A roundup of news from Eli Lilly and Company, Daiichi Sankyo, Merck KGaA, and Blueprint Medicines.

FDA OKs Lilly’s Biosimilar of Sanofi’s Lantus
The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Rezvoglar (insulin glargine-aglr), a biosimilar to Sanofi’s Lantus (insulin glargine), a long-acting insulin to treat Type 1 and Type 2 diabetes.

This is the second biosimilar of Lantus approved in the US. In July 2021, the US Food and Drug Administration approved Semglee (insulin glargine-yfgn), a biosimilar by Viatris and Biocon Biologics. Lantus had net sales of EUR 2.6 billion ($2.9 billion) in 2020.

Last month (December 29, 2021), Viatris reported that a prior ruling by the US Patent and Trademark Appeal Board was affirmed; the ruling had found challenged claims by Sanofi of Lantus SoloSTAR device patents were unpatentable.  

Source: US Food and Drug Administration and Viatris

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Daiichi Sankyo To Close R&D Subsidiary Plexxikon
Daiichi Sankyo has decided to close the offices of its research and development subsidiary, Plexxikon, based in South San Francisco, California.

Plexxikon, with approximately 60 employees, has been engaged in research and development in oncology and neurology since 2001 and has been part of Daiichi Sankyo since 2011. It has two marketed drugs, Zelboraf (vemurafenib) and Turalio (pexidartinib). The existing R&D pipeline at Plexxikon will be transferred to the Daiichi Sankyo Group. Plexxikon will be operational until March 31, 2022 and continue as a legal entity for the time being (as reported on January 12, 2022).

With the closing of Plexxikon, Daichi Sanyko says it will focus on its three oncology antibody drug conjugates: Enhertu (fam-trastuzumab – deruxtecan-nxki), Dato-DXd (datopotamab deruxtecan), and HER3-DXd (patritumab deruxtecan).

Source: Daiichi Sankyo

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Merck KGaA Appoints R&D Head & Chief Strategy Officer
Merck KGaA has appointed Danny Bar-Zohar, MD, currently Executive Vice President and Global Head of Development of Merck KGaA as Global Head of R&D, and Joern-Peter Halle, PhD, currently Executive Vice President, Global Head of Research at Merck KGaA, as Chief Strategy Officer.

As Global Head of R&D, Dr. Bar-Zohar will lead research and development, including medical Affairs. Dr. Bar-Zohar joined Merck KGaA in November 2020 as Executive Vice President, Global Head of Development. He has more than a decade of leadership experience in pharma, having worked previously at Novartis and Teva.

As Chief Strategy Officer, Dr. Halle will lead Strategy and Business Development. Dr. Halle previously served as Executive Vice President, Global Head of Research for the last 18 months, leading discovery through preclinical development for the company’s oncology/immuno-oncology and immunology therapeutic areas. Dr. Halle also served as Senior Vice President, Head of Immuno-Oncology Research, and Senior Vice President, Head of External Innovation. Mr. Halle brings more than 25 years of industry experience to this position. He joined Merck KGaA in 2005.

Both Dr. Bar-Zohar and Dr. Halle will continue to be part of the Healthcare Executive Committee and be based at the company’s global headquarters in Darmstadt, Germany.

Source: Merck KGaA

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Blueprint Medicines Names New CEO & President
Blueprint Medicines, a Cambridge, Massachusetts-based bio/pharmaceutical company, has named Kate Haviland, currently Chief Operating Officer (COO) at Blueprint, as CEO, President and a member of the company’s Board of Directors, effective April 4, 2022. Jeff Albers will transition from his current role as Chairman, President, and CEO to become Executive Chairman of the Board of Directors. Mr. Albers will serve as Executive Chairman through the end of 2022, with continued service as Chairman thereafter.

Ms. Haviland joined Blueprint Medicines in January 2016 as Chief Business Officer and has served as COO since January 2019. Prior to joining Blueprint Medicines, she held leadership roles focused on the development of therapies in oncology and rare diseases with several companies: as Vice President, Rare Diseases and Oncology Program Leadership at Idera Pharmaceuticals; Head of Commercial Development at Sarepta Therapeutics; Executive Director of Commercial Development at PTC Therapeutics. She also held roles in both corporate development and project management at Genzyme (now part of Sanofi).

Blueprint Medicines also announced that Christina Rossi has been promoted from Chief Commercial Officer to COO. In her new role, Ms. Rossi will retain leadership of global commercial strategy and operations and expand her oversight to include portfolio strategy and program management, corporate development, and corporate affairs, effective April 4, 2022.

Source: Blueprint Medicines