Laurus Labs transfers ownership rights of hepatitis B drug to CASI Pharma

Hyderabad-based Laurus Labs Limited said on Tuesday that it has transferred an abbreviated new drug application (ANDA) for Tenofovir Disoproxil Fumarate (TDF) to Nasdaq-listed biopharmaceutical company CASI Pharmaceuticals. CASI will be using the drug in China, for which it will make certain up-front and milestone payments.

Laurus Lab's new drug application for TDF was approved by the US Food and Drug Administration (USFDA).

TDF is prescribed for the treatment of Hepatitis B virus (HBV) infection. China is expected to have more than 90 million chronic carriers of hepatitis B, roughly one-third of all HBV cases in the world. TDF is used as first line therapy.

"The transfer of the TDF ANDA for use in China enhances our strategic focus of leveraging our development and manufacturing capabilities in markets where we have little presence. Partnering with CASI Pharmaceuticals, in particular, would enable Laurus Labs to monetise its asset in China while building a robust pipeline and commercialise quality drugs in other markets," Laurus Labs founder and CEO Satyanarayana Chava said.

The company said that both the parties were in discussions to allow Laurus Labs to continue to manufacture and market TDF for the US market and to potentially supply API for the China market. CASI is headquartered in Rockville, Maryland and has a wholly-owned subsidiary and R&D operations in Beijing, China.