Lipocine Announces Supply and Distribution Agreement with Pharmalink to Commercialize TLANDO® in the Gulf Cooperation Council (GCC) Countries
Lipocine Inc. (NASDAQ: LPCN) has announced an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO®, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries. The agreement covers Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, and Oman.
Under the terms of the agreement, Lipocine received an upfront payment from Pharmalink. Upon obtaining Marketing Authorizations in individual GCC countries, Lipocine will provide TLANDO drug product to Pharmalink at an agreed transfer price. Pharmalink will have exclusive rights to TLANDO in the GCC region and will be responsible for promotion, distribution, and sale of the product in the territory.
This partnership aligns with Lipocine's global strategy to expand the availability of TLANDO and make it broadly accessible. Pharmalink's expertise and established network in the GCC region make them an ideal partner to support the adoption and growth of TLANDO in these markets.
Lipocine Inc. (NASDAQ: LPCN) ha annunciato un accordo esclusivo di fornitura e distribuzione con Pharmalink per commercializzare TLANDO®, la sua terapia di sostituzione della testosterone orale, nei paesi del Consiglio di Cooperazione del Golfo (GCC). L'accordo riguarda Arabia Saudita, Kuwait, Emirati Arabi Uniti, Qatar, Bahrain e Oman.
Secondo i termini dell'accordo, Lipocine ha ricevuto un pagamento anticipato da Pharmalink. Una volta ottenute le autorizzazioni di commercializzazione nei singoli paesi del GCC, Lipocine fornirà il prodotto farmaceutico TLANDO a Pharmalink a un prezzo di trasferimento concordato. Pharmalink avrà diritti esclusivi su TLANDO nella regione GCC e sarà responsabile della promozione, distribuzione e vendita del prodotto nel territorio.
Questa partnership si allinea con la strategia globale di Lipocine per espandere la disponibilità di TLANDO e renderla ampiamente accessibile. L'expertise di Pharmalink e la sua rete consolidata nella regione GCC li rendono partner ideali per sostenere l'adozione e la crescita di TLANDO in questi mercati.
Lipocine Inc. (NASDAQ: LPCN) ha anunciado un acuerdo exclusivo de suministro y distribución con Pharmalink para comercializar TLANDO®, su terapia de reemplazo de testosterona oral, en los países del Consejo de Cooperación del Golfo (CCG). El acuerdo abarca Arabia Saudita, Kuwait, Emiratos Árabes Unidos, Qatar, Baréin y Omán.
Según los términos del acuerdo, Lipocine recibió un pago por adelantado de Pharmalink. Tras obtener las autorizaciones de comercialización en los países individuales del CCG, Lipocine suministrará el producto farmacéutico TLANDO a Pharmalink a un precio de transferencia acordado. Pharmalink tendrá derechos exclusivos sobre TLANDO en la región del CCG y será responsable de la promoción, distribución y venta del producto en el territorio.
Esta asociación se alinea con la estrategia global de Lipocine para expandir la disponibilidad de TLANDO y hacerla ampliamente accesible. La experiencia de Pharmalink y su red establecida en la región del CCG los convierten en un socio ideal para apoyar la adopción y el crecimiento de TLANDO en estos mercados.
리포신 Inc. (NASDAQ: LPCN)는 팔마링크와 독점 공급 및 배급 계약을 체결하여 TLANDO®, 구강용 테스토스테론 대체 치료제를 걸프 협력 회의(GCC) 회원국에서 상업화한다고 발표했습니다. 이 계약은 사우디아라비아, 쿠웨이트, 아랍에미리트, 카타르, 바레인, 오만을 포함합니다.
계약 조건에 따라, 리포신은 팔마링크로부터 선불금을 수령했습니다. 각 GCC 국가에서 마케팅 허가를 받는 대로, 리포신은 합의된 전송 가격으로 팔마링크에 TLANDO 의약품을 공급할 것입니다. 팔마링크는 GCC 지역에서 TLANDO에 대한 독점 권리를 가지며, 해당 지역 내에서 제품의 홍보, 유통 및 판매를 담당하게 됩니다.
이 파트너십은 TLANDO의 가용성을 확장하고 폭넓은 접근을 가능하게 하는 리포신의 글로벌 전략과 일치합니다. 팔마링크의 전문성과 GCC 지역에서의 확립된 네트워크는 이러한 시장에서 TLANDO의 채택과 성장을 지원하는 이상적인 파트너로 그들을 만들어 줍니다.
Lipocine Inc. (NASDAQ: LPCN) a annoncé un accord exclusif de fourniture et de distribution avec Pharmalink pour commercialiser TLANDO®, sa thérapie de remplacement de la testostérone orale, dans les pays du Conseil de coopération du Golfe (CCG). L'accord concerne l'Arabie saoudite, le Koweït, les Émirats arabes unis, le Qatar, Bahreïn et Oman.
