Eton Pharmaceuticals Advances Its Commitment to Rare Disease with the Acquisition of Galzin庐
Eton Pharmaceuticals (NASDAQ: ETON) has announced the acquisition of Galzin庐 (zinc acetate), an FDA-approved maintenance treatment for Wilson Disease. The drug serves an ultra-rare patient population with less than 5,000 patients currently being treated in the United States.
The company plans to begin commercialization in the U.S. during Q1 2025 through its metabolic sales force. Patients will have access to the Eton Cares support program, offering $0 co-pay for qualified commercial patients, prescription fulfillment, insurance benefits investigation, and educational support.
The acquisition also includes European rights to the product, where it's marketed as Wilzin庐 through a third-party distributor. Eton will continue supplying the product while the third party manages European commercialization. Stifel acted as exclusive financial advisor for the transaction.
Eton Pharmaceuticals (NASDAQ: ETON) ha annunciato l'acquisizione di Galzin庐 (acetato di zinco), un trattamento di mantenimento approvato dalla FDA per la Malattia di Wilson. Questo farmaco serve una popolazione di pazienti ultra-rara, con meno di 5.000 pazienti attualmente in trattamento negli Stati Uniti.
La societ脿 prevede di iniziare la commercializzazione negli Stati Uniti nel primo trimestre del 2025 attraverso la sua forza vendita metabolica. I pazienti avranno accesso al programma di supporto Eton Cares, che offre un co-pagamento di $0 per i pazienti commerciali qualificati, fornitura di prescrizioni, indagine sui benefici assicurativi e supporto educativo.
L'acquisizione include anche i diritti europei sul prodotto, dove 猫 commercializzato come Wilzin庐 tramite un distributore terzo. Eton continuer脿 a fornire il prodotto mentre la terza parte gestisce la commercializzazione europea. Stifel ha agito come consulente finanziario esclusivo per la transazione.
Eton Pharmaceuticals (NASDAQ: ETON) ha anunciado la adquisici贸n de Galzin庐 (acetato de zinc), un tratamiento de mantenimiento aprobado por la FDA para la Enfermedad de Wilson. Este medicamento atiende a una poblaci贸n de pacientes ultra-rara, con menos de 5,000 pacientes actualmente en tratamiento en los Estados Unidos.
La empresa planea comenzar la comercializaci贸n en EE. UU. durante el primer trimestre de 2025 a trav茅s de su fuerza de ventas metab贸lica. Los pacientes tendr谩n acceso al programa de apoyo Eton Cares, que ofrece un copago de $0 para pacientes comerciales calificados, cumplimiento de recetas, investigaci贸n de beneficios de seguro y soporte educativo.
La adquisici贸n tambi茅n incluye los derechos europeos del producto, donde se comercializa como Wilzin庐 a trav茅s de un distribuidor externo. Eton continuar谩 suministrando el producto mientras que la tercera parte maneja la comercializaci贸n europea. Stifel actu贸 como asesor financiero exclusivo para la transacci贸n.
鞚错啢 鞝滌暯 (NASDAQ: ETON)鞚赌 臧堨庐 (鞎勳劯韸胳偘 鞎勳棸)鞚� 鞚胳垬毳� 氚滍憸頄堨姷雼堧嫟. 鞚措姅 鞙岇姩氤戩棎 雽�頃� FDA 鞀轨澑 鞙犾 旃橂鞝滌瀰雼堧嫟. 鞚� 鞎诫鞚赌 順勳灛 氙戈淡鞐愳劀 旃橂氚涥碃 鞛堧姅 5,000氇� 氙鸽鞚� 齑堩潿攴� 頇橃瀽甑办棎瓴� 鞝滉车霅╇媹雼�.
須岇偓電� 2025雲� 1攵勱赴 欷戩棎 雽�靷� 韺愲Г韺�鞚� 韱淀暣 氙戈淡鞐愳劀 靸侅毄頇旊ゼ 鞁滌瀾頃� 瓿勴殟鞛呺媹雼�. 頇橃瀽霌れ澏� 鞛愱博鞚� 鞛堧姅 靸侅梾鞝� 頇橃瀽毳� 鞙勴暅 $0 瓿惦彊 攵�雼搓笀鞚� 鞝滉车頃橂姅 鞚错啢 旒�鞏挫姢 歆�鞗� 頂勲攴鸽灗鞐� 鞝戧芳頃� 靾� 鞛堨姷雼堧嫟. 鞚措姅 觳橂癌 鞚错枆, 氤错棙 順滍儩 臁办偓 氚� 甑愳湣 歆�鞗愲弰 韽暔霅╇媹雼�.
