Aligns with Eton's Mission to Develop and Distribute Medicines that Have a Life Changing Impact for Patients with Ultra-rare Conditions

与伊顿公学的使命相一致，开发和分发对极罕见疾病患者产生改变生活影响的药物

Acquisition to Bolster Eton’s Commercial Pediatric Endocrinology Portfolio

收购以支持伊顿公学的商业儿科内分泌组合

DEER PARK, Ill., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has entered into an asset purchase agreement to acquire Increlex® (mecasermin injection) from Ipsen S.A.

伊利诺伊州鹿园，2024年10月3日（环球通讯社）--伊顿制药公司（Eton Pharmaceuticals，Inc）（“伊顿”或“该公司”）（Nasdaq:Eton）是一家专注于开发罕见疾病治疗方法并将其商业化的创新制药公司，今天宣布已签订资产购买协议，从Ipsen S.A.收购Increlex®（mecasermin injection）。

(“Ipsen”). The acquisition is expected to close near year-end 2024..

（“Ipsen”）。该收购预计将于2024年底结束。。

'Eton's mission is to develop and distribute medicines that make a life changing impact for patients with the rarest of conditions. Increlex, a critical medication for patients with the ultra-rare condition of severe IGF-1 deficiency, aligns perfectly with our mission and our significant expertise in serving extremely rare patient populations,' said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

伊顿公学的使命是开发和分发药物，为病情最罕见的患者带来改变生活的影响。伊顿制药首席执行官肖恩·布林杰尔森（SeanBrynjelsen）说，肠易激肽（Increlex）是一种治疗严重IGF-1缺乏症极为罕见的患者的关键药物，与我们的使命和我们在服务极为罕见的患者群体方面的重要专业知识完全吻合。

'Leveraging our strong presence in the pediatric endocrinology community, we aim to raise awareness of this underdiagnosed and undertreated condition. We look forward to collaborating with Ipsen to ensure continuity of care and long-term supply for patients globally.'.

“利用我们在儿科内分泌学界的强大影响力，我们旨在提高人们对这种诊断不足和治疗不足的疾病的认识。我们期待着与Ipsen合作，确保全球患者的护理和长期供应的连续性。”。

Increlex is a biologic product used to treat children and adolescents from 2- to 18-years-old who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD) because their bodies do not make enough insulin-like growth factor 1 (IGF-1). The medicine is approved in 40 territories, including the United States (U.S.) and the European Union (EU).

Increlex是一种生物制品，用于治疗2至18岁的儿童和青少年，他们患有严重的原发性胰岛素样生长因子1缺乏症（SPIGFD），因为他们的身体不能产生足够的胰岛素样生长因子1（IGF-1）。该药已在40个地区获得批准，包括美国（U.S.）和欧盟（EU）。

It is estimated that approximately 200 patients in the United States and 900-1,000 patients in Europe live with SPIGFD. Increlex is the only treatment approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) for SPIGFD..

据估计，美国约有200名患者和欧洲约900-1000名患者患有SPIGFD。Increlex是美国食品和药物管理局（FDA）或欧洲药品管理局（EMA）批准用于SPIGFD的唯一治疗方法。。

Post closing, Eton will immediately commercialize the product in the U.S. without disruption to patient supply. Outside the U.S., Ipsen will continue distributing the product during a six-month transition period to ensure no disruption to patient supply, after which the commercialization will be continued by Eton..

交易结束后，伊顿公学将立即在美国将该产品商业化，而不会中断患者供应。在美国境外，益普生将在六个月的过渡期内继续分销该产品，以确保不会中断患者供应，之后伊顿公学将继续商业化。。

The transaction will be financed by Eton’s cash on hand and an expansion of the Company’s existing credit facility with SWK Holdings. Ipsen reported global sales for Increlex of €17.3 million in 2023.

该交易将由伊顿公学的库存现金以及该公司与SWK控股公司现有信贷额度的扩大提供资金。Ipsen报告称，2023年Increlex的全球销售额为1730万欧元。

Important Safety Information

重要安全信息

Contraindications

禁忌症

Hypersensitivity to mecasermin (rhIGF-1), any of the inactive ingredients in INCRELEX®, or who have experienced a severe hypersensitivity to INCRELEX®. Allergic reactions have been reported, including anaphylaxis requiring hospitalization.

