Novelos Inks Deal With Hong Kong-Based Lee’s Pharma For Cancer, Hepatitis Compounds

SHANGHAI - Novelos Therapeutics signed an exclusive license agreement with Hong Kong-based Lee's Pharmaceutical Dec. 17, with an aim to expand the sales of its cancer and hepatitis compounds - NOV-002 and NOV205 - in the Greater China region.

Under the agreement, Lee’s Pharm will be in charge of all regional regulatory submissions, marketing and clinical development for the compounds in China, Macau, Hong Kong and Taiwan.

U.S.-based Novelos will get royalties of 20 percent to 25 percent on Lee's net sales for NOV-002, and 12 percent to 15 percent for NOV-205.

Lee’s Pharm CEO Benjamin Li said the company sees a great need for its compounds in China, since more than 1.7 million people in China are diagnosed with cancer every year, while roughly 120 million are infected with hepatitis B.

"We have 12 to 15 hospitals as our trial partners," Li told PharmAsia News. “These hospitals are located in major cities in mainland China such as Beijing and Shanghai.”

“Trial conduction and regulatory submissions in mainland China will take two to three years,” added Li.

Lee’s Pharm will use its own marketing organization and infrastructure to promote the compounds, the prices and brand names of which have not been decided yet, according to Li.

Hong Kong-based Lee’s Pharmaceutical, which is 30 percent owned by Rome-based Sigma-Tau Group, has operated for 13 years in China's pharmaceutical industry.

Sigma-Tau will possibly be Novelos' European partner for the two compounds, but no final decision has been made so far, according to Lee’s Pharm.

Novelos Therapeutics specializes in oxidized glutathione-based compounds for treating cancer and hepatitis

NOV-002 is now in Phase III trials in the U.S. for non-small cell lung cancer, and FDA approval of the NDA is anticipated in 2009, according to Novelos.

NOV-002 is also in Phase II trials in ovarian cancer and early-stage breast cancer.

NOV-205 is currently in Phase 1b trials for chronic hepatitis C. A proof-of-concept trial for the compound will begin in 2008, according to the company.

Originally developed in Russia decades ago, both compounds have been approved to be used in the Russian Federation under the names Glutoxim (002) and Molixan (205). 

– Wang Fangqing (pharmasia@elsevier.com)

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