Regeneron - A Review: Strong Returns Look Likely For 2016 And Beyond
DoctoRx • 55 Comments
DoctoRx • 55 Comments
Regeneron Jumps Ahead In $10 Billion Race For Next Generation Cardio Drugs
Cheryl Swanson • 14 Comments
Cheryl Swanson • 14 Comments
Nov. 9, 2015, 12:40 PM
- Sanofi (SNY -2.9%) and development partner Regeneron Pharmaceuticals (REGN -0.1%) announce results from a pivotal Phase 3 clinical trial, SARIL-RA-TARGET, evaluating their investigational human antibody sarilumab in patients with rheumatoid arthritis (RA). The study met both co-primary efficacy endpoints as well as secondary objectives.
- SARIL-RA-TARGET enrolled 546 RA patients who responded inadequately or were intolerant of TNF-alpha inhibitors. Subjects were randomized to one of three treatment groups self-administered every other week: sarilumab 200 mg, sarilumab 150 mg or placebo.
- The two co-primary endpoints were the reduction in signs and symptoms of RA at Week 24 and the improvement in physical function at week 12, both versus placebo. The proportion of patients achieving ACR20 (20% improvement in symptoms) was 61% for the 200 mg arm, 56% in the 150 mg arm and 34% for placebo (p<0.0001). The change in physical function at week 12 versus baseline was statistically superior to placebo for both the 200 mg arm (p=0.0004) and the 150 mg arm (p=0.0007).
- Secondary endpoints achieved included the proportion of patients achieving ACR50 (200 mg: 41%, 150 mg 37%, placebo: 18%; p<0.0001) and the proportion achieving ACR70 (200 mg: 16%; p=0.0056; 150 mg: 20%; p=0.0002; placebo: 7%).
- Treatment-emergent adverse events were 65% in the 200 mg group, 66% in the 150 mg group and 50% for placebo. Serious adverse events were higher for placebo than the 200 mg group (5% vs. 3%) and comparable to the 150 mg group (3%). The most frequent adverse event was infection (200 mg: 30%, 150 mg: 22%, placebo: 27%).
- 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.
- The Biologics License Application (BLA) was recently submitted to the FDA.
- Previously: Regeneron/Sanofi IL-6 monoclonal antibody successful in Phase 3 arthritis study (May 21)
Nov. 5, 2015, 10:32 AM
- Thinly-traded nano cap Eyegate Pharmaceuticals (EYEG +68.1%) rockets up on a 13x surge in volume, albeit on turnover of only 220K shares, in response to its announcement of interim data on the effects of iontophoretic delivery of its EGP-437 ophthalmic solution on patients with macular edema.
- The data from the ongoing Phase 1b/2a study show that iontophoresis, a non-invasive process that uses low-level electrical current to deliver the drug, can deliver EGP-437 to the back of the eye. This potentially represents a significant route-of-administration advantage over an injection into the eye (e.g. Regeneron's (REGN) EYLEA).
- CEO Stephen From says, "The interim results of the trial are highly promising and suggest the ability of the EyeGate II Delivery System to deliver drug to the posterior segment of the eye....We look forward to additional data from the extension of this trial, which we expect in mid-2016." The extension phase, set to commence in December, will recruit an additional 15 patients with a modified dosing regimen, three days at the same iontophoretic dose.
Nov. 4, 2015, 7:17 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) Q3 results ($M): Total Revenues: 1,137.4 (+56.7%); Net Product Sales: 737.6 (+64.3%); Sanofi Collaboration Revenue: 224.7 (+69.1%); Bayer HealthCare Collaboration Revenue: 157.6 (+16.0%).
- Net Income: 210.4 (+152.3%); EPS: 1.82 (+149.3%); Non-GAAP EPS: 3.47 (+37.7%).
- EYLEA U.S. Net Sales: 734 (+64.9%); Praluent U.S. Net Sales: 4.
- 2015 Guidance: EYLEA Sales Growth: 50 - 55% from 45 - 50%.
- Shares are up 3% premarket on light volume.
Nov. 4, 2015, 6:32 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN): Q3 EPS of $3.47 beats by $0.27.
- Revenue of $1.14B (+57.1% Y/Y) beats by $90M.
