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Radius Pharmaceuticals Expands Abaloparatide Licensing Agreement with Theramex Granting Additional Commercialization Rights Including Mexico, Canada, South Africa, Israel, and Russia

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Radius Pharmaceuticals has expanded its licensing agreement with Theramex for ELADYNOS® (abaloparatide), granting exclusive commercialization rights in Mexico, Canada, Israel, South Africa, and Russia. The agreement includes an upfront payment, milestone payments, and tiered royalties.

ELADYNOS®, marketed as TYMLOS® in the U.S., is a novel bone-forming agent for treating osteoporosis in postmenopausal women and men at increased fracture risk. Theramex will maintain exclusive commercialization rights in the European Economic Area, United Kingdom, Australia, and Brazil, where the product received approval in December 2022 and November 2024 respectively.

Radius Pharmaceuticals ha ampliato il suo accordo di licenza con Theramex per ELADYNOS® (abaloparatide), concedendo diritti esclusivi di commercializzazione in Messico, Canada, Israele, Sudafrica e Russia. L'accordo include un pagamento iniziale, pagamenti legati a traguardi e royalties a livelli.

ELADYNOS®, commercializzato come TYMLOS® negli Stati Uniti, è un nuovo agente per la formazione ossea per il trattamento dell'osteoporosi in donne in menopausa e uomini a rischio aumentato di fratture. Theramex manterrà i diritti esclusivi di commercializzazione nell'Area Economica Europea, nel Regno Unito, in Australia e in Brasile, dove il prodotto ha ottenuto l'approvazione a dicembre 2022 e novembre 2024 rispettivamente.

Radius Pharmaceuticals ha expandido su acuerdo de licencia con Theramex para ELADYNOS® (abaloparatide), otorgando derechos exclusivos de comercialización en México, Canadá, Israel, Sudáfrica y Rusia. El acuerdo incluye un pago inicial, pagos por hitos y regalías escalonadas.

ELADYNOS®, comercializado como TYMLOS® en EE. UU., es un nuevo agente formador de hueso para tratar la osteoporosis en mujeres posmenopáusicas y hombres con mayor riesgo de fracturas. Theramex mantendrá los derechos exclusivos de comercialización en el Espacio Económico Europeo, Reino Unido, Australia y Brasil, donde el producto recibió aprobación en diciembre de 2022 y noviembre de 2024 respectivamente.

Radius PharmaceuticalsTheramex와의 라이센스 계약을 확대하여 ELADYNOS® (abaloparatide)의 독점 상용화 권리를 멕시코, 캐나다, 이스라엘, 남아프리카, 러시아에 부여했습니다. 이 계약에는 선불금, 이정표 지급금 및 단계별 로열티가 포함됩니다.

ELADYNOS®는 미국에서 TYMLOS®로 판매되며, 폐경 후 여성과 골절 위험이 증가한 남성을 위한 새로운 뼈 형성 제제입니다. Theramex는 유럽 경제 지역, 영국, 호주 및 브라질에서 독점 상용화 권리를 유지하며, 해당 제품은 각각 2022년 12월 및 2024년 11월에 승인되었습니다.

Radius Pharmaceuticals a élargi son accord de licence avec Theramex pour ELADYNOS® (abaloparatide), accordant des droits exclusifs de commercialisation au Mexique, au Canada, en Israël, en Afrique du Sud et en Russie. L'accord comprend un paiement initial, des paiements liés à des étapes clés et des redevances échelonnées.

ELADYNOS®, commercialisé sous le nom de TYMLOS® aux États-Unis, est un nouvel agent formateur d'os pour traiter l'ostéoporose chez les femmes ménopausées et les hommes à risque accru de fractures. Theramex conservera les droits exclusifs de commercialisation dans l'Espace économique européen, au Royaume-Uni, en Australie et au Brésil, où le produit a été approuvé en décembre 2022 et novembre 2024 respectivement.

Radius Pharmaceuticals hat sein Lizenzabkommen mit Theramex für ELADYNOS® (abaloparatide) erweitert und exklusive Vermarktungsrechte in Mexiko, Kanada, Israel, Südafrika und Russland eingeräumt. Das Abkommen umfasst eine Vorauszahlung, Meilensteinzahlungen und gestaffelte Lizenzgebühren.

ELADYNOS®, in den USA als TYMLOS® vermarktet, ist ein neuartiger knochenbildender Wirkstoff zur Behandlung von Osteoporose bei postmenopausalen Frauen und Männern mit erhöhtem Frakturrisiko. Theramex wird die exklusiven Vermarktungsrechte im Europäischen Wirtschaftsraum, im Vereinigten Königreich, in Australien und in Brasilien behalten, wo das Produkt im Dezember 2022 und November 2024 rispettive genehmigt wurde.

