Mon, Aug. 10, 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.
Tue, Aug. 4, 9:20 AM
Tue, Aug. 4, 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.
Tue, Aug. 4, 6:31 AM
Mon, Aug. 3, 11:28 AM
Thu, Jul. 30, 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%)
Tue, Jul. 28, 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.
Fri, Jul. 24, 3:48 PM| Fri, Jul. 24, 3:48 PM | 8 Comments
Fri, Jul. 24, 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.
Fri, Jul. 24, 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)
Fri, Jul. 24, 7:29 AM
- The European Medicine's Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval for Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab) for the treatment of certain adults with hypercholesterolemia. A final decision by the European Commission usually takes ~60 days.
- The PDUFA date for the FDA's decision is today.
Thu, Jul. 23, 1:47 PM
- Tomorrow is the FDA's action (PDUFA) date for its review of regulatory filings submitted by Amgen and Sanofi.
- Sanofi's (SNY +1.2%) NDA for cholesterol-lowering Praluent (alirocumab), co-developed with Regeneron Pharmaceuticals (REGN -0.2%). On June 9, the Ad Comm voted 13 - 3 supporting approval.
- Amgen's (AMGN -0.4%) sNDA for Kyprolis (carfilzomib) for the second-line treatment of relapsed multiple myeloma. Filing accepted for review on March 30.
Tue, Jul. 21, 8:03 AM
- As expected, the European Commission approves Amgen's (NASDAQ:AMGN) Repatha (evolocumab) for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet, in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximum tolerated dose of a statin or alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated. It is also approved to the treatment of adults and adolescents at least 12 years old with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies.
- Repatha is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor approved in the world. Regulatory clearance for Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab) should happen shortly, however. PCSK9 inhibitors are poised to dominate the post-statin cholesterol-lowering market.
- Previously: Amgen gets EU backing for Repatha (May 22)
- Previously: Regeneron up 1.1% as trading reopens after Ad Comm approval (June 9)
Thu, Jul. 16, 11:42 AM
- Screen criteria: Market cap at least $500M; number of mutual fund investors at least equal to prior period; 50-day average turnover at least 400,000; annual sales at least $300M and EPS growth has accelerated the past three quarters.
- (ALKS +1%)(ALR +0.4%)(CERN +0.1%)(DVA +0.1%)(IMS +0.2%)(LLY +1%)(OMI +0.4%)(REGN +1.2%)(UNH -1.6%)(WAT +0.1%)
- This is not a list of buy/sell recommendations but rather a targeted list of stock that may be suitable for more in-depth research.
Fri, Jul. 10, 7:05 AM
- Ultragenyx (NASDAQ:RARE) initiated with Market Outperform rating with a $119 (6% upside) price target by JMP Securities.
- Regeneron Pharmaceuticals (NASDAQ:REGN) downgraded to Sell from Neutral by UBS. Price target maintained at $500 (2% downside risk).
- Amgen (NASDAQ:AMGN) downgraded to Neutral from Buy by UBS. Price target lowered to $165 (9% upside) from $185.
Thu, Jul. 9, 7:32 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) report that a Phase 3 trial in 216 Japanese patients, called ODYSSEY JAPAN, evaluating bad cholesterol-lowering Praluent (alirocumab) successfully met its primary endpoint. At week 24, the Praluent arm experienced a mean 64% greater reduction in low-density lipoprotein cholesterol (LDL-C) when added to current standard-of-care including statins compared to standard-of-care alone (p<0.0001). Also at week 24, 97% of patients reached their LDL-C treatment goal, with 99% remaining on the lower dose of 75 mg.
- The results were presented at the Annual Scientific Meeting of the Japan Atherosclerosis Society in Sendai, Japan. A regulatory submission is expected in the near future.
- Praluent, a PCSK9 inhibitor, is currently under regulatory review in the U.S. and Europe.
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