Global Briefs: Pfizer, Novartis, Sanofi, J&J & More

A roundup of news from Pfizer, Novartis, Moderna, Sanofi, Johnson & Johnson, Nektar, and Astellas.

Pfizer Recalls Five Lots of Blood Pressure Drug for Nitrosamine Impurity
Pfizer is voluntarily recalling five lots of Accupril (quinapril HCl) tablets distributed to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-nitroso-quinapril, observed in recent testing above acceptable daily intake (ADI) level set by the US Food and Drug Administration (FDA). Accupril is indicated for the treatment of hypertension and for the management of heart failure.

Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. To date (as of April 22, 2022), Pfizer says it is not aware of reports of adverse events related to the recall.

The product lots were distributed nationwide to wholesalers and distributors in the US and Puerto Rico from December 2019 to April 2022.

Source: US Food and Drug Administration

Novartis Names New Chief Strategy & Growth Officer
Novartis has appointed Aharon Gal Ph.D., currently Senior Analyst at Sanford Bernstein, a brokerage firm, as Chief Strategy & Growth Officer, effective no later than August 1, 2022. He will report to Novartis’ CEO, Vas Narasimhan, and join the Executive Committee of Novartis.  

Dr. Gal will lead the newly created Strategy & Growth function that combines corporate strategy, R&D portfolio strategy, and business development. Dr. Gal joins Novartis from Sanford Bernstein, where he is a Senior Analyst covering the US bio/pharmaceutical industry. Prior to joining Sanford Bernstein, Dr. Gal worked at Canon and the Boston Consulting Group.

Source: Novartis

Moderna Names Ex-Merck Executive Chief Commercial Officer
Moderna has appointed Arpa Garay, currently the Chief Marketing Officer, Human Health at Merck & Co., as Chief Commercial Officer, effective May 31, 2022.

Ms. Garay will serve on Moderna’s Executive Committee and report to the company’s CEO, Stéphane Bancel. Ms. Garay most recently served as Chief Marketing Officer for Merck & Co.’s Human Health business, where she was responsible for long-term portfolio strategy and global marketing for Merck’s in-line and pipeline human health medicines and vaccines, including global market access and pricing strategy, data and analytics, digital marketing, and commercial business development.

Source: Moderna

Sanofi, McLaren Racing Partner To Optimize Mfg 
Sanofi is partnering with McLaren Racing, a Surrey, England-based company that uses data analysis to improve manufacturing operations, to optimize the company’s manufacturing operations.

Following a successful pilot in 2021, both companies have decided to extend their collaboration across multiple sites in seven countries, covering more than 100 production lines, across all technologies. Learnings from this partnership will provide insights and develop best practices for manufacturing that will then be implemented across Sanofi’s global industrial network.

Source: Sanofi

Nektar Announces Restructuring, Workforce Cuts of 70%
Nektar Therapeutics, a San Francisco, California-based bio/pharmaceutical company, has announced a restructuring plan that involves a workforce reduction of 70%. The announcement follows the company’s announcement earlier this month (April 2022) that it and Bristol-Myers Squibb were jointly ending a clinical development program for bempegaldesleukin, its lead immuno-oncology drug candidate, with BMS’ Opdivo (nivolumab), also a cancer immunotherapy.

The restructuring plan is designed to ensure Nektar has working capital to fund R&D programs without a need to raise external capital. Nektar now expects to end the year (2022) with approximately $440 million to $450 million in cash and investments. In connection with the business restructuring and reduction in workforce, Nektar expects to take a charge of between $150 million and $160 million, a portion of which will be recorded in the company’s financial results for the quarter ending June 30, 2022. The company says that it the restructuring will extend its cash runway into the first half of 2025.

Source: Nektar Therapeutics

J&J Opens Discovery Center Focused on Antimicrobial Resistance
Johnson & Johnson (J&J) has launched a discovery center in South Africa to address antimicrobial resistance. The Center is at the Holistic Drug Discovery and Development (H3D) Center at the University of Cape Town, in Cape Town, South Africa (AMR) and will focus on multidrug-resistant Gram-negative bacteria.

The Satellite Center in Cape Town is the second site to open in Johnson & Johnson’s network of research collaborations aimed at addressing pressing health challenges

Source: Johnson & Johnson

Astellas, University of Tokyo Advance Medicines Partnership
Astellas Pharma and the University of Tokyo have entered the second phase of their collaboration, called the Astellas Alliance Acceleration Program (AAAP), which is focused on joint drug development.

In its first phase, from September 2020 to March 2022, AAAP established a base for its collaborative relationship at the university’s Institute for Life Science Research and Education, and the University of Tokyo Center of Innovation. During this period, medical and pharmaceutical researchers from the two university organizations and drug-discovery researchers from Astellas collaborated on several new research projects that were identified and launched.

In the second phase, the University of Tokyo will expand its partnership involvement to include all of its institutions. Furthermore, a newly appointed AAAP-dedicated project manager will be stationed at the university to facilitate the collaboration.

Source: Astellas Pharma