Workers at Bayer AG's U. But the next day, New York Sen. Charles Schumer questioned whether Bayer could meet soaring demand for the potent anthrax antibiotic and called for government action to allow generic production. Sunday, Senate minority leader Trent Lott predicted the Senate would soon take up debate on whether to strip the patent on Bayer's flagship product.
Canada, with a looser patent-protection law, has already done so. You may change your billing preferences at any time in the Customer Center or call Customer Service. Westwood, who today is vice-president of global strategic marketing for Bayer's anti-infectives franchise, ran down to the marketing group to find out the story on the compound.
Looking back, he realizes that 20 years ago that was a surprising thing for a medical-affairs type to do. Team Cipro. Westwood's reach across disciplinary lines was prophetic. BAY o, better known as Cipro ciprofloxacin , launched in and turned out to be one of the great medicines of the 20th century.
Partly that was a matter of the molecule itself, an exceptionally useful, powerful broad-spectrum antibiotic. Among Cipro's accomplishments, it was:. Throughout its history, Cipro has been a compelling case study in how to manage a drug over the course of its lifecycle, through reformulation, research, and promotion.
It has also been a kind of training ground where a whole generation of Bayer marketing professionals learned their craft. 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, —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 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. Its broad-spectrum efficacy on other bugs including. 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.
This was before the heyday of managed care formularies, but the Cipro team was already making a pharmacoeconomic argument. Whichever the name and nation, Bayers message was always the same: Cipro meant power. 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.
Everybody said, 'Yeah, right. But this time it was. Within six months of launch, Cipro was on 99 percent of hospital formularies, and by year end, the forecast had proven true. In the s, Bayer put Cipro in the hands of a project team with membership from the key clinical functions, preclinical functions, and marketing.
Cross-functional teams always sounds good but often fail. If a medical person says they cannot do it, it's not, 'Oh, you're going to do it. In a sense, though, the team also included the substantial participation of the global community of microbiologists and infectious-disease specialists.
Key thought leaders came to Bayer with ideas for new indications and formulations, and the company funded everything that came its way—including preclinical studies.
At one point, according to Westwood, every hospital in the United Kingdom was testing Cipro for one thing or another. They understood how it worked. They recommended it in the hospital environment and then transferred that endorsement to community use. Although the FDA has labeled some second-generation quinolones for the treatment of lower respiratory tract infections and acute sinusitis, it should be stressed that S. Consequently, second-generation quinolones are not the drugs of first choice for lower respiratory tract infections and acute sinusitis.
Of the second-generation agents, ofloxacin has the greatest activity against Chlamydia trachomatis. Ciprofloxacin and ofloxacin are the most widely used second-generation quinolones because of their availability in oral and intravenous formulations and their broad set of FDA-labeled indications.
The third-generation quinolones currently include levofloxacin, gatifloxacin, moxifloxacin and sparfloxacin. These agents are separated into a third class because of their expanded activity against gram-positive organisms, particularly penicillin-sensitive and penicillin-resistant S. Because of their expanded antimicrobial spectrum, third-generation quinolones are useful in the treatment of community-acquired pneumonia, acute sinusitis and acute exacerbations of chronic bronchitis, which are their primary FDA-labeled indications.
Gatifloxacin also has FDA-labeled indications for urinary tract infections and gonorrhea. Sparfloxacin carries a significant risk of phototoxicity. However, the FDA recommends that all of these drugs should be avoided in patients who are taking drugs that are known to prolong the QT interval, such as tricyclic antidepressants, phenothiazines and class I antiarrhythmics.
Trovafloxacin, currently the only member of the fourth-generation class, adds significant antimicrobial activity against anaerobes while maintaining the gram-positive and gram-negative activity of the third-generation quinolones. It also retains activity against Pseudomonas species comparable to that of ciprofloxacin. Trovafloxacin is available in an oral tablet and as the prodrug alatrofloxacin Trovan IV in an intravenous formulation. Although the findings of few clinical trials on trovafloxacin have been published, the drug was originally labeled by the FDA for the treatment of a wide spectrum of infectious diseases.
Fluoroquinolones are more expensive than first-line agents such as trimethoprim-sulfamethoxazole Bactrim, Septra for the treatment of uncomplicated urinary tract infections or doxycycline Vibramycin for the treatment of acute exacerbations of chronic bronchitis.
However, the use of orally administered fluoroquinolones when indicated instead of intravenously administered antibiotics may provide significant advantages in terms of reduced hospitalization or home health care costs. The average wholesale costs of orally and intravenously administered quinolones are provided in Table 4. Montvale, N. Cost to the patient will be higher, depending on prescription filling fee.
Already a member or subscriber? Log in. Interested in AAFP membership? Learn more. Address correspondence to Dana E. King, M. Reprints are not available from the authors. The authors thank Susan Loftin and Julie Calder for technical assistance in the preparation of the manuscript.
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