Eton Pharmaceuticals Closes Acquisition of Increlex® (mecasermin injection)
Eton Pharmaceuticals has completed its acquisition of Increlex® (mecasermin injection) from Ipsen S.A. Increlex® is a biologic treatment for pediatric patients aged 2+ with severe primary insulin-like growth factor 1 deficiency (SPIGFD). The product is approved in 41 territories, including the US and EU, and is the only FDA/EMA-approved treatment for SPIGFD, serving approximately 200 US patients and 900-1,000 European patients.
The medication is now available in the US through AnovoRx, a specialty pharmacy for rare conditions. The Eton Cares Program offers prescription fulfillment, insurance benefits investigation, and financial assistance, including $0 co-pays for qualifying patients. Outside the US, Ipsen will continue distribution during a six-month transition period before Eton takes over commercialization.
Eton Pharmaceuticals ha completato l'acquisizione di Increlex® (iniezione di mecasermina) da Ipsen S.A. Increlex® è un trattamento biologico per pazienti pediatrici di età superiore ai 2 anni con grave carenza primaria del fattore di crescita insulino-simile 1 (SPIGFD). Il prodotto è approvato in 41 territori, tra cui gli Stati Uniti e l'UE, ed è l'unico trattamento approvato dalla FDA/EMA per SPIGFD, servendo circa 200 pazienti negli Stati Uniti e 900-1.000 pazienti europei.
Il medicinale è ora disponibile negli Stati Uniti tramite AnovoRx, una farmacia specializzata in condizioni rare. Il programma Eton Cares offre l'emissione di prescrizioni, indagini sui benefici assicurativi e assistenza finanziaria, inclusi co-pagamenti di $0 per i pazienti idonei. Al di fuori degli Stati Uniti, Ipsen continuerà la distribuzione durante un periodo di transizione di sei mesi prima che Eton assuma la commercializzazione.
Eton Pharmaceuticals ha completado su adquisición de Increlex® (inyección de mecasermina) de Ipsen S.A. Increlex® es un tratamiento biológico para pacientes pediátricos mayores de 2 años con deficiencia primaria severa del factor de crecimiento insulínico tipo 1 (SPIGFD). El producto está aprobado en 41 territorios, incluidos los Estados Unidos y la UE, y es el único tratamiento aprobado por la FDA/EMA para SPIGFD, atendiendo a aproximadamente 200 pacientes en EE. UU. y de 900 a 1.000 pacientes en Europa.
El medicamento ya está disponible en EE. UU. a través de AnovoRx, una farmacia especializada en condiciones raras. El programa Eton Cares ofrece cumplimiento de recetas, investigación de beneficios del seguro y asistencia financiera, incluidos copagos de $0 para pacientes calificados. Fuera de EE. UU., Ipsen continuará con la distribución durante un período de transición de seis meses antes de que Eton asuma la comercialización.
이튼 제약(Eton Pharmaceuticals)은 인크렉스(Increlex®) (메카서민 주사제)를 입센(Ipsen S.A.)로부터 인수 완료했다고 발표했습니다. 인크렉스는 2세 이상의 소아 환자에게 심각한 1형 인슐린 유사 성장 인자 결핍증(SPIGFD)을 치료하기 위한 생물학적 치료제입니다. 이 제품은 미국과 EU를 포함한 41개 지역에서 승인되었으며, SPIGFD에 대한 FDA/EMA 승인 치료제 중 유일한 제품으로, 미국에서 약 200명의 환자와 유럽에서 900~1,000명의 환자에게 서비스를 제공합니다.
이 약물은 이제 미국에서 AnovoRx를 통해 희귀 질환 전문 약국에서 구입할 수 있습니다. 이튼 케어 프로그램(Eton Cares Program)은 처방전 이행, 보험 혜택 조사 및 재정 지원을 제공하며, 자격이 있는 환자는 $0의 본인 부담금이 적용됩니다. 미국 외 지역에서는 이튼이 상용화를 인수하기 전 6개월의 전환 기간 동안 입센이 계속해서 유통할 것입니다.
Eton Pharmaceuticals a finalisé son acquisition de Increlex® (injection de mécasermine) auprès d'Ipsen S.A. Increlex® est un traitement biologique destiné aux patients pédiatriques de 2 ans et plus présentant une carence primaire sévère en facteur de croissance analogue à l'insuline 1 (SPIGFD). Le produit est approuvé dans 41 territoires, y compris les États-Unis et l'UE, et est le seul traitement approuvé par la FDA/EMA pour le SPIGFD, prenant en charge environ 200 patients aux États-Unis et 900 à 1 000 patients européens.
Le médicament est désormais disponible aux États-Unis via AnovoRx, une pharmacie spécialisée pour les maladies rares. Le programme Eton Cares offre la réalisation de prescriptions, l'examen des avantages d'assurance et une assistance financière, y compris des paiements à 0 $ pour les patients qualifiés. En dehors des États-Unis, Ipsen continuera la distribution pendant une période de transition de six mois avant qu'Eton ne prenne en charge la commercialisation.
Eton Pharmaceuticals hat die Übernahme von Increlex® (Mecasermin-Injektion) von Ipsen S.A. abgeschlossen. Increlex® ist eine biologische Behandlung für pädiatrische Patienten ab 2 Jahren mit schwerem primären Insulin-ähnlichem Wachstumsfaktor 1-Mangel (SPIGFD). Das Produkt ist in 41 Gebieten zugelassen, einschließlich der USA und der EU, und ist die einzige von der FDA/EMA zugelassene Behandlung für SPIGFD, die etwa 200 Patienten in den USA und 900-1.000 Patienten in Europa versorgt.
