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Aug. 31, 2015, 7:53 AM
- The Medicines Company (NASDAQ:MDCO) jumps 20% premarket on average volume in response to development partner Alnylam's (NASDAQ:ALNY) announcement that its investigational RNAi therapeutic, ALN-PCSsc, lowered LDL-C (bad cholesterol) up to 83% with a mean maximum reduction of up to 64% (+-5%) in an early stage study, results comparable to Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent (alirocumab). The data were presented at the ESC Congress in London.
- What's notable in this case is the difference in dosing regimens. ALN-PCSsc was administered in one subcutaneous dose that was effective for over 140 days, giving it the potential for once per quarter or twice per year administration. Praluent is dosed once every two weeks and Repatha once every two weeks or once per month at a higher dose.
- ALN-PCSsc turns off PCSK9 synthesis in the liver. This is a different mechanism of action compared to Praluent and Repatha, both of which bind to PCSK9 in the blood.
- The Medicines Company will take the lead in developing ALN-PCSsc under the ORION Program. A Phase 2 study will commence by the end of the year and a Phase 3 trial is planned for 2017. The clinical development will include comparisons to the anti-PCSK9 monoclonal antibodies.
- The companies will host a conference call this morning at 9:30 am ET to discuss the results and their development plan.
Aug. 27, 2015, 5:56 PM
- The FDA approves Amgen's (NASDAQ:AMGN) Repatha drug for patients with hereditary forms of high cholesterol and those at high risk of cardiovascular disease.
- The scope of the approval was similar to the recent approval given to Regeneron's (NASDAQ:REGN) Praluent, which was approved for patients with cardiovascular disease and those with heterozygous familial hypercholesterolemia.
- Each of the drugs are expected to generate more than $2B/year in sales by 2020.
Aug. 25, 2015, 5:35 PM
- investors should stick with "market darlings" - the 25 stocks that had performed the best during the six months before a market pullback - according to the analyst team at RBC.
- The firm notes that although many recent winners are leading the market lower, the extent of the underperformance is just 1%; it also says investing in the group following sharp market pullbacks is a winning strategy over the ensuing week, month and six months.
- RBC's 25 market darlings are AET, ALTR, AMZN, AIZ, CVC, CI, CAG, EA, EQIX, EXPE, GME, GOOGL, HAS, HCA, MNST, NFLX, NKE, PRGO, REGN, SBUX, TSO, TWC, TSS, UA, UHS
Aug. 20, 2015, 2:35 AM
- Yesterday was the 11th anniversary since Google's (GOOG, GOOGL) initial public offering, and there's no doubt the company has had a remarkable run (Class A shares +1,277%).
- Although the online advertising giant has given a massive return to investors, there are still 13 stocks that outperformed Google since 8/19/2004:
- Alexion Pharmaceuticals (NASDAQ:ALXN); Amazon (NASDAQ:AMZN); Apple (NASDAQ:AAPL); Celgene (NASDAQ:CELG); Gilead Sciences (NASDAQ:GILD); Intuitive Surgical (NASDAQ:ISRG); Keurig Green Mountain (NASDAQ:GMCR); Monster Beverage (NASDAQ:MNST); Netflix (NASDAQ:NFLX); Priceline (NASDAQ:PCLN); Regeneron Pharmaceuticals (NASDAQ:REGN); salesforce.com (NYSE:CRM); Vertex Pharmaceuticals (NASDAQ:VRTX).
Aug. 14, 2015, 7:16 AM
- Based on additional analyses of the data from a Phase 2a clinical trial in wet age-related macular degeneration, Avalanche Biotechnologies (NASDAQ:AAVL) decides not to proceed to Phase 2b with its lead product candidate AVA-101. Instead, it will conduct further preclinical studies to clarify the optimal dose and delivery of AVA-101 and AVA-201 compared to standard-of-care anti-VEGF protein therapy before advancing the best candidate back into the clinic. The process should be completed by the end of the year.
- The company's decision shouldn't be a surprise. The stock plummeted 40% in June after the company reported less-than-expected results from the Phase 2a study.
