Date: 2017-02-16
Type of information: Licensing agreement
Compound: AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx
Company: Akcea Therapeutics (USA - CA) Ionis Pharmaceuticals (USA - CA) Novartis (Switzerland)
Therapeutic area: Cardiovascular diseases
Type agreement: development -commercialisation
Action mechanism:
- antisense oligonucleotide/antisense drug. The lipoprotein Lp(a) is considered a key driver for cardiovascular disease due to its association with an increased risk of coronary heart disease. Lp(a) is assembled in the liver and consists of the apolipoprotein(a) protein covalently linked to LDL-cholesterol.
- AKCEA-APO(a)-LRx is an antisense drug that uses Ionis' advanced LIgand Conjugated Antisense, or LICA technology. It inhibits the production of apolipoprotein(a), thereby reducing Lp(a).
Disease:
Details:
- • On February 16, 2017, Ionis Pharmaceuticals and Akcea Therapeutics announced they have closed on their exclusive, worldwide option and collaboration agreement with Novartis to develop and commercialize AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx following clearance under the Hart-Scott-Rodino Antitrust Improvements Act. Following this approval and closing of the transaction, Novartis will pay Ionis and Akcea a $75 million up-front payment and make a $100 million equity investment in Ionis, which equates to 1,631,435 shares at $61.30 per share. Novartis has an obligation to make a further equity investment of $50 million in the next 18 months in either Ionis at the same premium as the initial investment or in Akcea.
- • On January 6, 2017, Ionis Pharmaceuticals and Akcea Therapeutics, a wholly-owned subsidiary of Ionis Pharmaceuticals, announced an exclusive, worldwide option and collaboration agreement with Novartis to develop and commercialize AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx. These two investigational treatments are expected to significantly reduce cardiovascular risk in patients living with elevated levels of lipoprotein Lp(a) or ApoCIII, which is a potent regulator of triglycerides.
- Ionis and Akcea plan to conduct a Phase 2 dose-ranging study for each drug, to choose the optimal dose and evaluate alternative dose schedules, such as monthly dosing, for the Phase 3 study. Following the successful completion of each Phase 2 dose-ranging study, and prior to initiation of the Phase 3 study, Novartis will be able to exercise its option to license and commercialize each drug.
Financial terms:
- Ionis and Akcea are eligible to receive $225 million in near-term payments, including an immediate $75 million up-front option payment and a $100 million equity investment in Ionis, which equates to 1,631,435 shares at $61.30 per share. Ionis and Akcea are also eligible to receive a license fee as well as development, regulatory and commercial milestone payments as each drug advances. In addition, Ionis and Akcea are eligible to receive tiered royalties in the mid-teens to low twenty percent range on net sales of each drug.
- For each drug, upon option exercise, Novartis will pay Ionis and Akcea a $150 million license fee, will initiate a global Phase 3 cardiovascular outcome study in a high-risk population and will be responsible for worldwide development and commercialization activities. Akcea retains the right to co-commercialize any successful drug through its specialty sales force focused on lipid specialists on terms and conditions to be agreed with Novartis. Ionis and Akcea are also eligible to receive up to $315 million and $265 million in development and regulatory milestone payments for AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx, respectively, as well as up to $285 million and $265 million in commercialization milestone payments, for each drug, respectively. Novartis has an obligation to make a further equity investment of $50 million in the next 18 months in either Ionis at the same premium as the initial investment or in Akcea.
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Is general: Yes
