Estrostep

NEW YORK -- Generic drug makers Barr Laboratories and Teva USA both reported satisfaction with recent quarterly earnings, due largely to each company's successful bids to produce generic versions of top-selling branded drugs.

Pomona, N.J.-based Barr reported net earnings of $67 million for the first quarter of fiscal 2002, which ended Sept. 30. Net earnings were $10.4 million during the same period last year. The increase translates into a per-share total of $1.80 on a fully diluted basis, compared with 28 cents per share last year. Total first quarter revenues were $315.3 million, up from $103.1 million in the first quarter last year.

Launching a generic version of Eli Lilly's depression drug Prozac is having an effect on Barr's bottom line, indeed.

"The launch of our fluoxetine 20 mg capsule drove unprecedented sales and earnings growth," Bruce Downey, Barr's chairman and chief executive officer, said. "Our capsule product accounts for approximately 65 percent of the total market for the 20 mg dosage form, generic and brand, [achieved] less than two months after the launch."

Tamoxifen, the generic version of AstraZeneca's breast cancer treatment and inhibitor Novaldex, did well for Barr, too. "Tamoxifen sales increased at double-digit rates during the first quarter, as did sales for non-tamoxifen products, which were fueled in part by sales of new products," Downey said.

Barr's two main growth strategies have been the pursuit of patent challenges and female health care products. The company has been aggressively challenging patent protection on some of the best-selling drugs, including Aventis Pharmaceuticals' allergy drug Allegra (fexofenadine HCI); Estrostep Fe (ethinyl estradiol and norethindrone acetateoral), an oral contraceptive from Pfizer; and Merck & Co.'s Fosamax (alendronate sodium tablets) for osteoporosis. All together, Barr has eight patent challenges pending in the courts.

Barr recently completed its acquisition of Duramed Pharmaceuticals, which will be absorbed under the Barr banner. One of the biggest plums in the Duramed pie is Cenestin, (synthetic conjugated estrogens), the plant-based estrogen replacement product that rivals Wyeth-Ayerst's Premarin.

Teva 'S generic Rocaltrol approved

Teva Pharmaceuticals, which reported net income of $79 million for its third quarter ended Sept. 30, posted a 75 percent increase over the same period last year. Sales rose 12 percent to $506 million. New products launched by the Jerusalem-based Teva in the U.S. market contributed to the strong quarterly showing, especially Teva' s generic version of GlaxoSmith Kline's arthritis drug Relafen (nabumetone) and its proprietary multiple sclerosis drug Copaxone (glatiramer acetate for injection). By quarter's end, Teva also got approval for calcitriol, the generic equivalent of Roche Laboratories' hyperthyroidism drug Rocaltrol, making it first to market.

Both Barr and Teva will face an ongoing court challenge from Merck before either can produce alendronate sodium, the generic version of popular osteoarthritis drug Fosamax. (See Generics Watch, page 36. Annual Fosamax sales are $762.7 million, making it the No. 1 osteoporosis drug in sales and prescriptions.

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