Maximize the value of innovation
Idorsia considers sophisticated partnerships to strategically access technologies or products, and to maximize the value of its discovery engine and clinical pipeline. In general, the purposes of our partnerships are to complement internal innovation with external projects, and to find suitable partners for maximizing the value of internal projects.
Collaboration Agreement with Janssen Biotech
On December 1, 2017, Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, entered into a collaboration agreement with Idorsia to jointly develop and commercialize aprocitentan and any of its derivative compounds or products.
Idorsia received a one-time milestone payment of USD 230 million. Both parties have joint development rights over aprocitentan. Idorsia will oversee the Phase 3 development and regulatory submission for the treatment of patients with hypertension that is not controlled by at least three therapies (called resistant hypertension in the medical community). The costs will be shared equally between both partners. Janssen will oversee the Phase 3 development and submission for any additional indications.
Revenue Sharing Agreement with Johnson & Johnson
Idorsia Pharmaceuticals Ltd, J&J and Actelion Pharmaceuticals Ltd have entered into the Revenue Sharing Agreement in respect to ponesimod. Under the terms of the Revenue Sharing Agreement, Idorsia Pharmaceuticals Ltd is entitled to receive quarterly payments of 8% of the net sales of ponesimod products from Actelion Pharmaceuticals Ltd.
Collaboration Agreements for vamorolone
Collaboration Agreement with ReveraGen
Idorsia Pharmaceuticals Ltd has a collaborative agreement with ReveraGen to research and co-develop vamorolone, a non-hormonal steroid modulator currently investigated for the treatment of Duchenne Muscular Dystrophy (DMD). Idorsia will be entitled to exercise an option to obtain the exclusive worldwide license rights on vamorolone at any time, but not later than upon receipt of the Phase 2b study results for a consideration of USD 20 million. If the option is exercised, ReveraGen will be entitled to receive regulatory and commercial milestone payments up to USD 75 million in the DMD indication and three new one-time sales milestone payments of up to USD 120 million. Furthermore, Idorsia has agreed to support R&D activities with up to a maximum amount of USD 1 million until mid-2020. ReveraGen will also be entitled to receive milestone payments for three additional indications up to USD 190 million. Idorsia will pay tiered single-digit to low double-digit royalties on the annual net sales of vamorolone.
Collaboration Agreement with Santhera
Idorsia Pharmaceuticals Ltd has entered into an agreement with Santhera Pharmaceuticals under which Idorsia will grant Santhera the option to obtain an exclusive sub-license for vamorolone in all indications and all territories except Japan and South Korea. Idorsia will receive as consideration for entering into the agreement 1,000,000 (one million) new registered shares from Santhera’s existing authorized share capital and an upfront cash component of USD 20 million, of which USD 15 million is intended to compensate Idorsia for its investment into the Phase 2b VISION-DMD study currently conducted by ReveraGen. While the cash component of the consideration is subject to financing, the share component of the consideration is unconditional and, like the cash component, not redeemable under any circumstances. As a consequence of the transaction, Idorsia will become the largest shareholder in Santhera with a 13.3% equity position. The shares to be issued to Idorsia will be subject to a lock-up undertaking expiring if and when vamorolone receives marketing authorization in DMD in the United States. Santhera may exercise the option upon receipt of data from the Phase 2b VISION-DMD study (VBP15-004) and following a one-time consideration to Idorsia of USD 30 million.
Following the exercise of the worldwide vamorolone license option by Idorsia and exercise of the vamorolone sub-license option for all territories worldwide except Japan and South Korea by Santhera, Santhera will pay to Idorsia regulatory and commercial milestone payments of up to USD 80 million in the DMD indication and four one-time sales milestone payments of up to USD 130 million in aggregate. Regulatory milestone payments by Santhera to Idorsia for three additional indications amount to up to USD 205 million in aggregate. Upon commercialization of vamorolone, Santhera has committed to pay tiered royalties ranging from a single-digit percentage to low double-digit percentage on the annual net sales of vamorolone to Idorsia.
Research collaboration with Roche
Idorsia has entered into a research collaboration that provides Roche with an exclusive option right to develop and market first-in-class compounds for a promising new approach in the field of cancer immunotherapy.
