Regeneron says expansions, collaborations possible in VEGF Trap eye disease program

By Jennifer Lanning Drey

Eugene, Ore., June 9 - Regeneron Pharmaceuticals, Inc. is working to expand its eye disease program through the use of its Vascular Endothelial Growth Factor (VEGF) blocking technology and believes the program has the potential to create future collaborations, the company said in a presentation given at its annual shareholders meeting.

Age-related macular degeneration (wet AMD) is its initial target for expanding the VEGF Trap eye program. Diabetic macular edema and diabetic proliferative retinopahthy are additional opportunities, the company said.

Regeneron has a phase 2 clinical study in wet AMD underway and a phase 3 study planned for initiation in early 2007.

Preliminary testing showed a rapid, substantial and prolonged reduction in retinal thickness with VEGF Trap, which positioned the program for rapid expansion, the company said in the presentation.

Regeneron's goal is to develop a product with a more convenient dosing interval and greater improvement of vision at optimal dosing interval than wet AMD products that are close to or already on the market.

The company said results from its phase 3 program in the United States are likely to be compared to Lucentis (ranibizumab), which is being developed by Genentech, Inc.

By mid-2007, the company plans to have begun exploring additional indications in its eye disease program.

Regeneron owns 100% of the VEGF Trap eye program and would consider a collaboration partner.

In its oncology program, Regeneron has a major collaboration with sanofi-aventis in which sanofi-aventis funds global development of VEGF Trap in oncology and is primarily responsible for execution of its clinical trails.

VEGF Trap oncology is currently being tested in three separate single agent studies of late stage cancer patients with non-small cell lung adenocarcinoma, ovarian cancer and symptomatic malignant ascites.

In addition, the company has five phase 1b studies looking at VEGF Trap oncology in different chemotherapy regimens, and the company said early data showed encouraging responses observed in heavily pretreated patients.

A phase 3 program in scheduled to begin in the second half of 2006, and Regeneron said it expects to make its first VEGF oncology submissions for approval in 2007 or 2008.

In its IL-1 Trap program for inflammatory diseases, Regeneron has completed enrollment in its phase 3 pivotal study and has received fast-track and orphan-designation from the Food and Drug Administration.

The company said it plans to conduct a six-month placebo controlled, double-blind study and a six-month label extension study.

Top-line efficacy data should be available in the second half of 2006, and the company has plans to submit a Biologics License Application in the first half of 2007.

Regeneron said each of its clinical product candidates are designed to address a clinically validated target and each has an opportunity to expand to new disease settings. In addition, the company has defined a regulatory approval strategy for each of its product candidates.

Regeneron is a biopharmaceutical company located in Tarrytown, N.Y.

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