The basics:

• Amneal closes approximately $1.1B Kashiv Biosciences acquisition
• Deal creates integrated global biosimilars company
• Combination adds R&D, manufacturing, commercialization capabilities to Bridgewater buyer
• Amneal aims to launch multiple biosimilars annually

Amneal Pharmaceuticals Inc. has established an integrated global biosimilars leader following its acquisition of Kashiv BioSciences LLC.

The Bridgewater-based company unveiled plans for the deal in April and announced the closing Aug. 10.

Valued at more than $1.1 billion, the combination establishes a worldwide company with end-to-end capabilities across research, development, manufacturing and commercialization. It also opens up the global biosimilars market to the buyer amid a looming “patent cliff.”

According to co-founder and co-CEO Chirag Patel, the transaction “marks a pivotal step in Amneal’s strategy to become America’s No. 1 Affordable Medicines company.” The executive went on to say that Amneal now has the capability to launch multiple biosimilars each year, extending its growth profile.

Added co-founder and co-CEO Chintu Patel, “This acquisition helps to position Amneal to capitalize on an unprecedented wave of biologic loss of exclusivity. Together, we will pursue this significant opportunity and work to expand patient access to high-quality, affordable biologic medicines.”

The financial terms of the deal include a $375 million cash payment along with $375 million of equity payable at closing, Amneal said in April. It also includes up to $350 million in potential payments based on the achievement of certain regulatory milestones, potential royalties based on commercial milestones and funding of operations through closing.

Loss of Exclusivity, chance for opportunity

The Patel brothers founded Amneal in 2002 on the belief that innovation matters only if it’s accessible. The company boasts a portfolio of approximately 300 complex generic, specialty and biosimilar medicines. It delivers more than 160 million prescriptions annually, mostly in the U.S.

The Piscataway-based target is described as among the few domestic companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences in the U.S., together with its subsidiaries in India, operates with global R&D, clinical, manufacturing, regulatory and IP capabilities.

This acquisition helps to position Amneal to capitalize on an unprecedented wave of biologic loss of exclusivity.
— Chintu Patel, co-founder and co-CEO, Amneal Pharmaceuticals

According to EY, $365 billion of worldwide branded sales are at risk from patent expiration from 2023–2028.

Meanwhile, a report from IQVIA found the impending wave of Loss of Exclusivity set to hit the life sciences and pharma industry will cause more than $90 billion in lost revenue from 2025–2029. The figure is more than in either of the last two five-year periods.

Other New Jersey-based industry giants have also worked to mitigate the drop off. Rahway-headquartered Merck has been busy expanding its own pipeline ahead of the 2028 patent expiration for its blockbuster cancer drug, Keytruda.

For Amneal and Kashiv, the latest step builds on a more than decade-long relationship. The companies said integration planning is underway. Beyond advancing the biosimilar pipeline, the plans also focus on combining each’s development and manufacturing capabilities.

Deal team

Goldman Sachs & Co. LLC served as financial advisor and Richards, Layton & Finger PA as legal counsel to the Committee of Independent Directors of the Board of Directors. Simpson Thacher & Bartlett LLP served as legal counsel, among other financial and compliance advisors, to Amneal.

J.P. Morgan Securities LLC served as financial advisor, Holland & Knight LLP served as legal counsel and Dhinal Shah Associates served as an advisor in India to Kashiv.

In April 2021, Holland & Knight also advised Kashiv in the $100 million sale of its subsidiary, Kashiv Specialty Pharmaceuticals LLC, to Amneal.