Tue, Nov. 24, 7:38 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) announce the completed enrollment of ~18,000 patients in their global Phase 3 study, ODYSSEY OUTCOMES, evaluating the potential cardiovascular (CV) benefits of cholesterol fighter Praluent (alirocumab) after an acute coronary syndrome (ACS). The trial is designed to determine if the addition of Praluent to intensive statin therapy reduces major adverse cardiac events in patients who have had an ACS (e.g., heart attack or unstable angina). The primary endpoint is time to first occurrence of coronary heart disease death, acute myocardial infarction (heart attack), hospitalization for unstable angina or fatal or non-fatal ischemic stroke. The study should be completed in 2017.
- The global ODYSSEY program includes 16 Phase 3 trials conducted across more than 2,000 medical centers around the world. More than 25,000 patients will be evaluated.
Mon, Nov. 23, 9:18 AM
- Round one in the Repatha (evolocumab) versus Praluent (alriocumab) competition goes to Amgen (NASDAQ:AMGN). After evaluating both PCSK9 inhibitors, Pharmacy benefit manager CVS Health (NYSE:CVS) exclusively adds Amgen's Repatha to its commercial formularies, effectively shutting out Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent.
- No word yet on the decisions from other PBMs.
Wed, Nov. 18, 1:14 PM
- Britain's National Institute for Health and Care Excellence (NICE), which advises the National Health Service (NHS) on costs, procedures and technologies with the aim of better managing the cost/benefit of services, issues draft guidance not recommending Amgen's (AMGN +0.7%) Repatha (evolocumab) for the treatment of high cholesterol and mixed dyslipidemia.
- The committee determined that Repatha was effective in lowering LDL cholesterol ("bad" cholesterol) in patients with primary hypercholesterolemia, but cited the lack of evidence that it reduces the risk of cardiovascular disease-related events such as heart attacks, strokes and angina, which claim 150K English lives each year. It also doubted the reliability of the company's cost-effectiveness data, citing the use of the Framingham risk equations, which overestimate CVD risk in the UK population, and an unrealistically high factor to adjust the CVD risk in people with heterozygous-familial hypercholesterolemia.
- "The Committee concluded that the degree of uncertainty in the cost-effectiveness evidence was too high for it to be able to make well-founded recommendations about evolocumab." The public has until December 8 to comment on the draft guidance, which will be reviewed and discussed at the next NICE meeting on January 13.
- Sharpen that pencil, Amgen.
- Related tickers: (SNY +1.6%)(REGN +1.7%)
Wed, Nov. 11, 1:00 PM
- Alnylam Pharmaceuticals (ALNY +1.1%) and development partner The Medicines Company (MDCO -0.8%) announce positive results from their ongoing Phase 1 clinical trial evaluating ALN-PCSsc for the potential treatment of high cholesterol. The data were presented at the American Heart Association Scientific Sessions in Orlando, FL.
- As previously reported, subcutaneous administration of ALN-PCSsc reduced LDL-C (bad cholesterol) up to 83% (average maximum: 59 - 69%). New data showed the effects were highly durable and could support a twice/year dosing regimen, significantly longer than Amgen's (AMGN +0.6%) Repatha (evolocumab), dosed every two weeks or once/month, and Sanofi (SNY +0.3%)/Regeneron's (REGN +1%) Praluent (alirocumab), dosed every two weeks.
- Specifically, the maximum PCSK9 knockdown was 89% (average 80.3 - 84.3%) and the maximum LDL-C reduction was up to 78% (average 54.3 - 64.3%) after a single injection of ALN-PCSsc. At day 180, LDL-C reduction was as high as 53% (average 47%) in the 300 mg cohort. No clinically significant drug-related adverse events were seen.
- In the multiple dose cohorts (n=45), the maximum PCSK9 knockdown and LDL-C reduction were 94% (av. 86.9 - 90.1%) and 83% (av. 59.0 - 69.8%), respectively. At day 208, the LDL-C reduction was as high as 60% (av. 44.4%). In clinical trials, the mean LDL-C reductions observed for Repatha and Praluent were 64% (week 12) and 58% (week 24), respectively.
- Both Repatha and Praluent bind to PCSK9 in the blood. ALN-PCSsc turns off PCSK9 synthesis in the liver.
- The Medicines Company plans to initiate a Phase 2 study by year end with a Phase 3 trial to follow in 2017.
- The companies will host a conference call this afternoon at 4:30 pm ET to discuss the data.
Wed, Nov. 11, 7:52 AM
- A post-hoc analysis of six Phase 3 clinical trials showed that 74% of patients receiving Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) (75 mg) were able to reach their pre-specified LDL cholesterol (LDL-C) targets within eight weeks of adding the drug to their standard-of-care treatment, including statins. In the 26% of patients whose Praluent dose was increased to 150 mg, most (61%) were able to achieve their LDL-C target, with an average additional reduction in LDL-C of 14%. The data were presented at the American Heart Association Scientific Sessions in Orlando, FL.
- The results are based on a pooled post-hoc analysis of 1,291 patients with high cardiovascular (CV) risk or an inherited form of high cholesterol called heterozygous familial hypercholesterolemia (HeFH).
- The incidence of adverse events was comparable for the two doses in the placebo-controlled studies (66%) and in the ezetimibe (Merck's Zetia)-controlled studies (55% vs. 56%).
- In a separate pooled post-hoc analysis of 3,499 patients, subjects with diabetes (n=1,051) who initially received Praluent (75 mg or 150 mg every two weeks) experienced mean percent reductions in LDL-C of 44% and 58%, respectively, compared to placebo at week 24 (p<0.0001).
- A third post-hoc analysis of 4,974 patients did not find an increased risk of diabetes-related adverse events among those who did not have diabetes when they entered the trials, regardless of whether they were receiving Praluent or were in a control group. There was no evidence that Praluent affected the incidence of new-onset diabetes or pre-diabetes.
- Praluent, a PCSK9 inhibitor, was cleared by the FDA in July 2015.
Mon, Nov. 9, 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)
Thu, Nov. 5, 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.
Wed, Nov. 4, 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.
Wed, Nov. 4, 6:32 AM
Tue, Nov. 3, 5:30 PM
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Tue, Nov. 3, 12:25 PM
Fri, Oct. 30, 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.
Mon, Oct. 26, 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)
Mon, Oct. 12, 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%.
Fri, Oct. 9, 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.
Tue, Oct. 6, 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.
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