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Relief Therapeutics Enters Into Exclusive U.S. License and Supply Agreement With Eton Pharmaceuticals for PKU GOLIKE

Relief Therapeutics Enters Into Exclusive U.S. License and Supply Agreement With Eton Pharmaceuticals for PKU GOLIKE

Relief Therapeutics與伊頓製藥就PKU GOLIKE簽訂美國獨家許可和供應協議
Accesswire ·  03/22 14:20

GENEVA, SWITZERLAND / ACCESSWIRE / March 22, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY ) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced it has granted an exclusive license to Eton Pharmaceuticals, Inc. (Nasdaq: ETON) (Eton) for the commercialization of GOLIKE family of products in the United States.

瑞士日內瓦/ACCESSWIRE /2024年3月22日/致力於爲特定特種疾病、未滿足的和罕見疾病提供創新治療選擇的生物製藥公司RELIEF THERAPEUTICS Holding SA(SIX: RLFTF)(OTCQB: RLFTY)(OTCQB: RLFTY)(Relief,或公司)今天宣佈,已向伊頓製藥公司(ETON Nasdaq)(Eton Nasdaq)(伊頓公學)(Eton)授予獨家許可用於 GOLIKE 的商業化 美國的產品系列。

"This transition is fully aligned with Relief's strategy of moving the GOLIKE products into partnership models in the U.S. and Europe. We are very pleased to be establishing this partnership with Eton for GOLIKE patients in the U.S. given their valuable experience in the metabolic area," said Michelle Lock, interim CEO of Relief.

“這種過渡完全符合Relief的戰略,即在美國和歐洲將GOLIKE產品轉變爲合作伙伴模式。鑑於美國GOLIKE患者在新陳代謝領域的寶貴經驗,我們很高興與伊頓建立這種合作伙伴關係。” Relief臨時首席執行官米歇爾·洛克說。

"We are excited to be partnering with Relief on PKU GOLIKE in the United States. After extensive discussions with metabolic geneticists, dieticians, and PKU patients, we believe PKU GOLIKE is the best product in the estimated $100 million U.S. PKU medical formula market. With our sales force and existing relationships in the metabolic community, we believe we can significantly increase the awareness, education, and adoption of this important product," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

“我們很高興能與救濟組織合作開發美國的PKU GOLIKE。在與代謝遺傳學家、營養師和PKU患者進行了廣泛討論後,我們認爲PKU GOLIKE是估計耗資1億美元的美國PKU醫療配方市場中最好的產品。憑藉我們的銷售隊伍和代謝界的現有關係,我們相信我們可以顯著提高對這一重要產品的認識、教育和採用率。” 伊頓製藥首席執行官肖恩·布林傑爾森說。

Under the terms of the agreement, Relief will receive an upfront payment of $2.2 million and is eligible to receive an additional $2.0 million in sales milestones payments as well as mid-teens royalties on net sales. In the fourth quarter of 2023, PKU GOLIKE's annualized net sales exceeded $1 million in the U.S., continuing its growth trajectory since its launch in late 2022.

根據協議條款,Relief將獲得220萬美元的預付款,並有資格額外獲得200萬美元的銷售里程碑款項以及十幾歲的淨銷售特許權使用費。2023年第四季度,北京大學GOLIKE在美國的年化淨銷售額超過100萬美元,延續了自2022年底推出以來的增長軌跡。

As part of the agreement, Eton also received U.S. rights to Relief's GOLIKE Medical Food line extensions under development for the management of other inherited rare metabolic diseases such as tyrosinemia and homocystinuria, which are both expected to launch in 2025 and 2026 under the same trademark. Relief is also in discussions with Eton related to additional development assets, including RLF-OD032. RLF‐OD032 is an innovative drug product candidate under development for the treatment of PKU expected to be filed for approval before the FDA in H2/2025 as 505(b)(2) application. Relief will continue to fully own GOLIKE rights outside the United States.

