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Investor Contact:
The Investor Relations Group
John Nesbett/Gino De Jesus
Phone: 212-825-3210
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Upsher-Smith Laboratories and Unigene Laboratories
Clarify Upsher-Smith’s Press Release Issued Earlier Today
Minneapolis, MN and Fairfield, NJ, July 18, 2005—Upsher-Smith
Laboratories, Inc. and Unigene Laboratories, Inc. (OTCBB: UGNE) clarified
a press release issued earlier today by Upsher-Smith.
Upsher-Smith reiterated its continuing disappointment in the longer
than expected review process by the FDA, but clarified that neither
company has received any communication of a decision by the FDA regarding
the approval of Fortical® calcitonin-salmon (rDNA origin) Nasal
Spray, a patented nasal calcitonin product for the treatment of postmenopausal
osteoporosis. Both companies remain optimistic that a final decision
will be rendered by the FDA shortly.
Upsher-Smith also emphasized that the restructuring and elimination
of positions at Upsher-Smith resulting from the lengthy approval
process will have no impact on their commitment to Fortical® and
its long-term success in the marketplace.
Mark Robbins, Vice President Legal and Regulatory Affairs of Upsher-Smith,
stated, “I regret any confusion that may have been created
by our earlier press release. While the Prescription Drug User
Fee Act (PDUFA) goal date for the FDA to render a decision on the
submission of this product was March 16, 2005, we are confident that
the FDA is concluding its review process and we look forward to a
rapid response.”
Mark Evenstad, President of Upsher-Smith, stated, “We remain
fully committed to the launch and the support of Fortical®. Furthermore,
we continue our preparations to effectively and expeditiously launch
this product immediately following its approval.”
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 regarding this press release or Upsher-Smith
Laboratories, Inc., please call 1-800-654-2299
or visit http://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 the U.S. rights for its nasal calcitonin product
to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology
to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing
technology to Novartis. Unigene is awaiting approval from the
FDA for Fortical®, its nasal calcitonin product for the treatment
of osteoporosis. 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.
Safe Harbor statements under the Private Securities Litigation
Reform Act of 1995: This press release contains forward-looking
statements as defined in Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Such forward-looking statements are based upon Unigene
Laboratories, Inc.’s management’s current expectations,
estimates, beliefs, assumptions, and projections about Unigene’s
business and industry. Words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “potential,” “continue,” and
variations of these words (or negatives of these words) or similar
expressions, are intended to identify forward-looking statements.
In addition, any statements that refer to expectations, projections,
or other characterizations of future events or circumstances, including
any underlying assumptions, are forward-looking statements. These
forward-looking statements are not guarantees of future performance
and are subject to certain risks, uncertainties, and assumptions
that are difficult to predict. Therefore, our actual results could
differ materially and adversely from those expressed in any forward-looking
statements as a result of various risk factors. These risks and
uncertainties include the risks associated with the effect of changing
economic conditions, trends in the products markets, variations
in Unigene's cash flow, market acceptance risks, technical development
risks and other risk factors detailed in Unigene's Securities and
Exchange Commission filings.
Minneapolis, Minn., July 18, 2005—Upsher-Smith Laboratories,
Inc., a Minnesota based pharmaceutical company, expressed disappointment
today the FDA’s decision to delay approval of Fortical® calcitonin-salmon
(rDNA origin) Nasal Spray, a patented nasal calcitonin product for
the treatment of postmenopausal osteoporosis.
“We are enormously saddened by what we feel is the unconscionable
delay by the FDA in the approval of Fortical, an important drug therapy
for the treatment of osteoporosis,” said Mark Robbins, Vice
President of Legal and Regulatory Affairs for Upsher-Smith Laboratories. “The
Prescription Drug User Fee Act (PDUFA) date for the FDA to issue
a final action on the submission of this product was March 16, 2005.
When Upsher-Smith launches this new drug therapy, the annual savings
to consumers are estimated to be over 100 million dollars. The patients
most affected are women 70 years and older, many of whom pay cash
for alternative therapies.”
Consumers spend over $4 billion annually for the treatment and
prevention of osteoporosis. With Fortical, Upsher-Smith will offer
the most affordable therapy in this category. “We are anxious
to launch this product upon approval and continue our longstanding
tradition of offering economic solutions to combat the problem of
rising healthcare costs,” said an Upsher-Smith executive.
Upsher-Smith also announced a restructuring and elimination of
positions in response to the FDA delay and market conditions.“We
remain committed to providing valuable therapies at affordable prices,” said
Mark Evenstad, President of Upsher-Smith. “We feel confident
that the changes we have made will place us in the best possible
position to ensure a healthy future for our employees and a continued
stream of important, affordable therapies for consumers.”
Upsher-Smith Laboratories, Inc. is a fully integrated pharmaceutical
company that manufactures and markets prescription pharmaceutical,
OTC and cosmetic products. Upsher-Smith Laboratories, Inc. is also
actively involved in licensing innovative compounds that are in clinical
development. For more information about Upsher-Smith Laboratories,
Inc., call 800-654-2299 or visit www.upsher-smith.com
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