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%)
Thu, Feb. 19, 9:25 AM
- The initiation of a clinical trial evaluating the rVSV-EBOV (Ebola) vaccine triggers a $20M milestone payment from Merck (NYSE:MRK) to NewLink Genetics (NASDAQ:NLNK).
- The rVSV-EBOV vaccine candidate, originally developed by the Public Health Agency of Canada, was licensed by NewLInk subsidiary BioProtection Systems. It was exclusively licensed to Merck on November 24, 2014.
Thu, Feb. 12, 1:18 PM
- Novavax (NVAX +1.7%) commences patient enrollment in a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M. The study, being conducted in Australia, involves 230 healthy subjects between the ages of 18 and 50. Each person will receive two intramuscular injections, one on Day 0 and one on Day 21.
- The trial will also evaluate immunogenicity as measured by serum concentrations of IgG antibodies to the Ebola Makona strain glycoprotein.
- According to CEO Stanley C. Erck, the company now has the capability to rapidly scale up manufacturing to produce millions of doses of Ebola vaccine.
- Related tickers: (GSK -1%)(JNJ -1.8%)(OTCPK:BVNRY)(MRK +0.1%)(NLNK +5.3%)
- Previously: Johnson & Johnson announces Ebola vaccine development consortia (Jan. 16)
- Previously: First Glaxo Ebola vaccine to arrive in Liberia (Jan. 23)
Thu, Feb. 12, 11:25 AM
- AbbVie (ABBV -0.5%) submits a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare seeking approval for its all-oral, ribavirin-free, interferon-free, 12-week antiviral treatment of ombitasvir/paritaprevir/ritonavir, dosed once daily, for the treatment of patients with chronic hepatitis C genotype 1 infection.
- The Phase 3 trial data supporting the application demonstrated an SVR12 of 95% (106 of 112 subjects) in a subgroup of treatment-naive, non-cirrhotic adult genotype 1b-infected Japanese patients with a high viral load (at least 100K IU/mL).
- 1.5M - 2M Japanese are infected with HCV, with HCV-1 being the most common genotype affecting 60 - 70% of infected people. Of this group, ~95% are infected with the sub-type 1b.
- Previously: AbbVie 2-DAA HCV treatment successful in Japan Phase 3 (Feb. 2)
- Related tickers: (GILD -0.3%)(MRK -0.2%)(ENTA -3.7%)
Fri, Feb. 6, 7:04 AM
- Merck (NYSE:MRK) prices a $8B debt offering that it will use to repay the commercial paper that financed its acquisition of Cubist Pharmaceuticals. The tranches are as follows:
- $300M floating rate notes due February 2017; $700M floating rate notes due February 2020; $1,250M of 1.85% notes due February 2020; $1,250M of 2.35% notes due February 2022; $2,500M of 2.75% notes due 2025 and $2,000M of 3.70% notes due February 2045.
- Closing date is February 10.
Wed, Feb. 4, 9:52 AM
- In an unprecedented move, the FDA rescinds its Breakthrough Therapy designation for Merck's (MRK -2.4%) investigational HCV combo treatment, grazoprevir/elbasvir. The agency declined to comment on its action, but it means that the review period for the company's New Drug Application (NDA), expected to be filed by mid-year, will now be the standard ten months instead of six.
- The FDA grants Breakthrough Therapy status to a drug candidate that treats a serious medical condition and preliminary clinical evidence shows that it may demonstrate a significant improvement on a clinically significant endpoint compared to available therapies. Considering the high level of efficacy of Gilead's (GILD -9.4%) Sovaldi and Harvoni, the potential advantages of Merck's offering are apparently no longer evident.
- Related ticker: (ABBV -6.1%)
Wed, Feb. 4, 7:46 AM
- Merck (NYSE:MRK) Q4 results ($M): Total Revenues: 10,482 (-7.4%); Pharmaceutical: 9,370 (-4.0%); Animal Health: 885 (+1.6%); Consumer Care: 16 (-95.9%); Other: 211 (-29.2%).
- Sales By Product: Januvia/Janumet: 1,652 (+1.7%); Zetia/Vytorin: 1,032 (-10.4%); Remicade: 557 (-10.2%); Isentress: 418 (-5.4%); Gardasil: 356: (-9.6%); Nasomex: 268 (-18.0%); Proquad, MMRII & Varivax: 366 (+34.1%); Singulair: 319 (+7.0%).
