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.
In 2017, Idorsia and Johnson & Johnson Innovative Medicine (formerly Actelion Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson) entered into a revenue-sharing agreement in respect of ponesimod.Show more
In 2021, ponesimod was approved and subsequently launched in the US, Europe, and Canada to treat patients with relapsing forms of multiple sclerosis. Under the terms of the revenue-sharing agreement, Idorsia is entitled to receive quarterly payments of 8% of the net sales of ponesimod products from Actelion Pharmaceuticals Ltd. For an amendment to this agreement, see the related update in the collaboration agreement with Janssen Biotech, Inc.Show less
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 December 2022, the new drug application was submitted to the US FDA for the treatment of patients with difficult-to-control hypertension. In January 2023, the marketing authorisation application was submitted to the EMA for the treatment of patients with resistant hypertension.
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.Show more
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.
The agreement also eliminates the revenue-sharing agreement in respect of ponesimod.Show less
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.Show more
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.Show less
In 2020, Idorsia entered into a global license agreement with Neurocrine Biosciences for the development and commercialization of ACT-709478 (NBI-827104), Idorsia’s potent, selective, orally active and brain-penetrating T-type calcium channel blocker. ACT-709478 is investigated in a Phase 2 open label extension (OLE) study for the treatment of pediatric patients with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (CSCW), a rare form of pediatric epilepsy. In 2022, Neurocrine announced that the blinded-study in CSWS did not meet the primary endpoint and that ACT-709478 was generally well tolerated. Neurocrine continues to analyze the totality of data coming from the OLE study to determine next steps.Show more
In May 2020, Neurocrine exercised an option to license ACT-709478 triggering an upfront payment of $45 million (in addition to the $5 million upfront fee for the option rights which was paid in 2019).
The agreement is subject to the following terms:
- Milestones: In addition to the up-front payment, Idorsia may also receive up to $365 million in additional development and regulatory milestone payments. Furthermore, Idorsia may also be entitled to one-time commercial payments based on sales thresholds.
- Royalties: Idorsia will have the right to receive a tiered royalty ranging from the low double-digits to upper teen percentage in the US and a tiered royalty at slightly lower rates outside the US based upon aggregate global net sales.
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.Show more
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.Show less
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.Show more
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.Show less
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.Show more
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.Show less
In 2023, Idorsia sold its Asia Pacific (ex-China) operations – including select license rights to products – to Sosei Heptares for a total consideration of CHF 400 million.Show more
The transaction includes the acquisition by Sosei Heptares 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 Sosei Heptares – 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 Sosei Heptares. In addition, there are transition service agreements (TSA) between Idorsia and Sosei Heptares mainly for regulatory/filing activities, clinical development, CMC (Chemistry, Manufacturing and Controls), and IT.
Idorsia has granted Sosei Heptares 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 Sosei Heptares as a preferred partner.
Territory: Australia, Brunei, Cambodia, Indonesia, Japan, Laos, Malaysia, Myanmar, New Zealand, Philippines, Singapore, South Korea, Thailand, Taiwan, and Vietnam.Show less