Societal CDMO Signs Master Service Agreement With CivicaScript to Provide CDMO Services
29 Junho 2023 - 8:00AM
Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL), a contract
development and manufacturing organization (CDMO) dedicated to
solving complex formulation and manufacturing challenges primarily
in small molecule therapeutic development, today announced the
signing of a master service agreement (MSA) with CivicaScript. This
agreement covers an initial project supporting a generic drug
candidate that is moving through development and registration
efforts, with the potential to expand to include support of
additional CivicaScript programs.
Under terms of the agreement, Societal CDMO will
execute a range of services including analytic method and tech
transfer, formulation development, process development, and non-GMP
batch manufacturing. The work will then culminate in registration
scale batch manufacturing to produce clinical trial materials
intended for registration with the U.S. Food and Drug
Administration. This will include registration batch bottle
packaging, labeling, and clinical supply distribution.
“The work that we will conduct under this MSA
with CivicaScript provides an excellent opportunity for Societal
CDMO to showcase our team’s ability to support the full range of
activities required for the development and registration of a
generic medicine. We are excited to team up with CivicaScript on
this project as we share the company’s commitment to making an
impact on the lives of patients. Their dedication to making quality
generic medicines affordable and available to everyone fits well
with our mission of bringing science to society,” said David Enloe,
chief executive officer of Societal CDMO.
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.
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
ryan.lake@societalcdmo.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)
Gráfico Histórico do Ativo
De Jun 2024 até Jul 2024
Societal CDMO (NASDAQ:SCTL)
Gráfico Histórico do Ativo
De Jul 2023 até Jul 2024