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Wall St. Journal on tykerb
Glaxo's Faith in Lab Is Tested
By JEANNE WHALEN
March 10, 2007; Page A2
Pharmaceutical giant GlaxoSmithKline PLC is counting on a big breakthrough this week: The U.S. Food and Drug Administration is scheduled to rule on Tykerb, a cancer drug that is the product of Glaxo's new approach to research and development.
Under Chief Executive J. P. Garnier, the world's second-biggest drug maker by sales behind Pfizer Inc. has changed how it develops drugs to give its scientists more decision-making power. Mr. Garnier has promised that his plan would help Glaxo to bring a wealth of new drugs to market -- and Tykerb is one of the first big tests.
Tykerb treats an aggressive form of breast cancer that affects 20% to 25% of women who have the disease. Tykerb has been shown to work in some patients who don't respond to Herceptin, the blockbuster treatment sold by Genentech Inc. and Roche Holding AG. Glaxo also hopes that further tests will show that Tykerb helps to stop tumors from spreading to the brain, which happens in some women taking Herceptin. It is one of five products Glaxo aims to introduce this year, including a vaccine for cervical cancer and a drug for allergic rhinitis, a condition similar to hay fever.
It isn't clear how the FDA will rule. The FDA declines to comment on drugs under review. In a phone interview, Mr. Garnier said he believes Tykerb's chances are good.
The FDA is considering Tykerb for only limited use, as a backup for women who don't respond to Herceptin. Glaxo is conducting additional clinical trials that could allow Tykerb to be used at an earlier stage of the disease. Citigroup analysts predict Tykerb could eventually achieve £1.3 billion ($2.51 billion) in annual sales.
Making drug discovery more productive is the biggest challenge facing pharmaceutical companies today. When Glaxo was formed through a merger of Glaxo Wellcome and SmithKline Beecham in 2000, its pipeline of drugs in development was particularly weak.
Tykerb emerged from Glaxo's new R&D structure, which was designed to boost innovation by giving more decision-making power to scientists in the lab. Mr. Garnier and then-research chief Tachi Yamada divided Glaxo's research scientists into seven separate groups, each concentrating on a specific disease area, such as cancer, psychiatry and respiratory disease. Each group controls its own budget and decides which projects to pursue. With this new authority, scientists in the cancer group moved Tykerb off the back burner and made it a priority. (Dr. Yamada later left the company to work for the Bill & Melinda Gates Foundation.)
"We've worked very hard to change R&D in the past seven or eight years," Mr. Garnier said. "Tykerb is everything we want in a compound. It's a life-saving drug. It's an excellent piece of science."
One FDA approval won't prove a total renaissance is under way in Glaxo's labs, of course. And there are some worrying signs that not all is well in R&D. Early this month, Glaxo, based in Brentford, England, published an updated list of the drugs it is developing, noting that 11 experimental compounds in midstage development had been scrapped. These losses were only partly offset by the seven compounds that Glaxo moved into midstage, or Phase 2, testing from Phase 1 testing, Morgan Stanley analyst Andrew Baum noted in a research note. "Our pre-existing concerns over the strength of GSK's much-hyped pipeline have grown," Mr. Baum wrote. Mr. Garnier calls the report an overreaction to the kind of attrition that is common in early and midstage drug research.
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