LONDON - The rampant rise of methicillin-resistant Staphylococcus aureus infections and the threat of anthrax, plague and smallpox being used as bioterrorism weapons led William Kidel to describe the planet as a "world replete with infectious diseases."
Other afflictions on our infected planet include hepatitis, HIV and even influenza, which in the U.S. kills 36,000 people annually, Kidel, chairman of a roundtable discussion on infectious diseases at the fourth annual European C21 BioVentures conference here, said Wednesday.
It's a growing problem, but that problem provides those in the biotech and pharmaceutical industry with a lucrative market. The worldwide antibacterial financial potential is estimated at $14 billion. The opportunity in antivirals is $8 billion and the vaccine market just beneath that at $7 billion. Even the antifungal market is impressive, estimated at $4 billion.
Given the financial potential, it's not surprising that biotech companies are lining up to take shots at infectious diseases. But there's another reason for that - the absence of big pharmaceutical companies in the field.
Many credit that absence to Strasbourg, France-based Aventis SA's struggle with the FDA in getting approval for Ketek, a ketolide designed to treat upper and lower respiratory tract infections, including those caused by drug-resistant Streptococcus pneumoniae pathogens. The drug was filed with the FDA in 2000 and first approved in Germany in October 2001. Aventis went on to conduct additional large clinical trials to broaden the drug's safety and efficacy database, but it wasn't until the FDA's Anti-Infective Drugs Advisory Committee recommended approval in early January 2003 that much progress was made on the application. The company received an approval letter later that month that asked for additional analyses and information, but not more trials.
Today, the drug is cleared but has not been administered to U.S. patients, said panel member Jeff Stein, executive vice president and chief scientific officer, as well as co-founder, of Quorex Pharmaceuticals Inc., of Carlsbad, Calif. Meanwhile, since its original filing in the U.S., Ketek has been safely used in 5 million patients worldwide.
That not only angered Aventis, panel members said, but it scared its big pharma brethren out of the infectious disease arena.
And biotechnology has stepped into the void.
A question posed by the audience during the panel dealt with the desire by physicians to resist broadly prescribing new antibiotics due to the fear that their overuse would spur resistance, basically bringing the new drugs down to a level already seen with current antibiotics.
Stein agreed that physicians should be "rightly concerned" and want to "hold something in reserve" when fighting infection, but added that doctors are "less concerned with [resistance] in a novel drug." As his company focuses on new molecular entities aimed at novel targets, he said its compounds aren't subject to existing resistance mechanisms.
Barbara Domayne-Hayman, commercial director of London-based Arrow Therapeutics Ltd., said that Americans' judicial obsession actually works in the favor of new drugs.
Given "the litigious culture of the U.S.," she said, "it makes it very difficult [for a physician] to keep a drug in reserve" for fear of a lawsuit if the patient gets sicker or dies and the physician didn't prescribe a drug that might have helped.
Another attendee pondered how the infectious disease markets would fare, with so many biotech companies working to develop drugs in the same indications.
Stein clarified that while many companies have products in development for soft-skin and tissue infection, for example, that might only be an initial indication and after approval, those labels would be expanded.
Jetta Heim, chief scientific officer of Basilea Pharmaceutica AG, of Basel, Switzerland, which just completed a CHF205.8 million (US$161.2 million) IPO on the Swiss market, told BioWorld Today that those companies also might simply be seeking to move quickly into Phase II studies in a known indication, and then branch out into other indications for Phase III work.
Michael Buschle, chief scientific officer at Intercell AG, of Vienna, Austria, said near the end of the panel that he felt "fear in the audience" when regarding what might have been perceived during the talk as obstinate regulatory authorities. He assured those listening that the FDA wasn't against drugs for infectious diseases. It can't afford to be, he said, and referenced the flu pandemic of 1918 that killed 50 million people.
"Another pandemic is coming," he said.