To: fred hayes who wrote (1865 ) 5/27/2005 7:23:00 AM From: nigel bates Read Replies (1) | Respond to of 3158 Glaxo says Cervarix to transform vaccine business By Ben Hirschler RIXENSART, Belgium, May 27 (Reuters) - The launch of Cervarix, GlaxoSmithKline Plc's (GSK.L) big new hope against cervical cancer, could transform the group's vaccine business within 5 years, according to the division's head."I think it will be the biggest vaccine ever," Jean Stephenne, the president of GSK Biologicals, the British drugmaker's vaccine subsidiary, told reporters visiting the unit's headquarters in Belgium. "I believe the introduction of this vaccine will be faster than for other vaccines, because we are speaking about cancer." Industry analysts have estimated Cervarix alone could double GSK current sales of vaccines, which totalled 1.2 billion pounds ($2.19 billion) in 2004, within 5 years of its global launch. Stephenne said GSK also had high hopes for other new vaccines, including a recently launched treatment to prevent rotavirus, the most common cause of childhood diarrhoea, called Rotarix, which he predicted would also be a blockbuster. A further five products are in final-stage Phase III trials. Vaccines currently account for a modest 7 percent of GSK's total pharmaceutical sales of 17.2 billion pounds but the group sees them as a key driver of future growth. That is largely thanks to Cervarix, which will take centre stage when Europe's biggest drugmaker outlines its vaccine portfolio at a keenly awaited investor seminar on June 30. FDA DISCUSSIONS GSK plans to file Cervarix for regulatory approval in Europe in 2006 but is still in discussions with the Food and Drug Administration about its U.S. filing. Stephenne said he hoped to give an update on the U.S. position on June 30. GSK Chief Executive Jean-Pierre Garnier told shareholders this week that Cervarix was key to the firm's pipeline of new drugs, designed to revive sales after recent patent losses, and he forecast it would be widely paid for by governments. There is little doubt that Cervarix will get to market in the next year or two -- but analysts are divided as to how big a product it will be, with forecasts for annual peak sales ranging from under $1 billion to $4 billion. Key imponderables include how GSK will position the vaccine in markets around the world, what price it will fetch and how it will fare against Merck & Co Inc.'s (MRK) rival shot Gardasil. Both vaccines target a sexually transmitted infection called human papillomavirus (HPV) which causes cervical cancer, the second biggest cancer killer in women. Cervarix project leader Philippe Monteyne said GSK's product had clear advantages over Gardasil since it prevented 100 percent of infections from HPV strains 16 and 18 -- responsible for 70 percent of cervical cancers -- against 90-95 percent for Gardasil. "So far, we are the only ones with 100 percent efficacy against both," he said. GSK also believes it has an edge because of the novel adjuvant, or additive, used in Cervarix, which gives a faster, stronger and longer immune response than conventional aluminium-based adjuvants. Monteyne said he not foresee significant pricing pressures between GSK and Merck. "The value of preventative medicines needs to be recognised and I think this is a common policy that all vaccine producers are defending," he said. Company officials declined to comment on the actual price, although analysts have speculated that both Cervarix and Gardasil are likely to cost around $300 per treatment course. In contrast to Merck, whose product also attacks two strains of HPV responsible for genital warts, GSK plans to position Cervarix purely as a cancer treatment -- a strategy it hopes will deflect criticism from campaigners for sexual abstinence. DEVELOPING WORLD MARKETS Cervical cancer kills a quarter of a million women each year, most of them in the developing world. Stephenne said emerging markets would be an important outlet for Cervarix and GSK hoped to be able to offer preferential prices if it can secure financial backing from governments or charities such as the Bill & Melinda Gates Foundation. He said reports GSK would not be able to sell Cervarix at a profit in poor countries because it has licensed some technology from the U.S. National Institute of Health were incorrect. In certain sectors of developing country markets, such as China, Stephenne said there was no reason why well-off private individuals should not pay the full price. GSK is working with MedImmune (MEDI) on its vaccine while Merck is partnering Gardasil in Europe with Sanofi-Aventis (SASY.PA) ...