By Anna Yukhananov
WASHINGTON (Reuters) - A proposed eye medicine from Regeneron Pharmaceuticals and Bayer AG was found by U.S. drug reviewers to be an effective way of treating vision loss from macular degeneration, raising expectations it will be recommended for approval.
The drug, which be marketed under the trade name Eylea, is as effective as the similar Lucentis treatment from Roche Holding, Food and Drug Administration staff said in documents released on Wednesday. But Lucentis has monthly dosing, while Eylea would only have to be taken once every two months, making it more convenient for patients. Analysts forecast Regeneron could reap at least $1 billion in annual Eylea sales.
Both drugs may face competition from Roche's cancer drug Avastin, a much less expensive medicine that is often used by doctors to treat macular degeneration even though it has not been approved by the FDA for that purpose.
Analysts said the FDA did not raise any major issues with Eylea and expect an advisory panel to recommend approval on Friday. Shares of Regeneron closed up 5.1 percent to $57.82 on the Nasdaq, after earlier reaching a high of $61.05.
"This removes both risk and uncertainty," said Edward Tenthoff, senior research analyst at Piper Jaffray. "The FDA documents were very benign, which increases the likelihood of approval.
The drug, known as VEGF Trap-Eye, uses a mechanism similar to the one employed by Lucentis to preserve vision in patients with the wet form of age-related macular degeneration (AMD) -- the leading cause of blindness in the elderly.
Some 13 million Americans have signs of AMD and more than 1 million Americans have the wet form, the most severe type. Both drugs block vascular endothelial growth factor (VEGF), a protein involved in the creation of blood vessels. The condition progressively worsens as blood vessels leak fluid and blood under the retina, creating scar tissue.
In clinical trials, VEGF Trap-Eye injected every two months was as safe and effective in maintaining vision as Lucentis injections given monthly. The FDA will ask the advisory panel to review appropriate dosing and labeling at its meeting.
The FDA also asked the panel to look at higher intraocular pressure after frequent injections of VEGF inhibitors. This is a low-frequency side effect seen in all similar medications, including Lucentis.
Analysts said Eylea's less-frequent dosing should give it a boost over Lucentis and take market share from the rival in the United States and worldwide.
Roche shares closed down 1.6 percent on the Swiss stock exchange. Piper Jaffray's Tenthoff sees Regeneron taking 25 percent of the U.S. market by 2016, with sales of $1.2 billion.
Roche's Avastin is not licensed for use in the eye, but it works in a way similar to Lucentis, and the tiny amount needed for an eye injection costs only around $50, against a U.S. price of $1,950 for Lucentis and probably a similar price for Eylea.
Many doctors, particularly in the United States, already use Avastin "off label" to treat wet age-related macular degeneration. And analysts said more may start to prescribe it after an April study showed Avastin was as effective as Lucentis, though it had more side effects.
"The feedback we've gotten from clinicians is that many of the listed side effects were not plausibly related to Avastin's mechanism of action. So they were largely viewed as noise," said Stifel Nicolaus analyst Maged Shenouda.
"We expect Avastin to grow dramatically based on these (study) results, and for Lucentis to feel significant pressure."
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Table V-2. The concentrations of elements (in ppm, indicated otherwise) in the Earth's primitive mantle, and the enrichment factors ( ) relative to the carbonaceous chondrite CI.
Z Upper mantle
Ref. Z Upper mantle
Ref.
