By Business Wire, September 30, 2013, 09:04:00 AM EDT
LEXINGTON, Mass.--(BUSINESS WIRE)--
BioPharma Corp. ("Synageva") (NASDAQ:GEVA), a biopharmaceutical
company developing therapeutic products for rare disorders, today
announced the closing of a $179 million underwritten public offering of
3.16 million shares of common stock, including 412,500 shares of common
stock that were issued pursuant to the exercise of the underwriters'
option to purchase additional shares, at a price of $56.63 per share.
Goldman, Sachs & Co. acted as the sole book-running manager in the
offering. Morgan Stanley & Co., Cowen and Company, and Canaccord Genuity
Inc. acted as co-managers in the offering.
The securities described above were offered by Synageva pursuant to a
Form S-3 shelf registration statement (including a base prospectus)
previously filed with the Securities and Exchange Commission (SEC). The
final prospectus supplement and accompanying base prospectus related to
this offering is available for free by visiting EDGAR on the SEC's
website located at www.sec.gov.
Copies of the final prospectus supplement and accompanying base
prospectus may also be obtained from the offices of Goldman, Sachs &
Co.; by mail, Attn: Prospectus Department, 200 West Street, New York, NY
10282; by facsimile: 212-902-9316; by email: email@example.com;
or by calling: 866-471-2526.
This news release shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor will there be any
sale of these securities in any state or other jurisdiction in which
such offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of any such
state or other jurisdiction.
About sebelipase alfa for LAL Deficiency
Lysosomal acid lipase deficiency (LAL
Deficiency) is a rare autosomal
recessive lysosomal storage disease (LSD) caused by a marked decrease in
LAL enzyme activity. LAL Deficiency in children and adults, sometimes
called Cholesteryl Ester Storage Disease (CESD), is an underappreciated
cause of cirrhosis and accelerated atherosclerosis. These complications
are due to the buildup of fatty material in the liver, blood vessel
walls and other tissues and organs as a result of decreased LAL enzyme
activity. Infants with LAL Deficiency, sometimes called Wolman disease,
suffer from the most rapidly progressive form of LAL Deficiency which is
usually fatal within the first six months of life. Affected infants
develop severe malabsorption, growth failure and liver failure.
alfa (SBC-102) is a recombinant form of the human LAL enzyme being
developed by Synageva as an enzyme replacement therapy for LAL
Deficiency. Synageva is evaluating sebelipase alfa in global Phase 3
clinical trials in infants, children and adults with LAL Deficiency.
Sebelipase alfa has been granted orphan designation by the U.S. Food and
Drug Administration (FDA), the European Medicines Agency (EMA), and the
Japanese Ministry of Health, Labour and Welfare. Additionally,
sebelipase alfa received fast track designation by the FDA, and
Breakthrough Therapy designation by the FDA for early onset LAL
About SBC-103 for MPS IIIB
The mucopolysaccharidoses (MPS) consist of a group of rare LSDs caused
by a deficiency of enzymes needed to break down complex sugars called
glycosaminoglycans. The MPS III syndromes (also known as Sanfilippo
syndromes) share complications with other MPS diseases but represent a
clinically distinct subset with marked central nervous system
IIIB (MPS IIIB, also known as Sanfilippo B syndrome) is caused by a
marked decrease in alpha-N-acetyl-glucosaminidase (NAGLU) enzyme
activity which leads to the buildup of abnormal sugars called heparan
sulfate disaccharides (HSD) in the brain and other organs. The
accumulation of abnormal HSD, particularly in the central nervous
system, leads to severe cognitive decline, behavioral problems, speech
loss, increasing loss of mobility, and premature death.
is a recombinant form of the human NAGLU enzyme being developed by
Synageva as an enzyme replacement therapy for MPS IIIB. Using various
dosing approaches, SBC-103 reduced HSD substrate storage in the brains,
liver and kidney tissues in an MPS IIIB animal model. SBC-103 has been
granted orphan designation by the FDA and the EMA. Synageva plans to be
in clinical trials with SBC-103 during the first half of 2014.
About Synageva's additional pipeline programs and manufacturing
Synageva's additional pipeline programs include other proteins targeting
rare diseases at various stages of preclinical development. These
diseases are characterized by significant morbidity and mortality and
these programs are selected based on scientific rationale, high unmet
medical need, potential to impact disease course and strategic alignment
with our corporate focus. In addition to these novel pipeline programs,
Synageva is leveraging its manufacturing platform to develop improved
biologic therapies for diseases with high unmet medical need.
Synageva's proprietary manufacturing platform utilizes technology to
produce drug product with consistent characteristics that enable
robustness and flexibility during scale-up. In addition, the platform
can provide favorable structural properties for bio-distribution and
cell targeting in comparison to glycoproteins produced from other
Synageva routinely posts information that may be important to investors
in the "Investor Relations" section of our web site at www.synageva.com.
Synageva encourages investors and potential investors to consult our web
site regularly for important information about us.
Further information regarding Synageva BioPharma Corp. is available at www.synageva.com.
This news release contains "forward-looking statements". Such statements
generally can be identified by the use of words such as "anticipate,"
"expect," "plan," "could," "intend," "believe," "may," "will,"
"estimate," "forecast," "project," or words of similar meaning. These
forward-looking statements address, among other matters, our plans to
enter into human clinical trials for MPS IIIB during the first half of
2014, our plans for leveraging the platform to develop improved biologic
therapies and our belief that our platform can provide favorable
structural properties for bio-distribution and cell targeting in
comparison to glycoproteins produced from other sources. Many factors
may cause actual results to differ materially from forward-looking
statements, including inaccurate assumptions and a broad variety of
risks and uncertainties, some of which are known, including, the
possibility that preclinical data or regulatory delays cause our MPS
IIIB program to not enter human clinical trials in the first half of
2014, the ability to maintain the current favorable protein structural
properties for bio-distribution and cell targeting as compared to
glycoproteins produced from other sources, the ability to rely on
Breakthrough Therapy designation the implications of which cannot be
determined at this time, and the risks identified under the heading
"Risk Factors" in the Company's prospectus supplement filed with the
Securities and Exchange Commission (the "SEC") on September 25, 2013 and
other filings Synageva periodically makes with the SEC, and others of
which are not known. No forward-looking statement is a guarantee of
future results or events, and investors should avoid placing undue
reliance on such statements. Synageva undertakes no obligation to update
any forward-looking statements, whether as a result of new information,
future events or otherwise. Our business is subject to substantial risks
and uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration to
these risks and uncertainties.
"Dedicated to Rare Diseases®" is a registered trademark of Synageva
BioPharma Corp. "Synageva BioPharma™" is a trademark of Synageva
Source: Synageva BioPharma Corp.