For Idorsia, sophisticated partnerships are a way of gaining strategic access to technologies or products and fully exploiting our discovery engine and clinical pipeline. In general, we seek suitable external project partners to maximize the value of internal innovation.
Partnerships
More potential –
Maximizing
the value of
innovation
“We team up with partners who share our enthusiasm for science, and a commitment to bringing innovative solutions to patients.”
— André C. Muller, CEO
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In 2017, Idorsia entered into a collaboration agreement with Johnson & Johnson Innovative Medicine (formerly Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson) to jointly develop aprocitentan and any of its derivative compounds or products. Janssen Biotech had sole commercialization rights worldwide. In May 2022, Idorsia announced positive results of the Phase 3 PRECISION study investigating aprocitentan. In March 2024, the US FDA approved TRYVIO™ (aprocitentan), the first and only endothelin receptor antagonist for the treatment of high blood pressure not adequately controlled in combination with other antihypertensives. In April 2024, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), adopted a positive opinion for the use of JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.
Idorsia received a one-time milestone payment of USD 230 million. The costs of the Phase 3 study were shared equally between both partners. In September 2023, Idorsia and Janssen entered into an amended and restated collaboration agreement whereby Idorsia will reacquire the development and commercialization rights for aprocitentan from Janssen.
In return, Idorsia will pay Janssen a conditional consideration up to a total cap of CHF 306 million, depending on Idorsia’s revenues, as follows:
- 30% of any consideration received by Idorsia from a potential out-licensing or divestment of aprocitentan,
- 10% of any consideration received by Idorsia from a potential out-licensing or the divestment of any other Idorsia product, following the first approval of aprocitentan, and
- low- to mid-single digit royalties on total group product net sales, beginning from the quarter after first aprocitentan approval.
Janssen funding obligations to aprocitentan cease at the effective date of the agreement. Janssen licenses to aprocitentan IP (excluding pulmonary hypertension) will terminate and Janssen will transfer the brand name and relating commercial materials to Idorsia. Janssen will retain licenses in the pulmonary hypertension field.
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In 2019, Idorsia entered into a global agreement with Halozyme to develop a novel drug-device product combining selatogrel – Idorsia’s potent, fast-acting, reversible and highly selective P2Y12 inhibitor – with Halozyme's subcutaneous QuickShot® auto-injector. In 2021, Idorsia initiated the Phase 3 study SOS-AMI with the selatogrel drug-device for the treatment of suspected acute myocardial infarction.
With almost 20 years of experience, Halozyme has a proven track record in developing and commercializing complex drug device products that are tailored to the patient and the therapeutic need.
Idorsia will pay for the development of the drug device product and will be responsible for applying for and obtaining global regulatory approvals for the product.
The parties intend to enter into a separate commercial license and supply agreement pursuant to which Halozyme will provide fully assembled and labelled product to Idorsia at cost plus margin. Idorsia will then be responsible for global commercialization of the product, pending regulatory approval.
Halozyme will be entitled to receive royalties on net sales of the commercial product.
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In March 2024, Idorsia entered into agreements for a significant global research and development collaboration with Viatris Inc., a global healthcare company, for the global development and commercialization of two Phase 3 assets – selatogrel and cenerimod – for an upfront payment of USD 350 million, potential development and regulatory milestone payments, and certain contingent payments of additional sales milestone payments and tiered royalties from mid-single- to low double-digit percentage on annual net sales.
A joint development committee is overseeing the development of the ongoing Phase 3 programs for selatogrel and cenerimod through regulatory approval. Idorsia will contribute up to USD 200 million in the next 3 years, and transferred dedicated personnel to Viatris.
Viatris will have worldwide commercialization rights for both selatogrel and cenerimod (excluding, for cenerimod only, Japan, South Korea and certain countries in the Asia-Pacific region).
Idorsia has also granted Viatris a Right of First Refusal and First Negotiation for certain other pipeline assets.
