Sep. 22, 2014, 7:46 AM
- The Japanese Ministry of Health, Labour and Welfare approves the use of Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) injection for the treatment of choroidal neovascularization (myopic CNV).
- Eylea is already approved for sale for neovascular age-related macular degeneration (wet AMD) and macular edema secondary to central vein occlusion (CRVO).
- Eylea is marketed in Japan by Bayer Healthcare's (OTCPK:BAYRY) (OTCPK:BAYZF) Japanese subsidiary Bayer Yakuhin, Ltd.
Sep. 16, 2014, 7:33 AM
- The FDA designates Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) a Breakthough Therapy (BTD) for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).
- Drugs tagged as Breakthrough Therapies must show credible evidence of a substantial improvement on a clinically significant endpoint over available therapies or over placebo if no therapies are available. It was created by the FDA to expedite the development and review of drugs for serious or life-threatening conditions. BTD-labelled drugs are Fast Track'd but have the additional benefit of more-intensive agency guidance and discussion.
- Eylea is currently approved for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
- The company expects to submit a supplemental BLA (sBLA) in the U.S. for diabetic retinopathy this year.
Sep. 4, 2014, 7:51 AM
- Bayer (OTCPK:BAYRY) (OTCPK:BAYZF) subsidiary Bayer Yakuhin, Ltd. submits a marketing authorization application to the Japanese Ministry of Health, Labour and Welfare for Eylea (aflibercept) Injection for the treatment of macular edema following branch retinal vein occlusion (BRVO).
- Eylea is currently approved for use in Japan for neovascular (wet) age-related macular degeneration and macular edema secondary to central retinal vein occlusion.
- Marketing applications for Eylea for the treatment of choroidal neovascularization secondary to pathologic myopia and for the treatment of diabetic macular edema are currently under regulatory review.
- Related ticker: (REGN +0.7%)
Aug. 11, 2014, 7:12 AM
- The European Commission approves Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) for the treatment of visual impairment caused by diabetic macular edema (DME). The new indication complements its current approvals for wet age-related macular degeneration (AMD) and macular edema following central retinal vein occulsion (CRVO).
- Partner Bayer (OTCPK:BAYRY) (OTCPK:BAYZF) plans to launch Eyea for DME this quarter.
Aug. 5, 2014, 6:56 AM
- Regeneron (NASDAQ:REGN) Q2 results: Total Revenues: $665.7M (+45.5%), Eylea Sales: $415M (+24.3%); Operating Expenses: $443.3M (+48.0%); Operating Income: $222.4M (+40.7%); Net Income: $92.7M (+6.1%); EPS: $0.82 (+3.8%); Quick Assets: $1,367.7M (+26.2%).
- 2014 Guidance: Eylea sales: $1.7B - 1.8M; R&D: $470M - 510M from $425M - 475M; SG&A: $310M - 350M from $330M - 380M; CAPEX: $350M - 425M.
Aug. 5, 2014, 6:31 AM
Jul. 30, 2014, 4:24 PM
- Regeneron Pharmaceuticals (REGN +5.8%) and partner Sanofi (SNY +1.4%) (OTCQB:SNYNF +0.3%) intend to use an FDA-issued rare pediatric disease review voucher for their alirocumab BLA. The voucher entitles the holder to designate a BLA for a six-month priority review instead of the standard 10-month review period.
- Regeneron subsidiary Regeneron Ireland purchased the voucher from a subsidiary of BioMarin Pharmaceuticals who received it through the FDA's program. The companies will each pay half of the $67.5M price. They intend to submit the BLA before the end of the year.
Jul. 30, 2014, 9:13 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and partner Sanofi (NYSE:SNY) (OTCQB:SNYNF) report that their PCSK9 inhibitor alirocumab met its primary endpoint of a greater percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at 24 weeks compared to placebo or active comparator in nine Phase 3 clinical trials involving over 5,000 patients (including the MONO trial). The results were consistent with earlier alirocumab trials.
- Three additional Phase 3 trials are ongoing.
Jul. 30, 2014, 9:09 AM
Jul. 29, 2014, 9:13 PM| Jul. 29, 2014, 9:13 PM | Comment!
Jul. 29, 2014, 7:25 PM
- Following positive Phase 3 trial data, the FDA has approved Regeneron's (NASDAQ:REGN) Eylea for the treatment of diabetic macular edema (DME).
- Eylea is already available in the U.S. for the treatment of neovascular age-related macular degeneration and macular edema following central retinal vein occulusion, following 2011 and 2012 approvals.
