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Cingulate signs commercialization agreement with Indegene for ADHD drug

15 Mar 2023

Indegene will take over the commercialization reins for Cingulate’s oral ADHD medication CTx-1301 as it enters Phase III trials.

Biopharma company Cingulate announced a joint commercialization agreement with Indegene this week, which pushes forward Cingulate’s lead drug candidate for attention deficit/hyperactivity disorder (ADHD).

The agreement provides Cingulate with pre-commercial support as the drug, CTx-1301, moves through Phase III clinical trials. Indegene would also help commercialize the drug if it’s approved by the Food and Drug Administration.

“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,” Cingulate CEO Shane Schaffer said in a statement.

The new pact gives Cingulate the space to focus on clinical development by handing Indegene the commercialization reins, including sales, medical affairs, medical communications and PRMA (pricing, reimbursement and market access), Schaffer said.

“[T]he 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,” he continued.

For Indegene, the agreement is a way to hop in on CTx-1301’s potential, with the company noting that its “unique attributes” differentiate it from other available ADHD drugs in the market. This also “aligns well to Indegene’s omnichannel approach to raising awareness among physicians and patients,” Timothy Moore, SVP of emerging biotech at Indegene, said in a statement.

Cingulate developed CTx-1301 using its precision timed release (PTR) drug delivery platform. The drug contains dexmethylphenidate, an FDA-approved stimulant used to treat ADHD.

Patients with ADHD would only have to take CTx-1301 once a day orally to see its effects, and it’s fast-acting, meaning it could take effect within 30 minutes or less. Additionally, CTx-1301’s efficacy lasts about 16 hours.

In February, Cingulate announced positive top-line results from its latest study on the drug, which was examining the effect of food on patients absorbing CTx-1301. Those results showed that the drug could be taken either with food or without food.

So far, Cingulate has started the first of two Phase III trials for the drug as part of its new drug application to the FDA. Its Phase III fixed-dose trial in adolescents is expected to start in mid-2023.

This is Indegene’s latest partnership involving a drugmaker utilizing its omnichannel chops. In November, it gained a deal with AstraZeneca to take over the pharma’s omnichannel operations.

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