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Jenene Thomas
Vice President, Investor Relations and Business
Administration
UNIGENE PROVIDES 2012 BUSINESS OUTLOOK |
-Company to continue successful execution of
targeted growth strategy to monetize assets and
unlock significant shareholder value- -Management and Board signal unified commitment and comprehensive vote of confidence and optimism with open market stock purchases- -Key elements in place to address debt and restructure balance sheet-
January 9, 2012 -BOONTON, N.J. - Unigene
Laboratories, Inc. (OTCBB: UGNE) today provided a
business outlook for 2012 and highlighted
multiple near-term catalysts that have the
potential to monetize assets and unlock
significant value over the next 12 months.
Management believes the key elements are in place
to address the Company's debt and begin
restructuring the balance sheet in 2012.
Unigene's CEO, Senior Management and Board of
Directors signaled confidence and optimism in the
Company's future with open market stock purchases
on December 21, 2010.
Ashleigh Palmer, President and CEO, commented,
"We are proud of the successful execution of our
turnaround strategy throughout 2011. We readied
the Company to take advantage of favorable events
such as the positive ORACAL and oral PTH Phase 2
proof-of-concept trial results and armed it to
reduce the impact of unexpected events outside of
our control. In particular, a year ago, the
Company would have been hard pressed to survive
the consecutive announcements of Novartis'
negative Phase 3 osteoporosis and osteoarthritis
trial results and GSK's strategic decision
against sponsoring the advanced development of
our otherwise intact and licensable oral PTH
program. With those events now behind us,
Unigene's management team has emerged even more
focused on our mission and extremely confident
that we will continue to deliver on our strategic
intent. We believe our near-term value driving
milestones will allow us to further extend our
cash runway, address the debt we inherited and
unlock the enormous growth potential and
shareholder value that resides within Unigene."
2012 Corporate Milestones
Palmer continued, "We have established Unigene
as the oral peptide delivery innovator and
partner-of-choice, and we are now ideally
positioned to capitalize on the numerous
opportunities our industry leading oral peptide
delivery platform can realize in 2012. In
addition, we intend to secure a superb
development and commercialization partner for
our oral PTH program, a high-value asset with
the potential to provide a more compliant and
patient friendly therapy for the estimated 75
million osteoporosis sufferers worldwide."
Palmer concluded, "Prospects for the successful
turnaround and long-term future of Unigene have
never been brighter or more realizable.
Given this cautious optimism and
confidence, all members of Unigene's senior
management team and I, along with our Board of
Directors, have chosen to increase our personal
investments in Unigene, to demonstrate our
strong commitment to the Company and our belief
in our ability to execute our targeted growth
strategy in 2012."
Unigene Therapeutics Outlook
Unigene is focused on advancing its own
pipeline of novel, proprietary peptide product
candidates focused on metabolic disease and
inflammation.
Oral PTH Program Achieves Phase 2
Proof-of-Concept
On November 9, 2011, Unigene announced positive
top-line results of its Phase 2 clinical study
evaluating an experimental oral PTH analog for
the treatment of osteoporosis in 93
postmenopausal women. The study achieved its
primary endpoint with statistical significance.
The Phase 2 study was conducted by Unigene as
part of a now terminated exclusive worldwide
option and licensing agreement with
GlaxoSmithKline (GSK).
Unigene is actively seeking a licensing partner
for the oral PTH program.
The primary objective of the Phase 2 study was
to assess the change in bone mineral density
(BMD) at the lumbar spine, a clinically
validated predictor of fracture risk. The study
demonstrated once-daily treatment with 5mg of
orally delivered PTH resulted in a
statistically significant mean increase in BMD
at the lumbar spine of 2.2 percent (p<0.001)
at week 24 as compared to baseline.
Secondary endpoints in the Phase 2 study
evaluated an open label comparator arm of
injectable Forsteo® (teriparatide), an
approved treatment for osteoporosis, and
placebo to assess the changes in BMD at the
lumbar spine at 24 weeks. The Forsteo®
comparator arm showed a statistically
significant increase in BMD compared to
baseline, consistent with previously reported
data. The placebo arm showed a
non-significant decline in BMD. Safety,
tolerability, pharmacokinetics (PK) and
biochemical markers of bone formation and
resorption were also evaluated in the study.