鞚措矆 鞚胳垬鞐愲姅 鞙犽熃鞐愳劀鞚� 甓岆Μ霃� 韽暔霅橂┌, 鞚搓吵鞐愳劀電� 韮�靷� 鞙犿喌鞐呾泊毳� 韱淀暣 鞙岇庐鞙茧 韺愲Г霅╇媹雼�. 鞚错啢鞚赌 韮�靷皜 鞙犽熃 靸侅毄頇旊ゼ 甏�毽晿電� 霃欖晥 鞝滍拡 瓿店笁鞚� 瓿勳啀頃� 瓴冹瀰雼堧嫟. 鞀ろ嫲韼犾澏� 瓯半灅鞐� 雽�頃� 霃呾爯 鞛 瓿犽鞙茧 頇滊彊頄堨姷雼堧嫟.
Eton Pharmaceuticals (NASDAQ: ETON) a annonc茅 l'acquisition de Galzin庐 (ac茅tate de zinc), un traitement d'entretien approuv茅 par la FDA pour la maladie de Wilson. Ce m茅dicament cible une population de patients ultra-rare, avec moins de 5 000 patients actuellement trait茅s aux 脡tats-Unis.
La soci茅t茅 pr茅voit de commencer la commercialisation aux 脡tats-Unis au premier trimestre 2025 via sa force de vente m茅tabolique. Les patients auront acc猫s au programme d'assistance Eton Cares, offrant un copaiement de 0 $ pour les patients commerciaux qualifi茅s, le remplissage des prescriptions, l'enqu锚te sur les avantages d'assurance et le soutien 茅ducatif.
L'acquisition comprend 茅galement les droits europ茅ens sur le produit, o霉 il est commercialis茅 sous le nom de Wilzin庐 par l'interm茅diaire d'un distributeur tiers. Eton continuera 脿 fournir le produit tandis que le tiers g茅rera la commercialisation europ茅enne. Stifel a agi en tant que conseiller financier exclusif pour la transaction.
Eton Pharmaceuticals (NASDAQ: ETON) hat die 脺bernahme von Galzin庐 (Zinkacetat) bekannt gegeben, einer von der FDA zugelassenen Erhaltungsbehandlung f眉r die Wilson-Krankheit. Das Medikament richtet sich an eine ultra-seltene Patientengruppe mit weniger als 5.000 Patienten, die derzeit in den USA behandelt werden.
Das Unternehmen plant, im ersten Quartal 2025 mit der Kommerzialisierung in den USA 眉ber seine metabolische Vertriebsmannschaft zu beginnen. Patienten haben Zugang zum Eton Cares Unterst眉tzungsprogramm, das eine Zuzahlung von $0 f眉r qualifizierte kommerzielle Patienten sowie Rezeptausf眉llung, Untersuchung von Versicherungsleistungen und Bildungsunterst眉tzung anbietet.
Die 脺bernahme umfasst auch die europ盲ischen Rechte an dem Produkt, wo es als Wilzin庐 眉ber einen Drittanbieter vertrieben wird. Eton wird weiterhin das Produkt liefern, w盲hrend der Drittanbieter die europ盲ische Kommerzialisierung verwaltet. Stifel fungierte als exklusiver Finanzberater f眉r die Transaktion.
- Acquisition expands rare disease portfolio with FDA-approved treatment
- Access to market of ~5,000 Wilson Disease patients in the US
- European market access through existing distribution agreement
- Revenue potential through comprehensive patient support program with $0 copay
- Product requires careful monitoring due to potential copper deficiency risks
- Post-marketing reports indicate risk of gastric ulcers with long-term use
- patient population may restrict revenue potential
Insights
- Adds an additional commercial and strategic rare disease product to Eton鈥檚 portfolio
- Galzin is FDA-approved for the treatment of the ultra-rare metabolic condition of Wilson Disease
DEER PARK, Ill., Jan. 03, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (鈥淓ton鈥� or the 鈥淐ompany鈥�) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has acquired Galzin庐 (zinc acetate).
鈥淭his acquisition furthers our mission of supporting life-saving treatments for conditions impacting ultra rare patient populations. Galzin is a critical medication for patients with Wilson Disease, and we look forward to supporting these patients with our comprehensive Eton Cares patient support program,鈥� said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
Galzin is FDA-approved as a maintenance treatment of patients with Wilson Disease who have been initially treated with a chelating agent. It is estimated that less than 5,000 patients in the United States are currently being treated for Wilson Disease.