Positive
  • Expansion of commercialization rights to additional major markets
  • Company to receive upfront payment, milestone payments, and tiered royalties
  • Recent regulatory approvals in European Economic Area (Dec 2022) and Australia (Nov 2024)
Negative
  • None.

Insights

The expanded licensing agreement represents a meaningful revenue opportunity for Radius Pharmaceuticals through upfront payments, milestone payments and tiered royalties. While specific financial terms weren't disclosed, the addition of major markets like Canada, Mexico and Russia significantly broadens the commercial potential for ELADYNOS®. The existing partnership has already yielded approvals in key regions including the EEA and Australia, demonstrating successful execution. This strategic expansion leverages Theramex's established commercial infrastructure to penetrate new markets efficiently, reducing Radius's operational costs while maintaining revenue streams. The deal structure with tiered royalties provides scalable upside as sales grow across territories.

The global expansion of ELADYNOS® (abaloparatide) access is significant for addressing the growing burden of osteoporosis worldwide. As a novel bone-forming agent, it offers an important treatment option for both postmenopausal women and men at high fracture risk. The drug's recent approvals in the EEA and Australia validate its clinical profile. The expansion into diverse markets like Israel, Russia and South Africa will help address unmet medical needs in regions with aging populations and high osteoporosis prevalence. Theramex's established presence in women's health makes them well-positioned to drive adoption in these new territories.

This geographic expansion significantly enhances ELADYNOS®'s global market potential. The newly added territories represent substantial markets, particularly Canada and Russia, with significant osteoporosis patient populations. The timing aligns well with recent regulatory approvals and ongoing launches in other regions, creating momentum for broader market penetration. Theramex's proven track record in women's health and existing commercial infrastructure in these regions should accelerate market access and adoption. The flexibility to expand into additional unpartnered regions provides further growth potential beyond the initially specified territories.

BOSTON, MA / ACCESSWIRE / December 9, 2024 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. ("Radius" or the "Company"), a specialty biopharmaceutical company focused on bone health and related areas, announced today it has granted Theramex the exclusive commercialization rights to ELADYNOS® (abaloparatide), a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, for Mexico, Canada, Israel, South Africa, and Russia. Theramex will also have the opportunity to commercialize ELADYNOS® in other agreed upon unpartnered regions. Abaloparatide is marketed in the U.S. by Radius under the tradename TYMLOS®.

Under the License Agreement, Radius will receive an upfront and milestone payment plus tiered royalties.

"Theramex has been an excellent collaborative partner, and we are very pleased to expand our abaloparatide partnership to include additional important global markets," said Scott Briggs, Chief Executive Officer of Radius. "Radius is committed to making abaloparatide accessible to patients, and the expansion of our existing partnership helps provide access to additional patients in need of osteoporosis treatment options."

"Following the launch of abaloparatide in Europe, we are excited to bring this innovative product to more patients globally and drive further growth through our direct markets and our commercial partnerships. This agreement expands our successful relationship with Radius, and we look forward to continuing our close collaboration," said Rob Stewart, Chief Executive Officer of Theramex.

In addition to these new territories, Theramex will continue to commercialize and distribute ELADYNOS® on an exclusive basis in the European Economic Area, the United Kingdom, Australia, and Brazil. ELADYNOS® received approval in the European Economic Area in December 2022 and Australia in November 2024 and has been launched in select countries.

About Radius:

Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also has an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company's presence in bone health.

About Theramex:

Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women at different stages of their lives by providing a broad portfolio of innovative and established brands covering osteoporosis, contraception, fertility, menopause and uterine health. Theramex's commitment is to listen to and understand its patients, serve their needs and offer healthcare solutions to help improve their lives. Theramex's vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through different stages of their life.

Contacts:
Al Medwar: Senior Vice President, Business and Corporate Development, Radius
Email: CorporateCommunications@radiuspharm.com

Edward Rees: Chief Corporate Development Officer, Theramex
Email: to BusinessDevelopment@theramex.com

SOURCE: Radius Health



View the original press release on accesswire.com

FAQ

What new markets did Radius Pharmaceuticals (RDUS) add to its Theramex licensing agreement for ELADYNOS?

Radius Pharmaceuticals added Mexico, Canada, Israel, South Africa, and Russia to its Theramex licensing agreement for ELADYNOS.

When did ELADYNOS receive approval in Australia and the European Economic Area?

ELADYNOS received approval in the European Economic Area in December 2022 and in Australia in November 2024.

What are the financial terms of Radius Pharmaceuticals' (RDUS) expanded licensing agreement with Theramex?

The licensing agreement includes an upfront payment, milestone payments, and tiered royalties, though specific amounts were not disclosed.

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