Zydus Lifesciences Ltd announced today an exclusive licensing and supply agreement with MSN Laboratories for the generic cancer treatment drug Cabozantinib tablets, targeting the US market. This strategic partnership marks a significant step in providing affordable cancer treatment options to patients in the United States.
According to a regulatory filing by Zydus Lifesciences, its wholly-owned subsidiary, Zydus Lifesciences Global FZE, will collaborate with MSN Laboratories under this exclusive agreement. MSN Laboratories will be responsible for the manufacturing and supply of the generic version of Cabozantinib tablets, marketed under the brand name CABOMETYX by Exelixis, following regulatory approval.
Under the terms of the agreement, Zydus will take charge of marketing, distributing, and selling the generic Cabozantinib tablets in the US market. MSN Laboratories holds the distinction of being the first sole ANDA (Abbreviated New Drug Application) applicant to submit a substantially complete ANDA with a paragraph IV certification for Cabozantinib tablets. This positions MSN potentially for 180 days of generic drug exclusivity for the product.
“Cabozantinib tablets are an important treatment option for many cancer patients, and we are pleased to work with MSN to bring the generic version of CABOMETYX to the US market,” said Sharvil Patel, Managing Director of Zydus Lifesciences. “This partnership underscores our commitment to providing patients with access to high-quality, affordable medications.”
The Chairman and Founder Managing Director of MSN Group, MSN Reddy, expressed confidence in the collaboration, highlighting MSN’s expertise in global development, manufacturing, and regulatory processes. “Bringing Cabozantinib tablets to market represents another example of MSN’s capabilities. We are confident that working with Zydus will allow us to successfully commercialize Cabozantinib, while advancing our mission of enabling access to high-quality, affordable medicines,” Reddy added.
Cabozantinib tablets, used primarily for the treatment of certain types of cancers, including renal cell carcinoma and hepatocellular carcinoma, present a significant market opportunity. According to IQVIA MAT data from March 2024, the total addressable market for Cabozantinib tablets in the US is approximately USD 1.464 billion.
This agreement between Zydus Lifesciences and MSN Laboratories is poised to make a considerable impact on the availability of cancer treatment options in the US, reinforcing both companies’ dedication to improving patient outcomes through accessible healthcare solutions.