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Q&A: Joanne Harack, vice president, Affinium Pharmaceuticals
September 2005


Affinium Pharmaceuticals is a small structure-guided drug discovery company founded in 2000 that is focused on the development and commercialization of novel anti-infective medicines. Recently, company vice president Dr. Joanne Harack and the scientific team at Affinium took the time to talk to Executive Editor Randall C Willis about the current state of the anti-infectives market.
DDN: How has the anti-infectives market developed over the years and what challenges does it face?
Harack: The first half of the last century was truly a golden age for the discovery of anti-infective compounds. Interestingly, however, at the same time that market opportunities were expanding in the latter half of the century, companies began to focus more on incremental developments in drugs, tweaking compounds from existing drug families and focusing less on identifying entirely novel chemical entities.
Similarly, the economics of drug discovery, combined with consolidation in the industry, has caused Big Pharma to turn away from anti-infective market toward the chronic disease and "lifestyle" markets, and to search for "blockbuster" drugs rather than niche anti-infectives.
At the same time, "bugs" (e.g., bacteria, viruses, fungi) have become "smarter", mutating and developing resistance to the current crop of drugs. The rapid development of resistance/mutation means that there is a very real and very urgent need for novel antibiotics and new antivirals and antifungals. That need is clearly articulated by infectious disease clinicians and various public interest groups. Resistance creates unmet medical needs that clinicians and patients look to the industry to fill.
In the post-9/11 era, there is increased interest on the part of the U. S. government in the development of drugs targeting infectious diseases to combat potential bioterrorism. The challenge for the industry is to be "smarter" and "faster" than the bugs. Speed and agility are not necessarily associated with Big Pharma, however, so small, more agile biopharmaceutical companies have taken up the cause of anti-infectives.
As well, developments in genomics and proteomics mean that we can design drugs more specifically and more efficiently than previously. We have not reaped the benefit from this yet, in part, because of issues such as regulatory approval of "unvalidated targets", which will be slower than that for incremental development of existing drugs. Many products will come off patent soon, and that is certainly fuelling some interest in developing completely new drugs.
DDN: Are events like the recent SARS outbreak in China and Toronto a wake-up call?
Harack: There is absolutely no doubt that the public has become more aware of and concerned about challenges in the infectious disease area: SARS was particularly close to us here in Toronto, but there is also a much elevated public awareness worldwide about hospital and community incidences of MRSA (methicillin-resistant Staphyl-ococcus aureus). West Nile

and Lyme disease are also causing concern as they become more common. It is inevitable that pharmaceutical companies are affected by increased public awareness and concern.
DDN: What role do you see smaller biopharmaceutical companies such as Affinium playing in the future development of anti-infective therapies?
Harack: Many smaller biopharmaceutical companies are applying innovative technologies and technology platforms to anti-infective development. We also see a renewed interest on the part of Big Pharma in the anti-infective space. The total market for antivirals, antibacterials, and antifungals is estimated to be $40 billion/year. Thus, there is room for smaller companies to work with Big Pharma in any of a variety of collaborative efforts, including discovery and/or development partnerships and in- or out-licensing opportunities.
DDN: From a biological perspective, what do you believe are the most effective approaches developed by companies recently?
Harack: Antibacterials have historically resulted from natural products discovery efforts. With recent advances in bacterial genetics and genomics/proteomics, scientists are now poised to apply structure-guided drug discovery methods to a variety of well understood and previously untapped targets. In some respects, we are just beginning the dawning of a new generation of discovery of much needed anti-infectives.
It would be erroneous, however, to suggest that natural products-based discovery has been "abandoned". Structure-guided, target-focused discovery allows us to screen natural product libraries more quickly and efficiently. Advances in structure-based discovery give us incremental knowledge, building upon what came before.
DDN: How do you see the anti-infectives marketplace developing over the next few years or decades?
Harack: With the growing concerns of resistance in both the hospital and community settings, the marketplace will need and reward new agents that are safe, efficacious and simple to use. So there are great opportunities for drug discovery companies, and also for diagnostic and device companies. One could foresee convergence of technologies in this therapeutic area: co-marketing of devices and drugs, for example; or co-development of drugs and diagnostics.
Code: E090522



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