- The value proposition of AVA-101, a gene therapy that contains a gene that encodes a naturally occurring anti-VEGF protein, is a single subretinal injection compared intravitreal (inside the eye) injections as frequent as once per month for Regeneron's (NASDAQ:REGN) Eylea and Roche's (OTCQX:RHHBY) Lucentis.
- Shares are down 14% premarket on light volume.
- Previously: Avalanche Bio plummets 40% after hours on less-than-expected AVA-101 data; chances dim for pick up by Regeneron (June 15)
Aug. 11, 2015, 10:15 AM
- In a letter published in the Journal of the American Medical Association (AMA), CVS Health (CVS -0.5%) urges heart specialists to revamp guidelines for treating patients with high cholesterol to provide clarity on how best to choose the best and most cost effective therapy now that expensive new drugs called PCSK9 inhibitors are now on (or will soon be on) the market.
- PCSK9 inhibitors, led by recently-approved Praluent (alirocumab) (SNY -0.4%)(REGN -0.8%) and soon-to-be-approved Repatha (evolocumab), are, at least initially, more than 20 times more expensive than statins. Pharmacy benefit managers, like CVS, aim to control costs by extracting significant discounts from manufacturers and controlling patient access to the pricier drugs.
- CVS wants the guidelines to include specific LDL targets, which older guidelines did before new ones issued in 2013 did away with them. The emphasis now is on a patient's risk of developing heart disease as the main determinant for more intensive treatment. Unsurprisingly, the American College of Cardiology and the AMA have shown scant enthusiasm for revisiting the issue.
- CVS Chief Medical Officer Dr. Troyen Brennan says that if the guidelines are not changed, then CVS will use its own targets, which will vary depending on each patent's medical history. "We expect patients to first use statins. If they can't use statins or can't make (NYSE:LDL) targets, then they would use PCSK9 inhibitors."
- The PDUFA date for Amgen's (AMGN -1%) Repatha is August 27.
Aug. 10, 2015, 12:25 PM
- CVS Health (CVS +0.8%), the number two pharmacy benefit manager (PBM), says it will wait until a second PCSK9 inhibitor is approved before adding either one to its list of covered drugs and negotiating price discounts, clearly an effective strategy if its hopes to win significant price reductions, which is likely if one firm secures exclusive coverage.
- Last month, the FDA cleared Praluent (alirocumab), co-developed by Sanofi (SNY +1.6%) and Regeneron Pharmaceuticals (REGN +0.9%). The PDUFA date for a second PCSK9 inhibitor, Amgen's (AMGN -0.8%) Repatha (evolocumab), is August 27.
- PCSK9 inhibitors are the "next big thing" in lowering bad cholesterol. They ain't cheap, though. Generic statins cost ~$50 per month while Praluent costs ~$1,200 before discounts.
Aug. 4, 2015, 9:20 AM
Aug. 4, 2015, 8:43 AM
- Regeneron Pharmaceuticals (REGN +0.1%) Q2 results: Revenues: $998.6M (+50.0%); COGS: $60.9M (+103.7%); R&D Expense: $390.3M (+32.5%); SG&A: $174.6M (+80.6%); Operating Income: $344.9M (+51.2%); Net Income: $194.6M (+101.9%); EPS: $1.69 (+98.8%); Quick Assets: $1,193.8M (-12.3%).
- Eylea U.S. sales: 655 (+57.8%).
- 2015 Guidance: Eylea U.S. net product sales growth: 45 - 50% from 30 - 35%; non-GAAP unreimbursed R&D: $510M - 550M from $525M - 575M; non-GAAP SG&A: $610M - 650M from $650M - 725M; CAPEX: $675M - 750M from $650M - 750M.
Aug. 4, 2015, 6:31 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN): Q2 EPS of $2.89 beats by $0.12.
- Revenue of $998.62M (+50.0% Y/Y) beats by $110.81M.
- Shares +1.21% PM.
Aug. 3, 2015, 11:28 AM
- Regeneron Pharmaceuticals (REGN -0.3%) will report Q2 results tomorrow before the open. Consensus view is EPS of $2.77 (+12%) on revenues of $888M (+33%).
