Roche Holding Ltd. (RHHBY) recently announced the European approval of Tarceva (erlotinib) for first-line use in patients with a genetically distinct type of advanced non-small cell lung cancer (NSCLC). The drug is already marketed as a treatment for advanced lung cancer after platinum-based chemotherapy.
We note that Roche is in talks with the US Food and Drug Administration (FDA) to gain approval to use Tarceva as a first-line treatment in people with advanced EGFR (epidermal growth factor receptor) activating mutation-positive NSCLC. Moreover, the company is in talks to gain approval for the use of a companion diagnostic test to help identify patients with activating EGFR mutations, who are appropriate candidates for Tarceva.
While Roche holds the marketing rights to the drug in the US and the European Union (EU), it has a global development and marketing alliance with Astellas Pharma for Tarceva, whereby Astellas and Roche evenly split the sales effort for marketing the drug.
Tarceva primarily faces competition from Eli Lilly & Co.’s (LLY) Alimta, Sanofi-Aventis’ (SNY) Taxotere and AstraZeneca plc’s (AZN) Iressa.
It has been quite an eventful quarter for Roche so far, with the FDA approving Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma (skin cancer) last month. The company is also seeking approval of Zelboraf for the said indication in the EU, Switzerland, Australia, New Zealand, Brazil, India, Mexico and Canada.
Also last month, the European Commission approved RoActemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients aged two years and above. The patients had responded inadequately to treatments by NSAIDs (nonsteroidal anti-inflammatory drugs) and systemic corticosteroids.
Outside Europe, where RoActemra is marketed as Actemra, the drug is already available as a treatment for active sJIA in patients two years and older.
Earlier, in July, Roche and Merck & Co. Inc. (MRK) inked a worldwide non-exclusive agreement to market the triple combination therapy, which includes Merck’s Victrelis (boceprevir), peginterferon alfa and ribavirin. The combination drug is targeted at treating hepatitis C virus (HCV). According to the agreement, Roche and Merck will work together worldwide and educate physicians and patients about HCV.
Victrelis is approved worldwide for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in treatment-indifferent adults with compensated liver disease.
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
MERCK & CO INC (MRK): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment