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Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc. (NASDAQ: SCNX) Announces Issuance of a New Patent Covering its first product SCN-102 (Losartan Potassium Oral Suspension, 10mg/mL) through 2041

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Scienture (NASDAQ: SCNX) announced that the U.S. Patent and Trademark Office has issued a new patent (No. 12,156,869) for its product SCN-102, a Losartan Potassium Oral Suspension. This patent, along with the previously granted patent No. 11,890,273, covers stable liquid pharmaceutical compositions of Losartan and treatment methods. Both patents extend protection through 2041.

The company's SCN-102 product, currently under FDA review, aims to provide a ready-to-use oral liquid formulation of Losartan, one of the most widely prescribed molecules in its class. The patents demonstrate Scienture's development capabilities and commitment to addressing underserved patient needs.

Scienture (NASDAQ: SCNX) ha annunciato che l'Ufficio Brevetti e Marchi degli Stati Uniti ha rilasciato un nuovo brevetto (No. 12,156,869) per il suo prodotto SCN-102, una sospensione orale di Losartan Potassico. Questo brevetto, insieme al brevetto precedentemente concesso No. 11,890,273, copre composizioni farmaceutiche liquide stabili di Losartan e metodi di trattamento. Entrambi i brevetti offrono protezione fino al 2041.

Il prodotto SCN-102 dell'azienda, attualmente in fase di revisione da parte della FDA, mira a fornire una formulazione liquida orale pronta all'uso di Losartan, una delle molecole più prescritte nella sua classe. I brevetti dimostrano le capacità di sviluppo di Scienture e il suo impegno nell'affrontare le esigenze dei pazienti non adeguatamente serviti.

Scienture (NASDAQ: SCNX) anunció que la Oficina de Patentes y Marcas de EE.UU. ha emitido una nueva patente (No. 12,156,869) para su producto SCN-102, una suspensión oral de Losartán Potásico. Esta patente, junto con la patente anteriormente concedida No. 11,890,273, cubre composiciones farmacéuticas líquidas estables de Losartán y métodos de tratamiento. Ambas patentes extienden la protección hasta 2041.

El producto SCN-102 de la compañía, actualmente bajo revisión de la FDA, tiene como objetivo proporcionar una formulación líquida oral lista para usar de Losartán, una de las moléculas más prescritas en su clase. Las patentes demuestran las capacidades de desarrollo de Scienture y su compromiso con las necesidades de los pacientes desatendidos.

Scienture (NASDAQ: SCNX)는 미국 특허청이 SCN-102 제품에 대한 새로운 특허(번호 12,156,869)를 발부했다고 발표했습니다. 이 제품은 로사르탄 포타슘 구강 현탁액입니다. 이번 특허는 이전에 부여된 특허 번호 11,890,273과 함께 로사르탄의 안정적인 액체 제제와 치료 방법을 포함합니다. 두 가지 특허 모두 2041년까지 보호를 연장합니다.

현재 FDA 심사 중에 있는 회사의 SCN-102 제품은 로사르탄의 즉시 사용 가능 구강 액상 제제를 제공하는 것을 목표로 합니다. 로사르탄은 이 분야에서 가장 널리 처방되는 분자 중 하나입니다. 이러한 특허는 Scienture의 개발 능력과 부족한 환자 요구를 해결하기 위한 헌신을 보여줍니다.

Scienture (NASDAQ: SCNX) a annoncé que l'Office américain des brevets et des marques a délivré un nouveau brevet (n° 12,156,869) pour son produit SCN-102, une suspension orale de Losartan Potassium. Ce brevet, associé au brevet précédemment accordé n° 11,890,273, couvre des compositions pharmaceutiques liquides stables de Losartan et des méthodes de traitement. Les deux brevets prolongent la protection jusqu'en 2041.

Le produit SCN-102 de la société, actuellement en cours d'examen par la FDA, vise à fournir une formulation liquide orale prête à l'emploi de Losartan, l'une des molécules les plus prescrites de sa catégorie. Les brevets témoignent des capacités de développement de Scienture et de son engagement à répondre aux besoins des patients mal desservis.

Scienture (NASDAQ: SCNX) gab bekannt, dass das US-Patent- und Markenamt ein neues Patent (Nr. 12,156,869) für sein Produkt SCN-102, eine Losartan-Potassium-Enteral-Suspension, erteilt hat. Dieses Patent deckt zusammen mit dem zuvor erteilten Patent Nr. 11,890,273 stabile flüssige pharmazeutische Zusammensetzungen von Losartan und Behandlungsmethoden ab. Beide Patente bieten Schutz bis 2041.

Das Produkt SCN-102 des Unternehmens, das sich derzeit in der Prüfung durch die FDA befindet, zielt darauf ab, eine gebrauchsfertige flüssige orale Formulierung von Losartan bereitzustellen, einer der am häufigsten verschriebenen Moleküle seiner Klasse. Die Patente belegen die Entwicklungskapazitäten von Scienture und das Engagement, unzureichend versorgte Patientenbedürfnisse zu adressieren.

Positive
  • Secured new patent protection through 2041 for SCN-102 product
  • Product under FDA review for potential market approval
  • Multiple patent protection strengthens intellectual property position
Negative
  • None.