Ag-47 0.008 0.016 2 Mo-42 0.05 0.019 10
Al-13 % 2.2 1 1 to 4 N-7 *10 0.001 5, 6
As-33 *0.1 0.021 1 Na-11 % 0.26 0.2 1 to 4
Au-79 ppb 1 0.003 1, 2, 8 Nb-41 0.6 1 4
B-5 *0.3 0.12 14 Nd-60 1.23 1.1 7
Ba-56 6 1 7 Ni-28 2000 0.071 1 to 4
Be-4 0.06 1 7 Os-76 ppb 3.7 0.003 1, 2, 8
Bi-83 0.002 0.007 2 P-15 80 0.026 2, 3
Br-35 *0.005 0.0006 11 Pb-82 0.156 0.025 15
C-6 *150 0.0017 2 Pd-46 ppb 4.3 0.003 2, 5, 8
Ca-20 % 2.6 1.2 1 to 4 Pr-59 0.25 1.1 7
Cd-48 0.06 0.04 2, 6 Pt-78 ppb 7.6 0.003 8
Ce-58 1.7 1.1 7 Rb-37 0.54 0.089 9
Cl-17 *0.5 0.0003 11 Re-75 ppb 0.28 0.003 2, 8
Co-27 100 0.078 1, 2, 4 Rh-45 ppb 1 0.003 8
Cr-24 3200 0.48 1 to 4 Ru-44 ppb 5.5 0.003 8
Cs-55 0.013 0.03 12 S-16 180 0.0012 2
Cu-29 *28 0.09 1 Sb-51 *0.003 0.0083 2
Dy-66 0.66 1.1 7 Sc-21 17 1.1 1 to 6
Er-68 0.43 1.1 7 Se-34 0.05 0.001 1, 2, 5
Eu-63 0.15 1.1 1, 2 Si-14 % 21 0.78 1 to 6
F-9 *16 0.11 1 Sm-62 0.4 1.1 7
Fe-26 % 6.4 0.19 1, 2, 3 Sn-50 0.15 0.034 13
Ga-31 3.4 0.13 1 Sr-38 20 1 3, 4, 7
Gd-64 0.53 1.1 7 Ta-73 0.04 1 7
Ge-32 1 0.012 1, 2 Tb-65 0.1 1.1 1, 3
Hf-72 0.26 1 2, 3, 7 Te-52 0.011 0.002 2
Hg-80 *0.01 0.016 5, 6 Th-90 0.074 1 3, 6, 7
Ho-67 0.15 1.1 7 Ti-22 1100 1 1 to 4
I-53 *0.004 0.004 11 Tl-81 0.006 0.017 12
In-49 0.014 0.069 2 Tm-69 0.066 1.1 7
Ir-77 ppb 3.7 0.003 1, 2 U-92 0.02 1 6, 7
K-19 % 0.025 0.18 2 V-23 82 0.57 1, 4
La-57 0.64 1.1 7 W-74 0.016 0.068 1, 12
Li-3 1.6 0.42 1, 6 Y-39 4.1 1.1 3, 7
Lu-71 0.066 1.1 1, 3 Yb-70 0.45 1.1 1, 2, 3
Mg-12 % 22.2 0.9 1, 2 Zn-30 50 0.063 1 to 4
Mn-25 1000 0.2 1, 2, 3 Zr-40 10 1 4, 7
Ref.: 1) Jagoutz et al. (1979) and Waenke et al. (1984): spinel lherzolites; 2) Basaltic Volcanism Study Project (1981): spinel lherzolites; 3) Basaltic Volcanism Study Project (1981): Archean komatiites; 4) Nesbitt and Sun (1976): Archean komatiites; 5) Turekian and Wedepohl (1961); 6) Wedepohl and Muramatsu (1979); 7) the concentration in CI multiplied by 2.69 for REE (2.69 = weight ratio of Lu in spinel lherzolites over CI) or by 2.53 for others (2.53 = weight ratio of Al in lherzolites over CI); 8) 0.003CI (0.003 = weight ratio of Ir in lherzolite over CI); 9) Rb/Sr = 0.0270.003 obtained from the 87Rb/86Sr ratio of 0.0780.009 for the primitive mantle at present (Faure, 1986); 10) Newson and Palme (1984); 11) Waenke et al. (1984); 12) Sun (1982); 13) Hofmann and White (1983); 14) Assuming for B is 0.12 as in the CV chondrite; 15) U/Pb = 0.128 obtained from the 238U/204Pb ratio of 8.0 for the primitive mantle at present (Faure, 1986). Asterisks: mostly volatile elements and data are less reliable.
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