Merck, Codexis extend supply deal for key API in Januvia, Janumet

Januvia box
Merck and Codexis agreed to extend their deal to license and supply a key enzyme used in the manufacture of sitagliptin for Januvia and Janumet. (Merck)

Merck and longtime partner Codexis have agreed to extend their deal to license and supply a key enzyme used in the manufacture of sitagliptin, the API for the pharma giant’s blockbuster Januvia and Janumet diabetes drugs.

The two companies entered into a supply agreement for the enzyme back in 2012 and by 2015 had agreed to a multiyear extension that was due to expire in February next year. The new extension for the license and supply of the enzyme runs through the end of 2026 and can be renewed for an additional five years upon mutual agreement.

Financial terms of the extension weren’t disclosed.

“We are proud to extend our partnership even further for the supply of this proprietary, high performance enzyme for the API,” John Nicols, president and CEO of Codexis, said in a statement.

The company’s enzyme engineering platform is capable of designing unique enzymes with performance improvements that reduce the cost while improving efficiency and sustainability of API manufacturing, he added.

Januvia, Merck’s stalwart Type 2 diabetes product, along with its offshoot Janumet, generated between $5.3 billion and $6.1 billion in global sales in each of the last nine years, though sales fell off 7% in 2019 and 4% last year. The Merck franchise is set to lose exclusivity in January 2023.

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After years of litigation by Merck to keep generic competitors at bay, Sun Pharmaceutical and Zydus Cadila of India have earned FDA approval for their versions of sitagliptin and are set to launch when Merck’s patent expires.

Meanwhile, Eli Lilly’s Trulicity and Novo Nordisk's Ozempic are gaining on Merck's diabetes medicines. Trulicity garnered a 24% increase in sales last year to $5.07 billion, while Novo's quickly rising Ozempic doubled sales in 2020 to $3.4 billion.