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.
May. 8, 2014, 7:24 AM
- Regeneron Pharmaceuticals (REGN) total revenues: $626M (+42.3%); collaboration revenues: $256M (+124.6%); net product sales: $362M (+13.5%); Eylea sales: $359M (+14.3%); Arcalyst sales: $3M (-40%); operating income: $186M (+21.5%); net income: $65.4M (-33.9%); EPS: $0.58 (-35.6%); quick assets (ex-A/R): $1.2B (+9.1%).
- Eylea PDUFA date for macular edema indication is August 18, 2014.
- Eylea PDUFA date for macular edema following branch retinal vein occlusion indication is October 23, 2014.
- Fifteen human monoclonal antibodies generated by the company's VelocImmune technology are in clinical development, including eight with Sanofi (SNY).
May. 8, 2014, 6:31 AM| Comment!
May. 5, 2014, 8:55 AM
- Regeneron Pharmaceuticals (REGN) and Avalanche Biotechnologies ink a collaboration deal to discover, develop and commercialize gene therapy products focused on ophthalmologic diseases. The agreement covers novel gene therapy vectors and proprietary molecules discovered jointly by the partners and developed by Avalanche's Ocular BioFactory, a gene therapy discovery platform based on adeno-associated virus technology.
- Avalanche will receive an upfront cash payment, milestone payments of up to $640M and royalties of global net sales of post-approval products.
- Regeneron will have exclusive worldwide rights for each product it moves forward in clinical development. It also has a time-limited right of first negotiation for certain rights to AVA-101, Avalanche's vascular endothelial growth factor gene therapy product for wet age-related macular degeneration. The rights negotiation time window starts when the ongoing Phase 2a clinical trial ends.
- The collaboration covers eight therapeutic targets.
Mar. 24, 2014, 7:27 PM
- As U.S. corporations sit on $1T-plus in cash and with many facing organic growth challenges, Morgan Stanley lists 44 multi-billion dollar cap companies it thinks have a high likelihood of receiving at least one tender offer over the next 12 months.
- In the energy sector: NFX, SD, TDW.
- In materials: CLF, AXLL, UFS, RGLD.
- Consumer discretionary: SBGI, WEN, TPX, EAT, BYI, DWA, JCP, AEO.
- Consumer staples: INGR, HAIN, HSH, WWAV.
- Health care: CELG, ESRX, WLP, REGN, ALXN, AET, CI, BDX, CERN.
- Financial: NSM.
- Tech: BRCD, ONNN, TIBX, SPWR, IM, JBL, SUNE, TER, ARRS, NSR.
- Telecom: CCI, SBAC, LVLT, WIN, FTR.
Mar. 7, 2014, 4:24 PM
- The FDA requests that Regeneron (REGN) and Sanofi (SNY) assess potential neurocognitive side effects of their late stage cholesterol drug alirocumab, a PCSK9 inhibitor.
- Memory loss, impaired concentration and paranoia, though rare, have been associated with the use of statins for lowering LDL cholesterol.
- Both firms disclosed in their regulatory filings that the appearance of these side effects could delay or stop the product's development.
- Pfizer (PFE) and Amgen (AMGN) are also working on PCSK9 inhibitors.
Mar. 3, 2014, 10:20 AM
- Bayer (BAYRY) has filed for Japanese approval of Regeneron's (REGN) Eylea therapy for treating patients with diabetic macular edema, the companies have said. Bayer has the rights to sell Eyelea outside the U.S.
- The submission is based on Phase 3 clinical trials that proved a statistically significant improvement in best-corrected visual acuity from baseline at 52 weeks compared with laser photcoagulation.
- The companies didn't provide a timetable for marketing approval, although the process is usually slower than with the FDA in the U.S. (PR)
Feb. 28, 2014, 7:37 AM
- Bayer believes that Xarelto (blood thinner) and Eylea (eye), which is developed by Regeneron (REGN), will hit peak revenues in 5-6 years. Bayer holds the license to sell Eylea outside the U.S.
- Bayer has increased its combined peak annual sales forecast for its five most important drugs - Adempas (lung), Stivarga (cancer) and Xofigo (cancer), as well as Eylea and Xarelto - to at least €7.5B from a prior forecast of €5.5B. The treatments generated sales of €1.52B in 2013.
- See Bayer's earnings
Feb. 24, 2014, 9:18 AM
- The FDA has accepted Regeneron's (REGN +3.3%) application to expand the use of its Eylea therapy to treat Macular Edema Following Branch Retinal Vein Occlusion, a common vascular disease among the elderly that is caused by a blockage of one of the small veins that carry blood away from the retina.
- Regeneron's application follows a successful Phase III trial.
- Eylea has already been authorized for other indications, including wet age-related macular edema.
Feb. 11, 2014, 4:48 PM
- Regeneron's (REGN) 7.4% gain topped today's S&P leader board following Q4 earnings which featured good news on the company’s blockbuster-to-be, Eylea.
- Q4 U.S. sales of the sight-saving drug rose 46% Y/Y to $402M, and REGN forecasts U.S. sales to reach $1.7B-$1.8B this year as it expects the drug to win approval for newer uses.
- RBC Capital thinks Eylea sales could be better than forecast, given that management is typically viewed as conservative when it comes to guidance.
- Brean Capital raises its price on shares to $380 from $367, as it looks to several Phase 3 trials for alirocumab - part of a new class of injectable cholesterol medicines - reading out around mid-2014; the firm views the drug as the next major value driver.
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