AVASTIN® (bevacizumab):
• On November 18, 2011, the Food and Drug Administration (FDA) revoked Avastin’s approval for the treatment of breast cancer tumors that are not positive for the HER2 gene. This decision does not affect any of the Avastin’s other approvals, as Avastin is approved and used to treat several different types of cancer.
• Genentech announced that it will start a Phase 3 trial in 2012 of Avastin plus a chemotherapy agent, paclitaxel, in breast cancer patients who have not yet been treated, but have cancer that has spread beyond the breast.
• EMEA narrowed, but did not withdraw, approval to treat patients with breast cancer that do not test positive for the HER2 gene with Avastin in combination with paclitaxel or with Xeloda.
• In December 2011, Avastin received approval in the EU for the treatment of women with newly diagnosed advanced ovarian cancer. This allows the use of Avastin in combination with standard chemotherapy (carboplatin and paclitaxel) for the front-line treatment (first-line treatment following surgery) of specific types of ovarian cancers including advanced epithelial ovarian, primary peritoneal or fallopian tube carcinoma.
LUCENTIS® (ranibizumab):
• On November 18, 2011, FDA approved Regeneron and Bayer’s Eylea (aflibercept) for the treatment of age-related macular degeneration (AMD). In February 2012, Regeneron reported that Eylea has been given to more than 30,000 patients since launch, and while there have been reports of inflammation inside the eye, it is within the expected incidence included in the Eylea medical literature.
• The FDA approved a dosing schedule of monthly injections for the first three months and bi-monthly injections thereafter.
• Eylea costs $1,850, $100 per injection less than Lucentis, which costs $1,950 per injection.
• On January 3, 2012, Regeneron and Genentech announced a settlement of their patent litigation regarding Eylea under which Regeneron will pay royalties to Genentech on Eylea sales.
TYSABRI® (natalizumab):
• As of December 2011, Biogen Idec estimates that approximately 64,400 patients were on commercial and clinical TYSABRI therapy worldwide.
Updates on Selected Development Stage Potential Royalty Bearing Products
PERTUZUMAB:
• In December, Roche and Genentech filed regulatory applications in the EU and US to market a drug called pertuzumab for the treatment of breast cancer that is positive for a gene called HER2 and has spread beyond the breast. The submissions are based on study results which showed that pertuzumab combined with Herceptin and chemotherapy significantly extended the length of time patients live without the cancer growing when compared with Herceptin and docetaxel alone.
• In February 2012, Roche announced that FDA accepted the company’s BLA for pertuzumab and grated Priority Review with an action date of June 8, 2012. Pertuzumab is under review for use in combination with two other drugs – Herceptin and docetaxel chemotherapy – for women with breast cancer that test positive for the HER2 gene where the breast cancer has spread beyond the breast, has recurred in the breast, or cannot be surgically removed, and where they woman has not been treated or relapsed after a treatment designed to eliminate all cancer.