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.
Feb. 11, 2014, 7:29 AM
- Regeneron (REGN +2%) net profit -79% to $97M, due to a non-cash tax benefit of $336M in Q4 2012, an income tax provision in 2013, and higher operating costs last year.
- Eylea net U.S. sales $402M vs $276M a year earlier; international $184M vs $19M.
- Cash position: $1.08B at end of 2013 vs $588M.
- Forecasts 2014 Eylea net product sales of $1.7-1.8B in U.S. vs. $1.41B in 2013.
- Expects Eylea to continue growing "through demographic and geographic expansion," as well as via potential approvals in new indications. (PR)
Feb. 11, 2014, 6:31 AM| Comment!
Feb. 11, 2014, 12:05 AM
Feb. 10, 2014, 5:30 PM
Feb. 10, 2014, 8:16 AM
- Regeneron's (REGN +3.15%) Eylea treatment improved vision and maintained that improvement over two years in a Phase III trial of patients with diabetic macular edema (DME).
- DME is a leading cause of blindness in younger and middle-aged adults; Eylea could potentially treat over 6M sufferers globally.
- Regeneron and partner Bayer (BAYRY) are waiting for U.S. and EU approval of Eylea to treat DME; the therapy has already been authorized for other indications, including wet age-related macular edema. (PR)
Jan. 15, 2014, 9:55 AM
- Shares of Regeneron (REGN -4.4%) are pulling back after a big run Tuesday.
- BMO has downgraded the stock to Market Perform from Outperform.
- Price target is unchanged at $331.
- See also: Roth upbeat on REGN amid new Bayer deal, genetics initiative
Jan. 14, 2014, 12:43 PM
- Roth Capital is out with a bullish note on Regeneron (REGN +9.1%) on the heels of the company's announcement of a new development agreement with Bayer.
- Here's analyst Joseph Pantginis, commenting: "Preclinical studies have suggested that blocking both PDGFR-beta and vascular endothelial growth factor (VEGF) can provide additional benefit over anti-VEGF treatment (such as EYLEA) alone in wet AMD."
- Buy rating maintained.
- Price target is $362.
- In other company news, REGN has announced a collaboration with Geisinger Health System under which the companies will "study the genetic determinants of human disease." Additionally, Sanofi (SNY) has amended its investor agreement with REGN and retains the right to "acquire up to 30% of REGN's outstanding common stock and Class A stock [while gaining] the right to nominate a single independent director to the Regeneron Board of Directors upon reaching 20% ownership [stake]."
Jan. 14, 2014, 7:40 AM
- Regeneron Pharmaceuticals (REGN) and Bayer (BAYZF) are deepening their relationship with a plan develop a new therapy for wet age-related macular degeneration.
- Bayer will make an upfront payment of $25.5M to Regeneron and up to $40M in options and milestone payments, and it will pay royalties on any product sales outside the U.S.
- Regeneron will retain 100% of U.S. profits.
- Human clinical studies are planned for early this year. (PR)
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