- COGS: 3,749 (-18.6%); R&D Expense: 2,283 (+24.3%); SG&A Expense: 2,924 (-1.9%); Net Income: 7,316 (+797.7%); EPS: 2.54 (+876.9%).
- Gross Profit: 6,733 (+0.3%); COGS: 35.8% (-12.1%); Gross Margin: 64.2% (+8.3%); Operating Earnings: 1,526 (-19.4%); Operating Earnings Yield: 14.6% (-13.0%); Net Earnings Yield: 69.8% (+869.3%).
- 2015 Guidance: Revenues: $38.3B - 39.8B; EPS: $1.62 - 1.91; Non-GAAP EPS: $3.32 - 3.47.
Wed, Feb. 4, 7:11 AM
Tue, Feb. 3, 5:30 PM
Tue, Feb. 3, 8:41 AM
- Merck (NYSE:MRK) announces that Belsomra (suvorexant), for the treatment of adult patients with insomnia or who have difficulty falling asleep or staying asleep, is now available in pharmacies in the U.S. It is the only orexin receptor antagonist approved for this indication in the United States.
- Belsomra suppresses the wake drive in the brain by blocking orexin receptors. Orexin is a neurotransmitter involved in promoting wakefulness. ~30M Americans suffer from insomnia.
Mon, Jan. 26, 10:29 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Merck's (MRK +0.2%) Sivextro (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Merck acquired the rights to Sivextro via its acquisition of Cubist Pharmaceuticals.
- A final decision from the European Commission usually takes ~60 days.
- The FDA approved Sivextro in June.
- Previously: FDA give thumbs up to Cubist antibiotic (June 21, 2014)
Wed, Jan. 21, 11:41 AM
- Merck (MRK) plans to withdraw its hepatitis C medicine, Victrelis (boceprevir), from the U.S. market by the end of this year due to declining demand in the wake of the Gilead Sciences (GILD +1.1%) juggernaut. Victrelis will remain available internationally.
- Vertex Pharmaceuticals (VRTX +0.4%) pulled its offering, Incivek (telaprevir) in August for the same reason and exited the hepatitis arena.
- Merck is not giving up yet. It plans to file an NDA by mid-year for an all-oral ribavirin-free hep C regimen, grazoprevir/elbasvir.
Wed, Jan. 21, 8:53 AM
Mon, Jan. 19, 5:11 PM
- As expected, the European Commission approves Novartis' (NYSE:NVS) Cosentyx (secukinumab) as a first-line systemic treatment for adult patients with moderate-to-severe psoriasis. It is the first interleukin-17A inhibitor cleared in Europe.
- Cosentyx is also cleared for sale in Australia and Japan. FDA approval is imminent considering the unanimous positive vote by the Dermatologic and Ophthalmic Drugs Advisory Committee in October.
- Previously: Europe Ad Comm gives thumbs up to Novartis psoriasis drug (Nov. 21, 2014)
- Previously: Ad Comm backs approval of secukinumab (Oct. 21, 2014)
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Fri, Jan. 16, 8:54 AM
- A consortia of global research institutions and non-government organizations has been formed to work with Janssen Pharmaceuticals (NYSE:JNJ) to accelerate the development of its Ebola vaccine. The Innovative Medicines Initiative intends to grant more than €100M to fund the development work. The project is delineated into three areas or topics:
- Topic 1: Vaccine development, Phases 1, 2 and 3. Consortia members: Janssen, London School of Hygiene and Tropical Medicine, Oxford University, Insititut National de la Sante et de la Recherche Medicale (INSERM), La Centre Muraz.
- Topic 2: Manufacturing capability: Janssen, Bavarian Nordic A/S, Vibalogics.
- Topic 3: Deployment and compliance of vaccination regimens: Janssen, London School of Hygiene and Tropical Medicine, Grameen Foundation, World Vision of Ireland.
- A recently-started Phase 1 trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics. Janssen, in partnership with Bavarian Nordic A/S (OTCPK:BVNRY), has produced more than 400K regimens of the prime-boost vaccine for use in large-scale trials that could begin as early as April.
- Ebola vaccine-related tickers: (NASDAQ:NLNK) (NYSE:MRK) (NYSE:GSK)
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)
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