TaiGen Biotechnology Co (太景生技) yesterday announced that it had signed an agreement with China-based Zhejiang Medicine Co (浙江醫藥) that gives the latter exclusive rights to manufacture and commercialize nemonoxacin in China, excluding Hong Kong and Macau.
Nemonoxacin is a novel broad-spectrum non-fluorinated quinolone antibiotic under development for respiratory infections.
Under the terms of the agreement, TaiGen will be responsible for completing the phase 3 clinical trial for community-acquired pneumonia (CAP) in China.
Zhejiang Medicine will be responsible for the manufacturing, sales and marketing of nemonoxacin in China through its wholly owned subsidiary, Xinchang Pharmaceuticals Co (新昌製藥). TaiGen will retain full development and commercialization rights outside the licensed territory including Taiwan, the US, the EU and Japan.
The Taiwanese biotechnology company will receive an upfront payment of US$8 million from Zhejiang Medicine and will receive additional milestones, as well as between 7 and 11 percent of royalties on product sales. The term of the agreement is 20 years.
“Nemonoxacin has demonstrated efficacy and safety in CAP and diabetic foot infection in clinical trials,” TaiGen chairwoman and chief executive officer Hsu Ming-chu (許明珠) told a press conference in Taipei.
“In particular, nemonoxacin has excellent efficacy against drug-resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA. Nemonoxacin is taken once a day and available in both oral and intravenous formulations,” she said.
TaiGen is completing a phase 3 CAP trial with more than 500 patients from Taiwan and China, and the company expects to file new drug applications in Taiwan and China simultaneously early next year.
According to healthcare information, services and technology provider IMS Health Inc, the global sales of antibiotics amounted to approximately US$11 billion last year and account for almost 20 percent of total pharmaceuticals sales.
The rate of antibiotic-resistant infections in China is among the highest in the world.
According to IMS, global sales of nemonoxacin for CAP and diabetic foot infection could reach US$1.2 billion a year, Hsu said.
She added that TaiGen chose Zhejiang Medicine Co as a partner because it was a first-class pharmaceutical company in China, with a strong antibiotics-marketing team.
“China is the world’s fastest-growing pharmaceutical market. It is poised to overtake Japan as the second-largest pharmaceutical market,” Hsu said. “This partnership will not only set a new record for pharmaceutical licensing involving a Taiwanese and a Chinese company, but hopefully will also become a model for future collaborations.”
“With the conclusion of the partnership in China, we will actively pursue nemonoxacin licensing discussions in other territories, such as the European Union,” Hsu said.
TaiGen currently has Burixafor for stem cell mobilization and TG-2349, a HCV NS3-4A Protease Inhibitor, under phase 2 and phase 1 clinical trials respectively, which will be the company’s focus after nemonoxacin, Hsu added.
Meanwhile, Academia Sinica President Wong Chi-huey (翁啟惠) said yesterday that Taiwan should step up its efforts to expand cooperation with China in clinical research, after the two sides concluded a medical cooperation agreement in December 2010.