Biotech Values

[kamehameha]

Provided TMC435 and 7977 make it to market, even in the absence of the FDA formally approving the combo and in the absence of any formal deal between the two companies, it's likely doctors will prescribe the drugs in combo anyways.

most doctors know about the experiences with nucs in Chronic Hepatitis B

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2861763/

and will want to rely on test results, rather than risking law suits.

"The side effect profile for the five approved agents was generally good during registration trials, but there have been reports of serious adverse events including myopathy, neuropathy, pancreatitis and renal impairment during post marketing surveillance."

"The five approved oral agents for CHB are analogues of nucleosides or nucleotides that pharmacologically inhibit the HBV polymerase in order to decrease viral replication and serum HBV DNA levels. ... All five approved agents carry a US Food and Drug Administration black box warning of potential mitochondrial toxicity "

"Another important consideration is lactic acidosis, for which all five approved oral agents carry a black box warning."