Human Genome hepatitis C drug disappoints, shares crash

BANGALORE (Reuters) - Human Genome Sciences' HGSI.O drug to treat chronic hepatitis C met the main goal in a late-stage trial, but failed to show numerically better efficacy compared to 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 Albuferon every two 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, which is a type of interferon, was also being studied in combination with ribavirin.

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

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.

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.

The company also has $404 million in convertible debt due in 2011 and 2012.

“We project Human Genome has sufficient cash to reach Albuferon approval next year. However, we believe the debt will remain an overhang and negatively impacts our cash flow projection,” Piper’s Tenthoff added.

Human Genome is developing Albuferon in partnership with Swiss drugmaker Novartis NOVN.VX under an agreement signed in June 2006.

The company expects to file for marketing approvals globally in the fall of 2009.

Shares of Human Genome, which touched an all-time low of 80 cents, recovered some losses to trade at 95 cents in midday trade on Nasdaq.

Editing by Himani Sarkar