--New Company Established by Unigene and Three Leading Venture
Capital Firms Launched with $24 Million Series A
Financing--
BOONTON, N.J. & PHILADELPHIA--(BUSINESS WIRE)--Oct. 20, 2009--
Unigene Laboratories, Inc. (OTCBB: UGNE) and Tarsa Therapeutics, Inc.
today announced that Unigene has licensed its Phase III oral calcitonin
program to Tarsa, a new company formed by a syndicate of three venture
capital funds specializing in the life sciences: MVM Life Science
Partners, Quaker BioVentures and Novo A/S. Simultaneously, Tarsa
announced the closing of a $24 million Series A financing from the
investor syndicate.
As part of the agreement, Unigene will own 25% of Tarsa on a fully
diluted basis and will be eligible to receive milestone payments based
on the achievement of certain sales benchmarks, as well as royalties on
product sales. Tarsa will be solely responsible for the costs of the
global Phase III clinical program that has recently been initiated and
also has reimbursed Unigene for its Phase III expenditures to date.
Calcitonin is approved for the treatment of osteoporosis, but its use
has been limited as it is currently available only in intranasal and
injectable forms. The oral formulation that Unigene has licensed to
Tarsa has been shown in prior clinical studies to deliver the desired
blood levels of calcitonin and reduce levels of plasma CTx-1, an
established marker of bone resorption. It has the potential to offer a
new therapeutic option for osteoporosis patients as the first
FDA-approved and commercially available oral formulation of calcitonin.
Tarsa also announced that David Brand has joined the company as
President, CEO and Director. He brings over 30 years of global
pharmaceutical experience in product development, acquisitions,
marketing and operational management with GlaxoSmithKline (GSK), its
predecessor companies, and most recently served as President and CEO of
Cardiokine Inc.
Mr. Brand stated, “Calcitonin has been proven safe and effective in the
treatment of osteoporosis in large numbers of patients over many years,
and current worldwide sales are estimated at about half a billion
dollars. The broader use of calcitonin, however, has been limited by its
availability solely in injectable and intranasal forms. Tarsa’s unique,
once-daily oral calcitonin tablet has the potential to offer patients
the proven safety and efficacy of calcitonin, with the significant
advantage of easier administration and enhanced long-term compliance.”
While at GSK, Mr. Brand held senior management positions in marketing,
business development and international operations. He led the launch
activities for the blockbuster products Paxil® and Kytril®
and subsequently was responsible for pre-launch commercial development
plans for Coreg®, Hycamtin® and Requip®.
He also led the business units that launched Requip and Avandia®.
As CEO of Cardiokine Mr. Brand assembled a management and development
team that closed a $50 million financing round and completed a worldwide
development and marketing agreement for lead product lixivaptan with
Biogen Idec.
“The new company assembled by this investor syndicate includes an
outstanding group of professionals who have the knowledge and experience
to ensure that the value of this asset is fully realized,” noted Dr.
Ronald S. Levy, Executive Vice President of Unigene. “We have always
believed that this program has substantial commercial potential.
Accordingly, it was important for us to retain a significant portion of
that value for Unigene’s shareholders, and this structure enables us to
accomplish that. The oral calcitonin program will be Tarsa’s number one
priority, and they intend to commit their substantial resources and
considerable expertise to successfully advancing the Phase III program
in the shortest possible time frame.”
“We view Tarsa as a creative partnership between the management team,
Unigene and this investor group, committed to completing the Phase III
program and enabling registration and commercialization of a compelling
new therapy in a focused and efficient manner,” added Dr. Eric Bednarski
of MVM Life Science Partners.
Dr. James P. Gilligan, Unigene’s Vice President of Product Development,
will become Tarsa’s Chief Scientific Officer while retaining certain
responsibilities at Unigene.
The Board of Directors of Tarsa will be headed by Chairman Dr. Bednarski
and includes Unigene’s Dr. Levy, Tarsa CEO Mr. Brand, Dr. Matthew Rieke,
Partner at Quaker BioVentures and Dr. Martin Edwards, Senior Partner at
Novo A/S.
Tarsa will be based in Philadelphia, PA.
About Unigene
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.
Fortical®, Unigene’s nasal calcitonin product for the
treatment of postmenopausal osteoporosis, received FDA approval and was
launched in 2005. Unigene has licensed the U.S. rights for Fortical®
to Upsher-Smith Laboratories, worldwide rights for its oral PTH
technology to GlaxoSmithKline and worldwide rights for its calcitonin
manufacturing technology to Novartis. 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 (973) 265-1100 or visit www.unigene.com.
For information about Fortical, visit www.fortical.com.
About Tarsa Therapeutics
Newly formed Tarsa Therapeutics is developing an oral formulation of
calcitonin, a peptide hormone for the treatment of osteoporosis that
slows the rate of bone destruction. Availability of an oral formulation
is expected to generate wider use of this established osteoporosis
treatment, which currently is available only in injectable and
intranasal formulations. Tarsa’s oral calcitonin has generated promising
data in Phase II studies and the global Phase III clinical program is
now underway. Tarsa will be based in Philadelphia, PA.
About MVM Life Science Partners LLP
MVM Life Science Partners LLP is a venture capital firm, founded in
1997, which manages three funds totaling more than $500 million and
invests in companies that discover, develop and commercialize
innovations in biotechnology, pharmaceuticals and medical devices for
the life science and healthcare markets. MVM has offices in both London
and Boston, making investments predominantly in Western Europe and the
Eastern US, and has a growing team with wide-ranging experience across
the life science and private equity markets (www.mvmlifescience.com).
About Quaker BioVentures
Quaker BioVentures is dedicated to investing in life science companies
in the Mid-Atlantic region and contiguous states. The firm leads
investments in companies across the spectrum of the life science
industry, including biopharmaceuticals, medical devices, human
diagnostics, specialty pharmaceuticals, and healthcare services. Quaker
BioVentures invests in companies at all stages of development from early
stage businesses to public companies. Founded in 2003, the firm manages
over $700 million in committed capital and is currently investing Quaker
BioVentures II, a $420 million fund formed in 2007. Please visit Quaker
BioVentures’ website at www.quakerbio.com.
About Novo A/S
Novo A/S is an active and independent company in its support of biotech
ventures. The aspiration is to bring together the best of both worlds:
industry insight and network from our pharma/biotech inheritance
combined with a venture capital mindset that focuses on results and
value creation. Novo has invested in more that 50 portfolio companies.
There is considerable diversity in the portfolio across technologies,
products and financial stages. The portfolio is international, currently
with more than half the invested capital in North American companies and
the rest in Denmark and Europe.
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.
Source: Unigene Laboratories, Inc. / Tarsa Therapeutics, Inc.
Unigene Investor Contact:
The Investor Relations Group
Erika
Moran/Dian Griesel, Ph.D.
Phone: 212-825-3210
Media Contact:
Susan Morgenbesser
Phone: 212-825-3210
or
Tarsa Media &
Corporate Contact
GendeLLindheim BioCom Partners
Barbara
Lindheim:212-918-4650
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