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Dicerna™ Announces Closing of Worldwide Collaboration and Licensing Agreement With Roche for Treatments for Chronic Hepatitis B Virus Infection

December 19, 2019 GMT

LEXINGTON, Mass.--(BUSINESS WIRE)--Dec 19, 2019--

Dicerna™ Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced the successful closing of the research collaboration and licensing agreement between Dicerna and Roche following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

As previously announced on Oct. 31, 2019, the companies entered into an agreement to develop novel therapies for the treatment of chronic hepatitis B virus (HBV) infection using Dicerna’s proprietary GalXC™ RNAi platform technology. The collaboration will focus on worldwide development and commercialization of DCR-HBVS, Dicerna’s investigational therapy in Phase 1 clinical development, and includes the discovery and development of therapies targeting multiple additional human and viral genes associated with HBV infection using the technology platforms of both companies.

Dicerna will receive an upfront payment of $200 million, which is due early in the first quarter of 2020. Under the terms of the agreement, Dicerna may be eligible to receive up to an additional $1.47 billion over time for the achievement of specified development, regulatory and commercial milestones for DCR-HBVS. In addition, Dicerna may be eligible to receive royalties on potential product sales of DCR-HBVS. Dicerna also retains an option to co-fund the development of DCR-HBVS worldwide and, if exercised, would receive enhanced royalties on net sales in the United States. If Dicerna exercises this co-funding option, it shall also have an option to co-promote products including DCR-HBVS in the United States.

Dicerna and Roche also agreed to collaborate on the research and development of additional therapies targeting multiple human and viral genes implicated in chronic HBV infection, using technology from both companies, for which Dicerna is eligible to receive additional milestones and royalties on any potential products.

About Dicerna’s GalXC™ RNAi Technology Platform

Dicerna’s proprietary ribonucleic acid interference (RNAi) 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.

About Dicerna™ Pharmaceuticals, Inc.

Dicerna™ Pharmaceuticals, Inc., is a biopharmaceutical company using ribonucleic acid interference (RNAi) 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 broad range of diseases, focusing on target genes where connections between gene and disease are well understood and documented. Dicerna intends to discover, develop and commercialize 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. For more information, please visit www.dicerna.com.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Examples of forward-looking statements include, among others, statements we make regarding: (i) the potential of DCR-HBVS and leveraging our GalXC platform to target and silence specific genes that contribute to HBV treatments; (ii) the potential to earn revenue from royalties and milestone payments under the collaboration with Roche; (iii) research and development plans related to GalXC and its utility in silencing genes that contribute to HBV; (iv) the potential of RNAi therapies for the treatment of chronic HBV infection; and (v) the potential for the collaboration between Roche and Dicerna. The process by which an early-stage platform such as GalXC could potentially lead to an approved product is long and subject to highly significant risks. Applicable risks and uncertainties include those relating to preclinical research and other risks identified under the heading “Risk Factors” included in Dicerna’s most recent Form 10-Q filing and in other future filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Dicerna’s current views with respect to future events, and Dicerna does not undertake and specifically disclaims any obligation to update any forward-looking statements, except as required by law.

* Novo Nordisk A/S transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions.

Dicerna™ and GalXC™ are trademarks of Dicerna Pharmaceuticals, Inc.

View source version on businesswire.com:https://www.businesswire.com/news/home/20191219005224/en/

CONTACT: Media:

Amy Trevvett, Dicerna Pharmaceuticals, Inc.

+1 617-612-6253

atrevvett@dicerna.comAlex Van Rees, SmithSolve

+1 973-442-1555 ext. 111

alex.vanrees@smithsolve.comInvestors:

Lauren Stival, Stern Investor Relations, Inc.

+1 212-362-1200

lauren.stival@sternir.com

KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS

INDUSTRY KEYWORD: RESEARCH FDA CLINICAL TRIALS BIOTECHNOLOGY OTHER HEALTH HEALTH PHARMACEUTICAL OTHER SCIENCE SCIENCE

SOURCE: Dicerna™ Pharmaceuticals, Inc.

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PUB: 12/19/2019 07:30 AM/DISC: 12/19/2019 07:30 AM

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