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Upsher-Smith launches NEW Fortical® Nasal
Spray for postmenopausal osteoporosis
Minneapolis, Minnesota. August 16,
2005—Upsher-Smith Laboratories, Inc. announces the
launch of New Fortical® calcitonin-salmon (rDNA
origin) Nasal Spray, an effective treatment option for postmenopausal
osteoporosis in women greater than 5 years postmenopause with
low bone mass relative to healthy premenopausal women. Upsher-Smith
commercializes the product today with shipments to the retail
and wholesale trade, and will begin aggressively promoting
to physicians through sales force detailing, national conventions,
professional advertising, and other promotion. Fortical® was
developed, and will be manufactured for Upsher-Smith by Unigene
Laboratories, Inc. (OTCBB:UGNE). Unigene announced FDA approval
of Fortical® on August 15, 2005.
“Fortical® presents an exciting new option
for women with postmenopausal osteoporosis,” said an
Upsher-Smith executive. “Fortical® represents
a pharmaceutically equivalent nasal calcitonin-salmon that
provides a significant cost savings compared to the existing
therapy. Further, Fortical® allows Upsher-Smith
the opportunity to capitalize on our unique ability to offer
an economical alternative and support physicians, retailers,
and managed care. Fortical® will conveniently
fit into a woman’s normal routine and can be taken before,
during, or even after meals. The convenience of Fortical® may
be just what many patients need to help diminish progressive
osteoporotic bone loss.”
New Fortical® Nasal Spray contains the active
ingredient calcitonin-salmon. Calcitonin-salmon has been proven
to produce statistically significant increases in lumbar vertebral
bone mineral density (BMD) at just 6 months compared to placebo,
with persistence at this level for up to
2 years of observation.1
Calcitonin-salmon has also been shown to increase hip BMD
at
12 months compared to placebo.1
Mark Evenstad, Vice Chairman and President, reflects on the
company’s pledge to market effective products to meet
the ever-changing needs of both physicians and patients. “We
continually strive to ensure the highest quality of our products.
Fortical® is manufactured with a unique, patented
recombinant DNA technology and safely treats postmenopausal
osteoporosis with no reported serious drug-related gastrointestinal
or esophageal adverse events.”1
“We are impressed that Upsher-Smith has launched Fortical® so
rapidly following FDA approval,” commented Dr. Warren
P. Levy, President and CEO of Unigene. “Upsher-Smith’s
commitment to Fortical® is clear and we are
enthusiastic about the product’s commercial prospects.”
New Fortical® Nasal Spray is available now,
with a prescription, and is recommended in conjunction with
adequate intake of calcium and vitamin D. Periodic nasal
examinations are recommended; if nasal ulceration occurs, discontinue
treatment until healed. Because calcitonin-salmon is
a protein, the possibility of systemic allergic reaction exists. For
more information and complete product information/most common
adverse events for Fortical® Nasal Spray, visit
www.upsher-smith.com or call 1-800-654-2299.
Upsher-Smith Laboratories, Inc. is a fully integrated pharmaceutical company that manufactures
and markets prescription pharmaceutical, OTC, and cosmetic products.
Upsher-Smith is also actively involved in licensing innovative
compounds that are in clinical development. For more information
about Upsher-Smith Laboratories, Inc., call
1-800-654-2299 or
visit www.upsher-smith.com.
Unigene Laboratories, Inc. is a biopharmaceutical
company focusing on the oral and nasal delivery of large-market
peptide drugs. Due to the size of the worldwide osteoporosis
market, Unigene is targeting its initial efforts on developing
calcitonin and PTH-based therapies. Unigene has licensed worldwide
rights for its oral PTH technology to GlaxoSmithKline. Unigene’s
patented oral delivery technology has successfully delivered,
in preclinical and/or clinical trials, various peptides including
calcitonin, PTH, and insulin. Unigene’s patented manufacturing
technology is designed to cost-effectively produce peptides
in quantities sufficient to support their worldwide commercialization
as oral or nasal therapeutics. For more information about
Unigene, call 1-973-882-0860 or visit www.unigene.com.
Reference:
- Fortical® calcitonin-salmon
(rDNA origin) Nasal Spray product information.
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