The FDA panel unanimously recommended the approval of Eylea

So it's official!

The FDA panel met today to decide on the effectiveness and safety of Regeneron's Eylea (love it!) and agreed unanimously that it is.  With the FDA panel backing of its approval, Eylea (VEGF-Trap-Eye) is now set to wait for the decision from the FDA which will happen on August 20, 2011.

Although the FDA is not required to follow the Panel's recommendation, it usually does.  With the data
collected for Eylea, the chance of it being approved is quite high.

Regeneron's stock is not traded in today session due to the meeting of the panel.  If approved, Eylea will be directly competing with Lucentis for the treatment neovascular form of age-related macular degeneration).

If approved, Eylea is to be dosed once every two months which is an advantage when compared to a once a month dosing of Lucentis.

About aflibercept ophthalmic solution or VEGF Trap-Eye

• It's a fully human, soluble VEGF receptor fusion protein.  It's capable of binding to all forms of VEGF-A in addition to other vascular growth factor such as the Placental Growth Factor.  VEGF Trap-Eye has high specificity for VEGF-A and PIGF.
• Bayer and Regeneron have entered into an agreement (in 2006) under which they will collaborate to develop VEGF Trap-Eye globally.  Regeneron retains exclusive rights to VEGF Trap-eye in the US while Bayer has rights to market VEGF Trap-eye outside of the US.  Both companies will share profits equally once VEGF Trap-Eye is commercialized.

 About the agreement between Bayer and Regeneron:

• In 2006, both companies entered into collaboration agreement to develop and commercialize VEGF Trap-Eye for treatment of eye disease.  Under the agreement, both companies will commercialize VEGF Trap-Eye together and share equal profits for product sales outside the US.  Regeneron retains commercialization rights in the US.
• As part of the agreement, Bayer paid an upfront payment of $75M to Regeneron. 
• Initially, Bayer and Regeneron will share the global development cost for VEGF Trap-Eye (as the agreement signed in 2006, the development cost will not be shared equally in 2007 and 2008 but in 2009 all expenses that are toward the development of VEGF will be shared equally).
• Regeneron is entitled to receive up to $110M in milestone payments as the compound reaches certain regulatory and clinical development for wet AMD and DME or other indications in countries other than the US.  Of this $110, 40M will be coming from the initiation of the phase III trial as potential treatment for wet AMD and DME.
• If VEGF Trap-Eye is approved in markets other than the US, Regeneron will use 50% share of the VEGF-profits outside the US to reimburse 50% of the development costs that Bayer has incurred.
• Regeneron will also be eligible to receive up to $135M in milestone sales if product sales outside of the US reaches certain levels starting at $200M.