Cingulate and Indegene Sign Joint Commercialization Agreement for Lead ADHD Candidate CTx-1301 Cingulate and Indegene Sign Joint Commercialization Agreement for...
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Cingulate and Indegene Sign Joint Commercialization Agreement for Lead ADHD Candidate CTx-1301

Pharma Tech Outlook | Thursday, March 16, 2023

Cingulate and Indegene have confirmed a joint commercialization agreement to support Cingulate's lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment.

FREMONT, CA: “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," says Shane J Schaffer, Chairman, and CEO, Cingulate. Cingulate, a biopharmaceutical company using 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,  have signed a joint commercialization agreement to support Cingulate's lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment (FDA).

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“We believe Indegene provides a comprehensive solution combining sales professionals and field medical personnel, and its AI-driven omnichannel marketing suite is unparalleled 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,” adds Schaffer.

The deal includes cross-functional services and an omnichannel marketing approach to successfully manage pre-commercial assistance throughout Cingulates Phase 3 clinical trials and sell CTx-1301 statewide after FDA approval. Cingulate recently launched its first Phase 3 trial for CTx-1301, an adult dose-optimization efficacy and safety study to examine onset and duration, with results expected in the third quarter of 2023. The primary Phase 3 trial, a fixed-dose, placebo-controlled research in pediatric and adolescent ADHD patients, will begin mid-2023.

The agreement between Cingulate and Indegene encompasses the majority of the commercialization process, such as sales, PRMA (price, reimbursement, and market access), medical affairs, medical communications, pharmacovigilance, regulatory, marketing, and commercial operations assistance. The agreement focuses on growing revenue, is meant to assure consistent financial flow, and will last three years following the launch of CTx-1301.

“We believe the unique attributes of CTx-1301 differentiate Cingulates product from other available products in the market, which aligns well to Indegenesomnichannel approach to raising awareness among physicians and patients,” says Timothy Moore, Senior Vice President of Emerging Biotech at Indegene.

According to the data, Indegenes'somnichannel marketing solution has a bigger impact than field sales professionals alone, delivering superior customer experiences at a fraction of the expense of the conventional strategy. Indegene leverages a massive database of healthcare professionals (HCPs) and HCP interactions to construct a customized sales and marketing plan. Next, an algorithm learns and adapts in real-time to present content that ultimately modifies prescription behavior.

"We believe the ability to deploy Indegenes 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 adds. "We have worked with 19 of the top 20 global pharmaceutical companies, and this joint commercialization agreement expands Indegenes services to an emerging growth company, positioning Cingulate for success in the event CTx-1301 is approved by the FDA."

There is currently no medicine for the more than 17 million child, teen, and adult patients in the United States with ADHD for which a single oral dose is effective for the duration of the patient's whole active day. CTx-1301 intends to be the first drug to accomplish a rapid onset of action (within 30 minutes or less) and a 16-hour duration of action while enhancing patient tolerability.

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