Therapy Areas: Infectious Diseases
Dicerna Closes Agreement with Novo Nordisk for Discovery and Development of RNAi Therapies for Liver-Related Cardio-Metabolic Diseases
3 January 2020 - - US-based ribonucleic acid interference therapeutics developer Dicerna Pharmaceuticals, Inc. (NASDAQ: DRNA) has closed a discovery and development agreement between Dicerna and Novo Nordisk A/S (Novo Nordisk) following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the company said.

As previously announced on Nov. 18, 2019, Dicerna and Novo Nordisk entered into an agreement to discover and develop novel therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna's proprietary GalXC RNAi platform technology.

The collaboration will explore more than 30 liver cell targets and may deliver multiple clinical candidates for disorders including chronic liver disease, non-alcoholic steatohepatitis, type 2 diabetes, obesity and rare diseases.

Dicerna will conduct and fund discovery and preclinical development to clinical candidate selection for each liver cell target, and Novo Nordisk will be responsible for all further development.

Dicerna retains the right to opt into two clinical-stage programs to be derived from the discovery collaboration.

Dicerna will receive an upfront payment of USD 175m, following delivery of a program start-up package to Novo Nordisk, expected early in 1Q20.

Under the terms of the agreement, Dicerna will receive USD 25m annually for each of the first three years of the collaboration subject to delivery of RNAi molecules for a defined number of targets to Novo Nordisk, and up to USD 357.5m per target in development, regulatory and commercialization milestone payments, plus tiered royalties on product sales ranging from the mid-single-digits to mid-teens.

As part of the agreement, the company issued to Novo Nordisk 2,279,982 shares of Dicerna common stock in connection with Novo Nordisk's USD 50m equity investment in Dicerna.

The agreement enables each company to co-develop and co-commercialize product candidates discovered under the collaboration.

Novo Nordisk will lead programmes targeting cardio-metabolic disorders and other indications with Dicerna having the option to opt into two programmes during clinical development. Dicerna retains rights to initiate two new orphan liver disease programmes for which Novo Nordisk can opt in.

For all co-development programmes, the companies will share in the profit/loss of net sales of products consistent with each company's contribution to co-development costs.

Dicerna's proprietary ribonucleic acid interference technology platform, called GalXC, aims to advance the development of next-generation RNAi-based therapies designed to silence disease-driving genes in the liver and other tissues.

Liver-targeted GalXC-based compounds enable subcutaneous delivery of RNAi therapies that are designed to bind specifically to receptors on liver cells, leading to internalization and access to the RNAi machinery within the cells.

The GalXC approach seeks to optimize the activity of the RNAi pathway so that it operates in the most specific and potent fashion.

Compounds produced via GalXC are intended to be broadly applicable across multiple therapeutic areas, including both liver and non-liver indications.

Dicerna Pharmaceuticals is a biopharmaceutical company using ribonucleic acid interference to develop medicines that silence genes that cause disease.

The company's proprietary GalXC technology is being applied to develop potent, selective and safe RNAi therapies to treat diseases involving the liver, including rare diseases, chronic liver diseases, cardiovascular diseases and viral infectious diseases.

Dicerna aims to treat disease by addressing the underlying causes of illness with capabilities that extend beyond the liver to address a range of diseases, focusing on target genes where connections between gene and disease are well understood and documented.

Dicerna intends to discover, develop and commercialise novel therapeutics either on its own or in collaboration with pharmaceutical partners. Dicerna has strategic collaborations with Novo Nordisk A/S, Roche, Eli Lilly and company, Alexion Pharmaceuticals, Inc. and Boehringer Ingelheim International GmbH.