。已经报道了过敏反应，包括需要住院治疗的过敏反应。

Intravenous Administration.

静脉注射。

Closed Epiphyses.

闭合的骨骺。

Benign and malignant Neoplasia in pediatric patients with active or suspected neoplasia or medical history with an increased risk of benign or malignant neoplasia.

患有活动性或疑似肿瘤或病史且良性或恶性肿瘤风险增加的儿科患者的良性和恶性肿瘤。

Warnings and Precautions

Hypoglycemia: INCRELEX® should be administered 20 minutes before or after a meal or snack and should not be administered when the meal or snack is omitted. Glucose monitoring and INCRELEX® dose titration are recommended until a well-tolerated dose is established and as medically indicated.

低血糖：应在进餐或零食之前或之后20分钟服用INCRELEX®，不应在省略进餐或零食时服用。建议进行葡萄糖监测和INCRELEX®剂量滴定，直到建立耐受良好的剂量并符合医学指示。

Intracranial Hypertension: Funduscopic examination is recommended at the initiation of and periodically during the course of therapy.

颅内高压：建议在治疗开始时和治疗过程中定期进行眼底镜检查。

Lymphoid Tissue Hypertrophy: Patients should have periodic examinations to rule out potential complications.

淋巴组织肥大：患者应定期检查以排除潜在的并发症。

Slipped Capital Femoral Epiphysis: Carefully evaluate any pediatric patient with the onset of a limp or hip/knee pain during INCRELEX® therapy.

股骨头骨骺滑脱：仔细评估任何在INCRELEX®治疗期间出现跛行或髋/膝关节疼痛的儿科患者。

Progression of Scoliosis: Patients with a history of scoliosis, treated with INCRELEX®, should be monitored.

脊柱侧弯的进展：应监测有脊柱侧弯病史并接受INCRELEX®治疗的患者。

Cardiomegaly: An echocardiogram is recommended before initiation and at termination of mecasermin treatment in all patients

心脏肥大：建议所有患者在开始和终止美卡西尔明治疗前进行超声心动图检查

Benign and malignant neoplasms: There have been postmarketing reports of malignant neoplasia in pediatric patients who received treatment with INCRELEX®. The tumors were observed more frequently in patients who received INCRELEX® at higher than recommended doses or at doses that produced serum IGF-1 levels above the normal reference ranges for age and sex.

良性和恶性肿瘤：上市后有报道称接受INCRELEX®治疗的儿科患者发生恶性肿瘤。在接受高于推荐剂量的INCRELEX®或产生血清IGF-1水平高于正常年龄和性别参考范围的剂量的患者中，观察到肿瘤的频率更高。

Monitor all patients receiving INCRELEX® carefully for development of neoplasms. If malignant neoplasia develops, discontinue INCRELEX® treatment..

仔细监测所有接受INCRELEX®治疗的患者的肿瘤发展情况。如果发生恶性肿瘤，请停止INCRELEX®治疗。。

Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preserved Solution: Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs. Use of INCRELEX® in infants is not recommended as well as in children below 3 years old..

苯甲醇保存液对婴儿产生严重不良反应的风险：使用苯甲醇保存液治疗的新生儿和婴儿可能会发生严重致命的不良反应，包括“喘息综合征”。不建议在婴儿和3岁以下儿童中使用INCRELEX®。。

Adverse Reactions

Common adverse reactions include hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy.

常见的不良反应包括低血糖，局部和全身超敏反应以及扁桃体肥大。

U.S. Indication

U、 S.指示

INCRELEX® (mecasermin) is indicated for the treatment of growth failure in pediatric patients aged 2 years and older with severe primary IGF-1 deficiency* (IGFD), or with hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

INCRELEX®（mecasermin）适用于治疗2岁及以上患有严重原发性IGF-1缺乏症*（IGFD）或激素（GH）基因缺失且已产生GH中和抗体的儿科患者的生长衰竭。

Limitations of use: INCRELEX® is not a substitute to GH for approved GH indications. INCRELEX® is not indicated for use in patients with secondary forms of IGFD, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

使用限制：对于批准的GH适应症，INCRELEX®不能替代GH。INCRELEX®不适用于患有继发性IGFD的患者，例如GH缺乏症，营养不良，甲状腺功能减退症或使用药理剂量的抗炎类固醇进行慢性治疗。

*Severe primary IGF-1 deficiency (IGFD) is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated GH.

