Wed, Feb. 18, 5:41 PM
- In an NIH-sponsored Diabetic Retinopathy Clinical Research Network comparative effectiveness study published in the New England Journal of Medicine, Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) was more effective than Genentech's (OTCQX:RHHBY) Avastin (bevacizumab) and Lucentis (ranibizumab). The 660-patient study was designed to compare three anti-VEGF therapies for the treatment of diabetic macular edema.
- Eylea demonstrated significantly greater improvement in mean visual acuity letter score at one year, the primary efficacy endpoint, than the comparators. Eylea's score was +13 letters from baseline versus +11 for Lucentis and +10 for Avastin.
- In patients with moderate or worse vision loss at the start of the trial, Eylea showed a statistically significant seven-letter (~1.5 lines on an eye chart) improvement over Avastin and a five-letter improvement over Lucentis (Eylea: +19 letters from baseline; Lucentis: +14; Avastin: +12).
- 42% of patients receiving Eylea gained at least 15 letters in best corrected visual acuity (BCVA) from baseline compared to 32% for Lucentis and 29% for Avastin.
- Eylea accounts for almost all of Regeneron's product revenue, posting $1.7B in sales last year.
- Investigators intend to present the results at next week's Annual Macula Society Meeting in Scottsdale, AZ.
Tue, Feb. 10, 9:47 AM
- Regeneron Pharmaceuticals (REGN -0.1%) Q4 results ($M): Total Revenues: 802.3 (+31.4%); Net Product Sales: 521.5 (+28.4%); Sanofi Collaboration Revenue: 135.3 (+21.9%); Bayer Collaboration Revenue: 137.1 (+60.0%); Eylea Sales: 518.0 (+28.9%); Operating Income: 247.4 (+16.6%); Net Income: 110.2 (+13.8%); EPS: 0.96 (+11.6%).
- 2015 Guidance: Net Product Sales: 25 - 30% growth; Non-GAAP R&D: $525M - 575M; Non-GAAP SG&A: $650M - 725M; CAPEX: $650M - 800M.
Tue, Feb. 10, 6:32 AM
Mon, Feb. 9, 5:30 PM
Mon, Jan. 26, 7:31 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) announced that the FDA has accepted under priority review the Biologics License Application (BLA) for Praluent (alirocumab) for the treatment of hypercholesterolemia.
- Priority review status shortens the review time to six months so the PDUFA date is July 24.
- The European Medicines Agency accepted the companies' Marketing Authorization Application (MAA) several weeks ago.
- Alirocumab is an investigational monoclonal antibody targeting proprotein subtilisin/kexin type 9 (PCSK9). It will be competing with Amgen's (NASDAQ:AMGN) evolocumab for supremacy in the post-statin anti-cholesterol market. The PDUFA date for the FDA's review of evolocumab is August 27.
- Previously: European regulator accepts Regeneron/Sanofi application for cholesterol-lowering med (Jan. 12)
- Previously: FDA OK with Amgen's BLA for cholesterol-lowering drug (Nov. 10, 2014)
Fri, Jan. 23, 8:58 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting marketing authorization for Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) for the treatment of visual impairment due to macular edema secondary to central or branch retinal vein occlusion (CRVO/BRVO).
- Eylea is currently approved in the EU for the treatment of age-related macular degeneration, diabetic macular edema and macular edema following central vein occlusion.
- A final decision by the European Commission usually takes ~60 days.
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
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.
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