SAN FRANCISCO --
Pharmacia & Upjohn
is a Big Pharma also-ran. It's small, it's not a powerhouse marketer and it's not particularly known for its science. But the company does have something special, and it has put it on display at the annual
Interscience Conference on Antimicrobial Agents and Chemotherapy
It's a whole new antibiotic. More than that, it's a member of a new class of drugs that work in a different way than other bug fighters. It's called
, a member of the oxazolidinones, which work by disrupting the initiation of bacterial protein synthesis. Doctors are desperate for new infection battlers, because strains that resist current treatments are multiplying. Some worry about an emerging health crisis. Hospitals spend heavily on vancomycin, the current last-resort antibiotic.
Zyvox is a piece of the answer to the emergency. Scientists are reporting here on a bunch of Phase III Zyvox trials that show good effectiveness against what are known as "gram-positive" hospital infections. These include hospital-acquired pneumonia, skin and soft-tissue infections and strains resistant to powerful antibiotics such as vancomycin and methicillin.
Pharmacia & Upjohn thinks the drug will make a major addition to its product line. The company needs a blockbuster badly and expects that Zyvox will turn in annual worldwide sales in the range of $750 million to $1 billion. It plans to file for approval for Zyvox, the subject of the company's largest clinical trial program ever, by the end of the year, meaning the drug could be on the market by the second half of next year. P&U expects the Zyvox launch to be its first-ever simultaneous global launch.
One of Zyvox's advantages is that it will be available in both oral and intravenous formulations. And it works on resistant strains. But being a good antibiotic can be a bit of a curse. Doctors may want to hold back on the drug, using it only for the sickest patients. If not, they might overuse it, as they did with
Trovan, which led to the discovery of a rare and dangerous side effect that has all but killed the drug. That may mean that blockbuster status will be long in coming, if it ever arrives.
"At the start, I'll be using it in my practice primarily for patients who are pretty sick," George Eliopoulos, a infectious disease specialist at Boston's
Beth Israel Deaconess
said at a P&U press conference on the new drug.
P&U's message will be that "Zyvox will be most effective used as soon as it can be," says Jeff Buchalter, the compay's group vice president for hospital products. "It's a very important drug for our company."
The drug looks good in the clinical trials reported here. In 397 patients with hospital-acquired pneumonia, intravenous Zyvox showed equivalence to vancomycin, working 68% of the time. In 526 patients with pneumonia caught outside a hospital, the IV version of the drug worked the same as the standard therapy, working 89% of the time. There were similar results in skin and soft-tissue infections, as well as methicillin-resistant staphylococcal strains and vancomycin-resistant enterococcus, two nasty bugs.