Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY) has suffered a major setback on the use of a proposed blood cancer drug to offset the threat posed by biosimilars on its lead drug Rituxan. Its candidate drug Gazyva has failed to show significant improvement to Rituxan in a Phase III trial.
Disappointing Phase III Results
According to posted results, Gazyva failed to meet primary endpoint that sought to reduce the risk of disease worsening or leading to death. The results are a big blow to the Swiss-based drug maker given that the drug had initially shown positive results when used to treat follicular lymphoma and chronic lymphocytic leukemia. Trials had shown that the drug could help patients live longer compared to Rituxan.
Roche Holding head of global product development, Sandra Horning, says they are currently studying the results with a view of seeing whether the drug can be used in other conditions.
A successful trial would have provided Roche the much-needed shield for Rituxan whose sales could come under pressure as biosimilars flood the market. Sales for the drug are expected to top highs of $7.37 billion this year before decelerating as other cheaper options come to market.
Gazyva is currently approved for the treatment of chronic lymphocytic leukemia in combination with chlorambucil. Early this year the FDA approved its use in combination with bendamustine for the treatment of follicular lymphoma in patients who do not react to Rituxan-containing regimen. Its sales could top highs of $256 million this year having received the much-needed approval in the UK.
Roche Courting BioMarin
Separately, reports indicate that Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY) is considering tabling a takeover bid for rare disease biotech BioMarin Pharmaceutical. According to people familiar with the matter, Roche is yet to table a bid but its executives are closely studying the possibility of tabling one.
Sanofi is also believed to have shown interest in acquiring BioMarin Pharmaceutical Inc. (NASDAQ:BMRN). However, that may not occur given that it has already signed a non-disclosure agreement as it inches closure to completing the acquisition of Medivation.