Lucentis Faces Academic Challenge
This article was originally published in The Pink Sheet Daily
Executive Summary
Funding for a multi-center trial to compare Genentech’s approved macular degeneration therapy with oncologic Avastin, used off-label to treat the disease, depends on NIH’s pending FY 2007 budget.
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The National Eye Institute is poised to award approximately $5 mil. for the first year of a multicenter trial to compare two angiogenesis inhibitors manufactured by Genentech in the treatment of advanced age-related macular degeneration (AMD), the agency told "The Pink Sheet" DAILY. The study will compare Lucentis (ranibizumab) and Avastin (bevacizumab), which is approved for treating colorectal cancer, but not for ophthalmic use - though it is "widely used off-label to treat advanced AMD," NIH noted. Lucentis was approved June 30 for treatment of wet age-related macular degeneration (1 (Also see "Genentech’s Lucentis Ships June 30 Following Approval" - Pink Sheet, 30 Jun, 2006.)). "The new comparative study will assess the relative safety and effectiveness" of the two, NEI said. Funding for the study, to be headed up by Emory University, is tied to NIH's FY 2007 funding, which was not in place at the start of the fiscal year Oct. 1 and now awaits post-election action by Congress. Two editorials in the Oct. 5 New England Journal of Medicine outline the case for such a study. "Since the two have never been directly compared, physicians can only speculate about which drug is superior with regard to safety, efficacy and frequency of administration," writes NEJM. "The price difference is also too big to ignore." According to the NEJM editorial the wholesale acquisition cost of a single 0.5 mg (0.05 ml) dose of ranibizumab is $1,950, compared to a 4-ml vial of bevacizumab, which contains 100 mg and has a wholesale acquisition cost of $550. An oncologic, bevacizumab is formulated for intravenous infusion, and must be prepared by compounding pharmacies or by physicians in syringes for intraocular injection, at an added expense of $17 to $50, according to the editorial. In 2005, within six months from the time a University of Miami ophthalmologist published two case reports citing benefit from intraocular injection of bevacizumab "the intraocular use of bevacizumab had spread around the world," NEJM states. In a second editorial, Edwin Stone (University of Iowa) notes that "a large and growing body of anecdotal experience and at least four clinical studies (which were admittedly uncontrolled and short-term) suggest that bevacizumab is an effective treatment." That "coupled with the fact that the cost of this drug is less than 1/10 that of ranibizumab, suggest that a head-to-head comparison of the two drugs is warranted," Stone argues. Genentech told "The Pink Sheet" DAILY it has no plans to study or develop Avastin for ophthalmic use. Instead, the company is focused on "making sure that the cost [of Lucentis] to patients is not a barrier to" the drug. The only other anti-VEGF therapy approved by FDA for treatment of AMD is Pfizer/OSI Pharmaceuticals' Macugen (pegaptanib), approved in December 2004. It is not included in the NEI study. OSI recently announced plans to curtail research on Macugen due to slumping revenues stemming from the launch of Lucentis (2 (Also see "Pfizer/OSI To Curtail Macugen Research In Response To Genentech Competition" - Pink Sheet, 8 Aug, 2006.)). -Shirley Haley ([email protected]) |