Insights

The issuance of two patents ('869 and '273) for SCN-102 significantly strengthens Scienture's intellectual property portfolio through 2041. This dual patent protection covering both the liquid formulation and methods of use creates a robust barrier to entry for potential competitors. The extended protection period is particularly valuable for pharmaceutical products, as it ensures market exclusivity well beyond the typical patent lifecycle. The timing aligns strategically with the pending FDA review of the NDA for SCN-102, potentially creating a strong commercial foundation if approved. The patents' scope covering stable liquid formulations addresses a specific market need and could provide Scienture with a competitive advantage in the Losartan market segment.

The development of a liquid Losartan formulation (SCN-102) addresses an important unmet need in hypertension treatment. Liquid formulations are important for patients who have difficulty swallowing tablets or require precise dose adjustments. Losartan, an angiotensin receptor blocker (ARB), is indeed one of the most prescribed antihypertensive medications and a ready-to-use liquid formulation could expand its accessibility to broader patient populations, including pediatric and elderly patients. The pending FDA review of the NDA suggests the product has completed necessary clinical development phases and could potentially reach the market soon, subject to regulatory approval.

COMMACK, NY and TAMPA, FL, Dec. 10, 2024 (GLOBE NEWSWIRE) -- SCIENTURE, LLC (“the “Company”), a wholly owned subsidiary of SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), focused on developing and commercializing novel branded, specialty pharma products, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a new patent, No. 12,156,869 (the ‘869 patent), further strengthening the intellectual property position and coverage for the Company’s SCN-102 product. The ‘869 patent is in addition to the previously granted patent for SCN-102 by the USPTO, No. 11,890,273 (the ‘273 patent).

The ‘869 patent and the ‘273 patent, both titled, “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE,” cover stable, liquid pharmaceutical compositions of Losartan and methods of treating patients in need of Losartan by administration of the novel formulations described.

“The two issued patents demonstrate our accomplished development capabilities for novel products and our commitment to bring to market high value products that address unique and underserved patient needs,” said Shankar Hariharan, Ph.D., CEO of Scienture, LLC. “We are pleased to note that the NDA filed for SCN-102 is currently under review at the FDA.”

“We are pleased with the issuance of these two patents supporting SCN-102, a transformative therapy containing Losartan, one of the most widely prescribed molecules in its class,” remarked Narasimhan Mani, Ph.D, MBA, President of Scienture, LLC. “SCN-102 on receiving final NDA approval, has the potential to address needs of patients who can benefit from a ready-to-use oral liquid formulation of Losartan.”

“This announcement is extremely exciting and reaffirms the optimism of the Board and management team in relation to the recent merger with Scienture. This is a clear demonstration of the value Scienture, LLC brings to the combined company and its shareholders,” said Suren Ajjarapu, Chairman of the Board, Scienture Holdings, Inc.

About SCN-102

Scienture LLC’s product candidate SCN-102, (Losartan Oral Suspension 10mg/mL), is a ready to use oral suspension of Losartan for increased patient convenience and ease of dosing. The Company believes that SCN-102, if approved by the FDA, would be the first liquid formulation of Losartan on the market that does not require compounding and has reduced dosing volume and long term shelf life at room temperature storage.

About Losartan

Losartan is an ARB (Angiotensin II Receptor Blocker) for treating hypertension and is one of the highest prescribed molecules for this indication. It is currently available in the market as an oral solid product. IQVIA data (MAT September 2024) indicates a total annual sales of $312 million and an annual prescription volume of 67 million for Losartan in the US market.

About Hypertension

Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.

About Scienture, LLC

Scienture, LLC is a Commack, NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments.. Learn more at https://www.scienture.com/.

About Scienture Holdings, Inc.

SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiaries, Scienture, LLC and Integra Pharma Solutions, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Our products in development at Scienture, LLC, are across therapeutic areas, indications and cater to different market segments and channels. Integra Pharma Solutions, LLC, is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products to healthcare markets including government organizations, hospitals, clinics and independent pharmacies nationwide.

Cautionary Statements Regarding Forward-Looking Statements

This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are 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. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for our SCN-102 product or any other products we may launch. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.

Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.

Contacts:

SCIENTURE, LLC

Scienture, LLC
20 Austin Boulevard
Commack, New York 11725
Phone: (631) 670-6039
Email: IR@Scienture.com

SCIENTURE HOLDINGS, INC.

SCIENTURE HOLDINGS, INC.
6308 Benjamin Rd, Suite 708
Tampa, Florida 33634
Phone: (866) 468-6535
Email: IR@Rxintegra.com


FAQ

What is the new patent number issued to Scienture (SCNX) for SCN-102?

The U.S. Patent and Trademark Office issued patent No. 12,156,869 to Scienture for their SCN-102 product (Losartan Potassium Oral Suspension).

How long does Scienture's (SCNX) patent protection extend for SCN-102?

The patent protection for Scienture's SCN-102 product extends through 2041.

What is Scienture's (SCNX) SCN-102 product currently under FDA review?

SCN-102 is a ready-to-use oral liquid formulation of Losartan Potassium (10mg/mL), which is currently under FDA review through a submitted NDA.

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