Benzinga | Dec 21, 2020 07:03AM EST

Agios to Focus on Developing and Commercializing Innovative Treatments for Genetically Defined Diseases and Sell Its Oncology Business to Servier for Up to $2B Plus Royalties

-- Agios to Dedicate All Resources to Advancing Mitapivat as a Potential Treatment for Three Initial Hemolytic Anemias and Building on its Scientific Expertise in Cellular Metabolism and PK Activation to Accelerate and Expand its Genetically Defined Disease Portfolio --

-- Agios to Receive $1.8 Billion in Upfront Cash, a Potential $200 Million Regulatory Milestone Payment for Vorasidenib and Future Royalties on U.S. Net Sales of TIBSOVO(r) and Vorasidenib --

-- Agios Plans to Return at Least $1.2 Billion to Shareholders Following the Close of the Transaction, Anticipated in Q2 2021 --

-- Company to Host Investor Event and Webcast Today at 8:00 a.m. ET --

CAMBRIDGE, Mass., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that it will move forward with a singular focus on accelerating and expanding its genetically defined disease portfolio, including the mitapivat clinical programs and a robust pipeline of therapeutic candidates, and has entered into a definitive agreement to sell its commercial, clinical and research-stage oncology portfolio to Servier, an independent global pharmaceutical company. Agios will receive a cash consideration of up to $2.0 billion, including $1.8 billion in upfront cash and $200 million in a potential future milestone payment for vorasidenib, as well as 5% royalties on U.S. net sales of TIBSOVO(r) (ivosidenib tablets) from transaction close through loss of exclusivity and 15% royalties on U.S. net sales of vorasidenib from first commercial sale through loss of exclusivity.

"Our decision to accelerate the next chapter of Agios' success with a singular focus on genetically defined diseases and sell our oncology portfolio to Servier is a transformational milestone for Agios. The result of a deliberative strategic review, this decision reflects the progress we have made understanding and harnessing the science and promise of PK activation and captures the full value of our oncology assets," said Jackie Fouse, Ph.D., chief executive officer of Agios. "With mitapivat poised to become a new potential treatment option for patients with pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease and with a rich pipeline based on our pioneering leadership in PK activation and cellular metabolism, Agios' near- and long-term future is filled with significant value-generating catalysts. The proceeds from the transaction will allow us to focus on rapidly advancing our genetically defined disease portfolio for patients in need, strengthen our capital structure and return at least $1.2 billion to shareholders post-closing, achieve capital markets independence and participate in the future success of TIBSOVO(r) and vorasidenib."

"We are proud of our heritage in oncology and the novel therapies we have advanced for patients with hematologic malignancies and solid tumors, and we are pleased to have found an excellent home for our oncology portfolio in Servier, a successful, patient-focused, global pharmaceutical company," continued Dr. Fouse. "Servier is committed to the oncology patient community and to investing in our assets and our people. This transaction will allow the oncology portfolio to grow and thrive with Servier and will provide Agios with the resources required to optimize the development of our promising genetically defined disease therapies, ultimately enabling the greatest overall positive impact for patients."

"The strategic acquisition of Agios' oncology business, including its precision medicine portfolio and pipeline, is aligned with our ambition to become a recognized player in oncology and further supports our commitment to provide innovative treatments to cancer patients with unmet medical needs. It is a key step for the Servier Group as it will significantly strengthen our position in the U.S. and reinforce our R&D capabilities in oncology," stated Olivier Laureau, president of Servier. "We look forward to welcoming the experienced Agios oncology teams to Servier following the closing."

"Agios is a leader in the cellular metabolism space with a proven track record of discovering, developing and commercializing precision medicines," said David K. Lee, CEO, Servier Pharmaceuticals, the U.S. subsidiary of Servier. "The acquisition of Agios' oncology business, including highly experienced talent from research, development, technical operations and commercial functions, allows for an immediate expansion of our U.S. business into other hematologic malignances and provides the potential for longer-term growth into the solid tumor space, thus ensuring that we can serve more patients living with unmet cancer needs than ever before."

Transaction Details

The transaction includes the transfer of Agios' oncology portfolio and associated employees, including its marketed medicine TIBSOVO(r) which is approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutant AML who are ?75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. TIBSOVO(r) is also under investigation in two Phase 3 combination trials in newly diagnosed AML, and as a potential treatment for previously treated IDH1-mutant cholangiocarcinoma and IDH1-mutant myelodysplastic syndrome (MDS). Servier will also acquire Agios' co-commercialization responsibilities for Bristol Myers Squibb's IDHIFA(r) (enasidenib) and conduct certain clinical development activities within the IDHIFA(r) development program.

In addition, the transaction includes Agios' oncology pipeline and clinical programs, including vorasidenib, an investigational, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 which is currently being studied in the registration-enabling Phase 3 INDIGO study in patients with IDH-mutant low-grade glioma; AG-270, an investigational first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor being evaluated in combination with taxanes in patients with methylthioadenosine phosphorylase (MTAP)-deleted non-small cell lung cancer and pancreatic cancer; AG-636, a novel inhibitor of dihydroorotate dehydrogenase (DHODH); and Agios' oncology research programs.

All of Agios' U.S.-based employees who primarily support the oncology business will receive a comparable offer at Servier.

The transaction has been approved by the Board of Directors and is subject to approval by Agios shareholders and satisfaction of regulatory conditions. It is currently expected that the transaction will close in the second quarter of 2021.

Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC are serving as financial advisers to Agios, and Wachtell, Lipton, Rosen & Katz is serving as its legal adviser.