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By William T. Elliott, MD, FACP
Genentech has high hopes for its nerve growth factor (neuleze), which is currently in Phase III testing. The company is seeking fast-track status for the drug, which is being studied for use in diabetic nephropathy. Although the results of the Phase III studies have not been published, Genentech is already gearing up its sales force for an early 2000 approval date. The drug is being evaluated for improvement in neuropathic impairment scores in diabetics. The drug’s main adverse effect is soreness at the injection site.
Generic drugs will be able to refer on their label to the brand name drug they are replacing, this according to a new ruling from the FDA. Generic companies feel that the ruling is important to show bioequivalence ratings, and also to avoid confusion on the part of patients who may be switched to a generic.
Common urinary tract pathogens, including E. coli, are becoming resistant to the most commonly used oral antibiotics. In a recent study (JAMA 1999; 281:736-738), researchers from Washington found that more than 20% of E. coli urine isolates were resistant to ampicillin, cephalothin, and sulfamethoxazole. More disturbingly, from 1992 to 1996, the rate of E. coli resistance to trimethoprim-sulfamethoxazole rose from 9% to 18%. These isolates remained sensitive to nitrofurantoin, gentamicin, and ciprofloxacin.
In related news, the much feared appearance of vancomycin-resistant S. aureus is a reality in this country. The CDC has reported on two cases from Michigan and New Jersey, both in diabetic men with chronic staph infections who had received 18 weeks of vancomycin for methicillin-resistant S. aureus (N Engl J Med 1999;340:493-501). In the same journal, a different case was reported from New York in a man who had received vancomycin for six weeks (N Engl J Med 1999;340:517-523). All three cases have the common thread of prolonged exposure of methicillin-resistant S. aureus to vancomycin, a scenario that is becoming increasingly common in hospitals around the country.
Astra’s omeprozole (Prilosec) remains the world’s best selling drug, with sales reaching the $5 billion mark in 1998. Merck’s simvastatin (Zocor) was second with sales of nearly $4 billion. In contrast, Pfizer’s sildenafil (Viagra), considered a sure-fire blockbuster drug, had relatively disappointing sales of only $788 million last year. About 25 drugs surpassed the $1 billion mark in 1998—the traditional standard for the designation of blockbuster. Searle’s celecoxib (Celebrex) is well on its way to blockbuster status this year. The first of the COX-2 inhibitors, celecoxib is gaining rapid acceptance among prescribers, with the number of prescriptions filled increasing almost 10-fold from 9500 in the third week of January to nearly 94,000 for the week ending February 5. All this before the company has begun its marketing push, which was scheduled to begin last month.
Invasive cervical cancer is best treated with a combination of radiation therapy and chemotherapy including cisplatin and 5-fluorouracil or hydroxyurea. This announcement from the National Cancer Institute has been made on the strength of five large clinical trials, which showed that combination therapy improves survival and improves disease-free intervals. In an unusual step, the New England Journal of Medicine allowed the prerelease of data from three studies scheduled for publication in the April 15th issue. All five studies found dramatic improvements of survival rates for women with invasive cervical cancer with the combination therapy, even though each study had differences in the design and even the chemotherapeutic agents used.
The controversial abortfacient drug mifepristone, commonly known as RU-486, may be commercially available by the end of this year. The drug was deemed approvable in 1996, but no drug manufacturer was willing to bring the drug to market, primarily because of the intense abortion debate that continues to rage in this country. The Population Council, which owns the US rights to the drug, has settled a number of outstanding legal issues that have plagued the final steps in bringing the drug to market and have found backing to begin the manufacturing process.