Contact: Karen Kaplan, Solvay Pharmaceuticals, Inc.
Phone: 770-578-5637
Contact: Laurie Flatt or Megan McDowell, Fleishman Hillard, Inc.
Phone: 404-659-4446
U.S. DISTRICT COURT RULES IN FAVOR OF SOLVAY PHARMACEUTICALS, INC. IN LAWSUIT AGAINST GENERIC MANUFACTURER
Marietta, Ga., (January 30, 1998) -- Solvay Pharmaceuticals, Inc.
announced today that the United States District Court ruled that MENOGEN
and MENOGEN H.S. (Half Strength) Tablets have not been shown to be
bioequivalent to Solvay Pharmaceuticals' ESTRATEST(r) (Esterified
Estrogens and Methyltestosterone) and ESTRATEST(r) H.S. (Half Strength)
Tablets.
The court ordered that Sage Pharmaceuticals, Inc., manufacturer of
MENOGEN Tablets, immediately and permanently cease all manufacturing,
marketing promotion, sale and distribution of MENOGEN Tablets. Sage
Pharmaceuticals manufactured MENOGEN Tablets for a distributor,
Breckenridge Pharmaceutical, Inc., who claimed comparability to Solvay
Pharmaceuticals' ESTRATEST(r) Tablets and marketed MENOGEN Tablets as a
generic equivalent to ESTRATEST(r) Tablets. Sage Pharmaceuticals did not
perform comparative testing on MENOGEN Tablets to establish
comparability or bioequivalence to ESTRATEST(r) Tablets. In contrast,
Solvay Pharmaceuticals performed comparative testing of MENOGEN Tablets
validated through an independent third party, which identified
differences in the composition of the esterified estrogens ingredients
in MENOGEN Tablets when compared to those in ESTRATEST(r) Tablets.
"We are pleased that the court, in examining the evidence, has found
that MENOGEN has not been demonstrated to be a generic equivalent for
ESTRATEST(r) Tablets and ESTRATEST(r) H.S. Tablets," said Laurence J.
Downey, M.D., Senior Vice President, Commercial Operations, for Solvay
Pharmaceuticals.
"We were very concerned that the marketing of this product had the
potential to confuse physicians, pharmacists and patients. The court's
ruling protects ESTRATEST(r) Tablet's 30-year reputation for safety and
physician/patient confidence," he said.
ESTRATEST(r) Tablets is indicated for the management of moderate to severe
vasomotor symptoms associated with menopause in patients who do not
respond to estrogens alone.
Solvay Pharmaceuticals, Inc., of Marietta, Ga., is a research-based
pharmaceutical company active in the therapeutic areas of women's
health, gastroenterology, and mental health and manufacturer of
ESTRATEST(r) Tablets, ESTRATAB(r) Tablets and ZENATE(r) (Prenatal
Multivitamin/Mineral Supplement) Tablets. The company co-promotes
FAMVIR(r) (Famciclovir), manufactured by SmithKline Beecham, and recently
acquired licensing rights for ESTROGEL(r) (17-beta estradiol), a topical
estrogen gel, and a combination estrogen/progestin transdermal patch,
containing 17-beta estradiol/levonorgestrel. Both of the newly licensed
products are currently in Phase III clinical trials.
The company also recently acquired U.S. marketing rights to PROMETRIUM(r)
(Progesterone, USP) Capsules, a natural micronized progesterone that is
identical in chemical structure to endogenous (naturally occurring)
progesterone. PROMETRIUM(r) Capsules is currently under review by the
Food and Drug Administration (FDA)
Solvay Pharmaceuticals is a member of the worldwide Solvay SA group of
chemical and pharmaceutical companies. Solvay SA is headquartered in
Brussels, Belgium.
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