Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company
utilizing its proprietary Precision Timed Release™ (PTR™) drug
delivery platform technology to build and advance a pipeline of
next-generation pharmaceutical products, and Indegene, a
digital-first, life sciences commercialization company, today
announced a joint commercialization agreement to provide commercial
support for Cingulate’s lead candidate CTx-1301
(dexmethylphenidate), a novel, investigational treatment being
developed as a true, once-daily stimulant medication for attention
deficit/hyperactivity disorder (ADHD), upon approval from the U.S.
Food and Drug Administration (FDA).
The agreement spans cross-functional services
through an omnichannel marketing approach uniquely designed to
successfully manage pre-commercial support during Cingulate’s Phase
3 clinical trials and to effectively commercialize CTx-1301
nationwide following potential FDA approval. Cingulate recently
announced the initiation of its first Phase 3 trial for CTx-1301,
an adult dose-optimization efficacy and safety study to assess
onset and duration, with results expected in the third quarter of
2023. In addition, the Company plans to initiate its pivotal Phase
3 trial, a fixed-dose, placebo-controlled study in pediatric and
adolescent patients with ADHD, in mid-2023.
“This agreement provides a clear path to
commercialize CTx-1301, upon FDA approval, designed specifically to
tackle the unmet needs of this $20 billion market by providing the
first true, entire-active-day treatment for ADHD. But the clinical
success of a potential treatment can only be realized with
commercial excellence, making this partnership between Cingulate
and Indegene a critical step for our Company,” said Shane J
Schaffer, Chairman and CEO, Cingulate. “We believe Indegene
provides a comprehensive solution combining sales professionals and
field medical personnel, and its AI-driven omnichannel marketing
suite is unparrellled in the industry, making them the right
partner at the right time to help Cingulate redefine the ADHD
treatment paradigm. Additionally, this allows Cingulate to focus on
clinical development by reducing the internal resources and risks
associated with building out these functional areas.”
Cingulate’s comprehensive agreement with
Indegene covers most facets of the commercialization process,
including sales, PRMA (pricing, reimbursement and market access),
medical affairs, medical communications, pharmacovigilance,
regulatory, marketing and commercial operations support. The
partnership is focused on driving revenue and is designed to ensure
predictable cash outflow and continues through three years
post-launch of CTx-1301.
“We believe the unique attributes of CTx-1301
differentiate Cingulate’s product from other available products in
the market, which aligns well to Indegene’s omnichannel approach to
raising awareness among physicians and patients,” said Timothy
Moore, Senior Vice President of Emerging Biotech at Indegene.
Data show that Indegene’s omnichannel marketing
solution has a greater impact than field sales representatives
alone, with better customer experiences at a fraction of the cost
of the more traditional model. Utilizing proprietary artificial
intelligence (AI) and data to reach health care professional (HCP)
targets in the most effective and efficient manner, Indegene
leverages a large database of HCPs and HCP interactions to develop
a curated sales and marketing strategy. An algorithm then learns
and adapts in real-time to deliver content that ultimately changes
prescribing behaviors.
“We believe the ability to deploy Indegene’s
range of digital best practices and new communications channels
will play a large role in the pre-launch preparation, and enable
Cingulate to immediately tap into the proven market access, sales
force effectiveness and medical commercialization operations
critical to a successful launch,” Moore added. “We have worked with
19 of the top 20 global pharmaceutical companies, and this joint
commercialization agreement expands Indegene’s services to an
emerging growth company, positioning Cingulate for success in the
event CTx-1301 is approved by the FDA.”
Of the multitude of medications available for
the more than 17 million child, adolescent, and adult patients in
the U.S. living with ADHD, there is currently no available
medication offering a single oral dose that provides patients
entire active-day efficacy. CTx-1301 aims to be the first
medication to achieve fast onset of action (in 30 minutes or less)
and efficacy that lasts up to 16 hours while improving patient
tolerability.
About CTx-1301Cingulate’s lead
candidate, CTx-1301, utilizes the Company’s proprietary PTR drug
delivery platform to create a breakthrough, multi-core formulation
of the active pharmaceutical ingredient dexmethylphenidate, a
compound approved by the FDA for the treatment of ADHD.
Dexmethylphenidate is part of the stimulant class of medicines and
increases norepinephrine and dopamine activity in the brain to
affect attention and behavior.
