Exhibit 99.1
Investor Contact:
The Investor Relations Group
Lisa Lindberg/Dian Griesel, Ph.D.
Phone: 212-825-3210
Email: TheProTeam@aol.com
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UNIGENE RELEASES LETTER TO SHAREHOLDERS
Fairfield, NJ--September 5, 2002 - Unigene Laboratories, Inc. (OTCBB: UGNE) is
publishing the following letter to its shareholders:
Dear Fellow Shareholders,
This is a very exciting time for Unigene. We continue to make strong progress
with our core osteoporosis programs as evidenced by our recent $150 million
licensing agreement with GlaxoSmithKline and by the advancement of our nasal
calcitonin program.
I wanted to update you on the progress we have made to date and highlight our
initiatives and operational focus over the coming months:
o Oral PTH Program. As announced in April of this year, our $150 million
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licensing agreement with GlaxoSmithKline for our oral parathyroid
hormone (PTH) product represents a significant milestone for Unigene.
The fact that one of the world's leading pharmaceutical companies
chose to work with Unigene, after a thorough evaluation of alternative
opportunities, is a tribute to the quality and potential of Unigene's
patented technologies. The most exciting aspect of PTH is its unique
ability to grow significant amounts of new bone, unlike all of the
current therapies which principally act to reduce the rate of bone
loss. Published reports estimate that formulations of PTH requiring a
daily injection could generate annual sales in excess of $500 million
by 2005. We believe that an oral formulation is more desirable and
could be expected to exceed those levels. During the development
program, Unigene will receive significant milestone payments from GSK
and GSK will fund its development activities and will purchase
Unigene's bulk PTH.
o Nasal Calcitonin Program. We believe that sales of our nasal
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calcitonin product may commence as soon as 2003. Last year, U.S. sales
of the currently marketed nasal calcitonin product were approximately
$300 million. Recent concerns over hormone replacement therapies have
led many patients and practitioners to consider alternative
osteoporosis therapies. This could mean that sales of calcitonin, a
product with an excellent safety profile, may increase in the coming
years. This has also increased interest from potential marketing and
distribution partners and should allow us to select a partner whose
marketing capabilities and strategy seem best suited to maximize the
return on this opportunity. We are currently in negotiations with
several potential distribution partners and expect to finalize a
licensing agreement in 2002. We expect that the licensing agreement
would involve upfront, milestone and royalty payments. Because we
anticipate that our potential partner may take the opportunity to
review the New Drug Application (NDA) for our nasal calcitonin
product, we expect that the NDA will not be filed until the fourth
quarter of 2002.
o Chinese Calcitonin Programs. Our joint venture with the Shijiazhuang
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Pharmaceutical Group intends to file a Chinese NDA for injectable and
nasal calcitonin products by year end. There are more than 90 million
osteoporosis sufferers in China and the Chinese government has
identified osteoporosis as one of the country's top three health
priorities. An approved Chinese NDA will give us significant
advantages in the market and our partnership with one of the largest
pharmaceutical companies in China should provide us with the resources
to maximize this opportunity.
o Oral Calcitonin Program. The recent negative news regarding hormone
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replacement therapy has heightened interest in this product. We have
now received the data generated from our prior collaboration and are
in discussion with pharmaceutical companies who are interested in
completing the development of and assuming responsibility for the
manufacturing of the product.
o Manufacturing Capabilities. We expect that the manufacturing capacity
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for PTH and calcitonin in our state of the art GMP manufacturing
facility will be sufficient to meet the expected demand for clinical
trials and where appropriate, for commercialization of these products.
This factory may also be used for production of other peptides in the
future.
o Other Oral Peptides. In preclinical studies we have successfully
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delivered insulin and other glucose regulating peptides, DDAVP and
leuprolide which have potential applications in treating diabetes,
incontinence, and endometriosis and prostate cancer, respectively. We
believe that there will be significant licensing opportunities for
these and other peptide products.
We believe that our focus on therapies to treat osteoporosis will deliver
significant value to our shareholders both in the near term and long-term. The
market opportunity for osteoporosis therapies is vast with approximately 44
million people in the U.S. afflicted with either osteoporosis or low bone mass
and over 200 million sufferers worldwide. More than 800,000 new prescriptions
were written for osteoporosis in the first month of this year alone.
The value of our technologies is not limited solely to osteoporosis. We believe
that our platform oral delivery and manufacturing technologies and patent
positions are strong with potential applications in the treatment of many
diseases including diabetes and cancer. While these programs are still in
pre-clinical stages, we believe that the long-term value to our shareholders is
significant and we expect to continue to develop these programs.
We are excited by recent developments at Unigene over the past months and we are
even more excited by what we expect to achieve in 2002 and in 2003. We will work
to continue to keep our shareholders updated on the progress of our licensing
activities and our nasal calcitonin NDA by hosting conference calls and/or
through additional shareholder letters.
Thank you for your continued support.
Sincerely,
Warren P. Levy, Ph.D.
President & CEO
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," "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.