- Europe's CHMP has given a positive opinion for approving Eylea for DME treatment, and regulatory submissions for DME treatment have also been made in Japan, Asia-Pac, and Latin America.
- REGN +3.1% AH.
- Prior Eylea coverage
Jul. 18, 2014, 7:24 AM
- In a Phase 3 clinical trial comparing the safety and efficacy of Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) to laser photocoagulation in patients with diabetic macular edema, those receiving injections of Eylea showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100.
- Study subjects receiving Eylea 2 mg every month had a mean change in BCVA from baseline of 11.4 letters (mean change at 52 weeks was 10.5 letters). Subjects receiving Eylea 2 mg every 2 months after receiving five monthly injections showed a mean change in BCVA from baseline of 9.4 letters (down from 10.5 letters at 52 weeks). Subjects receiving laser coagulation showed a mean change in BCVA from baseline of 0.7 letters (1.2 letters at 52 weeks).
- 31.1% of the Eylea test group dosed every 2 months achieved an increase of at least 15 letters (~3 lines of vision) compared to 38.2% of the Eylea group dosed monthly compared to 12.1% of the laser group.
- The two-year data will be presented at upcoming medical conferences.
Jul. 9, 2014, 5:22 PM
- Regeneron (REGN +0.1%) and development partner Sanofi (SNY +0.8%) report encouraging Phase 2b results for their investigational mAb dupilumab as a treatment for adults with moderate-to-severe atopic dermatitis. All doses of dupilumab met the primary endpoint of a greater improvement in Eczema and Severity Index (EASI) scores from baseline compared to placebo. The mAb works by blocking the signaling of IL-4 and IL-13, two cytokines that play important roles in the pathogenesis of moderate-to-severe atopic dermatitis.
- At week 16 in the 380-patient study, 12 - 33% of the test group achieved clearing or near-clearing of skin lesions and experienced a 16.5 - 47% reduction in itching.
Jun. 27, 2014, 8:42 AM
- Europe's Committee for Medicinal Products for Human Use (CHMP) recommends that the European Medicines Agency (EMA) approve Regeneron Pharmaceuticals' (REGN) Eylea (aflibercept) injection as a treatment for visual impairment due to diabetic macular edema (DME). Eylea is currently approved as a treatment for neovascular (wet) age-related macular degeneration (AMD) and macular edema following central retinal vein occlusion (CRVO).
- Regeneron and Bayer Healthcare (BAYRY) (BAYZF) are collaborating on the global development of Eylea. Regeneron has exclusive rights to the product in the U.S. while Bayer Healthcare has the license for exclusive marketing rights ex. U.S. where the companies equally share the profits from Eylea sales. In Japan, Regeneron receives a percentage of net sales.
Jun. 12, 2014, 9:50 AM
- In a 1,197-subject Phase 3 clinical trial evaluating the safety and efficacy of sarilumab in patients with moderate-to-severe rheumatoid arthritis (RA) who have not responded adequately to methotrexate (MTX) therapy, the mAb met all three co-primary endpoints: demonstrating improvement in disease signs and symptoms at 24 weeks, physical function at 16 weeks and inhibition of joint damage progession at 52 weeks. All results were statistically significant.
- On a secondary endpoint, sarilumab combined with MTX showed a statistically significantly greater effect than MTX alone in achieving a major clinical response for at least 24 weeks.
- Sarilumab is a human mAb that is an IL-6 inhibitor. By blocking the binding of IL-6 to its receptor, it interrupts the resultant cytokine-mediated inflammatory signalling.
- Sarilumab is being co-developed by Regeneron Pharmaceuticals (REGN -0.2%) and Sanofi (SNY).
Jun. 11, 2014, 7:23 AM
- Regeneron Pharmaceuticals (REGN) reports that collaboration partner Bayer HealthCare (BAYZF) (BAYRY) has submitted an application to the EMA for marketing authorization in the European Union for Eylea (aflibercept) for the treatment of macular edema following branch retinal vein occlusion (BRVO).
- The U.S. FDA approved the drug for the treatment of wet Age-related Macular Degeneration (AMD) in November 2011 and for Central Retinal Vein Occlusion (CRVO) in September 2012. The EMA has also approved Eylea for wet AMD and Macular Edema following CRVO.
- Regulatory submissions have been made to the FDA for Macular Edema following BRVO and in the EU for Diabetic Macular Edema.
- Regeneron has exclusive rights to Eylea in the U.S. Bayer HealthCare has exclusive marketing rights ex-U.S. (the companies equally share the profits). In Japan, Regeneron receives a percentage of sales.
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