Positive trends in bone formation at week 24
were seen in both the oral PTH and Forsteo®
arms. Importantly, the 5mg dose of oral PTH
demonstrated consistency of exposure at weeks
1 and 24 with the appropriate pulsatile PK
profile. There were no drug-related serious
adverse events and no occurrences of
hypercalcemia which is a common side effect
of PTH therapies. The most common
adverse event in the oral PTH arm was
abdominal pain.
The Company expects to present the full data
from the Phase 2 study in a peer review
journal and/or prestigious scientific
congress over the course of 2012.
Oral Calcitonin Program with
Tarsa Therapeutics Preparing for NDA
Submission
In 2009, Unigene licensed its late-stage
oral calcitonin formulation to Tarsa
Therapeutics (Tarsa), a venture financed
company founded exclusively to conduct
Phase 3 clinical testing and prepare
Unigene's proprietary oral calcitonin
formulation for commercialization. Unigene
owns a 20% equity position in Tarsa on a
fully diluted basis, subject to liquidating
preferences. The Company is also eligible
to receive sales-related milestone payments
and royalties on worldwide sales excluding
China.
On September 19, 2011, Unigene announced
that Tarsa presented positive Phase 3 data
from its ORACAL trial of OSTORA™ during the
annual American Society for Bone and
Mineral Research (ASBMR) 2011 meeting. The
data demonstrated that OSTORA achieved all
of the efficacy endpoints in the trial,
indicated that the safety p rofile of
OSTORA did not substantially differ from
nasal calcitonin or placebo and that OSTORA
also appeared to be significantly less
immunogenic than calcitonin
spray. Developed by Unigene and
licensed to Tarsa,
OSTORA™ is an oral recombinant salmon
calcitonin tablet in development for the
treatment of postmenopausal osteoporosis.
The ORACAL study was a Phase 3
multinational, randomized, double-blind,
double-dummy, placebo-controlled trial of
OSTORA™ compared to placebo and to
commercially available, synthetic salmon
calcitonin administered by nasal spray. The
primary efficacy endpoint was the
percentage change in lumbar spine bone
mineral density (BMD) after one year of
treatment. The trial enrolled 565
postmenopausal women with established
osteoporosis in six countries.
Tarsa also currently has a Phase 2
osteoporosis prevention trial ongoing.
TAR01-201, is a Phase 2 double-blind study
comparing oral recombinant salmon
calcitonin to placebo in approximately 120
postmenopausal women who have low bone mass
(osteopenia) and are at increased risk of
fracture. This proof-of-concept study is
evaluating the ability of oral calcitonin
to prevent osteoporosis and maintain bone
mass in this population. Tarsa expects to
report top-line results from this study in
the second half of 2012.
Tarsa expects to file its New Drug
Application (NDA) submission schedule to
the FDA for OSTORA, in the second half of
2012.
Metabolic Peptide
Programs Advancing in Preclinical
Development
Unigene's lead proprietary anorexigenic
peptide, UGP281, is currently in advanced
preclinical development. An anorexigenic
peptide is one that diminishes or controls
appetite and offers potential therapeutic
benefit to morbidly obese patients.
UGP281 is a peptide hormone analog that has
shown an acute dramatic reduction in food
intake in rat and dog model preclinical
studies at low doses. The peptide has been
produced by recombinant expression in E.
coli and has also been formulated in
enteric-coated capsules for oral delivery.
Longer term oral studies with UGP281 in dog
models are currently ongoing. Unigene
expects to file an Investigational New Drug
(IND) application with the FDA and initiate
Phase 1 clinical studies before the end of
2012.
