The Lifecycle of Cipro - Pharmaceutical Executive


The Lifecycle of Cipro
A cross-functional team of medical, clinical, marketing, and regulatory experts has kept Cipro's lifecycle going for an impressive 17 years--and counting.

Pharmaceutical Executive

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."

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.
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/CiproXR.

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."


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