On December 9, 2003, the patent for Cipro twice-a-day (BID) tablet expired in the United States, but it was extended when
FDA granted Bayer six-month pediatric exclusivity. Other patents remain, including one for its extended-release formulation
CiproXR, and Bayer is exploring the possibility of others. But for many observers, June 9, 2004—the date the extension expired—was
the end of an era. To mark the event, eight Cipro veterans, past and present, gathered to recall the drug's history and what
it meant to them.
As Good as an IV
As a product, Cipro was a blend of marketing pluses and minuses. The second approved drug in the fluoroquinolone class, it
was effective against the organism Pseudomonas aeruginosa, which causes hard-to-treat hospital-acquired infections. Its broad-spectrum efficacy on other bugs including Escherichia coli earned it the respect of physicians. On the other hand, it is less potent against streptococcus—and thus respiratory infections,
the biggest chunk of the anti-infectives market.
Cipro's main advantage was strength: It was comparable to the IV antibiotics that ruled the field at the time. "That was key
for clinicians," says Steven Kowalsky, PharmD, global medical director for global clinical development. "The idea of being
able to have a drug that you can give orally that is as effective as a parenteral meant a huge cost savings."
This was before the heyday of managed care formularies, but the Cipro team was already making a pharmacoeconomic argument.
"The quinolones were expensive drugs," says Carol D'Eugenio, deputy director of marketing research. "The economic story was
that we kept you out of the hospital, so you saved $5,000 a day." And there was another problem. "In some cases the reimbursement
system was not ready for the idea of putting a patient on an oral tablet in the hospital and then sending them home," says
Jennifer Stahl, current director of oncology new product development, previously director of anti-infective marketing for
Cipro was known around the world but had different names in different countries—in Germany, it was known as Ciprobay; in
Japan, as Ciproxan; in Latin America, as Ciproxina; and in France, as Ciflox. Whichever the name and nation, Bayers message
was always the same: Cipro meant power.
The key, for Jonathan Harris, deputy director of anti-infective marketing for Cipro/CiproXR, was the support of an international
network of opinion leaders. "They believed in the studies," he says. "Almost every key thought leader had been involved in
them. They were the ones saying, 'Look, you have got to believe this. I know we have never seen it before, but trust us. We
have done the studies.'"
The result was a launch that surprised even insiders. "Just before launch in 1987," says D'Eugenio, "our German colleagues
had presented a model, which was the first time we would forecast by indication. The model came out that Cipro would reach
$100 million in its first year. Everybody said, 'Yeah, right.' It had never been done before."