On October 6, 2011, Unigene and Nordic
Bioscience announced the companies
established a Joint Development Vehicle
(JDV) to progress up to three of Unigene's
internally developed, proprietary
calcitonin analogs through Phase 2
proof-of-concept in humans for the
treatment of Type 2 diabetes,
osteoarthritis and osteoporosis. Unigene
and Nordic each own 50% of the JDV.
In exchange for 50% ownership interest in
the JDV, Unigene has licensed, on an
exclusive royalty free basis, up to three
(3) proprietary calcitonin analogs for
development by the JDV for use in the
treatment of Type 2 diabetes,
osteoarthritis and osteoporosis. In
addition to the license grant, Unigene will
supply the analogs selected for development
by the JDV for preclinical studies and,
thereafter, manufacture sufficient
quantities of the selected lead analog for
clinical trials. In exchange for a 50%
ownership of the JDV, Nordic will conduct
and fully fund all preclinical, toxicology
and clinical development through Phase 2
proof-of-concept for the Type 2 diabetes
indication.
Unigene and Nordic expect
select the lead molecule
for the Type 2
diabetes indication,
conduct early-stage preclinical
studies and report preclinical results of
this lead molecule in the second half of
2012.
Unigene Biotechnologies Outlook
One year ago, the Company launched the
Unigene Biotechnologies strategic business
unit to target and exploit its
industry-leading Peptelligence™ platform of
peptide oral drug delivery and
manufacturing assets, expertise and
capabilities and build a robust portfolio
of strategically partnered opportunities.
The Company's business-to-business
marketing initiatives and, now well
established and validated, business
development capabilities continue to
generate near-term revenue from the eight
ongoing/completed feasibility studies
evaluating Unigene's ability to orally
deliver synthetic and natural peptides.
The Company anticipates that at least
one feasibility study will have the
potential to convert into a high-value
milestone and royalty payment licensing
agreement over the next 6-9 months.
During the second quarter of 2011, the
Unigene Biotechnologies strategy was
validated by the signing of a Clinical
Manufacturing Services Agreement with Cara
Therapeutics, Inc. Unigene provided
clinical supply material for Cara's Phase 1
study of investigational drug, CR845, a
peripherally acting kappa opioid agonist
being developed for the treatment of both
acute and chronic pain. Cara's expects to
report the results from its Phase 1 study
in the first quarter of 2012.
2012 Financial Outlook
Based on the Company's current projections,
cash flow is expected to be sufficient to
fund its business operations into the
second half of 2012.
About Unigene Laboratories, Inc.
Unigene Laboratories, Inc. is a leader in
the design, delivery, manufacture and
development of peptide-based therapeutics.
The Company is building a robust portfolio
of proprietary partnerships in this
expanding drug class based on its
Peptelligence™ platform. Peptelligence
encompasses extensive intellectual property
covering delivery and manufacturing
technologies, unsurpassed research and
development expertise, and proprietary
know-how representing a genuine distinctive
competence. Core Peptelligence assets
include proprietary oral and nasal peptide
delivery technologies,
and proprietary,
high-yield,
scalable and
reproducible E.
coli-based manufacturing
technologies.