En vertu des termes de l'accord, Lipocine a reçu un paiement initial de Pharmalink. Après avoir obtenu les autorisations de commercialisation dans les pays du CCG, Lipocine fournira le produit pharmaceutique TLANDO à Pharmalink à un prix de transfert convenu. Pharmalink aura des droits exclusifs sur TLANDO dans la région du CCG et sera responsable de la promotion, de la distribution et de la vente du produit sur le territoire.
Ce partenariat s'inscrit dans la stratégie mondiale de Lipocine pour élargir la disponibilité de TLANDO et le rendre largement accessible. L'expertise de Pharmalink et son réseau établi dans la région du CCG en font un partenaire idéal pour soutenir l'adoption et la croissance de TLANDO dans ces marchés.
Lipocine Inc. (NASDAQ: LPCN) hat eine exklusive Liefer- und Vertriebsvereinbarung mit Pharmalink veröffentlicht, um TLANDO®, seine orale Testosteron-Ersatztherapie, in den Ländern des Golf-Kooperationsrates (GCC) zu vermarkten. Die Vereinbarung umfasst Saudi-Arabien, Kuwait, die Vereinigten Arabischen Emirate, Katar, Bahrain und Oman.
Gemäß den Bedingungen der Vereinbarung erhielt Lipocine eine Vorauszahlung von Pharmalink. Nach Erhalt der Marktzulassungen in den einzelnen GCC-Ländern wird Lipocine das Arzneimittel TLANDO zu einem vereinbarten Transferpreis an Pharmalink liefern. Pharmalink wird exklusive Rechte an TLANDO in der GCC-Region haben und für die Förderung, Verteilung und den Verkauf des Produkts im Gebiet verantwortlich sein.
Diese Partnerschaft entspricht Lipocines globaler Strategie, die Verfügbarkeit von TLANDO zu erweitern und es weitreichend zugänglich zu machen. Das Fachwissen und das etablierte Netzwerk von Pharmalink in der GCC-Region machen sie zu einem idealen Partner zur Unterstützung der Annahme und des Wachstums von TLANDO in diesen Märkten.
- Exclusive supply and distribution agreement for TLANDO in GCC countries
- Upfront payment received from Pharmalink
- Potential for additional revenue through agreed transfer price for TLANDO drug product
- Expansion of TLANDO's market reach into new territories
- None.
Insights
This supply and distribution agreement with Pharmalink is a positive development for Lipocine, expanding TLANDO's market reach into the Gulf Cooperation Council countries. The deal includes an upfront payment, which provides immediate cash flow and a transfer pricing arrangement for future drug product supply. This structure offers Lipocine a balanced mix of near-term revenue and long-term commercial potential.
The GCC market, with its high-income countries and growing healthcare sector, presents a valuable opportunity for TLANDO. However, it's important to note that the agreement's full financial impact depends on obtaining Marketing Authorizations in individual GCC countries, which introduces some uncertainty to the timeline and potential returns.
For a company with a market cap of
The partnership with Pharmalink is strategically sound for Lipocine, aligning with global expansion goals for TLANDO. The GCC region represents a lucrative market for pharmaceutical products, characterized by high healthcare spending and a growing awareness of men's health issues.
Key advantages of this deal include:
- Leveraging Pharmalink's established network and expertise in the GCC
- Potential for increased market share in a region with rising demand for testosterone replacement therapies
- Diversification of revenue streams across multiple countries
However, challenges may include navigating different regulatory environments across the GCC and potential competition from established products. The success of this venture will largely depend on Pharmalink's ability to effectively promote and distribute TLANDO in these markets. Investors should view this as a long-term growth opportunity rather than an immediate revenue booster.
Under the terms of the agreement, Lipocine received an upfront payment from Pharmalink and, upon Marketing Authorizations (MA) in individual GCC countries, Lipocine will provide TLANDO drug product to Pharmalink at an agreed transfer price. Pharmalink will have the exclusive rights to TLANDO throughout the GCC region and will be responsible for promotion, distribution and sale of the product in the territory.
"We are very pleased to partner with Pharmalink to bring TLANDO to the GCC region," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "This agreement is aligned with our global strategy to expand the availability of TLANDO and make it broadly accessible. Pharmalink's expertise and established network in GCC make them an ideal partner to support the adoption and growth of TLANDO in the region."
About TLANDO
TLANDO is approved in
For full prescribing information, please visit www.TLANDO.com.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. 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, comprised of an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics as an aid for improved body composition in chronic weight 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 chronic weight management, LPCN 1148 for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. 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 development efforts, our strategic plans for developing products, our ability to monetize product candidates, including through entering into partnering arrangements, our product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, 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, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-supply-and-distribution-agreement-with-pharmalink-to-commercialize-tlando-in-the-gulf-cooperation-council-gcc-countries-302269378.html
SOURCE Lipocine Inc.
FAQ
What is the purpose of Lipocine's agreement with Pharmalink for TLANDO?
What are the key terms of the supply and distribution agreement between Lipocine (LPCN) and Pharmalink?
How does the Pharmalink agreement align with Lipocine's (LPCN) global strategy?
When was the supply and distribution agreement for TLANDO announced by Lipocine (LPCN)?