While stimulants are the gold-standard of ADHD
treatment due to their efficacy and safety, the long-standing
challenge remains, providing patients entire active-day duration of
action. CTx-1301 is designed to precisely deliver three releases of
medication at the predefined time, ratio, and style of release to
optimize patient care in one tablet. The result is a rapid onset
and entire active-day efficacy, with the third dose being released
around the time when other extended-release stimulant products
begin to wear off.
The company has initiated the first of two Phase
3 clinical studies of CTx-1301 to support its NDA submission. The
pivotal, Phase 3 fixed-dose trial in children and adolescents is
scheduled to begin in mid-2023.
About Precision Timed Release™ (PTR™)
Platform TechnologyCingulate is developing ADHD and
anxiety disorder product candidates capable of achieving true
once-daily dosing using the Company’s innovative PTR drug delivery
platform technology. It incorporates a proprietary Erosion Barrier
Layer (EBL) providing control of drug release at precise,
pre-defined times with no release of drug prior to the intended
release. The EBL technology is enrobed around a drug-containing
core to give a tablet-in-tablet dose form. It is designed to erode
at a controlled rate until eventually the drug is released from the
core tablet. The EBL formulation, Oralogik™, is licensed from BDD
Pharma.
Cingulate intends to utilize its PTR technology
to expand and augment its clinical-stage pipeline by identifying
and developing additional product candidates in other therapeutic
areas where one or more active pharmaceutical ingredients need to
be delivered several times a day at specific, predefined time
intervals and released in a manner that would offer significant
improvement over existing therapies.
For more information visit
Cingulate.com/technology.
About Cingulate Inc.Cingulate
Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its
proprietary PTR™ drug delivery platform technology to build and
advance a pipeline of next-generation pharmaceutical products,
designed to improve the lives of patients suffering from frequently
diagnosed conditions characterized by burdensome daily dosing
regimens and suboptimal treatment outcomes. With an initial focus
on the treatment of ADHD, Cingulate is identifying and evaluating
additional therapeutic areas where PTR technology may be employed
to develop future product candidates, including to treat anxiety
disorders. Cingulate is headquartered in Kansas City. For more
information visit Cingulate.com.
About Indegene We are a
digital-first, life sciences commercialization company. We help
biopharmaceutical, emerging biotech and medical device companies
develop products, get them to the market, and grow their impact
through the life cycle in a more effective, efficient, and modern
way. We bring together healthcare domain expertise, fit-for-purpose
technology, and an agile operating model to provide a diverse range
of solutions. These aim to deliver, amongst other outcomes, a
personalized, scalable and omnichannel experience for patients and
physicians. It’s what drives our team and our purpose to enable
healthcare organizations to be future ready. To learn more, please
visit www.indegene.com
Forward-Looking Statements This
press release contains “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
These forward-looking statements include all statements, other than
statements of historical fact, regarding our current views and
assumptions with respect to future events regarding our business,
including statements with respect to our plans, assumptions,
expectations, beliefs and objectives with respect to product
development, clinical studies, clinical and regulatory timelines,
market opportunity, competitive position, business strategies,
potential growth opportunities and other statements that are
predictive in nature.
These statements are generally identified by the
use of such words as “may,” “could,” “should,” “would,” “believe,”
“anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,”
“continue,” “outlook,” “will,” “potential” and similar statements
of a future or forward-looking nature. Readers are cautioned that
any forward-looking information provided by us or on our behalf is
not a guarantee of future performance. Actual results may differ
materially from those contained in these forward-looking statements
as a result of various factors disclosed in our filings with the
Securities and Exchange Commission (SEC), including the “Risk
Factors” section of our Annual Report on Form 10-K filed with the
SEC on March 28, 2022. All forward-looking statements speak only as
of the date on which they are made, and we undertake no duty to
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise, except to
the extent required by law.
Investor Relations:
Thomas DaltonVice President, Investor &
Public Relations, Cingulatetdalton@cingulate.com(913) 942-2301
Matt KrepsDarrow Associatesmkreps@darrowir.com
214-597-8200
Media Relations:
Melysa WeibleElixir Health
Public Relations mweible@elixirhealthpr.com201-723-5805
Yadunandan K VDirector -
Corporate Communications, Indegeneyadunandan.kv@indegene.com
CING-US-120-0324
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