Agreements

Date: 2018-04-11

Type of information: Joint-venture agreement

Compound:

• RNA-based therapeutics enabled by Arbutus’ proprietary lipid nanoparticle (LNP) and ligand conjugate delivery technologies.

Company: Arbutus Biopharma (Canada) Roivant Sciences (USA) Genevant Sciences (USA - MA)

Therapeutic area: Rare diseases - Genetic diseases

Type agreement:

• development
• joint-venture

Action mechanism: RNA-based therapeutics.

Disease:

Details:

• • On April 11, 2018, Arbutus Biopharma and Roivant Sciences announced that they have entered into an agreement to launch Genevant Sciences, a jointly-owned company focused on the discovery, development, and commercialization of a broad range of RNA-based therapeutics enabled by Arbutus’ proprietary lipid nanoparticle (LNP) and ligand conjugate delivery technologies. Arbutus will license exclusive rights to its LNP and ligand conjugate delivery platforms to Genevant for RNA-based applications outside of Hepatitis B virus. Through its expert team and dominant intellectual property in RNA delivery, Genevant plans to develop products in-house and pursue industry partnerships to build a diverse pipeline of therapeutics across multiple modalities, including RNAi, mRNA, and gene editing.
• The industry-leading LNP platform developed by Arbutus is the only clinically-validated LNP delivery technology with safety and efficacy evaluated in over 400 patients across multiple clinical programs. It is the first and only LNP platform to enable an approved therapy, and has enabled a second NDA filing through its licensed use by Alnylam Pharmaceuticals for the delivery of patisiran, a therapy to treat patients with hereditary ATTR amyloidosis. This platform is protected by over 125 international patent families. Genevant will also receive a license to a proprietary ligand conjugate technology developed by Arbutus to enable subcutaneous delivery of RNA-based therapeutics.
• Biopharmaceutical companies developing nucleic acid therapeutics today include companies singularly focused on individual treatment modalities. Through its proprietary delivery platforms, Genevant is able to pursue mRNA, RNAi, and gene editing modalities and select the optimal approach for any given disease. By 2020, Genevant aims to have 5 to 10 RNA programs in the clinic targeting a range of genetic disorders with limited or no treatment options.
• Genevant’s Executive Chairman will be Paris Panayiotopoulos. Mr. Panayiotopoulos most recently served as President and Chief Executive Officer and member of the Board of Directors of Ariad Pharmaceuticals through its acquisition by Takeda Pharmaceuticals in 2017 for $5.2 billion. Prior to joining Ariad, Mr. Panayiotopoulos was President of the North American and Japanese biopharmaceutical businesses of Merck KGaA, and President of the Serono Research & Development Institute. Mr. Panayiotopoulos currently serves as a director of The Medicines Company and Corbus Pharmaceuticals, and has previously served on the boards of BIO, MassBio, and EFPIA.
• Bo Rode Hansen, Ph.D., will be joining Genevant as President, Chief Scientific Officer, and Head of Research & Development. Dr. Hansen currently serves as Global Head of RNA Therapeutics at Roche and General Manager of the Roche Innovation Center Copenhagen. Dr. Hansen was Vice President for Drug Discovery and Alliance at Santaris Pharma A/S through its acquisition by Roche in 2014. Peter Lutwyche, Ph.D., will join Genevant as Chief Technology Officer and Vancouver Site Head. Dr. Lutwyche most recently served as Chief Technology Officer at Arbutus where he led the development of the company’s delivery technologies. Konstantin Linnik, J.D., Ph.D., will join Genevant as General Counsel and Senior Vice President of Intellectual Property and Legal Affairs. Dr. Linnik formerly served as Lead Patent Counsel for Oligonucleotide Therapeutics at Pfizer and was a partner at Nutter McClennen & Fish LLP. James Heyes, Ph.D., will join Genevant as Senior Vice President of Technology Development. Dr. Heyes has 17 years of experience as a lipid chemist discovering and developing novel nucleic acid-delivery platforms. He most recently served as Vice President of Drug Delivery at Arbutus where he was a key inventor on a majority of the company’s lipid chemistry and ligand conjugate patents.
• Genevant intends to establish its US headquarters in Cambridge, Massachusetts and its principal operating company in Basel, Switzerland. Genevant will also establish its R&D Center of Excellence in Burnaby, British Columbia with a team of core scientists from Arbutus who will join Genevant as part of the transaction. This scientific team has decades of experience in developing RNA therapeutics and delivery technologies.
• • On February 14, 2018, Arbutus Biopharma and Roivant entered into an exclusivity agreement providing for a period that expires on March 15, 2018. Pursuant to the Exclusivity Agreement, during this period, Arbutus and Roivant agree to negotiate on an exclusive basis the terms and conditions of a proposal to jointly develop Arbutus’ nucleic acid delivery platform based on its Lipid Nanoparticle (LNP) technology and GalNAc technology (collectively, Delivery Technologies) through a new company that would jointly own, manage, and develop the Delivery Technologies. There are no assurances that Arbutus and Roivant will reach an agreement regarding any such transaction or that any such transaction will be consummated.

Financial terms:

• Under the terms of the agreement, Roivant will contribute $37.5 million in transaction-related seed capital for Genevant. Roivant is committed to financially support Genevant in its aim to advance 5 to 10 product candidates into the clinic by 2020. Arbutus will retain all rights to the LNP and conjugate delivery platforms for HBV, and will be entitled to a tiered royalty from Genevant on future sales of products enabled by those delivery platforms. Arbutus will also retain the entirety of its royalty entitlement on the commercialization of Alnylam’s patisiran, which could see regulatory approval as early as the second half of 2018.

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