Nov. 19, 2014, 12:35 PM
- During the scientific sessions at the American Heart Association meeting in Chicago, investigators presented results from six Phase 3 clinical trials of Regeneron Pharmaceuticals (REGN +1.2%) and Sanofi's (SNY -0.2%) (OTCQB:SNYNF) cholesterol-lowering product candidate, alirocumab, compared to placebo or statins.
- The trials assessed alirocumab in patients with hypercholesterolemia who were at high cardiovascular risk, had an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH) and/or a history of intolerance to two or more statins. All six studies met their primary efficacy endpoint of change from baseline in LDL-C at week 24. Patients receiving alirocumab showed a mean reduction in LDL-C from baseline of 36 - 62%, depending on the study, compared to the comparator drugs' mean reduction of 0.5 - 23%.
- Regulatory submissions will be made to the FDA and EMA by the end of next month.
- Alirocumab is a PCSK9 inhibitor that will compete with Amgen's (AMGN +0.2%) evolocumab for supremacy in what is expected to be a $10B post-statin market. Amgen filed its BLA in August, but Regeneron and Sanofi bought an FDA voucher for $67.5M a few months ago that will cut the FDA's review time from 10 months to six, meaning that the projected approval time for both drugs will be about the same (June).
- Amgen filed a patent infringement lawsuit against the two firms last month.
- Previously: Amgen sues Sanofi and Regeneron
- Previously: FDA OK with Amgen's BLA for cholesterol-lowering drug
- Previously: Biotechs to use priority review voucher for cholesterol-lowering drug candidate
Nov. 18, 2014, 9:32 AM
- The Japanese Ministry of Health, Labour and Welfare approves Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NYSE:SNY) (OTCQB:SNYNF) Eylea (aflibercept) for the treatment of diabetic macular edema.
- Eylea was previously cleared for the treatment of neovascular age-related macular degeneration, macular edema secondary to central retinal vein occlusion and myopic choroidal neovascularization.
Nov. 14, 2014, 12:00 PM| 41 Comments
Nov. 11, 2014, 7:44 AM
- Dupilumab, a fully-human monoclonal antibody being co-developed by Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN), showed showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.
- The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.
- Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.
- Sanofi plans to proceed to Phase 3 development.
- Asthma-related tickers: (NYSE:GSK) (NYSE:TEVA) (NYSE:AZN) (OTCQX:RHHBY) (NASDAQ:AMGN) (NYSE:MRK) (NYSE:NVS) (NASDAQ:THRX)
Nov. 6, 2014, 11:09 AM
- Regeneron (REGN +1.1%) Q3 results: Revenues: $725.8M (+21.6%); Eylea Sales: $448.8M (+22.3%); R&D Expense: $337.7M (+50.8%); SG&A: $149.7M (+53.4%); Operating Income: $182.7M (-22.8%); Net Income: $79.7M (-43.6%); EPS: $0.70 (-44.0%); Quick Assets: $1,495.6M (+38.0%).
- 2014 Guidance: Eylea sales: $1.7B - 1.74B from $1.7B - 1.8B; R&D: $490M - 510M from $470M - 510M; SG&A: $330M - 350M from $310M - 350M; CAPEX: $300M - 350M from $350M - 425M.
- Follow up from initial post on November 4.
Nov. 4, 2014, 9:15 AM
Nov. 4, 2014, 6:31 AM| 1 Comment
Nov. 3, 2014, 1:06 PM
- The FDA accepts Boehringer Ingelheim's NDA for Spiriva Respimat (tiotropium bromide) for the maintenance treatment of asthma in patients at least 12 years old who remain symptomatic on at least inhaled corticosteroids.
- Spiriva is currently cleared for the maintenance treatment of bronchospasm (HandiHaler) associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.
- The Respimat inhaler provides a pre-measured amount of medicine in a slow moving mist that helps the patient inhale the drug. It is designed to deliver the medication in a way that does not depend on how fast air is breathed in from the inhaler.