The parties will collaborate on the discovery of products through the formation of a joint committee, chaired by Idorsia.
Roche has paid Idorsia an upfront payment of CHF 15 million and has the option to exclusively license Idorsia compounds and compounds resulting from the collaboration, for a further payment of CHF 35 million, after a pre-determined period. After the exercise of its option right, Roche would have the exclusive worldwide right to develop and commercialize the Idorsia and collaboration compounds.
Idorsia will be eligible to receive one-time development and regulatory milestones of up to CHF 410 million. Idorsia will also be entitled to one-time milestones based on sales thresholds, as well as tiered royalties on annual net sales of all products resulting from the collaboration.
Equity stake in Vaxxilon AG
In 2015, Actelion established Vaxxilon as a new majority-owned company that aims to discover, develop and commercialize synthetic carbohydrate vaccines. Vaxxilon was incorporated under the laws of Switzerland together with the Max Planck Society, a publicly funded non-profit organization in Munich, Germany, and Seeberger Science GmbH, a private company in Kleinmachnow, Germany. Actelion was the principal investor and majority shareholder, holding a 73.9% equity stake of the company. Vaxxilon has licensed exclusive rights to multiple preclinical vaccine candidates and additional technologies from MPI.
The equity stake of 73.9% as well as all rights and obligations in connection with Vaxxilon were transferred to Idorsia. Consequently, Idorsia is committed to provide funding of up to the CHF equivalent of EUR 10 million to Vaxxilon, contingent upon successful completion of predefined clinical and development milestones, funding which will be released over an estimated period of two to three years.
Global agreement with Antares Pharma
Idorsia entered into a global agreement with Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) to develop a novel drug-device product combining selatogrel, Idorsia’s potent, fast-acting, reversible, and highly selective P2Y12 receptor antagonist with the Antares subcutaneous QuickShot® auto-injector.
With almost 20 years of experience, Antares 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 Antares 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.
Antares will be entitled to receive royalties on net sales of the commercial product.
License Agreement with Mochida
Idorsia and Mochida Pharmaceutical Co., Ltd. entered into an exclusive license agreement for the supply, co-development and co-marketing of daridorexant, Idorsia’s dual orexin receptor antagonist (DORA), for insomnia and related disorders in Japan.
Idorsia will receive an initial payment of 1 billion Japanese yen (approximately 9 million Swiss francs) and will be entitled to three additional development and regulatory milestones. Idorsia will also be entitled to sales milestones and tiered royalty payments based on net sales achieved by Mochida. Costs associated with the co-development of daridorexant will be shared.
With regards to the future development program, Idorsia will be responsible for the design and conduct of additional preclinical and clinical studies, and for health authority registration, with oversight from a Joint Development Committee. Should Idorsia wish to out-license daridorexant for use in any field other than insomnia and related disorders to a third party in Japan, Mochida will be offered the right of first refusal.
Global license agreement and research collaboration with Neurocrine
In May 2020, Idorsia entered into a global license agreement with Neurocrine Biosciences, Inc. (Nasdaq: NBIX) for the development and commercialization of ACT-709478, Idorsia's potent, selective, orally-active, and brain penetrating T-type calcium channel blocker for the treatment of a rare pediatric epilepsy, and a research collaboration to discover, identify and develop additional novel T-type calcium channel blockers.
In 2019, Neurocrine Biosciences paid a $5 million upfront fee to Idorsia for the option rights to ACT-709478 and a preclinical research collaboration. In May 2020, upon Investigational New Drug (IND) application acceptance by the US Food and Drug Administration (FDA), Neurocrine Biosciences exercised the option to license ACT-709478. The exercise of the option triggered an upfront payment of $45 million in cash from Neurocrine Biosciences to Idorsia. In addition, Neurocrine Biosciences will provide an incremental $7 million in funding to Idorsia as part of the research collaboration to discover, identify and develop additional novel T-type calcium channel blockers.
The agreement is subject to the following terms:
- ACT-709478 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.
- ACT-709478 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.
- Preclinical research collaboration: The parties will work together to identify novel T-type channel blockers and explore their use in potential new disease states. Idorsia may be entitled to additional development, regulatory and commercial milestones as well as tiered royalties on annual sales for each product included in the research collaboration.