Lipocine Announces License and Supply Agreement for TLANDO® in Brazil
Lipocine Inc. (NASDAQ: LPCN) has secured a license and supply agreement with Aché Laboratórios Farmacêuitcos for TLANDO® in Brazil. The agreement grants Aché exclusive marketing rights in Brazil, where the prescription testosterone market has shown impressive growth with a 34% CAGR from 2019 to 2023. Notably, Brazil currently has no registered oral testosterone therapy.
The deal includes an upfront payment to Lipocine, with potential additional regulatory milestone payments and royalties on net sales. Aché will handle regulatory submission and approval processes in Brazil. This partnership leverages Aché's established commercial presence and regulatory expertise in the Brazilian pharmaceutical market.
Lipocine Inc. (NASDAQ: LPCN) ha siglato un accordo di licenza e fornitura con Aché Laboratórios Farmacêuticos per TLANDO® in Brasile. L'accordo concede ad Aché i diritti esclusivi di commercializzazione in Brasile, dove il mercato del testosterone su prescrizione ha registrato una crescita impressionante con un CAGR del 34% dal 2019 al 2023. È importante sottolineare che attualmente in Brasile non esistono terapie orali a base di testosterone registrate.
L'accordo prevede un pagamento iniziale a Lipocine, con possibili ulteriori pagamenti legati a traguardi regolatori e royalties sulle vendite nette. Aché si occuperà delle procedure di sottomissione e approvazione regolatoria in Brasile. Questa collaborazione sfrutta la presenza commerciale consolidata di Aché e la sua esperienza regolatoria nel mercato farmaceutico brasiliano.
Lipocine Inc. (NASDAQ: LPCN) ha asegurado un acuerdo de licencia y suministro con Aché Laboratórios Farmacêuticos para TLANDO® en Brasil. El acuerdo otorga a Aché derechos exclusivos de comercialización en Brasil, donde el mercado de testosterona con receta ha mostrado un crecimiento impresionante con un CAGR del 34% de 2019 a 2023. Cabe destacar que actualmente no existe ninguna terapia oral de testosterona registrada en Brasil.
El acuerdo incluye un pago inicial a Lipocine, con posibles pagos adicionales por hitos regulatorios y regalías sobre las ventas netas. Aché se encargará de los procesos de presentación y aprobación regulatoria en Brasil. Esta asociación aprovecha la presencia comercial establecida de Aché y su experiencia regulatoria en el mercado farmacéutico brasileño.
Lipocine Inc. (NASDAQ: LPCN)는 브라질에서 TLANDO®에 대한 라이선스 및 공급 계약을 Aché Laboratórios Farmacêuticos와 체결했습니다. 이 계약은 브라질에서 Aché에 독점 마케팅 권리를 부여하며, 해당 국가의 처방용 테스토스테론 시장은 2019년부터 2023년까지 연평균 성장률 34%라는 인상적인 성장을 보였습니다. 특히 브라질에는 현재 등록된 경구용 테스토스테론 치료제가 없습니다.
이번 계약에는 Lipocine에 대한 선급금이 포함되며, 추가적인 규제 마일스톤 지급 및 순매출에 대한 로열티도 발생할 수 있습니다. Aché는 브라질 내 규제 제출 및 승인 절차를 담당합니다. 이번 파트너십은 브라질 제약 시장에서 Aché의 확립된 상업적 입지와 규제 전문성을 활용합니다.
Lipocine Inc. (NASDAQ : LPCN) a conclu un accord de licence et de fourniture avec Aché Laboratórios Farmacêuticos pour TLANDO® au Brésil. Cet accord accorde à Aché les droits exclusifs de commercialisation au Brésil, où le marché des testostérones sur ordonnance a connu une croissance impressionnante avec un TCAC de 34 % entre 2019 et 2023. Il est à noter qu'il n'existe actuellement aucune thérapie orale à base de testostérone enregistrée au Brésil.
L'accord comprend un paiement initial à Lipocine, ainsi que des paiements supplémentaires potentiels liés à des étapes réglementaires et des redevances sur les ventes nettes. Aché prendra en charge les démarches de soumission et d'approbation réglementaire au Brésil. Ce partenariat tire parti de la présence commerciale établie d'Aché et de son expertise réglementaire sur le marché pharmaceutique brésilien.
Lipocine Inc. (NASDAQ: LPCN) hat einen Lizenz- und Liefervertrag mit Aché Laboratórios Farmacêuticos für TLANDO® in Brasilien abgeschlossen. Der Vertrag gewährt Aché exklusive Vermarktungsrechte in Brasilien, wo der verschreibungspflichtige Testosteronmarkt von 2019 bis 2023 ein beeindruckendes Wachstum mit einer jährlichen Wachstumsrate (CAGR) von 34% verzeichnet hat. Bemerkenswert ist, dass es in Brasilien derzeit keine zugelassene orale Testosterontherapie gibt.
Der Vertrag beinhaltet eine Vorauszahlung an Lipocine sowie mögliche zusätzliche Zahlungen bei regulatorischen Meilensteinen und Lizenzgebühren auf den Nettoumsatz. Aché wird die regulatorischen Einreichungs- und Zulassungsverfahren in Brasilien übernehmen. Diese Partnerschaft nutzt die etablierte kommerzielle Präsenz und regulatorische Expertise von Aché auf dem brasilianischen Pharmamarkt.
- Entry into Brazil's rapidly growing testosterone market (34% CAGR 2019-2023)
- First-mover advantage as no oral testosterone therapy is currently registered in Brazil
- Agreement includes upfront payment, milestone payments, and royalties on sales
- Partnership with an established leader in Brazilian pharmaceutical market
- Regulatory approval timeline and success in Brazil remains uncertain
- Exact financial terms of the agreement not disclosed
The market for prescription testosterone products in
"We are pleased to partner with Aché, one of the leaders in the Brazilian pharmaceutical market, to further expand the opportunity for TLANDO," said Mahesh Patel, CEO of Lipocine. "
Under the terms of the agreement, Lipocine has received an upfront payment and is eligible to receive additional payments upon the achievement of certain regulatory milestones and royalties on net sales. Aché assumes full responsibility for the regulatory submission and approval process in
About TLANDO®
TLANDO is approved by the US FDA as a testosterone replacement therapy (TRT) in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). It was developed using Lipocine's proprietary Lip'ral drug delivery technology platform.
For full prescribing information, please visit www.TLANDO.com.
About Aché
Aché is a Brazilian pharmaceutical company founded nearly 60 years ago with a mission to improve people's lives. A leader in the prescription market in
Aché is recognized as a top-of-mind company and a brand of choice among Brazilian healthcare professionals, with over 350 brands and 900 drug presentations across more than 150 therapeutic categories and 30 medical specialties. Today, Aché's products reach more than 20 countries across
https://www.ache.com.br/en/about-us/
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs.
Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit www.lipocine.com.
Forward-Looking Statements
This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our P3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, potential partnering of our product candidates with third parties, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.
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SOURCE Lipocine Inc.
FAQ
What is the growth rate of the testosterone market in Brazil where LPCN's TLANDO will be marketed?
What are the key terms of Lipocine's (LPCN) license agreement with Aché for TLANDO?
Are there any other oral testosterone therapies available in Brazil?
Who is Lipocine's partner for TLANDO distribution in Brazil?
