Cingulate Issued European Patent for Lead Asset CTx-1301 for the Treatment of ADHD
Cingulate Inc. (NASDAQ: CING) has been granted a European patent for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The patent, issued on August 14, 2024, as EP Patent No. 3261625, covers up to 30 European territories, including the United Kingdom. This adds to Cingulate's existing patents in Australia, Canada, and Israel, with pending patents in Hong Kong, the Republic of Korea, and the United States.
The company views this as a significant milestone in its efforts to expand beyond the US market and make an impact on the growing ADHD markets in Europe and other territories. Cingulate utilizes its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to develop next-generation pharmaceutical products.
Cingulate Inc. (NASDAQ: CING) ha ricevuto un brevetto europeo per il suo principale asset CTx-1301 (dexmetilfenidato) per il trattamento del Disturbo da Deficit di Attenzione e Iperattività (ADHD). Il brevetto, rilasciato il 14 agosto 2024, con il numero di brevetto EP 3261625, copre fino a 30 territori europei, incluso il Regno Unito. Ciò si aggiunge ai brevetti esistenti di Cingulate in Australia, Canada e Israele, con brevetti in attesa in Hong Kong, nella Repubblica di Corea e negli Stati Uniti.
L'azienda considera questo un traguardo significativo nei suoi sforzi per espandersi oltre il mercato statunitense e avere un impatto sui crescenti mercati dell'ADHD in Europa e in altri territori. Cingulate utilizza la sua tecnologia proprietaria di Precision Timed Release™ (PTR™) per sviluppare prodotti farmaceutici di nuova generazione.
Cingulate Inc. (NASDAQ: CING) ha obtenido un patente europeo para su activo principal CTx-1301 (dexmetilfenidato) para el tratamiento del Trastorno por Déficit de Atención e Hiperactividad (TDAH). La patente, emitida el 14 de agosto de 2024, con el número EP 3261625, abarca hasta 30 territorios europeos, incluyendo el Reino Unido. Esto se suma a las patentes existentes de Cingulate en Australia, Canadá e Israel, con patentes pendientes en Hong Kong, la República de Corea y los Estados Unidos.
La empresa considera esto como un hito significativo en sus esfuerzos por expandirse más allá del mercado estadounidense y tener un impacto en los crecientes mercados de TDAH en Europa y otros territorios. Cingulate utiliza su plataforma de entrega de medicamentos Precision Timed Release™ (PTR™) para desarrollar productos farmacéuticos de próxima generación.
Cingulate Inc. (NASDAQ: CING)는 주력 자산 CTx-1301 (덱스메틸페니데이트)에 대해 유럽 특허를 부여받았습니다. 이 약물은 주의력 결핍 과잉 행동 장애 (ADHD) 치료를 위해 개발되었습니다. 2024년 8월 14일에 발급된 EP 특허 번호 3261625는 영국을 포함하여 최대 30개의 유럽 지역을 포괄합니다. 이는 호주, 캐나다, 이스라엘에서의 Cingulate의 기존 특허에 추가되며, 홍콩, 대한민국, 미국에서는 특허가 대기 중입니다.
회사는 이것을 미국 시장을 넘어 확장하기 위한 중요한 이정표로 보고 있으며, 유럽 및 기타 지역의 ADHD 시장에서 영향력을 미치려는 노력의 일환으로 보고 있습니다. Cingulate는 Precision Timed Release™ (PTR™) 약물 전달 플랫폼 기술을 활용하여 차세대 제약 제품을 개발하고 있습니다.
Cingulate Inc. (NASDAQ: CING) a obtenu un brevet européen pour son actif principal CTx-1301 (dexmethylphénidate) pour le traitement du trouble déficitaire de l'attention avec hyperactivité (TDAH). Le brevet, délivré le 14 août 2024, sous le numéro EP 3261625, couvre jusqu'à 30 territoires européens, y compris le Royaume-Uni. Cela s'ajoute aux brevets existants de Cingulate en Australie, au Canada et en Israël, avec des brevets en attente à Hong Kong, en République de Corée et aux États-Unis.
L'entreprise considère cela comme une étape importante dans ses efforts pour s'étendre au-delà du marché américain et avoir un impact sur les marchés croissants du TDAH en Europe et dans d'autres territoires. Cingulate utilise sa technologie de plateforme de délivrance de médicaments Precision Timed Release™ (PTR™) pour développer des produits pharmaceutiques de nouvelle génération.
