FDA stopped short of approving what would have been the first therapeutic vaccine for prostate (or, really, any) cancer--but the prospect has clearly moved out of the domain of risk-taking biotechs and into mainstream pharma.
Earlier this month Dendreon received an "approvable" letter for Provenge (sipuleucel-T)--an immunotherapy product being tested for metastatic, hormone-refractory prostate cancer. FDA has requested more efficacy data.
Sanofi-Aventis, long a world leader in vaccine development and possessor of 25 percent of the market, has also named therapeutic cancer vaccines as a core area of its R&D focus. Its initial target is colorectal cancer, but it is also developing clinical programs for melanoma and lung cancer. The company plans to invest $350 million in cancer vaccines over the next decade, according to Jim Tartaglia, vice president of R&D at Sanofi-Pasteur, the drug giant's vaccine division.
"Scientifically, we know more about the human immune system--about how to turn it on and keep it on," he said. But he was also wary about overstating the role that cancer vaccines will play in treatment. He noted, for instance, that since chemotherapy already has an effect on the immune system, adding a vaccine to the treatment mix could lower the amount of chemo needed--reducing toxicity and side effects. "We're not thinking of these [vaccines] as a magic bullet," Tartaglia said. "We're thinking of these being used in combination therapies."
The debut of the first blockbuster vaccine--Wyeth's Prevnar for pneumonia in 2004--renewed interest in a market that many companies had concluded offered low returns on the high cost of investment and the special challenges of vaccine trials. AstraZeneca, Pfizer, and Novartis are among the companies over the past two years that gained a foothold in the market through acquisitions.
With more players angling for a piece of the market, companies are expanding their horizons beyond the obvious targets and going after diseases like hepatitis B and C, smallpox, and herpes simplex. For cancer, in particular, the market is expected to reach $8 billion by 2012, according to a November report from market research firm Kalorama Information.The surge of interest has increased pressure on the market's stalwarts, which now have to vie with firms large and small. For instance, where Sanofi-Pasteur used to have 100 percent of the Canadian flu market, it now has just 25 percent. "It's fierce," Tartaglia said about the competition. "People see more and more that there's a business--there's an opportunity."
In its first quarter earnings report, Sanofi-Aventis reported 44.4 percent growth in its vaccines division compared to the same period last year. Its vaccine revenue for the quarter totaled $1.45 billion.