Eton expects to assume the commercialization of the product in the United States in the first quarter of 2025 with its metabolic sales force supporting healthcare professionals who treat Wilson Disease. Once available, Eton plans to offer the product through its Eton Cares patient support program that provides high-touch, personalized service tailored for rare disease patients and their providers. The program will offer a
As part of the transaction, Eton has also acquired European rights to the product, where it is commercialized under the tradename Wilzin庐 by a third party. Under an existing distribution agreement, Eton will continue to supply the product to the third party and the third party is responsible for all commercialization activities in Europe.
Stifel served as exclusive financial advisor to Eton on the transaction.
INDICATION AND IMPORTANT SAFETY INFORMATION鈥�听
IMPORTANT SAFETY INFORMATION鈥�听
INDICATION鈥�
Zinc acetate therapy is indicated for maintenance treatment of patients with Wilson鈥檚 disease who have been initially treated with a chelating agent听听
Warning and Precautions鈥�听
- Copper Deficiency: Several post-marketing cases reported that zinc acetate taken over extended periods of time (i.e., months to years) may result in decreased enteral copper absorption and copper deficiency. The cases reported the following complications of copper deficiency: anemia, granulocytopenia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and myeloneuropathy.
If a patient develops signs and/or symptoms of copper deficiency during treatment with zinc acetate, interrupt zinc treatment and measure zinc, 24-hr urinary copper, and non-ceruloplasmin bound copper (NCC) levels. Consider restarting zinc acetate treatment based on periodic monitoring of 24-hr urinary copper and NCC levels.鈥�
- Gastric Ulcer: There have been postmarketing reports of gastric ulcers with long-term use of zinc acetate. The cases reported the complications of anemia and gastric ulcer perforation with peritonitis. In some cases, ulcers persisted after treatment until zinc acetate was discontinued.
If a patient develops signs and/or symptoms of gastric ulcer during treatment with zinc acetate, discontinue zinc treatment. Most patients showed improvement after cessation of zinc treatment.听听
- General: Zinc acetate is not recommended for the initial therapy of symptomatic patients because of the delay required for zinc-induced increase in enterocytic metallothionein and blockade of copper uptake. Symptomatic patients should be treated initially, using chelating agents. During initial therapy, neurological deterioration may occur as stores of copper are mobilized. Once initial therapy has been completed, and the patient is clinically stable, maintenance treatment with zinc acetate can be considered, but patients may be continued on initial therapy as clinically indicated.听
- Information for Patients: Patients should take GALZIN庐 on an empty stomach, at least one hour before or two to three hours after meals. Capsules should be swallowed whole, not opened or chewed. In the rare event of gastric intolerance of zinc, generally occurring with the morning dose, this dose may be taken between breakfast and lunch. Patients must be clinically monitored to determine the adequacy of zinc acetate therapy. Since strict adherence to the zinc regimen is essential for optimal control of copper distribution and metabolism, the physician must reinforce the need for compliance at each contact with the patient.鈥�
- Monitoring Patients: Patients should be monitored primarily by assessment of existing signs and symptoms of Wilson鈥檚 disease and 24-hour urine copper. Neuropsychiatric evaluations including speech as well as liver function tests including bilirubin and aminotransferases, should be done as appropriate.听
Adverse Reactions鈥�
The following adverse reactions associated with the use of zinc acetate were identified from postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.听听
Gastrointestinal disorders: gastric irritation听
Investigations: elevations of serum alkaline phosphatase, amylase, and lipase lasting from weeks to months suggesting pancreatitis; the levels usually return to high normal within the first one or two years of zinc therapy.鈥�
Please see for more information.鈥��
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庐, ALKINDI SPRINKLE庐, PKU GOLIKE庐, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: ET-400, ET-600, Amglidia庐, and ZENEO庐 hydrocortisone autoinjector. For more information, please visit our website at .
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are 鈥渇orward-looking statements鈥� 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鈥檚 business strategy, Eton鈥檚 plans to develop and commercialize its product candidates, the safety and efficacy of Eton鈥檚 product candidates, Eton鈥檚 plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton鈥檚 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 鈥渂elieves,鈥� 鈥渁nticipates,鈥� 鈥減lans,鈥� 鈥渆xpects,鈥� 鈥渋ntends,鈥� 鈥渨ill,鈥� 鈥済oal,鈥� 鈥減otential鈥� and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton鈥檚 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鈥檚 development programs and financial position are described in additional detail in Eton鈥檚 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:
FAQ
What is the purpose of Eton Pharmaceuticals' acquisition of Galzin?
How many patients will ETON's Galzin potentially serve in the US market?
What benefits does ETON's patient support program offer for Galzin users?
What are the major safety concerns associated with ETON's Galzin treatment?
How will ETON handle Galzin's European distribution?