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In 2020, Idorsia’s license, collaborative development and commercialization agreement with ReveraGen BioPharma in respect of vamorolone was transferred in its entirety to Santhera Pharmaceuticals, with the latter replacing Idorsia as a party to the agreement. Idorsia will be entitled to development and sales milestones, as well as low single-digit percentage payments on net sales of vamorolone.
As part of this transition, Santhera exercised the option to obtain the worldwide rights to vamorolone in Duchenne Muscular Dystrophy and all other indications from ReveraGen.
In exchange for the assignment and transfer of the agreement, Idorsia received 0.4 million shares of Santhera and an exchangeable note in the amount of CHF 10 million, which was redeemed against a payment in cash of CHF 3.5 million and 3.6 million shares in Santhera.
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In 2020, Idorsia and Syneos Health entered into an innovative commercial partnership to build the salesforce for the US launch of QUVIVIQ™ (daridorexant). In January 2022, Idorsia expanded this commercialization partnership to support the potential launch of QUVIVIQ and effectively reach the primary care market in Europe and Canada.
The strategic collaboration brings Idorsia’s lead investigational compound, daridorexant, and expertise in the science of the orexin system, together with Syneos Health’s robust customer-facing sales expertise and proven track record in launching new products.
Idorsia is building the core capabilities needed to successfully launch QUVIVIQ, while collaborating with Syneos Health in order to effectively reach the primary care market, which accounts for a large volume of insomnia prescriptions. Together the companies will collaborate to lead the transformation and modernization of the insomnia market.
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In 2022, Idorsia and Simcere entered into an exclusive licensing agreement for Idorsia’s daridorexant in China. Under the agreement, Simcere has an exclusive right to develop and commercialize daridorexant in the Greater China region (Mainland China, Hong Kong, and Macau), one of the world's largest pharmaceutical markets.
Simcere will be responsible for the local development program with Chinese patients. Simcere successfully commercializes Sanbexin for acute ischemic stroke and daridorexant will expand Simcere’s pipeline of Central Nervous System (CNS) products in China.
According to the terms of the agreement, Idorsia receives a US$ 30 million upfront payment, and will be eligible to receive an additional milestone payment of US$ 20 million upon regulatory approval by the National Medical Products Administration, as well as commercial milestone payments and low double-digit tiered royalties based upon future sales.
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In 2023, Idorsia sold its Asia Pacific (ex-China) operations – including select license rights to products – to Nxera Pharma (previously known as Sosei Heptares) for a total consideration of CHF 400 million.
The transaction includes the acquisition by Nxera Pharma of Idorsia’s affiliates in Japan and South Korea, the assignment of the license for PIVLAZ (clazosentan) for the territory, and a co-exclusive license for daridorexant for the territory and the assignment of all potential milestones in connection with the co-exclusive license of daridorexant granted to Mochida Pharmaceutical. The transaction also includes an option for Nxera Pharma – upon payment of separate option fees – to license cenerimod and lucerastat for the development and commercialization in the territory.
Idorsia supplies PIVLAZ and daridorexant to Nxera Pharma. In addition, there are transition service agreements (TSA) between Idorsia and Nxera Pharma mainly for regulatory/filing activities, clinical development, CMC (Chemistry, Manufacturing and Controls), and IT.
Idorsia has granted Nxera Pharma a right of first negotiation and right of first refusal on certain pipeline assets for the Territory showing a clear commitment from Idorsia to continue to work with Nxera Pharma as a preferred partner.
Territory: Australia, Brunei, Cambodia, Indonesia, Japan, Laos, Malaysia, Myanmar, New Zealand, Philippines, Singapore, South Korea, Thailand, Taiwan, and Vietnam.
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Owkin has a global license to develop and commercialize ACT-1002-4391, Idorsia’s novel, potent EP2/EP4 receptor antagonist with antitumor efficacy, to be used both as monotherapy and in combination with other oncology agents. The compound is in preparation for Phase 1 clinical pharmacology studies. Owkin will use its proprietary AI-based data-mining platform to generate clinical trial designs and to identify patients who may benefit from, and potential targets for, the compound.
