Laurus Labs has transferred its USFDA-approved Abbreviated New Drug Application (ANDA) of Tenofovir Disoproxil Fumarate (TDF) to CASI Pharmaceuticals, Inc.
As part of the transaction, the company, in exchange of the transfer of ANDA, would receive certain upfront and milestone payments in different phases. Both parties are in discussions to allow Laurus to continue to manufacture and market TDF for the US market and to potentially supply API for the China market.
The TDF is prescribed for the treatment of Hepatitis B virus (HBV). There are more than 90 million chronic carriers of hepatitis B in China which accounts for roughly one-third of all HBV chronic carriers in the world with TDF currently the first line therapy.
CASI Pharmaceuticals is a biopharmaceutical company dedicated to the development and delivery of pharmaceutical products and innovative therapeutics to China and other markets.
“Partnering with CASI Pharmaceuticals would enable Laurus Labs to monetise its asset in China while building a pipeline and commercialise drugs in other markets,’’ Satyanarayana Chava, Founder and CEO, Laurus Labs, said in a release issued here on Tuesday.
Laurus Labs was looking forward to venture into the new geographies where it has no footprint and would offer its manufacturing capabilities through strategic ventures and partnerships, he added.