Roche nabs European approval for time-saving formulation of Rituxan

MabThera--Courtesy of Roche

A common tactic for pharma companies facing patent expirations is to try to extend the lives of blockbuster drugs by developing new formulations or follow-on products that offer some sort of advantage over the original. Swiss pharma giant Roche ($RHHBY) is pursuing that game plan for some of its hit biotech drugs--and today it scored a victory when European regulators approved a subcutaneous version of its cancer drug Rituxan (rituximab), known as MabThera overseas.

The new formulation, which was approved to treat some patients with non-Hodgkin lymphoma, cuts the treatment time from two-and-a-half hours for the original intravenous version to 5 minutes. "We believe that the faster 5-minute administration will significantly improve the treatment experience for patients and providers," said Dr. Sandra Horning, Roche's chief medical officer and head of global product development, in a statement. The company says it intends to launch subcutaneous MabThera in a number of European markets this year.

Rituxan/MabThera has been on the market for 15 years and is still a major growth driver for Roche. It was one of the world's 10 best selling drugs last year, hauling in $7.5 billion worldwide. But the patent on the drug expires in 2018, and rivals hoping to market biosimilar versions are looming. Novartis' ($NVS) Sandoz unit and Boehringer Ingelheim are both in Phase III trials of their rituximab products.

Roche has adopted a multipronged defensive strategy against biosimilar competition, and developing more convenient formulations of its drugs is part of that plan. Last fall, the company won European approval for a subcutaneous version of its breast cancer drug Herceptin (trastuzumab). Roche also continues to aggressively defend its patents, most recently suing Mylan ($MYL), Biocon, and the Drug Controller General of India for launching a biosimilar version of Herceptin that Roche says has not been properly tested. The Delhi High Court placed an injunction on the copies.

Another element of Roche's strategy is to improve upon its past hits, developing follow-on biotech drugs that it hopes will prove more effective than the originals. Late last year, the company presented promising data on its Rituxan successor, Gazyva. In a head-to-head trial against Rituxan in patients with chronic lymphocytic leukemia (CLL), Gazyva combined with chemo helped patients live a median of 26.7 months without their cancer progressing, compared with 15.2 months for the Rituxan-plus-chemo cocktail.

- here's the Roche statement
- read more at Reuters

Special Report: The 10 best selling drugs of 2013 - Rituxan/MabThera