Societal CDMO Selected by Spinnaker Biosciences to Provide CDMO Services to Support Clinical Development of Novel Therapeutic Candidate
10 Julio 2023 - 6:00AM
Societal CDMO, Inc. (“Societal CDMO”; Nasdaq: SCTL), a contract
development and manufacturing organization (CDMO) dedicated to
solving complex formulation and manufacturing challenges primarily
in small molecule therapeutic development, today announced that it
has been selected by Spinnaker Biosciences, Inc., to execute CDMO
services in support of the company’s clinical development of a
novel therapeutic candidate. The activities to be conducted under
the agreement include analytical method transfer and qualification,
aseptic process development, manufacture of a prototype batch of
the therapeutic, cGMP filling of the resultant sterile powder into
vials, and stability testing of the therapeutic candidate to be
used in a planned Phase 1/2 study.
“Our new agreement with Spinnaker is an exciting
opportunity for the Societal CDMO team to showcase its range of
expertise across a number of offerings designed to support
innovative drug developers as they work to advance novel
therapeutic candidates into the clinic. We are well suited to carry
out this work which involves several complexities, including
aseptic filling of the final product,” said David Enloe, chief
executive officer of Societal CDMO. “We are excited to add
Spinnaker to our growing list of customers and pleased that the
company has entrusted us to carry out these important aseptic
process development and manufacturing activities on its
behalf.”
About Societal CDMOSocietal
CDMO (NASDAQ: SCTL) is a bi-coastal contract development and
manufacturing organization (CDMO) with capabilities spanning
pre-Investigational New Drug (IND) development to commercial
manufacturing and packaging for a wide range of therapeutic dosage
forms with a primary focus in the area of small molecules. With an
expertise in solving complex manufacturing problems, Societal CDMO
is a leading CDMO providing therapeutic development, end-to-end
regulatory support, clinical and commercial manufacturing, aseptic
fill/finish, lyophilization, packaging and logistics services to
the global pharmaceutical market.
In addition to our experience in handling DEA
controlled substances and developing and manufacturing
modified-release dosage forms, Societal CDMO has the expertise to
deliver on our clients’ pharmaceutical development and
manufacturing projects, regardless of complexity level. We do all
of this in our best-in-class facilities, which total 145,000 square
feet, in Gainesville, Georgia and San Diego, California.
Societal CDMO: Bringing Science to Society. For
more information about Societal CDMO’s customer solutions, visit
societalcdmo.com.
About Spinnaker
BiosciencesSpinnaker Biosciences is focused on the
development of proprietary technology for sustained/controlled
release drug delivery using non-toxic, biocompatible, and
biodegradable nanoporous silicon based microparticles and
nanoparticles. Spinnaker’s lead programs include a long-acting
sustained release ranibizumab drug product for the treatment of
neovascular age-related macular degeneration. For more information,
please visit www.spinnakerbiosciences.com.
Forward-Looking StatementsThis
press release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. These statements, among
other things, the Company’s expectations regarding the completion
of the proposed public offering, the Company’s use of proceeds from
the proposed offering, and other statements. The words
“anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”,
“intend”, “may”, “plan”, “predict”, “project”, “will” and similar
terms and phrases may be used to identify forward-looking
statements in this press release. Our operations involve risks and
uncertainties, many of which are outside our control, and any one
of which, or a combination of which, could materially affect our
results of operations and whether the forward-looking statements
ultimately prove to be correct. Factors that could cause the
company’s actual outcomes to differ materially from those expressed
in or underlying these forward-looking statements include risks and
uncertainties associated with demand for the company’s services,
which depends in part on customers’ research and development and
the clinical plans and market success of their products; customers’
changing inventory requirements and manufacturing plans; customers
and prospective customers decisions to move forward with the
company’s manufacturing services; the average profitability, or
mix, of the products the company manufactures; the company’s
ability to enhance existing or introduce new services in a timely
manner; fluctuations in the costs, availability, and suitability of
the components of the products the company manufactures, including
active pharmaceutical ingredients, excipients, purchased components
and raw materials, or the company’s customers facing increasing or
new competition. These forward-looking statements should be
considered together with the risks and uncertainties that may
affect our business and future results presented herein along with
those risks and uncertainties discussed in our filings with the
Securities and Exchange Commission at www.sec.gov. These
forward-looking statements are based on information currently
available to us, and we assume no obligation to update any
forward-looking statements except as required by applicable
law.
Contacts:
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
Ryan D. Lake (CFO)
Societal CDMO
770-531-8365
ryan.lake@societalcdmo.com
Societal CDMO (NASDAQ:SCTL)
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