Mon, Jan. 12, 7:37 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) announce that the European Medicines Agency (EMA) accepts for review the Marketing Authorization Application (MAA) for the PCSK9 inhibitor Praluent (alirocumab) for the treatment of patients with hypercholesterolemia.
- Praluent is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor that represents the next generation of cholesterol-lowering medicines beyond statins.
- The BLA for Praluent was submitted to the FDA last quarter. The firms seek approval under the Priority Review process.
- Previously: Biotechs to use priority review voucher for cholesterol-lowering drug candidate (July 30, 2014)
Fri, Jan. 9, 10:00 AM
Fri, Jan. 9, 7:31 AM
- Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN) announce that two Phase 3 clinical trials evaluating alirocumab dosed once every four weeks for the treatment of hypercholesterolemia met their primary efficacy endpoints.
- The first study, Odyssey Choice I, evaluated the safety and efficacy of 300 mg alirocumab compared to placebo in 803 patients with hypercholesterolemia at moderate-to-high cardiovascular risk (CV). More than two thirds of the subjects also received statin therapy.
- The second study, Odyssey Choice II, evaluated the safety and efficacy of 150 mg alirocumab in 233 patients with hypercholesterolemia with high CV risk and/or a history of intolerance to two or more statins. No subjects received statin therapy.
- Both trials met their primary efficacy endpoint of a reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24 versus placebo. The results were comparable to previous studies evaluating a dosing regimen of once every two weeks of alirocumab.
- Alirocumab is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9).
- The data will be presented at a future medical conference.
Dec. 15, 2014, 10:03 AM
- Germany's healthcare cost watchdog, the German Institute for Quality and Efficiency in Health Care, determines that Bayer's (OTCPK:BAYRY +0.9%) (OTCPK:BAYZF) eye drug Eylea (aflibercept) offers no additional benefit over Novartis' (NVS -0.6%) Lucentis (ranibizumab) for the treatment of diabetic macular edema. The agency's decision could affect the amount of reimbursement for Eylea.
- In January, the Institute came to the same conclusion for the indication of macular edema. Last year, it determined that it could not assess the potential advantages of Eylea in wet age-related macular degeneration because Bayer has not provided the relevant data.
- Eylea was developed by Regeneron Pharmaceuticals (REGN -1.5%) and licensed to Bayer in ex-U.S. territories.
Dec. 1, 2014, 7:56 AM
- The FDA accepts for Priority Review Regeneron Pharmaceuticals' (NASDAQ:REGN) supplemental biologics license application (sBLA) for Eylea (aflibercept) for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). The PDUFA date for the Breakthrough Therapy-designated indication is March 30, 2015.
- Elyea is currently approved for the treatment of diabetic macular edema, macular edema following retinal vein occlusion and wet age-related macular degeneration.
Nov. 24, 2014, 8:02 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
- The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
- Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
- COPD-related tickers: (NYSE:GSK) (NYSE:NVS) (NASDAQ:THRX) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Nov. 20, 2014, 8:16 AM
- The FDA grants Breakthrough Therapy status to Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NYSE:SNY) (OTCQB:SNYNF) dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. Dupilumab is currently in Phase 3 development.
- The Breakthrough Therapy designation includes all of the Fast Track features as well as more intensive FDA guidance and discussion including access to more senior agency managers.
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| 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
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)
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