GENENTECH ACTIVASE GROWTH SLOWED BY SHRINKING THROMBOLYTICS MARKET, FIRM SAYS: PFIZER ZITHROMAX SALES UP 75% ON SEVERE FLU SEASON, NEW INDICATIONS

Genentech maintained a two-thirds share of the U.S. growth hormone market in 1996 with Protropin and Nutropin, the company said.

Combined sales of the two human growth hormones totaled $218.2 mil. in 1996, an uptick from $216.7 mil. in 1995 on a pro forma basis. The company sees "potentially important competitive advantages" from its liquid formulation Nutropin AQ and GenJect injection device. Nutropin received an additional indication, treatment of short stature associated with Turner Syndrome, in December.

The upcoming year could see increased competition for Genentech's growth hormones: a preliminary injunction against Novo Nordisk's hGH Norditropin was stayed by a D.C. appeals court in December, allowing Norditropin to enter the U.S. market ("The Pink Sheet" Dec. 23, In Brief). Bio-Technology General's BioTropin remains off the market due to a preliminary injunction.

Genentech's Activase held an 80% share of the U.S. market for thrombolytic therapies for treatment of acute MI, up from 75% at the end of 1995. However, "the overall size of the thrombolytic therapy market during 1996 has declined by approximately 6.5% compared to 1995 as a result of some heart attack patients receiving mechanical reperfusion rather than thrombolytic therapy and others receiving therapy through ongoing large scale clinical trials," Genentech said. The upcoming year will see increased competition to Activase from Boehringer Mannheim's Retavase.

Activase sales dipped from $288.3 mil. in 1995 to $284.1 mil. in 1996 on a pro forma basis, despite the June approval of Activase for treatment of acute ischemic stroke. The new indication is "undergoing a review and adoption period," Genentech maintained.

Genentech's 1996 product sales were $582.8 mil., up from $578.7 mil. in 1995 pro forma sales. The sales figures take "into account the new arrangement with Roche by including sales to Roche in 1996 and excluding Canadian and European customer sales in 1995," Genentech notes. Genentech's royalties increased from $190.8 mil. in 1995 to $214.7 mil. in 1996.

Pulmozyme recorded pro forma sales of $76 mil. in 1996 compared to $70 mil. the preceding year. The increase was "driven primarily by sales of Pulmozyme to Roche for ex-U.S. sales," Genentech commented. FDA approved Pulmozyme use in cystic fibrosis patients with advanced disease in November. Genentech's interferon gamma-1b Actimmune sales were $4.5 mil. in 1996 and $3.6 mil. in 1995 on a pro forma basis.

The severe flu and respiratory infection season that closed out 1996 raised the temperature of sales of antibiotics in the U.S., including Pfizer's Zithromax and Abbott's Biaxin.

Zithromax jumped 75% to $372 mil. in U.S. sales for the year, making it "the fastest-growing oral antibiotic" in the U.S., according to Pfizer. Zithromax is "second in new prescriptions among U.S. branded pediatric oral antibiotics," the company added. Worldwide sales grew 53% to $619 mil.

FDA approved a number of new indications for Zithromax in 1996, including MAC prophylaxis, treatment of lower respiratory tract infections in children, treatment of Chlamydia pneumoniae and Mycoplasma pneumoniae, a two-gram dose for gonorrhea treatment and a one-gram dose for chanchroid treatment.

Biaxin reached $1 bil. in worldwide sales in 1996, the company reported. Abbott's pharmaceutical and nutritional sales for the year were $6.31 bil., up 12%. The U.S. accounted for $4.14 bil. in sales.

Another antibiotic, Bristol-Myers Squibb's Maxipime had $61 mil. in 1996 worldwide sales, up 147%. The injectable cephalosporin was introduced in the U.S. in the third quarter.

Pfizer pharmaceutical sales grew 21% to $4.46 bil. in the U.S. over 1996; international sales were up 11% to $3.72 bil.

Pfizer's antihistamine Zyrtec posted U.S. sales of $140 mil. in its first year on the market. International markets contributed another $6 mil. in Zyrtec sales, down 33%. Schering-Plough's market-leading antihistamine Claritin had worldwide sales of $1.15 bil. in 1996, an increase of 46%.

Pfizer's Zoloft U.S. sales were $1.12 bil. for the year, a 27% increase. Zoloft was approved for treatment of obsessive-compulsive disorder in October; the SSRI antidepressant is "approvable" for treatment of panic disorder. Worldwide sales grew 29% to $1.34 bil.

Bristol's antidepressant Serzone grew 89% over 1996, contributing $109 mil. in worldwide sales. The company's anxiolytic BuSpar had a 19% increase in sales to $370 mil. worldwide.

Diflucan "remains the world's best-selling prescription antifungal product," Pfizer maintained. U.S. sales grew 5% to $409 mil.; worldwide, sales rose 4% to $910 mil. Diflucan use is "increasing in both presumptive and documented cases of systemic candidiasis," the company said, and "a one-pill regimen for vaginal candidiasis has been an important source of sales growth." Pfizer filed an application for an onychomycosis indication in November.

The oral antidiabetic market also continues to be hot. Bristol's oral antidiabetic Glucophage, which has been on the U.S. market for 18 months, had $332 mil. in worldwide 1996 sales.

Pfizer's antidiabetic Glucotrol XL rose 57% to $133 mil. in U.S. 1996 sales as the older formulation, Glucotrol, dropped 44% to $40 mil. The extended-release formulation is sold only in the U.S.

The increasing sales of Glucotrol XL contributed to Alza's $171 mil. in 1996 royalties and fees. In 1995, Alza recognized $145 mil. in royalties and fees. Pfizer's royalty arrangement with Alza for Procardia XL was amended in 1996. Ethyol, which is co-promoted by Alza and U.S. Bioscience, posted $9 mil. in sales.

Bristol's pharmaceutical sales increased 11% in 1996. Excluding sales of Capoten, the sector grew 21%. Capoten declined 68%, or $377 mil., in the U.S. and 7% internationally. Worldwide Capoten sales for the year were $1.1 bil.

Taxol showed "strong volume growth" for the year, leading to $813 mil. in worldwide sales, up 40%, Bristol said. Paraplatin had a 16% rise to $373 mil. Bristol's antiretroviral Zerit contributed the company's greatest annual increase, a 167% leap to $140 mil. in 1996 worldwide sales. Videx also saw strong sales growth, rising 71% to $112 mil.

Bristol's statin Pravachol recorded $1.1 bil. in 1996 worldwide sales, an increase of 39%. Monopril sales were up 31% to $257 mil. with "strong volume growth" for the ACE inhibitor.

Schering-Plough's interferon product Intron A provided sales growth of 21% to post $524 mil. in worldwide sales. "Domestic sales of Intron A benefited from greater use of the product as adjuvant treatment for malignant melanoma and as a treatment for hepatitis C," Schering stated. "International sales of Intron A were higher due to the extended dosage regimen approved in Europe for treating hepatitis C."

Schering's U.S. pharmaceutical sales grew 23% over 1996, the company reported. Globally, the pharmaceutical business rose 13%. Overall pharmaceutical sales were $5.05 bil.