Servier Completes Acquisition of Agios Pharmaceuticals' Oncology Business

Transaction includes TIBSOVO®, co-commercialization responsibilities for Bristol Myers Squibb's IDHIFA® as well as a strong oncology pipeline of Phase 3 and early-stage assets

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Servier Pharmaceuticals

Apr 01, 2021, 07:00 ET

PARIS and BOSTON, April 1, 2021 /PRNewswire/ -- Servier, a global pharmaceutical company, today announced that it has successfully completed its acquisition of Agios Pharmaceuticals' commercial, clinical, and research-stage oncology portfolio for up to $2 billion plus royalties. The acquisition immediately strengthens Servier's commercial presence in the U.S. malignant hematology market and provides the potential for long-term growth into the solid tumor space.

"We are pleased to welcome an exceptionally talented team that will allow us to strengthen our strategic focus in oncology and expand our scientific capabilities in cellular metabolism," said Olivier Laureau, President of Servier. "It is an important milestone in Servier's oncology strategy as it significantly reinforces the Group's presence in the U.S. Together, with this expanded team, we remain committed to addressing the unmet needs of patients living with cancer across the globe."

"We appreciate the support of our employees, partners and Agios team in ensuring a seamless integration," said David K. Lee, CEO, Servier Pharmaceuticals. "The addition of TIBSOVO^® and IDHIFA^® to our pipeline allows us to expand our oncology leadership capabilities in the U.S. and accelerate scientific advancements for patients with hematological malignancies, including acute myeloid leukemia."

As part of the transaction, U.S.-based Agios employees who primarily support the oncology business will join Servier Pharmaceuticals LLC, a U.S. subsidiary of Servier. The transaction includes the transfer to Servier of Agios Pharmaceuticals' oncology portfolio, development pipeline and research programs, notably:

TIBSOVO (ivosidenib tablets), 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 is also under investigation in two Phase 3 combination trials in newly diagnosed AML, and as a potential treatment for IDH1-mutant myelodysplastic syndrome (MDS). Additionally, last month, a supplemental new drug application (sNDA) has been submitted to the FDA for TIBSOVO as a potential therapeutic option for patients with previously treated, IDH1-mutated cholangiocarcinoma (bile duct cancer) in the U.S. A priority review was requested for the application, which, if granted, could result in a six-month review process.
IDHIFA (enasidenib)^*, a medicine co-promoted with Bristol Myers Squibb in the U.S. where it is approved for the treatment of adult patients with relapsed or refractory AML with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
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.

Under the terms of the transaction agreement, Agios received an upfront payment of $1.8 billion from Servier and is eligible to receive an additional $200 million in a potential regulatory milestone, plus royalties. The transaction has been approved by both companies' respective boards of directors and Agios' shareholders. All regulatory clearances have been received from government authorities outlined in the agreement.

About Servier Group
Servier is a global pharmaceutical group governed by a Foundation. With a strong international presence in 150 countries and a total revenue of 4.7 billion euros in 2020, Servier employs 22,500 people worldwide. Servier is an independent group that invests over 20% of its brand-name revenue in Research and Development every year. To accelerate therapeutic innovation for the benefit of patients, the Group is committed to open and collaborative innovation with academic partners, pharmaceutical groups, and biotech companies. It also integrates the patient's voice at the heart of its activities, from research to support beyond the pill.

A leader in cardiology, the ambition of the Servier Group is to become a recognized and innovative player in oncology. Its growth is based on a sustained commitment to cardiovascular and metabolic diseases, oncology and immuno-inflammatory, and neurodegenerative diseases. To promote access to healthcare for all, the Servier Group also offers a range of quality generic drugs covering most pathologies.

More information: www.servier.com

About Servier Pharmaceuticals
Servier Pharmaceuticals, LLC is a commercial-stage company with a passion for innovation and improving the lives of patients, their families and caregivers. A privately held company, Servier has the unique freedom to devote its time and energy toward putting those who require our treatment and care first, with future growth driven by innovation in areas of unmet medical need.

Servier is committed to finding solutions that will address today's challenges. The company's oncology portfolio of innovative medicines is designed to bring more life-saving treatments to a greater number of patients, across the entire spectrum of disease and in a variety of tumor types.

Servier believes co-creation is fundamental to driving innovation and is actively building alliances, acquisitions, licensing deals and partnerships that bring solutions and accelerate access to therapies. With our commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier Pharmaceuticals is dedicated to bringing the promise of tomorrow to the patients that we serve.

More information: www.servier.us

Press Contacts

Servier Group (France and worldwide)
Sonia Marques
[email protected]
+33 (0)1 55 72 40 21 / + 33 (0)7 84 28 76 13

Servier Pharmaceuticals (U.S.)
Kelly Schlemm
[email protected]

Disclosures
This release contains general information about the Servier Group and its entities (hereinafter "Servier and its Affiliates") and is intended for informational purposes only. The information is thought to be reliable; however, Servier and its Affiliates make no representation as to the accuracy or completeness of the information contained herein or otherwise provided and accept no responsibility or liability, in contract, in tort, in negligence, or otherwise, should the information be found to be inaccurate or incomplete in any respect.

Servier and its Affiliates are not acting as an advisor to the recipient of this information, and the ultimate decision to proceed with any transaction rests solely with the recipient of this information. Therefore, prior to entering into any proposed transaction, the recipient of this information should determine, without reliance upon Servier or its Affiliates, the economic risks and merits, as well as the legal, tax, and accounting characterizations and consequences, of the transaction and that it is able to assume these risks.

This statement also contains forward-looking statements that are subject to varying levels of uncertainty and risk. Investigational new drugs and indications are subject to further scientific and medical review and regulatory approval. They are not approved for use by the FDA.

Any reliance placed on this document is done entirely at the risk of the person placing such reliance. The information contained in this document is neither an offer to sell nor the solicitation of an offer to enter into a transaction.

The content of this document is a summary only, is not complete, and does not include all material information about Servier and its Affiliates, including potential conflicts of interest.

To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates disclaim all representations, warranties, conditions and guarantees, whether express, implied, statutory or of other kind, nor does it accept any duty to any person, in connection with this document. Without prejudice to the generality of the foregoing, Servier and its Affiliates do not warrant or represent that the information or opinions contained in this document is accurate or complete.

To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates shall not be liable for any loss, damage or expense whatsoever, whether direct or indirect, howsoever arising, whether in contract, tort (including negligence), strict liability or otherwise, for direct, indirect, incidental, consequential, punitive or special damages arising out of or in connection with this document, including (without limitation) any course of action taken on the basis of the same.

The estimates, strategies, and views expressed in this document are based upon past or current data and information and are subject to change without notice.

^*Please see the full prescribing information for IDHIFA (enasidenib) and TIBSOVO (ivosidenib), including the Boxed WARNINGS.

SOURCE Servier Pharmaceuticals