Das Medikament ist nun in den USA über AnovoRx, eine Fachapotheke für seltene Erkrankungen, erhältlich. Das Eton Cares-Programm bietet die Einlösung von Rezepten, eine Untersuchung von Versicherungsleistungen und finanzielle Unterstützung, einschließlich $0 Zuzahlung für berechtigte Patienten. Außerhalb der USA wird Ipsen während einer sechsmonatigen Übergangsperiode weiterhin vertreiben, bevor Eton die Kommerzialisierung übernimmt.
- Acquisition expands pediatric endocrinology portfolio
- Product has market exclusivity as only FDA/EMA-approved treatment for SPIGFD
- Established patient base of approximately 1,100-1,200 patients globally
- Leverages existing sales infrastructure and relationships
- Offering $0 co-pay assistance for qualifying patients
- market size with only 200 US patients
- Six-month transition period required for international commercialization
- Required additional financing through credit facility expansion
Insights
The acquisition of Increlex® represents a strategic expansion of Eton's rare disease portfolio. This product, with its unique market position as the only FDA and EMA-approved treatment for SPIGFD, creates a defensible revenue stream. The addressable market of approximately 1,100-1,200 patients across the US and Europe, while small, typically commands premium pricing in rare disease treatments.
The transaction structure, financed through cash reserves and credit facility expansion with SWK Holdings, suggests prudent capital allocation. The six-month transition period for ex-US commercialization provides operational continuity while allowing Eton to prepare for full global commercialization.
Increlex's unique position in treating SPIGFD represents significant medical value. The condition affects growth in pediatric patients and mecasermin (rhIGF-1) addresses a fundamental biological deficiency. The established AnovoRx specialty pharmacy partnership and Eton Cares Program, offering
The comprehensive safety profile and clear administration guidelines demonstrate strong clinical governance. The therapy's approval in 41 territories validates its medical efficacy and regulatory acceptance, while the patient support infrastructure suggests potential for improved diagnosis rates in this undertreated condition.
This acquisition strengthens Eton's position in pediatric endocrinology, leveraging existing sales infrastructure to potentially increase SPIGFD diagnosis rates. The rare disease market typically yields higher margins and faces competition. The global rights acquisition positions Eton for international market expansion after the transition period.
The AnovoRx partnership streamlines distribution and patient access, important factors in rare disease commercialization. The established patient support program could drive better market penetration in an underdiagnosed condition, potentially expanding the current patient base beyond the identified 200 US and 900-1,000 European patients.
- Acquisition bolsters Eton’s commercial pediatric endocrinology portfolio
- Product is now available through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions
DEER PARK, Ill., Dec. 20, 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 completed its previously announced asset purchase of Increlex® (mecasermin injection) from Ipsen S.A. (“Ipsen”). Increlex® is a biologic product used to treat pediatric patients 2 years of age and older who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD).
“We are excited to close this transformational acquisition and add another important treatment to our commercial portfolio. Increlex® is perfectly aligned with our expertise and strong relationships in pediatric endocrinology and we’re well-positioned to leverage our existing sales team to increase awareness of SPIGFD, an underdiagnosed and undertreated condition,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “In the U.S., Increlex® is now available through a specialty pharmacy dedicated to rare and chronic conditions and we are proud to be able to continue supplying this crucial product worldwide without disruption.”
Increlex® is a biologic product used to treat pediatric patients 2 years of age and older 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 41 territories, including the United States (U.S.) and the European Union (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.
Increlex® is now available in the United States exclusively through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. AnovoRx will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program provides prescription fulfillment, insurance benefits investigation, educational support, financial assistance for qualified patients, and other services designed to help patients access treatment. Eton Cares will offer co-pay assistance to allow for
Outside the U.S., Ipsen will continue distributing Increlex® during a six-month transition period, after which Eton will take over commercialization. The transaction was financed by Eton’s cash on hand and an expansion of the Company’s existing credit facility with SWK Holdings.
Clinicians seeking to prescribe Increlex® can e-prescribe by selecting AnovoRx #5 or fax in a patient referral form to 855-831-2039. Additional product details can be found on the product website, https://www.increlex.com/en-us.
For questions regarding prescription fulfillment, please contact AnovoRx at 1-833-343-2500.
Important Safety Information
Contraindications
- 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.
- Intravenous Administration.
- Closed Epiphyses.
- Benign and malignant Neoplasia in pediatric patients with active or suspected neoplasia or medical history with an increased risk of benign or malignant neoplasia.
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.
- Intracranial Hypertension: Funduscopic examination is recommended at the initiation of and periodically during the course of therapy.
- Lymphoid Tissue Hypertrophy: Patients should have periodic examinations to rule out potential complications.
- Slipped Capital Femoral Epiphysis: Carefully evaluate any pediatric patient with the onset of a limp or hip/knee pain during INCRELEX® therapy.
- Progression of Scoliosis: Patients with a history of scoliosis, treated with INCRELEX®, should be monitored.
- Cardiomegaly: An echocardiogram is recommended before initiation and at termination of mecasermin treatment in all patients
- 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. Monitor all patients receiving INCRELEX® carefully for development of neoplasms. If malignant neoplasia develops, discontinue INCRELEX® treatment.
- 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.
Adverse Reactions
Common adverse reactions include hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy.
U.S. Indication
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.
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.
*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.
Full U.S. Prescribing Information for Increlex® is available at: 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.
EU Indication
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. 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.
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has six commercial rare disease products: INCRELEX®, 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. For more information, please visit our website at www.etonpharma.com.
Forward-Looking Statements
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. 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. 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. 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. 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 Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
FAQ
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