Mon, Feb. 23, 11:04 AM
- The FDA's Orthopedic and Rehabilitation Devices Advisory Panel votes 5 -1 (2 abstain) that VertiFlex's Superion Interspinous Spacer System is safe and 4 -2 (2 abstain) that the risk-benefit profile is adequate.
- The FDA does not have to abide by the vote in its final decision, but it usually follows the committee's recommendation.
- Related tickers: (ABT -0.2%)(MDT +0.3%)(JNJ +0.2%)
- Previously: Ad Comm review approaches for Vertiflex spinal implant (Feb. 18)
Fri, Feb. 20, 10:42 AM
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Wed, Feb. 18, 1:54 PM
- The FDA's Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meets Friday, February 20 to discuss the Premarket Approval Application (PMA) from privately-held San Clemente, CA-based VertiFlex for its Superion InterSpinous Spacer for the treatment of moderate lumbar stenosis (narrowing of the openings for the spinal cord and nerve roots).
- The device, CE marked in Europe since 2007, alleviates back pain via insertion in the lumbar area which decompresses the spine and relieves the pressure. Its value proposition is a one-piece expandable, reversible and motion preserving implant that is easily inserted via a small incision in the back under local anesthesia in the outpatient setting.
- Executive Summary, Panel Questions
- Related tickers: (NYSE:ABT) (NYSE:MDT) (NYSE:JNJ)
Thu, Jan. 29, 8:54 AM
- Abbott Laboratories (NYSE:ABT) Q4 results ($M): Total Revenues: 5,356 (-5.3%); U.S.: 1,548 (-2.6%); Intl: 3,808 (-6.3%); Nutrition: 1,804 (+6.0%); Diagnostics: 1,234 (+3.2%); Est. Pharmaceuticals: 922 (-28.4%); Medical Devices: 1,379 (-3.8%).
- COGS: 2,337 (-1.6%); R&D Expense: 361 (-0.6%); SG&A Expense: 1,666 (+6.7%); Net Income: 905 (+53.7%); EPS: 0.59 (+59.5%).
- Gross Profit: 3,019 (-8.0%); COGS: 43.6% (+3.9%); Gross Margin: 56.4% (-2.8%); Non-GAAP Operating Earnings: 992 (-26.9%); Operating Earnings Yield: 18.5% (-22.8%); Net Earnings Yield: 16.9% (+62.2%).
- 2015 Guidance: Non-GAAP EPS: $2.10 - 2.20; GAAP EPS: $1.33 - 1.43.
- Q1 Guidance: Non-GAAP EPS: $0.41 - 0.43; GAAP EPS: $0.18 - 0.20.
Thu, Jan. 29, 8:07 AM| Comment!
Wed, Jan. 28, 5:30 PM
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Wed, Jan. 28, 12:38 PM
- The European Commission clears Mylan's (MYL -0.1%) $5.3B acquisition of Abbott's (ABT +0.7%) non-U.S. Developed Markets Specialty and Branded Generics Business. The EC is concerned that the transaction would potentially reduce competition so its approval is contingent upon the divestment of some of Mylan's businesses in Germany, the U.K., France, Ireland and Italy.
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)
Thu, Jan. 8, 1:08 PM
Dec. 30, 2014, 4:09 PM
- Thinly-traded nano cap BG Medicine (NASDAQ:BGMD) jumps 63% on a massive 17x surge in volume in response the FDA clearance of the automated version of its galectin-3 test. The test will marketed by Abbott Laboratories' (NYSE:ABT) Diagnostics Division as part of the test menu of its Architect fully-automated immunoassay analyzer.
Dec. 22, 2014, 6:58 PM
- The DOJ has filed a False Claims Act complaint against Omnicare (NYSE:OCR), alleging the healthcare services firm "solicited and received millions of dollars in kickbacks" from drug giant Abbott Labs (NYSE:ABT) in exchange for "purchasing and recommending the prescription drug Depakote for controlling behavioral disturbances exhibited by dementia patients residing in nursing homes serviced by Omnicare."
- The complaint states Omnicare's pharmacists "reviewed nursing home patients’ charts at least monthly and made recommendations to physicians on what drugs should be prescribed for those patients," and that the company "touted its influence over physicians in nursing homes in order to secure kickbacks from pharmaceutical companies such as Abbott."
- OCR -0.8% AH.
Dec. 12, 2014, 12:22 PM
- Abbott Laboratories (ABT -0.7%) finalizes its takeout of Russian pharmaceutical firm Veropharm. It acquired control of the company via its purchase of the holding company, Limited Liability Company Garden Hills, that owned ~98% of Veropharm, for 16.7B rubles (~$305M).
- Previously: Abbott to buy Russian pharma company (June 23, 2014)
Dec. 12, 2014, 11:24 AM
Dec. 3, 2014, 12:06 PM
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
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Abbott Laboratories discovers, develops, manufactures and sells health care products. Its products include branded generic pharmaceuticals manufactured internationally, marketed and sold outside the United States.
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