作爲協議的一部分,伊頓還獲得了美國救濟基金GOLIKE Medical Food系列延期的權利,該產品線用於管理酪氨酸血癥和高半胱氨酸尿症等其他遺傳性罕見代謝疾病,這些疾病預計都將在2025年和2026年以同一商標推出。還正在與伊頓公學就包括 RLF-OD032 在內的其他開發資產進行救濟討論。RLF‐OD032是一種正在開發的用於治療PKU的創新候選藥物,預計將於2025年下半年作爲505(b)(2)申請向美國食品藥品管理局申請批准。救濟將繼續完全擁有GOLIKE在美國以外的版權。

About Relief

關於救濟

Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief's portfolio offers a balanced mix of marketed, revenue-generating products, our proprietary, globally patented Physiomimic and TEHCLO platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare metabolic disorders, rare skin diseases and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Relief's mission is to provide therapeutic relief to those suffering from rare diseases and is being advanced by an international team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief is headquartered in Geneva, with additional offices in Balerna, Switzerland, Offenbach am Main, Germany and Monza, Italy. Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, please visit our website or follow Relief on LinkedIn.

Relief 是一家處於商業階段的生物製藥公司,致力於推進治療模式,改善療效、安全性和便利性,以造福特定特種和罕見疾病患者的生活。Reliev的產品組合平衡地組合了已上市的創收產品、我們在全球獲得專利的Physiomic和TEHCLO平台技術,以及由風險緩解資產組成的有針對性的臨床開發管線,這些資產側重於三個核心治療領域:罕見代謝疾病、罕見皮膚病和罕見呼吸道疾病。此外,Relief正在通過許可和分銷合作伙伴將幾種傳統產品商業化。Relief的使命是爲罕見疾病患者提供治療性救濟,由一支由知名的、經驗豐富的生物製藥行業領導者組成的具有廣泛研究、開發和罕見病專業知識的國際團隊正在推動這一使命。Relief總部設在日內瓦,在瑞士巴萊爾納、德國美因河畔奧芬巴赫和意大利蒙扎設有辦事處。救濟在瑞士證券交易所上市,股票代碼爲RLF,並在美國的OTCQB上市,股票代碼爲RLFTF和RLFTY。欲了解更多信息,請訪問我們的網站或在 LinkedIn 上關注 Relief。

About Eton Pharmaceuticals

關於伊頓製藥

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. It currently has five commercial rare disease products: ALKINDI SPRINKLE , PKU GOLIKE , Carglumic Acid, Betaine Anhydrous, and Nitisinone. Eton has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO hydrocortisone autoinjector. For more information, visit .

伊頓是一家創新制藥公司,專注於開發和商業化罕見疾病的治療方法。它目前有五種商業罕見病產品:ALKINDI SPRINKLE ,PKU GOLIKE 、葡萄糖酸、無水甜菜鹼和尼替西農。伊頓還有三款處於後期開發階段的候選產品:ET-400、ET-600 和 ZENEO 氫化可的松自動注射器。欲了解更多信息,請訪問。

About Phenylketonuria (PKU)

關於苯丙酮尿症(PKU)

Phenylketonuria (PKU) is caused by a defect of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of Phe from the consumption of foods containing protein or aspartame. Untreated PKU can result in global developmental delay or severe irreversible intellectual disability, as well as growth failure, hypopigmentation, motor deficits, ataxia and seizures. Living with PKU requires a limited diet and very careful management. If left unmanaged, PKU can lead to devastating consequences, such as brain damage. People living with PKU do not have the ability to metabolize Phe, which is found in many foods, and they require supplementation of amino acid-based phenylalanine-free Medical Foods to prevent protein deficiency and optimize metabolic control. Currently available Medical Foods may lead to poor or suboptimal clinical outcomes and compliance because they are rapidly absorbed and are characterized by an unpleasant odor and aftertaste. Such factors contribute to barriers to social interaction for PKU patients, further limiting Medical Foods compliance and exposing patients to the risks of poor disease control.

