Drug & Device Development

Human Genome hepatitis C drug disappoints, shares crash

Last Updated: 2009-03-09 17:41:45 -0400 (Reuters Health)

By Jennifer Robin Raj

BANGALORE (Reuters) - Human Genome Sciences' drug to treat chronic hepatitis C - Albuferon -- met the main goal in a late-stage trial, but failed to show better efficacy compared to the standard-of-care, raising questions about the drug's adoption and sending shares crashing to an all-time low.

Analysts had expected the trial to meet its main goal of non-inferiority compared to Pegasys, but they had also said that the trial must show numerically better sustained virologic response (SVR) rates to convince the market of the drug's commercial viability.

In the trial, named ACHIEVE 1, patients were either given the drug

every 2 weeks or standard-of-care Pegasys once weekly and the company said the rate of SVR among the two groups was "comparable."

"This means that you have a drug that is statistically comparable but for the vast majority of prescribers who have used Pegasys for ever, they are not going to change their prescribing trends based on this data," said Piper Jaffray analyst Edward Tenthoff.

The current standard of care for hepatitis C is antiviral ribavirin in combination with an interferon. Human Genome's Albuferon, another type of interferon known generically as albinterferon alfa-2b, was also being studied in combination with ribavirin.

Interferons currently in the market are Roche's Pegasys and Schering-Plough Corp's PegIntron. Interferon treatment is hard to tolerate and can cause flu-like symptoms, fatigue and depression.

Patients on the arm receiving 900 micrograms of Albuferon had SVR rates of 48.2 percent, while patients on the Pegasys arm achieved SVR rates of 51.0 percent.

Patients originally randomized to receive 1,200 micrograms of Albuferon had SVR rates of 47.3 percent.

"SVR rate is the key prescribing criteria (for physicians). With a numerically inferior SVR rate, Albuferon will have difficulty unseating market leader Pegasys," said Tenthoff, who downgraded the stock to "neutral".

Albuferon's sole benefit is less frequent dosing but the trial did not show the quality of life benefits observed in prior studies, Tenthoff said and cut his price target on the stock to $1.70 from $6.

A higher rate of pulmonary adverse events and discontinuations in the Albuferon arm may limit its ability to take market share from Pegasys, said Leerink Swann's Joseph Schwartz.

Human Genome is developing Albuferon in partnership with Swiss drugmaker Novartis under an agreement signed in June 2006 and expects to file for marketing approvals globally in the fall of 2009.