To: Marc Kahn who wrote (117 ) 2/25/1998 8:03:00 PM From: geewiz Read Replies (1) | Respond to of 534
Marc, Thanks for the comprehensive report. I found a very interesting article in the WSJ today. I have omitted significant portions of it and post it as follows. It shows the potential we have with our vaccine platform! Vaccine Business Is Heating Up; Drug Companies See Sales Surge By -- February 25, 1998 ELYSE TANOUYE Staff Reporter of THE WALL STREET JOURNAL After more than two decades of languor, the vaccine business is heating up, with potentially huge implications for drug-industry profits and public health. New bioengineered vaccines -- unlike their predecessors -- are patentable, and are luring drug companies with the promise of high prices. What's more, changes in product-liability laws have reduced the risk of litigation that had helped chill product development. Drug companies are now working to develop new vaccines against some of the world's most prevalent and costly illnesses, including AIDS, malaria, Lyme disease and herpes. One of the biggest potential blockbusters in the pipeline: a novel biotech vaccine from American Home Products Corp. for ear infections that cause severe discomfort and threaten hearing damage in millions of children under the age of three. R. Gordon Douglas Jr., head of Merck & Co.'s vaccine business, calls this the "best time" for vaccine research in decades, and predicts that 20 to 30 new vaccines will be developed in the next 20 years. SmithKline Beecham PLC's vaccine sales in 1997 surged past $1 billion, up from $250 million six years ago. This growth persuaded the company to invest more than $1 billion on research and expansion of facilities, says J. P. Garnier, chief operating officer of SmithKline. Pasteur Merieux Connaught, a unit of Rhone Poulenc SA, has doubled the size of its U.S. vaccine staff in the last five years. And American Home's 30 vaccine projects are triple what they were 10 years ago. The new wave of research is especially striking because it had been stalled for so long. As devastating diseases like polio and diphtheria became distant memories -- thanks to vaccines -- public attention shifted in the 1970s to side effects suffered by a small fraction of those inoculated. A raft of lawsuits over adverse reactions to vaccines for "swine flu" and other diseases followed. The combination of low profitability and rising liability forced many companies out of the vaccine business. During this lull, vaccine research was considered "the dead-end of the pharmaceutical industry," recalls David Williams, head of U.S. operations for Pasteur Merieux Connaught, the world's largest vaccine maker. The climate slowly began to change again in 1986, after passage of a federal law that shields vaccine producers from all liability not related to manufacturing error. Since 1988, a tax on each dose of vaccine purchased goes into a fund to compensate patients who suffer adverse reactions. Claims for inoculations before 1988 are paid by the federal government. The law "turned the industry around" and encouraged biotech companies to jump into the vaccine field, says Mr. Williams of Pasteur Merieux Connaught. One of the most eagerly awaited products is the vaccine against ear infections, which afflict 85% of kids before the age of three and cost, by some estimates, between $3 billion and $4 billion a year to treat. Between one-third and one-half of visits by sick children to pediatricians' offices involve ear infections. "We would have people lined up outside the door to get the shots," predicts Paul Miles, a pediatrician in Twin Falls, Idaho. American Home's initial vaccine will immunize kids under the age of two against Streptococcus pneumoniae, one of three bacteria that cause ear infections. The vaccine emerged from breakthroughs in the early years of the biotechnology revolution. Scientists isolated the coatings that surround each of the three organisms and figured out how to attach them to a bit of other viruses -- including one that causes diphtheria -- that the body readily recognizes as a threat. The resulting synthetic vaccine activates the immune system to attack the ear-infection microbes whenever they invade. The new ear-infection vaccine is expected to be expensive. Most new bioengineered vaccines cost around four times what old-line inoculations cost. American Home foresees potential billion-dollar markets world-wide for each of several new-generation vaccines, including one it is developing against the respiratory syncytial virus that causes common respiratory infections. SmithKline predicts that in 10 years the worldwide vaccine market will triple from the current $3 billion. American Home believes the global market for just the ear-infection vaccine could reach $1.5 billion annually, of which it figures its share might be $700 million. That would rival some of its top-selling drugs, and would dwarf other vaccines, which typically generate sales of $200 million a year or less each. Such heady estimates are based on the anticipation of high prices for bioengineered vaccines. Traditional vaccines that employ a weakened version of the actual virus are cheap because they can't be effectively patented. By contrast, uniquely engineered vaccines can be patented, providing the creator with exclusive ownership-and profits. Some emerging technologies allow companies to reproduce in large quantities pieces of an infectious microbe that can stimulate an immune response and thus be used as a vaccine. Most exciting to some scientists are efforts to use bits of DNA from viruses that cause AIDS, the common cold, flu and herpes. Some companies are trying to use vaccines to coax the body to fight ovarian, skin and other cancers. And vaccines one day may be used to prevent ulcers and heart disease. 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