- Asthma and COPD-related tickers: (THRX -3%)(GSK -0.3%)(AZN -0.8%)(NVS -1.3%)(REGN +0.6%)(SNY -1.5%)(TEVA +1.5%)(OTCQX:RHHBY -1.3%)
Oct. 21, 2014, 9:08 AM
- Privately-held Boehringer Ingelheim commences patient enrollment in a Phase 3 clinical trial evaluating the safety and efficacy of nintedanib in patients with colorectal cancer refractory to standard treatments. The double-blind randomized, placebo-controlled study will enroll more that 750 patients at 150 sites worldwide.
- Nintedanib (trade name Ofev) is a small molecule tyrosine kinase inhibitor that was recently approved by the FDA for idiopathic pulmonary fibrosis.
- CRC-related tickers: (NASDAQ:GILD) (NYSE:LLY) (NASDAQ:MGNX) (OTCPK:BAYRY) (OTCPK:BAYZF) (NASDAQ:AMGN) (OTC:MKGAF) (NYSE:BMY) (NASDAQ:ONXX) (NASDAQ:IMMU) (NASDAQ:ONCY) (NASDAQ:ARQL) (NYSE:SNY) (OTCQB:SNYNF) (NASDAQ:REGN)
Oct. 20, 2014, 8:56 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) (OTCQB:SNYNF) initiate a Phase 3 clinical trial to assess the safety and efficacy of dupilumab administered concomitantly with topical corticosteroids for the treatment of adults with moderate-to-severe atopic dermatitis (AD). The 16-week randomized, double-blind, placebo-controlled multinational study will enroll ~700 patients.
- Dupilumab is a fully-human mAb that blocks IL-4 and IL-13 signalling. It was created using Regeneron's VelocImmune technology and is being co-developed with Sanofi.
- Dermatitis-related tickers: (NYSE:VRX) (NASDAQ:ANAC) (NYSE:GSK) (NYSE:PRGO)
Oct. 17, 2014, 9:30 AM
- Amgen (NASDAQ:AMGN) files suit in the U.S. District Court of Delaware against Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN) alleging infringement on three of its patents covering monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9). Amgen seeks an injunction to prevent the manufacture, use and sale of Sanofi and Regeneron's PCSK9 inhibitor alirocumab.
- Amgen recently submitted its BLA to the FDA for its PCSK9 inhibitor evolocumab.
Oct. 17, 2014, 9:20 AM
Oct. 17, 2014, 7:40 AM
- In a comparative study sponsored by the National Institutes of Health and run by the Diabetic Retinopathy Clinical Research Network (DRCR.net), Regeneron's (NASDAQ:REGN) Eylea (aflibercept) injection demonstrated a significantly greater improvement in mean change in best-corrected visual acuity from baseline at week 52 compared to both Genentech's (OTCQX:RHHBY) Avastin (bevacizumab) and Lucentis (ranibizumab) injection. The was the study's primary endpoint.
- The mean number of injections using the protocol-specified retreatment regimen was one fewer in the Eylea cohort compared to Avastin and Lucentis and fewer patients in the Eylea group received criteria-based macular laser treatments.
- DRCR.net is finalizing and verifying the data before submitting it for publication.
Oct. 15, 2014, 4:30 PM
Oct. 8, 2014, 12:35 PM
- The FDA accepts and grants priority review of Roche unit Genentech's (OTCQX:RHHBY +0.1%) supplemental Biologics License Application (sBLA) of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy. The PDUFA date is February 6, 2015.
- Lucentis is currently cleared for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
- Related tickers: (REGN -0.4%)(AGN +1.1%)(ALIM +1%)(OTCPK:BAYRY +0.2%)(OTCPK:BAYZF)(PSDV -4.8%)
Oct. 6, 2014, 5:32 PM
- The FDA approves Regeneron Pharmaceuticals' (REGN -0.7%) Eylea (aflibercept) for the treatment of macular edema following retinal vein occlusion. It was previously cleared for the treatment of neovascular age-related macular degeneration, macular edema following central retinal vein occlusion and for diabetic macular edema.
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