its progression-free survival (PFS) endpoint, and the results are being submitted for presentation at European Society for Medical Oncology (ESMO) (Sept. 27-Oct. 1). Roche anticipates data in the first-line setting from the MARIANNE trial in 2014 and indicates that it expects to file for approval in 2015 (previously
Roche announced that CH5424802/RO5424802 has entered a two part Phase II study in anaplastic lymphoma kinase positive metastatic non-small cell lung cancer (ALK+ NSCLC) patients that have failed Xalkori. This 215-paitent study has a dose escalation phase and followed by an expansion phase. It is unclear if Roche/Chugai will elect to file for accelerated approval based on this Phase II study, which would put them slightly ahead of Ariad Pharmaceuticals' (ARIA) AP26113. Roche initiated the trial in the second quarter and expects to have some data at ESMO, though we would expect these results to be very preliminary. Ariad and Tesaro (TSRO) also plan to present new data from ongoing studies of their ALK inhibitors.
Roche reported second-quarter results and provided updates for products that are either partnered or competitive with covered companies.
The most incremental updates included sales data for Kadcyla (partner ImmunoGen (ticker: IMGN)) and Lucentis (competitor Regeneron Pharmaceuticals (REGN)) and plans to partner its anti-PCSK9 antibody (competitor Regeneron).
Roche's [of Switzerland] Lucentis sales were up 9% sequentially, driven largely by growth in diabetic macular edema (DME). The growth of Lucentis in DME is a positive forward indicator for the market potential of Regeneron's Eylea in new indications. The age-related macular degeneration (AMD) segment continues to be under pressure, and we expect Eylea to continue to grow in the AMD market. We forecast $324 million of revenue for Eylea in the second quarter, up 3.2% over the first quarter. Roche's Actemra [rheumatoid arthritis] was also strong, which is positive for the future market opportunity of Regeneron's sarilumab. We believe that the subcutaneous formulation for Actemra will drive future growth. This formulation was recently approved in Japan (March 2013) and Food and Drug Administration/European Medicines Agency (FDA/EMA) approval could come in the second half. Roche disclosed plans to seek a partner for further development of its PCSK-9 antibody [regulating cholesterol in the bloodstream], potentially suggesting a non-differentiated profile emerging from the Phase II study. Additionally, Eli Lilly (LLY) announced on its second-quarter earnings call that it has an anti-PCSK antibody in Phase II development.
Kadcyla [metastatic breast cancer] is off to a good start. ImmunoGen will receive a 3% royalty booked on a one-quarter lag or approximately $2.1 million in the first quarter of fiscal 2014 (versus our estimate of $1.7 million). The next data for Kadcyla will be the TH3RESA trial in third-line Her2-positive breast cancer. Roche previously reported that the trial met.
Agreed / still in phase 2 - and just because ROCHE is trying to get it fast tracked does not mean they will succeed in getting the fast track and/or FDA approval
ARIAD's Inclusig is approved and selling in US and Europe, we should have great earnings and great forecasts - this article will be shrugged off / the facts / the science / the sales are on ARIAD's side
short covering will bring it over 19 by EOD. Barron's always does this kind of dirty work.
ARIA has one drug in market for cancer already. With its several candidates in the pipeline, it could be 10bln company in a few years, like ONXX, PCYC and REGN.