Jul. 30, 2015, 1:37 PM
- Unsurprisingly, Express Scripts (ESRX -0.6%) takes a dim view of the proposed price of the cholesterol-lowering PCSK9 inhibitor Praluent (alirocumab). Last Friday, co-developers Sanofi (SNY +1.6%) and Regeneron Pharmaceuticals (REGN +0.4%) announced that the wholesale acquisition cost (WAC) of the once-every-two-week injection will be $40 per day or $14,600 per year. This is several orders of magnitude above the cost of statins, which average $2 - 3 per day.
- WAC is the average price that wholesalers and distributors pay for the drug. Patients will, of course, pay quite a bit more.
- Pharmacy benefit managers, still feeling the pinch from Gilead's (GILD +1.8%) HCV meds Sovaldi and Harvoni, will likely ratchet up their opposition as Praluent's U.S. launch commences.
- Related tickers: (AET +0.9%)(CTRX)(CNC +0.9%)(CI -0.7%)(HUM)(MRK +0.3%)(OCR +0.4%)(UNH -0.7%)(CVS -0.5%)
Jul. 28, 2015, 8:42 AM
- Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN) enter into a new global collaboration to discover, develop and commercialize new immuno-oncology products, including a Phase 1-stage programmed cell death protein (PD-1) inhibitor. The initial term of the partnership is five years with a possible three-year extension for selected programs. Clinical trials are expected to start next year.
- Regeneron will be responsible for discovery, antibody generation and development through proof-of-concept (typically Phase 2). At this point, Sanofi has the option to opt-in to take over late-stage development and commercialization. In their current collaboration, Sanofi has the option to opt-in at the time of an IND filing. For programs where Regeneron is the lead, including the PD-1 inhibitor REGN2810, Regeneron will be the U.S. commercial lead while Sanofi will be the commercial lead ex-U.S. Both firms will retain the right to co-promote the products in the non-lead territories and both will share equally in global profits.
- Under the terms of the agreement, Sanofi will make an upfront payment to Regeneron of $640M. Both companies will invest $1B for discovery through proof-of-concept, split on a 75/25 basis (SNY: $750M/REGN: $250M). The partners will also invest $650M on a 50/50 basis to develop EGN2810. Sanofi will pay Regeneron a milestone of $375M if the sales of a PD-1 inhibitor or any other antibody developed under the collaboration exceeds $2B for any consecutive 12-month period. Both firms have agreed to re-allocate $75M over three years from Sanofi's $160M annual contribution to the current antibody collaboration to the development of immuno-oncology antibodies. Additional funding will be allocated as programs proceed into late-stage development.
- REGN is up 2% premarket while SNY is up a fraction, both on light volume.
Jul. 24, 2015, 3:48 PM| Jul. 24, 2015, 3:48 PM | 8 Comments
Jul. 24, 2015, 2:31 PM
- Esperion Therapeutics (NASDAQ:ESPR) has taken a dive, -20.4%, as the FDA approves Praluent (alirocumab), the competing cholesterol-lowering drug developed by Regeneron (NASDAQ:REGN) and Sanofi (SNY +0.2%).
- Praluent is the first cholesterol-lowering treatment in the PCSK9 inhibitor class.
- Esperion fell sharply in June in response to a positive FDA AdComm vote for Praluent, which stands to compete against Esperion's ETC-1002 cholesterol drug candidate (provided it's approved).
- Regeneron shares remain halted.
Jul. 24, 2015, 2:11 PM
- Regeneron (NASDAQ:REGN) shares have been halted, down 2.6% beforehand, for news pending.
- Today is the FDA's action date for reviewing Praluent (alirocumab), the cholesterol-lowering drug developed by Regeneron and Sanofi.
- Updated 2:25 p.m.: The FDA approves Praluent to treat certain patients with high cholesterol.
- Updated 3:25 p.m.: Regeneron will resume trading at 3:40 p.m. ET.
- Previously: Europe's CHMP give thumbs up to Regeneron and Sanofi's Praluent (Jul. 24 2015)
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