ViewPoints: Roche's follow-on biologic strategy validated in three steps

Swiss pharmaceutical manufacturer Roche enjoyed a positive stream of news flow last week, which provided further validation of the strategic approach it is taking to protect the revenue it generates from its three biggest cancer products: Rituxan, Herceptin and Avastin.

Insight, Analysis & Opinion

GA101 superior to Rituxan

On Wednesday, the company unveiled top-line data demonstrating that its experimental late-stage drug GA101 was superior to Rituxan in a Phase III trial for patients with previously untreated chronic lymphocytic leukaemia (CLL).

Positive stage 2 data for GA101 does not come as a surprise; the drug has already been filed for CLL in the US and EU on the back of stage 1 data (the FDA has granted GA101 both breakthrough therapy status and priority review). However, that final data was reached at an interim analysis, well ahead of the expected completion date in 2014, would appear to demonstrate that GA101 has a better than expected progression-free survival benefit versus Rituxan, noted analysts at Goldman Sachs.

Full data from the study – in addition to early-stage data for GA101 in combination with other chemotherapies – will be presented at the ASH annual meeting in December. Goldman Sachs analysts believe that the drug will steadily replace Rituxan as the standard of care in CLL, which accounts for approximately 20 percent of oncology sales generated by the franchise.

Data from studies comparing GA101 to Rituxan in larger indications – including the prominent non-Hodgkin’s lymphoma indication – are expected to read out from 2016 onwards. Analysts note that the performance of GA101 in CLL should firm up confidence ahead of these results.

Delay to Rituxan biosimilar causes Teva/Lonza joint venture to collapse

Concurrent to Roche achieving incremental momentum in its Rituxan defence strategy via the GA101 results, the company received a further boost on Thursday when Teva and Lonza confirmed the termination of their biosimilars joint venture. The future of this collaboration has been in doubt since April when Lonza announced it was reassessing the strategic assumptions that had been made when the deal was first signed. In turn, this reassessment appears to have been driven heavily by reports in October that Teva had suspended Phase III studies for its biosimilar version of Rituxan.

One swallow does not make a summer, but the decision by Teva and Lonza to go their separate ways provides further evidence that there are no easy pickings in the race to develop biosimilars, a trend that will be welcomed by Roche and other branded biologic players.

Q2 results demonstrate commercial feasibility of Roche's follow-on strategy

Further validation of Roche's strategy to defend its key oncology MAb franchises via the launch of more efficacious follow-up products was provided by the company’s Q2 results, also published on Thursday.

The company’s financial results both reiterated the significance of Rituxan, Herceptin and Avastin in driving Roche’s top-line performance (the three drugs accounted for 53 percent of total pharma sales during the first half of 2013), but also demonstrated the steady commercial emergence of Perjeta and Kadcyla – two potential successor products to Herceptin in the HER2-positive breast cancer market. Roche indicated that Perjeta is steadily increasing its penetration in the first-line setting in the US market and European launch (still early) should gain momentum in H2.

Q2 sales performance and management sentiment for Perjeta and Kadcyla confirm positive momentum as demonstrated by a FirstWord Physician Views poll conducted in late May. FirstWord Pharma PLUS users can access the results here.

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