Genovate, ScinoPharm to jointly develop new-generation oral Hepatitis B drug Livepro

Genovate Biotechnology Co. Ltd. (4130:TT) and ScinoPharm Taiwan Ltd. (1789:TT) announced today that they have jointly developed the highly potent oral generic drug Livepro (Entecavir), representing a new generation of drugs for the treatment of Hepatitis B. It is expected to be commercially available by the end of the year in Taiwan, accounting for more than NT$2 billion (US$70 million) worth of market opportunity.

The new-generation oral Hepatitis B drug Livepro is a drug jointly developed by Genovate and ScinoPharm. Both companies combined their resources with ScinoPharm being responsible for the development and manufacturing of the active pharmaceutical ingredient for Livepro, "Entecavir". Additionally, formulations were developed with the joint involvement of Genovate in order to enter the markets in Taiwan and China.

Jo Shen, President and CEO of ScinoPharm, stated, "This collaboration with Genovate signifies ScinoPharm's strategic move into the formulation development field. Livepro is the first commercially available product produced through the company's branching out into the field of formulation, specifically its "double A" strategy (API + ANDA) of combining Active Pharmaceutical Ingredient manufacturing with formulations required in Abbreviated New Drug Applications (ANDA). The company's strategy is to respond to customers' demand for high-quality drugs through its one-stop shop services."

Jen Chen, CEO of Genovate, noted, "Formulation drug development engaging in upward vertical integration with active pharmaceutical ingredient sources and starting from the process patent, combined with formulation design will add products' value and ensure market niche. ScinoPharm boasts world-class API development and manufacturing capacity. The cooperation between Genovate and ScinoPharm is a win-win strategy devised through the expertise of both sides. Additionally, patients will also benefit from it, making it a triple-win collaboration model." He further stressed, "The launch of Livepro is not for vying for existing market share but to extend the overall demands and save more untreated patients, because less than 20% of the estimated three million people with hepatitis B actually receive treatment. Potential patients should be encouraged to come forward for treatment."

According to the clinical data collected over the past two years, the drug not only effectively reduces the amount of the Hepatitis B virus to undetectable levels, but also produces no drug resistance after intake by patients. The therapeutic effect appears to be better than any other commercially available drug.

The treatment of chronic hepatitis B has been one of the most important medical issues in the field of medicine in Chinese society. Three million hepatitis B carriers in Taiwan, which accounts for one-eighth of the population, is under health threats associated with hepatitis B. According to the September 2010 issue of "The Journal of Hepatology", a clinical study by National Cheng Kung University reported that chronic hepatitis B patients' liver biopsies showed significant tissue improvement after continuous treatment for at least three years. In addition, their liver fibrosis or cirrhosis showed signs of recovery.