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Competition Heats Up in Macular Degeneration

Regeneron/Bayer’s VEGF Trap-Eye versus Genentech’s Ranibizumab … and Avastin versus Advanced Cell Technology’s stem cell therapy.

Regeneron Pharmaceuticals and Bayer HealthCare announced 2 Phase 3 studies with VEGF Trap-Eye in wet age-related macular degeneration met the primary endpoint compared to the current standard of care, Ranibizumab dosed every month.

  • Regeneron Pharma (NASDAQ:REGN) and Bayer said that the primary endpoint was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to Ranibizumab;
  • Ranibizumab (trade name Lucentis) is a monoclonal antibody fragment  derived from the same parent murine antibody as bevacizumab (Avastin). It is much smaller than the parent molecule and has been affinity matured to provide stronger binding to VEGF-A;
  • It is an anti-angiogenic that has been approved to treat the “wet” type of age-related macular degeneration (ARMD), a common form of age-related vision loss.
  • However, some investigators believe that bevacizumab at a cost of $42 a dose is as effective as ranibizumab at a cost of over $1,593 a dose;
  • Ranibizumab was developed by Genentech and is marketed in the US by Genentech and elsewhere by Novartis under the brand name Lucentis.

In testing, an experimental drug being developed by Regeneron (REGN), when injected (into the eye) every 8 weeks proved effective.

  • However, Lucentis from Genentech (Private:DNA) can restore a person’s ability to drive and read, in some cases. But the drug works best when given every 4 weeks, which can be inconvenient for patients and doctors. Doctors often give Lucentis less frequently, but even if that regimen produces good results, patients must still get check-ups every month to make sure their vision is not deteriorating;
  • REGN’s drug will/could face competition from off-label use of DNA’s cancer drug Avastin. When used in the eye, Avastin costs about $50 a dose, compared with about $1593 for Lucentis. Still, even with such low-priced competition, Lucentis has sales exceeding $2 B globally;
  • Also,  announced 11/22/10, was Advance Cell Technology (ACTC.OB) receiving clearance to test its stem cell therapy on 12 adults with severe vision loss caused by an inherited Stargardts Disease;
  • ACTC.OB has turned human embryonic stem cells into retinal pigment epithelial cells, which will be surgically implanted into the eye. The hope is that the implanted cells will replace those injured by the disease. Human embryonic stem cells (hESCs) are controversial … embryonic cells can also form tumors  if injected into the body.  But, ACTC.OB has to prove to the FDA that its retinal cells contained virtually no residual embryonic stem cells;
  • It is likely to be several years before such a treatment can reach the market, if it works;
  •  Still, even starting the trial is a boost to ACTC.OB.