Regeneron Pharmaceuticals, Inc. has entered into agreements with Genentech, Inc. relating to the worldwide sales of EYLEA (aflibercept) Injection and ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion (also known as aflibercept outside of the United States). These agreements resolve all pending litigation with Genentech over EYLEA and ZALTRAP worldwide. Regeneron and Genentech entered into an Amended and Restated Non-Exclusive License and Settlement Agreement, effective as of May 17, 2013 (the Amended Agreement), which amended their Non-Exclusive License and Partial Settlement Agreement, dated December 31, 2011 (the Original Agreement), relating to the sales of EYLEA in the United States to now include all sales of EYLEA worldwide. Under the Amended Agreement, Regeneron received a worldwide non-exclusive license to certain patents relating to VEGF receptor proteins, known as the Davis-Smyth patents, and certain other patents, for the prevention or treatment of eye diseases and eye disorders in a human through administration of EYLEA to the eye (the ocular field). The Davis-Smyth patents are the subject of patent litigation between Regeneron and Genentech relating to EYLEA, now pending in the United States District Court, Southern District of New York, which will be dismissed pursuant to the Amended Agreement. Regeneron will make payments to Genentech based on sales of EYLEA in the United States and EYLEA manufactured in the United States and sold outside the United States through May 7, 2016 using the same milestone and royalty rates as in the Original Agreement. EYLEA is sold outside the United States by affiliates of Bayer HealthCare LLC under a license and collaboration agreement (the Bayer Agreement). Under the Original Agreement, a $60 million milestone payment was made when cumulative U.S. sales reached $400 million, and Regeneron is obligated to pay royalties of 4.75% on cumulative relevant sales of EYLEA between $400 million and $3 billion and 5.5% on any cumulative relevant sales of EYLEA over $3 billion. All payments to Genentech under the Original Agreement and the Amended Agreement are made by Regeneron. Bayer HealthCare will share in all such payments based on the proportion of ex-U.S. EYLEA sales to worldwide EYLEA sales and determined consistent with the Bayer Agreement. Regeneron, Genentech, Sanofi U.S. Services, Inc. and Sanofi-Aventis U.S. LLC (the latter two entities, collectively, Sanofi) entered into a Non-Exclusive License and Settlement Agreement, effective as of May 17, 2013 (the Zaltrap Agreement), under which Regeneron and Sanofi (Regeneron's global marketing partner for ZALTRAP) received a worldwide non-exclusive license to the Davis-Smyth patents, and certain other patents, in all indications for human use other than the ocular field. The Davis-Smyth patents are the subject of patent litigation between Sanofi, Regeneron and Genentech relating to ZALTRAP now pending in the United States District Court, Southern District of New York, which will be dismissed pursuant to the ZALTRAP Agreement. Under the terms of the ZALTRAP Agreement, Sanofi and Regeneron will make payments to Genentech based on sales of ZALTRAP in the United States and of ZALTRAP that is manufactured in the United States and sold outside the United States through May 7, 2016. Sanofi and Regeneron will pay $19 million upon cumulative relevant sales of ZALTRAP reaching $200 million. The companies will also pay royalties of 4.5% on cumulative relevant sales of ZALTRAP between $400 million and $1 billion and 6.5% on any cumulative relevant sales of ZALTRAP over $1 billion.

Genentech announced the first results from CLL11, a Phase III study of the investigational medicine GA101 which is being conducted in collaboration with the German CLL Study Group (GCLLSG). The CLL11 study compared the combination of either GA101 or Rituxan(R) (rituximab) and chlorambucil, a standard chemotherapy, to chlorambucil alone in chronic lymphocytic leukemia (CLL). CLL is one of the most common forms of blood cancer and in 2013, it is expected that there will be nearly 5,000 deaths from CLL in the United States. The CLL11 study included elderly people with previously untreated CLL who were often not able to tolerate existing aggressive treatment options. GA101 combined with chlorambucil demonstrated a significant 86% reduction in the risk of disease progression, relapse or death. Additionally, the length of time during which people lived without their disease worsening was more than doubled when compared to chlorambucil alone. GA101 is the first type II anti-CD20 medicine that is glycoengineered, which means specific sugar molecules in GA101 were modified to change its interaction with the body's immune cells with the goal of helping the immune system remove cancer cells from the body. In addition, as a type II anti-CD20 antibody, GA101 binds to CD20 with the aim of killing cancerous cells directly. Based on the CLL11 data, marketing applications have been submitted to regulatory authorities including the European Medicines Association and the FDA. The FDA has granted GA101 Breakthrough Therapy Designation. This designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. Genentech will open an Expanded Access Program to provide GA101 to people with CLL under certain circumstances while the company seeks regulatory approval.

Genentech and Astellas Pharma US, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Tarceva(R) (erlotinib) tablets for the initial (first-line) treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR) activating mutations as detected by an FDA-approved test. The FDA also approved the cobas(R) EGFR Mutation Test, which was developed by Roche and validated in the pivotal EURTAC study. In the study, treatment with Tarceva demonstrated that patients lived longer without their disease getting worse (median progression-free survival [PFS] 10.4 months vs. 5.2 months; HR=0.34; p<0.001 [95% CI 0.23 to 0.49]) compared to chemotherapy. The safety profile for Tarceva in the EURTAC study was consistent with previous studies of Tarceva in NSCLC. In the United States, Tarceva is already approved, irrespective of histology or biomarker status for people with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment). Tarceva is also approved for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (second- or third-line treatment). Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC. This FDA approval for Tarceva is based on the results of the Phase III EURTAC study, which evaluated the first-line use of Tarceva versus platinum-based chemotherapy in people with EGFR-activating mutation-positive advanced NSCLC. Tumor shrinkage (response rate) was observed in 65% of patients treated with Tarceva and 16% of patients treated with chemotherapy. The most frequent (greater than or equal to 30%) adverse events in Tarceva-treated patients were diarrhea, weakness, rash, cough, shortness of breath and decreased appetite. The most frequent Grade 3-4 reactions in Tarceva-treated patients were rash and diarrhea.