Nov. 3, 2015, 5:30 PM
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Nov. 3, 2015, 12:25 PM
- Regeneron Pharmaceuticals (REGN -0.7%) will report Q3 results tomorrow before the open. Consensus view is EPS of $3.20 (+27.0%) on revenues of $1.05B (+44.6%).
Oct. 30, 2015, 9:24 AM
- The European Commission approves EYLEA (aflibercept) for the treatment of visual impairment due to myopic choroidal neovascularization, a disease of the retina associated with a high degree of myopia (near-sightedness). Bayer (OTCPK:BAYRY), co-developing EYLEA with Regeneron Pharmaceuticals (NASDAQ:REGN), plans to immediately launch the new application in Germany.
- EYLEA was previously approved for wet age-related macular degeneration and visual impairment due to diabetic macular edema and macular edema secondary to retinal vein occlusion.
Oct. 26, 2015, 5:24 PM
- Ophthotech (NASDAQ:OPHT) hits its enrollment target in its second Phase 3 clinical trial evaluating Fast Track-tagged Fovista (pegleranib), in combination with Roche's (OTCQX:RHHBY) Lucentis (ranibizumab), for the treatment of wet age-related macular degeneration (wet AMD). Top-line data from both studies are expected in Q4 2016.
- CEO David Guyer, M.D., says, "Completion of patient recruitment in these two large scale Phase 3 clinical trials of [Fovista] in combination with Lucentis is a significant milestone in the Fovista Phase 3 pivotal program. We believe that Fovista, administered in combination with anti-VEGF therapy, may represent a significant advancement in the treatment of wet AMD and we look forward to obtaining data from both of these studies."
- A third Phase 3 study assessing Fovista in combination with either Regeneron (NASDAQ:REGN) and Bayer's (OTCPK:BAYRY) Eylea (aflibercept) or Roche's Avastin (bevacizumab) continues to enroll participants.
- Fovista is an anti-platelet-derived growth factor (anti-PDGF) agent.
- Previously: Ophthotech moving ahead with Fovista studies (May 11)
Oct. 12, 2015, 8:38 AM
- Eli Lilly (NYSE:LLY) is down 10% premarket on robust volume in response to its announcement that it has terminated the development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease due to lack of efficacy. Its decision was based on a review by the independent data monitoring committee.
- The move will result in a Q4 charge to R&D expense of up to $90M ($0.05 per share after tax). The company will incorporate the change in its 2015 guidance that it will provide during its earnings call on October 22.
- SVP and President of Lilly Bio-Medicines David Ricks says, "We're obviously disappointed in this outcome, as we hoped the evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease. We'll be working with investigators to appropriately conclude these trials. We remain confident in our pipeline as we prepare for launches in other therapeutics areas with significant unmet needs."
- Related tickers and status premarket: (NASDAQ:REGN) +4%; (NASDAQ:AMGN) +3%; (NASDAQ:ESPR) +14%; (NYSE:SNY) +1%.
Oct. 9, 2015, 10:15 AM
- Gilead Sciences (GILD +0.5%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target maintained at $127 (27% upside).
- Valeant Pharmaceuticals (VRX +3.3%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $200 (14% upside) from $284.
- Mead Johnson (MJN +0.7%) downgraded to Underperform from Neutral by BofA Merrill Lynch. Price target lowered to $78 (7% upside) from $80.
- Ilumina (ILMN +1.9%) downgraded to Neutral from Buy by Mizuho Securities. Price target lowered to $150 (5% upside) from $250.
- Chimerix (CMRX +1.7%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $50 (34% upside) from $56.
- Regeneron Pharmaceuticals (REGN +0.6%) downgraded to Equal Weight from Overweight with a price target of $593 (20% upside) by Morgan Stanley.
- Diplomat Pharmacy (DPLO +1.1%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $31 (24% upside) from $58.
- AmerisourceBergen (ABC -0.3%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $93 (0% upside) from $120.
Oct. 6, 2015, 6:44 PM
- Leading pharmacy benefits manager Express Scripts (ESRX -1%) has settled an investor debate about which pricey cholesterol drug it will cover -- by saying it will cover both of them.