*严重的原发性IGF-1缺乏症（IGFD）的定义是身高标准差得分≤-3.0，基础IGF-1标准差得分≤-3.0，GH正常或升高。

Full U.S. Prescribing Information for Increlex® is available at: http://increlex.com/pdf/hcp-full-prescribing-information.pdf

有关Increlex®的完整美国处方信息，请访问：http://increlex.com/pdf/hcp-full-prescribing-information.pdf

You are encouraged to report negative effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

鼓励您向FDA报告处方药的负面影响。访问www.fda.gov/medwatch，或致电1-800-fda-1088。

EU Indication

欧盟指示

In the European Union, INCRELEX is indicated for the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor 1 deficiency (Primary IGFD). Severe Primary IGFD is defined by: height standard deviation score <–3.0 and basal IGF-1 levels below the 2.5th percentile for age and gender and GH sufficiency.

在欧盟，INCRELEX适用于2至18岁儿童和青少年生长衰竭的长期治疗，确诊为严重的原发性胰岛素样生长因子1缺乏症（原发性IGFD）。严重的原发性IGFD的定义为：身高标准差得分<–3.0，基础IGF-1水平低于年龄，性别和GH充足率的2.5%。

Exclusion of secondary forms of IGF 1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids..

。。

Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF 1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test..

严重的原发性IGFD包括GH受体（GHR），GHR后信号通路突变和IGF 1基因缺陷的患者；它们不是GH缺乏症，因此，不能期望它们对外源性GH治疗有足够的反应。在某些情况下，如果认为有必要，医生可能会决定通过进行IGF-I生成测试来帮助诊断。。

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

有关该药品的详细信息，请访问欧洲药品管理局的网站：http://www.ema.europa.eu

About Eton

关于伊顿公学

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

伊顿是一家创新的制药公司，专注于开发罕见疾病的治疗方法并将其商业化。该公司目前有五种商业罕见病产品：ALKINDI Spread®，PKU GOLIKE®，Carglumic Acid，甜菜碱无水和尼替尼酮。该公司在后期开发中还有三种候选产品：ET-400、ET-600和ZENEO®氢化可的松自动注射器。

For more information, please visit our website at www.etonpharma.com..

有关更多信息，请访问我们的网站www.etonpharma.com。。

Forward Looking Statements

前瞻性声明

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives.

本新闻稿中关于非历史事实的声明是1995年《私人证券诉讼改革法案》所指的“前瞻性声明”，包括与伊顿公学开展某些活动和实现某些目标的预期能力相关的声明。

These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates.

这些声明包括但不限于关于伊顿公学的商业战略、伊顿公学开发和商业化其候选产品的计划、伊顿公学候选产品的安全性和有效性、伊顿公学的计划和监管备案和批准的预期时间，以及伊顿公学候选产品市场的规模和增长潜力的声明。

Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements.

由于此类报表存在风险和不确定性，因此实际结果可能与此类前瞻性报表明示或暗示的结果存在重大差异。诸如“相信”、“预期”、“计划”、“期望”、“打算”、“意志”、“目标”、“潜力”等词语以及类似的表达方式旨在识别前瞻性陈述。

These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.

这些前瞻性陈述基于伊顿公学目前的预期，并涉及可能永远不会实现或可能被证明不正确的假设。。

These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Ex.

关于伊顿公学的发展计划和财务状况的这些风险和其他风险，在伊顿公学向证券和交易所提交的文件中有详细描述。

Eton Contacts

Eton联系人

Investors Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com

投资者Lisa M.Wilson，In-Site Communications，Inc.电话：212-452-2793E：lwilson@insitecony.com

MediaEliza Schleifstein, ES MediaT: 917-763-8106E: eliza@schleifsteinpr.com

媒体Eliza Schleifstein，ES媒体：917-763-8106E：eliza@schleifsteinpr.com

Source: Eton Pharmaceuticals