China Pharma Holdings Completes Phase I Trial of Antibiotic

Sep.23.10 | About: China Pharma (CPHI)

China Pharma Holdings (NYSEMKT:CPHI) announced it has completed Phase I trials of its novel cephalosporin antibiotic. The drug candidate combines a third generation cephalosporin with a bacterial-enzyme inhibitor to increase its effectiveness against resistant strains of bacteria, including hospital-acquired and respiratory infections, bacterial meningitis, and pneumonia.

According to the SFDA, about 50% of antibiotic revenues are cephalosporin-based antibiotics, making them the most widely used class of antibiotics in China. Sales of cephalosporin antibiotics are estimated to reach $7.5 billion in 2010, a figure that is expected to rise to $17.4 billion in 2015. Because of their use, resistance is becoming a problem.

China Pharma Holdings expects that its new combination antibiotic will carve out a niche in this market. The company hopes revenues for the product will attain the $50 million level within three years of product launch. The SFDA has conferred the Class 1 drug designation on the combination antibiotic. That gives it five-year exclusivity after approval.

The combination of cephalosporin and a beta-lactamase inhibitor has demonstrated a 95% efficacy in the lab against drug-resistant extended-spectrum beta-lactamase (ESBL) producing bacteria, such as the enterobacteriaceae family. It has also shown greater activity against microorganisms like anaerobic bacteria and pseudomonas, which are not susceptible to the cephalosporin component alone.

The company pointed out that cephalosporin has been included in China’s Essential Drug List. By combining the drug with a beta-lactamase inhibitor, China Pharma Holdings hopes to provide hospitals a competitive advantage for fighting difficult infections.

In October 2008, China Pharma Holdings was originally given SFDA approval to begin clinical trials of the antibiotic combination formula.

Disclosure: none.