Wed, Apr. 29, 10:05 AM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on June 10 to discuss Amgen's (AMGN +0.2%) Biologics License Application (BLA) for Repatha (evolocumab) for the treatment of high cholesterol. The FDA's PDUFA date is August 27.
- Evolocumab is an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) (the "bad" cholesterol) from the blood. It, along with Regeneron's (REGN +0.8%) Praluent (alirocumab), are the front-runners to dominate the post-statin cholesterol-lowering market. Praluent's PDUFA date is July 24. Both drugs should be blockbusters.
- Previously: Evolocumab successful in two Phase 3 studies (Oct. 2, 2014)
- Previously: Regeneron's alirocumab shows durable effect in lowering "bad" cholesterol in high risk patients (March 16)
Wed, Mar. 25, 11:21 AM
- The FDA approves the use of Regeneron Pharmaceuticals' (REGN -3%) Eylea (aflibercept) for the treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
- Diabetic retinopathy is the most common diabetic eye disease and the leading cause of blindness in adults in the U.S., affecting more than 29M Americans. About a third of diabetics over the age of 40 have some form of DR. In some cases of DR with DME, abnormal new blood vessels grow on the surface of the retina. If they break, severe vision loss or blindness can occur.
- The FDA previously cleared Eylea for the treatment of wet age-related macular degeneration, DME and macular edema secondary to retinal vein occlusions.
- Eylea generates the bulk of the company's sales, pulling in $1.7B last year (62% of total revenues).
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Wed, Mar. 18, 7:45 AM
- Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
- PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
- PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
- The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
- Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Mon, Mar. 16, 8:26 AM
- A Phase 3 study evaluating Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) in patients with hypercholesterolemia showed that patients receiving Praluent 150 mg every two weeks lowered their low-density lipoprotein cholesterol (LDL-C) by an additional 62% (p<0.0001) at Week 24 compared to placebo, with consistent LDL-C lowering maintained over 78 weeks (56% reduction, p<0.0001).
- The trial, call ODYSSEY LONG TERM, assessed Praluent 150 mg (n=1,553) compared to placebo (n=788) in patients judged at high cardiovascular (CV) risk and who were receiving the maximum tolerated dose of statin therapy with or without other lipid-lowering treatment. Patients self-administered a subcutaneous injection of Praluent every two weeks via a pre-filled syringe.
- At Week 24, 81% of patients in the Praluent cohort achieved their pre-specified LDL-C goal compared to 8.5% for placebo (p<0.0001).
- Praluent is an investigational human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Inhibiting PCSK9 frees up more LDL receptors on the surface of liver cells which enables the more LDL-C to be removed from the blood.
- Alirocumab and Amgen's (NASDAQ:AMGN) evolocumab are the front-runners to dominate the post-statin cholesterol-lowering market. They will be competing right out the blocks in the U.S. The FDA's PDUFA dates are July 24 alirocumab and August 27 for evolocumab. Praluent is being co-developed by Sanofi (NYSE:SNY).
Tue, Mar. 10, 3:55 AM
- Prescription drug spending rose by a record 13% in the U.S. last year, the biggest annual increase in over a decade.
- "For the past several years, annual drug spending increases have been below the annual rate of overall health-care inflation in the U.S.," said Glen Stettin, senior vice president at Express Scripts. "But that paradigm is shifting dramatically as prices for medications increase at an unsustainable rate."
- Spending on specialty medicines, such as those for inflammatory diseases, multiple sclerosis, cancer and hepatitis C rose an unprecedented 31%.
Fri, Feb. 27, 9:01 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) amend their long -standing collaboration agreement to transition the sole responsibility for the development and commercialization of Zaltrap (ziv-aflibercept) Injection for Intravenous Infusion for cancer indications worldwide to Sanofi.
- Sanofi will now bear all development and commercialization costs and will reimburse Regeneron for its costs related to such activities. It will also pay Regeneron 15 - 30% of aggregate net sales of Zaltrap each year. Regeneron will no longer be required to reimburse Sanofi for 50% of the development expenses pertaining to Zaltrap per the original agreement.
- Zaltrap generated €69M in sales for Sanofi last year. Regeneron booked a total of $541.3M in 2014 from its overall collaboration with Sanofi.
Thu, Feb. 26, 8:59 AM
- The European Commission approves the use of Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion. The new indication includes macular edema following branch retinal vein occlusion in addition to the previously approved indication of macular edema secondary to central retinal vein occlusion.
- Elyea is Regeneron's top product, generating $1.7B in U.S. sales last year (62% of the firm's total revenue).
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)
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