On April 1, 2021 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, reported the closing of the sale of its commercial, clinical and research-stage oncology portfolio to Servier Pharmaceuticals, LLC, an independent global pharmaceutical company (Press release, Agios Pharmaceuticals, APR 1, 2021, View Source [SID1234577497]). The transaction was approved by Agios shareholders on March 25, 2021.

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In consideration for its oncology portfolio, Agios received from Servier $1.8 billion in upfront cash and is eligible to receive an additional $200 million in a potential future milestone payment for vorasidenib, as well as 5% royalties on U.S. net sales of TIBSOVO (ivosidenib tablets) from sales after the closing through loss of exclusivity and 15% royalties on U.S. net sales of vorasidenib from the first commercial sale through loss of exclusivity.

"First, I want to thank each and every employee within the oncology franchise who helped create truly meaningful, differentiated therapies for patients over the past decade. With your expertise and Servier’s deep commitment to its expanding oncology portfolio, we look forward to watching these programs flourish," said Jackie Fouse, Ph.D., chief executive officer of Agios. "As we look ahead, Agios is poised for a bright and focused future as we seek to rapidly advance our genetically defined disease portfolio, delivering sustainable, long-term value to shareholders and superior outcomes for patients. In the near-term, mitapivat has the potential to be a blockbuster product with approvals in our three initial focus areas – pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease – and we have tremendous untapped potential for both the pyruvate kinase R (PKR) activation portfolio as well as our other preclinical assets."

In addition, Agios reported that it has entered into a definitive agreement with Bristol-Myers Squibb Company (BMS) to repurchase 7,121,658 shares of Agios common stock held by BMS and its affiliates for an aggregate purchase price of $344.5 million, or $48.3785 per share, using the proceeds from the sale of the oncology business. As previously disclosed, the Agios board of directors authorized the company to repurchase up to $1.2 billion of its outstanding shares, using the proceeds from the sale of the oncology business. Following completion of the repurchase of shares from BMS, Agios expects to conduct the remaining $855.5 million of share repurchases over the next 12-18 months, including executing a meaningful portion of the planned repurchases by year-end through a combination of 10b5-1 plans and open market purchases.

With a singular focus on growing the company’s genetically defined disease clinical and research pipeline, Agios anticipates significant key milestones in 2021, including filing for regulatory approval for mitapivat in adults with PK deficiency in both the U.S. and EU; initiating two Phase 3 studies of mitapivat in transfusion dependent and non-transfusion dependent thalassemia; initiating a Phase 2/3 study of mitapivat in sickle cell disease; presenting the first data from the healthy volunteer study of AG-946, the next generation PKR activator; and prioritizing new indications for PKR and pyruvate kinase M2 (PKM2) activator clinical development. In addition, Agios will explore all options to maximize the patient impact and value of mitapivat globally, including strategic transactions.

Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC acted as financial advisors to Agios on this transaction. Wachtell, Lipton, Rosen & Katz acted as legal advisor to Agios.

On April 1, 2021 Novocure (NASDAQ: NVCR) reported that it will report financial results for the first quarter 2021 on Thursday, April 29, 2021, before the U.S. financial markets open (Press release, NovoCure, APR 1, 2021, View Source [SID1234577513]). Novocure’s management will host a conference call and webcast to discuss its financial results for the three months ended March 31, 2021, at 8 a.m. EDT on Thursday, April 29, 2021. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 2286525.

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The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On April 1, 2021 Servier, a global pharmaceutical company, reported that it has successfully completed its acquisition of Agios Pharmaceuticals’ commercial, clinical, and research-stage oncology portfolio for up to $2 billion plus royalties (Press release, Servier, APR 1, 2021, View Source [SID1234577571]). 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.

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"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)*.
IDHIFA (enasidenib)[i], a medicine co-promoted with Bristol Myers Squibb in the U.S.
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.

[i]Please see the full prescribing information for IDHIFA (enasidenib) and TIBSOVO (ivosidenib), including the Boxed WARNINGS.

On April 1, 2021 Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) (Theratechnologies), a biopharmaceutical company focused on the development and commercialization of innovative therapies reported that it will report its financial results for the first quarter of fiscal 2021 ended February 28, 2021 on Wednesday, April 14, 2021 (Press release, Theratechnologies, APR 1, 2021, View Source [SID1234577498]).

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A conference call will be held on April 14, 2021 at 8:30 a.m. (ET) to discuss the results. The call will be hosted by Paul Lévesque, President and Chief Executive Officer. The conference call will be open to questions from financial analysts. Media and other interested individuals are invited to participate in the call on a "listen-only" basis.

The conference call can be accessed by dialing 1-844-400-1697 (toll free) or 1-703-736-7400 (International). The conference call will also be accessible via webcast at View Source Audio replay of the conference call will be available on the same day starting at 11:30 a.m. (ET) until April 21, 2021, by dialing 1-855-859-2056 (North America) or 1-404-537-3406 (International) and by entering the access code: 7982427. The audio replay is also available until April 14, 2022 on View Source

On April 1, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported it will collaborate with the Melanoma Research Foundation (MRF) to present "Ask the Expert" Managing Melanoma, a webinar series, throughout the month of April (Press release, Castle Biosciences, APR 1, 2021, View Source [SID1234577514]).

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The MRF is the largest independent organization dedicated to melanoma research, education of patients and their caregivers and advocacy on both the federal and state-level. The "Ask the Expert" Managing Melanoma series is aimed at increasing awareness and engagement in the melanoma community and will feature leading dermatologists and melanoma experts.

The Facebook Live webinars are accessible to the public and will take place on the MRF Facebook page with the following industry leaders:

April 6, 2021 @ 3 p.m. E.T.: Abel Jarrell, M.D., dermatology/dermatopathology, Melanoma Patient Journey
April 13, 2021 @ 4 p.m. E.T.: Brent Moody, M.D., Mohs surgeon, Familial Genetics vs. Tumor Genetics
April 20, 2021 @ 4 p.m. E.T.: Shannon Trotter, D.O., dermatology, Use of Gene Expressing Profiling in Melanoma Prognosis
April 27, 2021 @ 3 p.m. E.T.: Steven Trocha, M.D., surgical oncologist, Lifetime Clinic for High-Risk Melanoma Patients
"Disease awareness, preventive methods and early detection are all key factors that contribute to the best patient outcomes," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We are proud to support the MRF and its ‘Ask the Expert’ sessions to provide additional resources for patients and educate the public on melanoma and on the role of tumor biology and genomic testing in informing cancer treatment plan decisions for this aggressive form of skin cancer."

"Our mission is to prevent melanoma in as many people as possible," said Kyleigh Lipira, M.B.A., chief executive officer of the MRF. "Our work with Castle complements our goal of providing the necessary insight and resources to vigilantly prevent and detect melanoma."

For more information on the "Ask the Expert" Facebook Live webinars, or to access a recorded playback of the sessions, please visit the MRF Facebook page here.