Societal CDMO Selected by Longboard Pharmaceuticals to Provide CDMO Services to Support Clinical Development of LP352
April 05 2023 - 7:00AM
Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL), a contract
development and manufacturing organization (CDMO), today announced
that it has been selected by Longboard Pharmaceuticals, Inc. (NASD:
LBPH) to provide CDMO services. The agreement spans a range of
Societal CDMO’s offerings including technology transfer and
analytical method validation activities to support Longboard’s lead
asset, LP352, a 5-HT2C receptor superagonist. LP352 is currently
being evaluated in the PACIFIC Study, a Phase 1b/2a basket trial,
in participants with developmental and epileptic encephalopathies
or DEEs, such as Dravet syndrome, Lennox-Gastaut syndrome, tuberous
sclerosis complex, CDKL5 deficiency disorder, SCN2A-related
disorders, among others.
“This agreement with Longboard offers an
excellent illustration of the strides that Societal CDMO continues
to make in establishing itself as a preferred CDMO partner for
biopharmaceutical companies developing innovative therapeutic
candidates. The scope of work for this project highlights the broad
range of services we offer to support drug developers as they
advance their innovative candidates through clinical development,
spanning tech transfer through to cGMP manufacturing,” said David
Enloe, chief executive officer of Societal CDMO. “We are grateful
for the trust that Longboard has placed in our team to make a
contribution to the development of an important therapeutic that
has the potential to meaningfully impact the lives of patients in
need. At the end of the day, that is the mission that drives all
members of the Societal CDMO team.”
About Longboard
PharmaceuticalsLongboard Pharmaceuticals, Inc., is a
clinical-stage biopharmaceutical company focused on developing
novel, transformative medicines for neurological diseases.
Longboard is working to advance a portfolio of centrally
acting product candidates designed to be highly selective
for specific G protein-coupled receptors (GPCRs). Longboard’s small
molecule product candidates are based on more than 20 years of GPCR
research. Longboard is evaluating LP352, an oral, centrally acting
5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, with no
observed impact on 5-HT2B and 5-HT2A receptor subtypes, in
development for the potential treatment of seizures associated with
a broad range of developmental and epileptic encephalopathies.
Longboard is also evaluating LP659, a centrally acting,
sphingosine-1-phosphate (S1P) receptor subtypes 1 and 5 modulator,
which is in development for the potential treatment of multiple
neurological diseases.
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
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
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