苯丙酮尿症(PKU)是由分解苯丙氨酸(Phe)所需的酶缺陷引起的,食用含有蛋白質或阿斯巴甜的食物會導致Phe的毒性積聚。未經治療的PKU可能導致全球發育遲緩或嚴重的不可逆的智力障礙,以及生長衰竭、色素減退、運動缺陷、共濟失調和癲癇發作。與PKU一起生活需要有限的飲食和非常謹慎的管理。如果不加以管理,PKU可能導致毀滅性的後果,例如腦損傷。PKU患者沒有能力代謝PHE,PHE存在於許多食物中,他們需要補充基於氨基酸的無苯丙氨酸醫療食品,以防止蛋白質缺乏和優化代謝控制。目前可用的醫療食品可能會導致較差或次優的臨床結果和依從性,因爲它們會被迅速吸收,並且具有難聞的氣味和回味。這些因素構成了PKU患者的社交互動障礙,進一步限制了醫療食品的依從性,使患者面臨疾病控制不佳的風險。

About PKU GOLIKE

關於 PKU GOLIKE

PKU GOLIKE products are Medical Foods for the dietary management of PKU in both children and adults. Developed with the Relief proprietary, patent-protected Physiomimic Technology drug delivery platform, PKU GOLIKE products are the first prolonged-release amino acid Medical Food, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins. The special coating also masks the unpleasant taste, odor and aftertaste of the amino acids. PKU GOLIKE granules are flavorless and can be mixed with many foods. PKU GOLIKE granule products contain all 19 amino acids that people with PKU need to maintain neurological and muscular health and is fortified with vitamins and minerals, including ones normally found in protein-rich foods like iron, calcium, and vitamin B12. The PKU GOLIKE line of products is available in convenient packets (PKU GOLIKE Plus 3-16 and 16+) and medical food bars (PKU GOLIKE BAR ). PKU GOLIKE products have been commercially available in the U.S. since October 2022. For more information, visit (this site is intended for U.S. audiences only).

PKU GOLIKE 產品是用於兒童和成人 PKU 膳食管理的醫療食品。採用 Relief 專有的、受專利保護的 Physiomic Technology 藥物遞送平台 PKU GOLIKE 開發 產品是第一款長釋氨基酸醫用食品,其特點是特殊塗層可確保氨基酸的生理吸收,與天然蛋白質類似。特殊塗層還掩蓋了氨基酸的難聞味道、氣味和回味。PKU GOLIKE 顆粒無味,可以與許多食物混合。PKU GOLIKE 顆粒產品含有PKU患者維持神經和肌肉健康所需的全部19種氨基酸,並富含維生素和礦物質,包括通常存在於鐵、鈣和維生素B12等富含蛋白質的食物中的維生素和礦物質。PKU GOLIKE 產品系列有方便的包裝可供選擇(PKU GOLIKE Plus) 3-16 和 16 歲以上)和醫療食品棒(PKU GOLIKE BAR) )。PKU GOLIKE 自2022年10月以來,產品已在美國上市。欲了解更多信息,請訪問(本網站僅供美國受衆使用)。

CONTACT :

聯繫 :

RELIEF THERAPEUTICS Holding SA
Avenue de Sécheron 15
1202 Geneva
Switzerland
contact@relieftherapeutics.com

救濟療法控股有限公司
塞切隆大道 15
1202 日內瓦
瑞士
contact@relieftherapeutics.com

DISCLAIMER

免責聲明

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief's filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief's filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.

本新聞稿包含前瞻性陳述。前瞻性陳述涉及已知和未知的風險、不確定性,包括其實現公司、發展和商業目標的能力,以及其他可能導致救濟基金的實際業績、財務狀況、業績或成就與此類前瞻性陳述所表達或暗示的任何未來業績、業績或成就存在重大差異的因素。許多因素,包括救濟基金向瑞士證券交易所和美國證券交易委員會(SEC)提交的文件中描述的因素,可能會對救濟產生不利影響。救濟組織向美國證券交易委員會提交的文件副本可在美國證券交易委員會EDGAR數據庫www.sec.gov上查閱。Relief不承擔任何義務更新此處包含的信息,這些信息僅涉及截至該日期。

SOURCE: Relief Therapeutics Holdings AG

資料來源:救濟療控股股份公司


譯文內容由第三人軟體翻譯。


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