Cingulate Inc. (NASDAQ: CING) hat ein europäisches Patent für sein Hauptprodukt CTx-1301 (Dexmethylphenidat) zur Behandlung von Aufmerksamkeitsdefizit-Hyperaktivitätsstörung (ADHS) erhalten. Das Patent, das am 14. August 2024 erteilt wurde, trägt die Patentnummer EP 3261625 und umfasst bis zu 30 europäische Gebiete, einschließlich des Vereinigten Königreichs. Dies ergänzt die bestehenden Patente von Cingulate in Australien, Kanada und Israel und die ausstehenden Patente in Hongkong, der Republik Korea und den Vereinigten Staaten.
Das Unternehmen betrachtet dies als einen bedeutenden Meilenstein in seinen Bestrebungen, über den US-Markt hinaus zu expandieren und Einfluss auf die wachsenden ADHS-Märkte in Europa und anderen Gebieten zu nehmen. Cingulate nutzt seine proprietäre Precision Timed Release™ (PTR™) Medikamentenabgabeplattformtechnologie, um Produkte der nächsten Generation zu entwickeln.
- Granted European patent for lead ADHD treatment asset CTx-1301
- Patent coverage extends to 30 European territories, including the UK
- Existing patents in Australia, Canada, and Israel
- Pending patents in Hong Kong, South Korea, and the US
- None.
Insights
The issuance of a European patent for Cingulate's CTx-1301 is a significant intellectual property milestone. This patent, covering up to 30 European territories, substantially strengthens the company's market position and potential for revenue generation in Europe. The extended geographical coverage, including the UK, provides Cingulate with a competitive advantage and potential for licensing opportunities.
However, it's important to note that while patent protection is vital, it doesn't guarantee market success. The company still faces challenges in regulatory approval, market entry and competition. The pending patents in Hong Kong, South Korea and the US also indicate potential for further expansion, but their approval remains uncertain. Investors should monitor the progress of these pending applications and any potential patent challenges that may arise.
Cingulate's CTx-1301, utilizing their Precision Timed Release™ (PTR™) technology, represents a potential advancement in ADHD treatment. The European patent grant suggests that the drug's formulation is considered novel and non-obvious, which are key criteria for patentability. This could indicate a significant improvement over existing ADHD medications.
However, it's important to note that patent approval doesn't equate to clinical efficacy or regulatory approval. The company still needs to demonstrate safety and efficacy through clinical trials. The mention of "clinical success" in the CEO's statement is encouraging, but without specific data, it's difficult to assess the true potential of CTx-1301. Investors should closely monitor upcoming clinical trial results and the FDA new drug application process to better evaluate the drug's market potential.
The European ADHD market presents a significant opportunity for Cingulate. With the patent grant, the company is well-positioned to tap into this growing market. However, market entry and success depend on various factors beyond patent protection, including pricing strategies, reimbursement policies and competition from established ADHD treatments.
The company's global patent strategy, with patents already secured in Australia, Canada and Israel, indicates a clear international expansion plan. This could potentially diversify revenue streams and reduce dependence on any single market. However, each market comes with its own regulatory challenges and competitive landscape. Investors should assess Cingulate's ability to navigate these complexities and successfully commercialize CTx-1301 across different regions.
KANSAS CITY, Kan., Aug. 15, 2024 (GLOBE NEWSWIRE) -- 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, announced today that it was issued a European patent for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The patent application was granted on August 14, 2024, as EP Patent No. 3261625, and will include up to 30 European territories, including the United Kingdom. In addition to the European patent, Cingulate has patents in Australia, Canada and Israel, as well as pending patents in Hong Kong, the Republic of Korea, and the United States.
“The granting of this patent is another meaningful milestone as Cingulate seeks to expand its reach beyond the United States and make a positive impact on the growing ADHD markets in Europe and other territories abroad. We look forward to obtaining additional patents in the near-term as we continue to showcase the clinical success of CTx-1301 and move closer to filing a new drug application with the FDA,” said Cingulate Chairman and CEO Shane J. Schaffer.
About Attention Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., approximately 6.4 million children and adolescents (11 percent) aged under the age of 18 have been diagnosed with ADHD. Among this group, approximately 80 percent receive treatment, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4 percent), almost double the size of the child and adolescent segment combined. However, only an estimated 20 percent receive treatment.
About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’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 continues to be providing patients with an 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.
About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’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 in addition to Anxiety and ADHD 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. To see Cingulate’s PTR Platform, click here.
About Cingulate®
Cingulate Inc. (NASDAQ: CING), is 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, 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 attention deficit/hyperactivity disorder (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.
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 April 1, 2024. 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 Dalton
Vice President, Investor & Public Relations, Cingulate
TDalton@cingulate.com
913-942-2301
Matt Kreps
Darrow Associates
mkreps@darrowir.com
214-597-8200
FAQ
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