OREANDA-NEWS. NGM Biopharmaceuticals, Inc., a privately-held biotechnology company and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced they have entered into a multi-year collaboration to research, discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. This agreement will become effective upon the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

“We are very pleased to establish this alliance with Merck, which will be transformational for NGM, providing us with the resources and flexibility to pursue our ambitious research and development goals while preserving our unique drug discovery culture,” said William J. Rieflin, Chief Executive Officer of NGM. “We look forward to working with Merck to generate a robust pipeline of therapies with the potential to make a significant difference in the lives of patients.”

“NGM has developed a uniquely powerful research program that has permitted identification of novel, and quite consequential, pathways for metabolic regulation,” said Dr. Roger M. Perlmutter, President of Merck Research Laboratories. “Through this new collaboration, we hope to apply Merck’s well-established translational capabilities to advance innovative biologics that address the needs of patients suffering from diabetes, metabolic dysregulation, and malignancy.”

The collaboration includes multiple drug candidates currently in preclinical development at NGM, including NP201, which is being evaluated for the treatment of diabetes, obesity and nonalcoholic steatohepatitis (NASH). NGM will lead the research and development of the existing preclinical candidates and have the autonomy to identify and pursue other discovery stage programs at its discretion. Merck will have the option to license all resulting NGM programs following human proof of concept trials. If Merck exercises this option, Merck will lead global product development and commercialization for the resulting products, if approved.

Under the terms of the agreement, Merck will make an upfront payment to NGM of \$94 million and will purchase a 15 percent equity stake in NGM for \$106 million at a price per share that represents a 20 percent premium to NGM’s most recent financing. Merck will commit up to \$250 million to fund all of NGM’s efforts under the initial five-year term of the collaboration, with the potential for additional funding if certain conditions are met.

Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50 percent. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. Merck will have the option to extend the research agreement for two additional two-year terms.

“This collaboration brings together our biology-driven research and development product platform with Merck’s late-stage development and commercialization expertise, while also enabling NGM to explore exciting new drug targets,” commented Dr. Jin-Long Chen, Founder and Chief Scientific Officer of NGM. “Both companies' commitment to scientific excellence and willingness to creatively combine our strengths was key to establishing this relationship."

NGM’s lead program, NGM282, currently in clinical development for primary biliary cirrhosis (PBC) and NASH, as well as programs that are the focus of NGM’s pre-existing collaboration agreements, are not subject to the option under the Merck collaboration.

NGM Conference Call Information

NGM will host a conference call and live audio webcast today at 9:30 a.m. ET. To participate in the conference call, please dial 1-877-930-8423 (domestic) or 1-253-642-1003 (international) and refer to conference ID 89756919.

About NGM Biopharmaceuticals

NGM Biopharmaceuticals is a private biopharmaceutical company using a biology-centric approach to create novel biologics for the treatment of a broad spectrum of life-threatening diseases. NGM’s lead compound, NGM282, is in a Phase 2b study for the treatment of PBC. NGM282 has received Orphan Drug Designations in the U.S. and EU, and has been granted Fast Track Designation for PBC by the U.S. Food and Drug Administration. NGM has established collaborations with Merck, MedImmune, Daiichi Sankyo and JDRF. NGM is financed by The Column Group, Prospect Ventures, Rho Ventures, Tichenor Ventures, Topspin Ventures and other leading investors around the world. 

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. 

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.