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| 8-K - FORM 8-K - UNIGENE LABORATORIES INC | unigene_8k-022411.htm |
Exhibit 99.1
Unigene
Accelerates the Development of its Lead Proprietary Anorexigenic Peptide UGP281
for Obesity
-Company
expects to file an IND and initiate Phase 1 clinical studies in 1H
2012-
-Company
also exploring partnering opportunities for sister compound for companion animal
obesity-
February
24, 2011 –BOONTON, N.J. -- (BUSINESS WIRE) -- Unigene Laboratories, Inc. (OTCBB:
UGNE) announced today that the Company is accelerating the development of its
lead proprietary anorexigenic peptide, UGP281. An anorexigenic peptide is one
that diminishes or controls appetite and offers potential therapeutic benefit to
morbidly obese patients. The Company expects to file an
Investigational New Drug (IND) application with the U.S. Food and Drug
Administration (FDA) and initiate Phase 1 clinical studies in the first half of
2012.
Given
Unigene’s aggressive cash conservancy and revenue generation initiatives since
launching its new corporate strategy in the fourth quarter of 2010, the
acceleration of the UGP281 program will not impact Unigene’s cash
runway. The Company reiterates its financial guidance today and
continues to expect its cash position to last into the second half of
2012.
As
previously reported, Unigene is also currently exploring the opportunity to
license a pharmacologically distinct sister analog to a veterinary partner for
companion animal obesity to subsidize a portion of the human proof of concept
development costs of UGP281.
Ashleigh
Palmer, Unigene’s President and CEO stated, “We believe our decision to
accelerate UGP281’s development could have tremendous strategic benefits for
Unigene as we have the potential to address a significant unmet medical need.
The launch of our turnaround strategy following Victory Park Capital’s debt
restructuring last year, coupled with the successful implementation of cash
conservancy and revenue generation initiatives, provides the near-term funding
for the accelerated development of UGP281.” Palmer continued, “Our
goal is to file an IND and commence the clinical testing of UGP281 in the first
half of 2012.”
Unigene’s
lead satiety compound, UGP281, a potent anorexigenic peptide, has demonstrated
substantial decreases in food consumption and weight in multiple in vivo preclinical studies.
Unigene’s “Peptelligence™” core competence will allow UGP281 to be manufactured
and delivered by way of our proprietary recombinant production and oral delivery
technologies. Potential competitors with peptide or protein based drugs are
likely to have to resort to injectable, depot or patch
formulations. Longer term oral studies with UGP281 in dog models are
currently ongoing.
Dr. Nozer
Mehta, Unigene’s Vice President of Research and Development commented, “UGP281
is a custom designed, potent amylin receptor super agonist and is an analog of
naturally occurring peptide hormones. It has a very favorable pharmacological
profile in terms of selectivity, safety and potency. These attributes
offer the potential for a therapeutic product without the safety issues of
several small molecule drugs or drug combinations. We,
therefore, believe UGP281 has the potential to fill the void left by a spate of
recent late-stage obesity drug development failures.”
Obesity
is associated with increased risk for coronary heart disease, diabetes, cancer,
hypertension, stroke, depression, sleep apnea and overall
mortality. Moderate weight loss (5-10%) has been shown to
significantly decrease many of these risks. With the Centers for
Disease Control and Prevention (CDC) estimating the total economic cost of
obesity-associated diseases in the U.S. to be in the order of $90 billion per
year or more, there remains a high unmet medical need and compelling
socioeconomic justification for effective and safe anti-obesity
agents.
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.
Unigene’s
technologies have extensive clinical and partner validation. The Company’s first
product to market, Fortical®, a nasal calcitonin product, received FDA approval
in 2005 and is marketed in the U.S. by Upsher-Smith for the treatment of
postmenopausal osteoporosis. Pivotal clinical programs include an oral
calcitonin licensed to Tarsa Therapeutics, with Phase 3 results for the
treatment of osteoporosis expected in Q2 2011. Other validating relationships
include an oral parathyroid hormone entering Phase 2 in Q1 2011 and licensed to
GlaxoSmithKline. In addition, Unigene has a manufacturing license
agreement with Novartis, which is completing three Phase 3 studies of oral
calcitonin for the treatment of osteoporosis and osteoarthritis.
For more
information about Unigene, please visit http://www.unigene.com. For information
about Fortical, please visit http://www.fortical.com.
Safe
Harbor statements under the Private Securities Litigation Reform Act of 1995:
This press release contains forward-looking statements, including with respect
to clinical studies of one of our licensees. We have based these forward-looking
statements on our current expectations and projections about future events.
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, 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.
Contacts:
Unigene
Laboratories, Inc.
Jenene
Thomas
VP,
Investor Relations and Corporate Communications
Email: jthomas@unigene.com
Direct: 973-265-1107