- Praluent, from Regeneron (REGN -2.9%) and Sanofi (SNY -0.7%), and Repatha, from Amgen (AMGN -1.8%), will both be included on Express Scripts' formulary. Each of the PCSK9 inhibitors is at least $14,000/year, significantly higher than the cost of now-generic statins, though more effective.
- The drugs are injectables that dramatically lower LDL (the "bad cholesterol").
- Express Scripts has said that the drugs won't be "budget busters," and that most prescriptions are getting rejected because patients don't meet medical criteria.
- In after-hours action: ESRX flat; REGN +0.1%; SNY +0.8%; AMGN flat.
Oct. 2, 2015, 11:44 AM
- House Democrats' keen interest in certain drug firms' pricing strategies prompted Morgan Stanley's David Risinger to downgrade Valeant Pharmaceuticals (VRX -3.2%) to Equal Weight from Overweight with a price target of $200 (14% upside) citing the large contribution (14%) that price increases have to its top-line growth.
- He also downgraded Regeneron Pharmaceuticals (REGN -0.2%) to Equal Weight with a price target of $593 (26% upside) citing potential headwinds created by competitors, including an anticipated tough fight with Amgen (Praluent vs. Repatha). Gilead Sciences (GILD -1.3%) got a haircut to Equal Weight with a price target of $127 (31% upside) citing slowing Hep C volume growth.
- Mr. Risinger also slapped AmerisourceBergen (ABC -1.3%) with an Underweight (Sell) rating due to its reliance on branded drug price inflation. He cut his price target to $93 (0% upside) from $120.
Oct. 1, 2015, 4:38 PM
- Regeneron Pharmaceuticals (NASDAQ:REGN) grants exclusive development and commercial rights to its Nerve Growth Factor (NGF) antibody, fasinumab, to Mitsubishi Tanabe Pharma for the territory of Japan, Korea and nine other Asian countries, excluding China. Fasinumab is in late-stage development for the treatment of musculoskeletal pain.
- Under the terms of the agreement, Regeneron will receive an upfront payment of $55M as well as other near-term payments. It will also be eligible to receive up to $170M in R&D reimbursement payments and development milestones, a portion of the profits and additional one-time purchase price adjustment payments of up to $100M upon the achievement of certain annual sales targets.
Sep. 30, 2015, 12:49 PM
- Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
- Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
Sep. 28, 2015, 7:03 AM
- As expected, the European Commission (EC) approves Praluent (alirocumab) for lowering low-density lipoprotein (LDL) cholesterol in certain adults with hypercholesterolemia. The approval follows CHMP's positive opinion in July. Praluent, co-developed by Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN), will be available in a single-dose (75 mg or 150 mg) pre-filled pen that patients can self-administer.
- The EC approved Amgen's (NASDAQ:AMGN) Repatha (evolocumab) in July.
- Previously: Amgen's Repatha cleared in Europe (July 21)
- Previously: Europe's CHMP give thumbs up to Regeneron and Sanofi's Praluent (July 24)
Sep. 27, 2015, 8:59 AM
- The $8B iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) fell 4.9% on Friday and 13% for the week - its worst weekly performance since the height of the financial panic seven years ago. Many biotech ETFs eat the same cooking - Gilead (NASDAQ:GILD), Amgen (NASDAQ:AMGN), Biogen (NASDAQ:BIIB), and Regeneron (NASDAQ:REGN) among the popular names - and FBT, XBI, and BBP fell in amounts similar to IBB.
- The news flow was relatively quiet late in the week, but Hilary Clinton's promise Monday to clamp down on drug prices set things in negative motion for the momo sector.
- Barron's Chris Dieterich reminds that a flood of biotech IPOs in recent years has filled the small cap universe with these highly speculative names, and biotech now makes up 7% of the iShares Russell 2000 Index (NYSEARCA:IWM). Indeed. The IWM fell 3.7% for the week, nearly tripling the decline of the S&P 500.
- ETFs: IWM, TZA, TNA, UWM, VB, VBK, URTY, SCHA, TWM, IWO, RWM, SRTY, VTWO, RCG, JKJ, VTWG, TWOK, FYX, JKK, EWRS, ZSML, FYC, SMLL, RYRSX
Regeneron Pharmaceuticals, Inc. operates as a biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer and a rare inflammatory condition... More
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