Safe Harbor statements under the Private
Securities Litigation Reform Act of 1995:
This press release contains forward-looking
statements, including statements relating
to whether: the Company will achieve the
highlighted multiple near-term catalysts
and unlock significant value over the next
12 months; the key elements are in place to
address the Company's debt in 2012; there
will be significant growth in the Company
in 2012; the Company will continue to
deliver results; the Company's near-term
milestones will allow it to extend its cash
runway, address the debt and continue to
unlock the Company's growth potential and
shareholder value; the Company will present
full data of oral parathyroid hormone (PTH)
analog Phase 2 results in peer review
journal and/or prestigious scientific
congress; the Company will be successful in
seeking a licensing partner for oral PTH
program; the Company will continue to build
a robust portfolio of feasibility studies
on behalf of various pharmaceutical
companies evaluating Unigene's
Peptelligence™ platform for oral delivery
of proprietary peptides across a broad
spectrum of high potential valuation
therapeutic areas; whether the Company will
be able to convert at least one
Peptelligence™ feasibility study into a
definitive license agreement with
significant milestones and royalties; the
Company will file an IND and begin Phase 1
clinical testing of its lead metabolic
peptide, UGP281, targeting patients with
morbid obesity; the Company will select a
lead molecule for Type 2 diabetes
indication under the joint development
vehicle (JDV) with Nordic Bioscience; the
Company will announce preclinical results
for Type 2 diabetes indication under JDV
with Nordic Bioscience; the Company will
advance its own pipeline of novel,
proprietary peptide product candidates
focused on metabolic disease and
inflammation; a licensing partner for the
Company's oral PTH program will be found
and an agreement will be entered into; will
present the full date from the Phase 2 PTH
study in a peer review journal and/or
prestigious scientific congress over the
course of 2012; Tarsa's oral calcitonin
program will be successful, a product will
be approved and any sales-related milestone
payments and royalties will be paid to the
Company on worldwide sales, excluding
China; Tarsa will report top-line results
from its TAR01-201 study in the second half
of 2012; Tarsa will file an NDA submission
to the FDA for OSTORA in the second half of
2012; the Company will file an
Investigational New Drug (IND) application
with the FDA and initiate Phase 1 clinical
studies of UGP281 before the end of 2012;
the lead molecule for the Type 2 diabetes
indication will be selected by the Company
with Nordic, early-stage preclinical
studies will be conducted and the
preclinical results of a lead molecule will
be reported in the second half of 2012; at
least one feasibility study will convert
into a high-value milestone and royalty
payment licensing agreement over the next
6-9 months; Cara will report the results
from its Phase 1 study in the first quarter
of 2012; the Company is well positioned to
capitalize on the numerous opportunities
that its oral peptide delivery platform and
pipeline are expected to realize in 2012;
the Company will secure a development
partner and licensee for its oral PTH
program and, if so, whether it will become
a game-changing treatment option for the
estimated 75 million people in Europe, the
US and Japan who are impacted by
osteoporosis; the Company and its
stockholders will reap rewards and achieve
substantial growth in 2012; and the
Company's current cash flow will be
sufficient to fund its business operations
into the second half of 2012. We have
based these forward-looking statements on
our current expectations and projections
about future events, including our cash
flow projections. 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 known and
unknown risk factors include, but are not
limited to: the delay in obtaining or the
failure to obtain regulatory approvals for
our products and the products of our
licensees that may generate royalty and
milestone payments to us, our ability to
achieve product sales and royalties,
competition, our dependence on other
companies to commercialize, manufacture and
sell products using our technologies and
our ability to enter into favorable new
agreements with such companies, our ability
to cut expenses and maintain efficiencies,
our ability to enter into new financing
arrangements, the ability of our
products to gain market acceptance and
increase market share, the uncertainty of
results of animal and human testing, the
risk of product liability and liability for
human clinical trials, our dependence on
patents and other proprietary rights and
the risks associated with patent
litigation, dependence on key management
officials, the availability and cost of
capital, the availability of qualified
personnel, changes in, or the failure to
comply with, governmental regulations,
general economic and business conditions,
our history of losses and ability to
achieve profitability, litigation and other
risk factors discussed in our Securities
and Exchange Commission ("SEC") filings,
including our annual report on Form 10-K
and our quarterly reports on Form 10-Q.
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, but are not the exclusive means
of identifying forward-looking statements.
In addition, any statements that refer to
expectations, projections, contingencies,
goals, targets or other characterizations
of future events or
circumstances, including any
underlying assumptions, are forward
-looking statements and are not statements
of historical fact. Except as required by
applicable law, including the securities
laws of the United States and the rules and
regulations of the SEC, we are under no
obligation to publicly update or revise any
forward-looking statements after the date
of this release.
Investor Contact:
Unigene Laboratories, Inc.
Jenene Thomas
VP, Investor Relations and Business
Administration 973-265-1107
Media Contact:
Tiberend Strategic Advisors, Inc. Jason Rando / Andrew Mielach
212-827-0020
SOURCE: Unigene Laboratories, Inc.
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