Lannett Company has signed an agreement with Chinese pharmaceutical company Sinotherapeutics to distribute Posaconazole delayed-release tablets 100mg in the US.
The US Food and Drug Administration (FDA) granted final approval to Sinotherapeutics’ Abbreviated New Drug Application (ANDA) for the drug, which is an AB-rated generic equivalent of Merck’s Noxafil Delayed-Release Tablets.
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Lannett CEO Tim Crew said: “The Sinotherapeutics team is highly skilled at formulating particularly difficult-to-develop products, such as Posaconazole Delayed-Release Tablets.
“Given the market dynamics of the product, we expect Posaconazole to be a meaningful contributor to our business.”
Under the terms of the distribution agreement, Lannett will make milestone payments depending on performance and market dynamics.
The company is also responsible for sales, marketing and distribution of the drug and will receive a part of the profits.
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By GlobalDataShipping of the product is expected to start soon, Lannett said.
Sinotherapeutics has developed and launched several controlled and delayed-release ANDAs for the US and Chinese markets.
In a separate development, Lannett signed a services advisory agreement for a period of three years with Neolpharma Group subsidiary, Cediprof.
The agreement is in addition to the supply and distribution agreement for Levothyroxine Sodium Tablets USP.
Lannett will now advise Cediprof and its affiliated entities on different matters relating to the development and commercialisation of products suitable for the US market.
In May last year, Lannett Pharmaceuticals acquired 23 approved drug product applications and one pending from a subsidiary of Endo International.
The portfolio, which primarily consists of oral solutions and a few semi-solid products, was acquired for an upfront payment plus future milestone payments.
