no paragraph IV challenges, many more generic manufacturers have shown a strong interest in developing Oseltamivir and generic competition is predicted to be fierce. Cipla is the only company with an active US DMF and a commercially available source of API even as five other companies have confirmed commercially available capabilities. These include Hetero and Ranbaxy of India, and Chongging Shenghuaxi and Shanghai Sunve of China (source: Newport Premium).
How can one begin to understand the innovation trend and attempt to predict the future innovation of influenza and H1N1 virus-related technology through patent analysis? One way is to use a visualization analytic called the Themescape Map on Thomson Innovation. From an innovation perspective, there are 1,324 patent records (or patent families) related to the therapy area Influenza Virus Infection (source: Thomson Pharma and Derwent World Patents Index). Patents retrieved via Thomson Innovation may be uploaded into the Themescape Map software tool. Each color dot represents a patent record that has been plotted using keywords from the Derwent valued-added patent title and abstract. The application brings technically similar patent documents into proximity clusters in order to easily understand different technology inventions.
Figure 2 also shows an additional time-slice information of patent filing trends comparing 2000 to 2004 (330 patent records) and 2005 to current (667 patent records). It can be inferred that research & development (R&D) has been more intense in the last three years for influenza virus vaccines and related technology as seen in the two-fold increase in the rate of patent filings over the last eight years, particularly in patents related to genetic studies. The map can also isolate trends of assignees and inventor filling pattern to help in strategic business planning.
In addition to vigilance and screening by global health organizations, such an analysis reassures us that R&D continues its pace to aid us in fighting the threat of an epidemic. We certainly hope that newer and more effective drugs continue to find their way to the market and the patients who need them.
Figure 2: Themescape map of 1,324 influenza-virus-infection therapy area patent records; including Zanamivir and Oseltamivir (source: Thomson Innovation)
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