The Trovan study,
encompassing eight
Asian countries,
is the largest clinical
trial Pfizer has ever
conducted in Asia. |
Health Care – Pharmaceuticals (cont'd)Infectious Diseases
Pfizer has long helped doctors battle the world’s number one killer—infectious disease. We were a pioneer in that effort in the 1940s as the first company to mass-produce penicillin. Today, Pfizer remains a leader in the field, marketing a broad range of antibiotics, including the most-prescribed branded oral antibiotic in the United States—Zithromax—and the world’s largest-selling prescription antifungal—Diflucan. The Company continues to work at the cutting edge of anti-infective medicine, with projects that include continued development of existing compounds for new indications; the early 1998 launch of Trovan, an advanced quinolone antibiotic with unprecedented breadth of coverage; advanced clinical testing of a new broad-spectrum antifungal, voriconazole; and numerous early-stage research and development programs using novel approaches to anti-infective treatment.
 Worldwide sales of Zithromax grew 33 percent in 1997 to $821 million in the product’s 6th year of marketing. Strong growth in sales resulted from the increasing recognition by physicians of the product’s broad efficacy, convenient dosing, favorable side-effect profile, and, in the case of the oral liquid suspension dosage form for children, a pleasant taste as well. The product is primarily used to treat respiratory tract infections, and is also used for skin infections in adults, middle ear infections and strep throat in children, and a broad range of other uses. Product enhancements approved by the FDA in recent years, including treatment of the atypical pathogens Chlamydia pneumoniae and Mycoplasma pneumoniae, plus an intravenous dosage form, and an oral capsule dosage form that allows the product to be taken with food, have further increased physician acceptance and patient compliance. Pfizer is engaged in clinical programs to support a new use for Zithromax in decreasing cardiovascular risk in patients with atherosclerosis caused by Chlamydia. U.S. patent protection extends to November 2005.
In December 1997, Pfizer received approval from the FDA to market the new broad-spectrum quinolone antibiotic Trovan. The product was shipped to customers in the United States in January 1998, and regulatory review in Europe is advancing. More than 13,000 patients participated in 87 studies involving Trovan and 30 comparator drug regimens, representing the largest clinical trial program in Pfizer history and the largest regulatory filing ever received by the Anti-Infectives Division of the FDA.
|
Worldwide Revenues of Therapeutic Lines,
Major Products, and Recently Introduced Products |
| % Change* |
|
|
(millions of dollars) |
1997 |
1996 |
1995 |
97/96 |
96/95 |
|
| Worldwide Pharmaceuticals |
$9,239 |
$8,188 |
$7,072 |
+13 |
+16 |
|
| Cardiovascular Diseases |
3,806 |
3,486 |
2,981 |
+ 9 |
+17 |
Norvasc
Procardia XL(U.S. only)
Cardura |
2,217
822
626 |
1,795
1,005
533 |
1,265
1,133
413 |
+23
-18
+17 |
+42
-11
+29 |
| Infectious Diseases** |
2,483 |
2,325 |
2,153 |
+ 7 |
+ 8 |
Diflucan
Zithromax
Unasyn
Sulperazon(Int’l. only)
Vibramycin |
881
821
346
139
78 |
910
619
326
139
87 |
878
406
333
160
99 |
- 3
+33
+ 6
–
-10 |
+ 4
+53
- 2
-13
-12 |
| Central Nervous System Disorders |
1,553 |
1,382 |
1,092 |
+12 |
+27 |
| Zoloft |
1,507 |
1,337 |
1,037 |
+13 |
+29 |
| Diabetes** |
234 |
213 |
200 |
+ 9 |
+ 7 |
Glucotrol XL
Glucotrol |
175
33 |
135
49 |
85
80 |
+30
-33 |
+59
-39 |
| Allergy |
273 |
156 |
21 |
+74 |
– |
| Zyrtec/Reactine |
265 |
146 |
10 |
+81 |
– |
| Arthritis/Inflamation** |
269 |
315 |
369 |
-15 |
-15 |
| Feldene |
241 |
282 |
305 |
-14 |
- 8 |
| Alliance Revenue |
316 |
– |
– |
– |
– |
| Other** |
305 |
311 |
256 |
- 2 |
+21 |
|
*Percentages may reflect rounding adjustments.
* * Certain prior year data have been reclassified to conform to the current year presentation. |
These trials found Trovan to be effective against all four important bacterial groups: gram-positive aerobic, gram-negative aerobic, anaerobic, and atypical pathogens. The FDA approved Trovan for 14 indications, the largest number of indications ever included in an initial drug approval in the United States. These indications include common respiratory tract infections—community- and hospital-acquired pneumonia, acute exacerbations of chronic bronchitis, and acute sinusitis. Because of its high oral bioavailability and comprehensive activity against the gut flora, the product is also the first antibiotic ever approved for oral prophylactic use in surgery. Trovan is also approved for uncomplicated urinary tract infections; gonorrhea; chlamydial cervicitis; uncomplicated and complicated skin infections, including diabetic foot infections; and prostatitis. Trovan is available in oral and intravenous formulations and can be administered just once a day in all approved indications.
Pneumonia represents the number one cause of death from infectious disease in the United States. Four million Americans develop pneumonia each year, nearly one quarter of whom require hospitalization. In clinical trials, Trovan demonstrated a remarkable 95 percent overall cure rate against pneumonia.
Trovan also exhibits a good safety profile. The incidence of side effects, most commonly dizziness, nausea, headache, and light-headedness, was generally low and the effects usually mild and transient.
In its 10th year on world markets, Diflucan’s sales decreased 3 percent in 1997 to $881 million, reflecting in part the lower incidence of fungal infections in AIDS patients. The product continues to be the therapy of choice for a wide range of fungal infections, particularly in patients with compromised immune systems. Diflucan retains U.S. patent protection until January 2004.
Other anti-infective projects continue to advance. Voriconazole, a new antifungal with strong efficacy against Aspergillus and Cryptococcus as well as Candida fungal infections, is advancing in Phase III clinical trials. |
