Today, 2:58 AM
- GlaxoSmithKline (NYSE:GSK) and Novartis (NYSE:NVS) have completed a series of asset swaps worth more than $20B that will reshape both drugmakers.
- Glaxo is forming a consumer health joint venture with Novartis, while at the same time buying the Swiss company's vaccines business and divesting its cancer drugs portfolio to Novartis.
- Following completion of the transactions, Glaxo plans to return £4B ($6.16B) to shareholders.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly (Apr. 22 2014)
Fri, Feb. 27, 12:20 PM
- According the the World Health Organization (WHO), a recommendation from the Strategy Advisory Group of Experts (SAGE), an independent advisory body, to commence the widespread introduction of an Ebola vaccine won't happen until at least August due to the timing of results from clinical trials.
- Liberia is currently testing vaccine candidates from GlaxoSmithKline and Merck-NewLink. Sierra Leone and Guinea will announce their plans soon.
- The steep decline in Ebola cases will make it more difficult to prove the efficacy of the experimental vaccines so some of the testing may have to be moved to Sierra Leone, according to the U.S. National Institutes of Health.
- More than 23,500 cases of Ebola have been reported in the three African countries, with more than 9,500 fatalities. Only 99 new confirmed cases were reported for last week.
- (GSK -0.6%)(MRK -0.5%)(NLNK +1.2%)(GILD -0.8%)
Thu, Feb. 26, 3:26 AM
- Posting its seventh straight annual loss, Royal Bank of Scotland (NYSE:RBS) reported a £3.47B net loss for 2014 after booking a £4B writedown on the value of U.S. offshoot Citizens.
- The bank also named Howard Davies as chairman. Davies, the former head of the now-defunct Financial Services Authority, succeeds Philip Hampton, who is to replace Christopher Gent as chairman of GlaxoSmithKline (NYSE:GSK).
- Previously: Sir Howard Davies set to take chairman's role at RBS (Feb. 23 2015)
Wed, Feb. 25, 12:36 PM
- Citing good progress in obtaining clearances and approvals, GlaxoSmithKline (GSK +0.1%) expects to complete its three-part deal with Novartis (NVS -0.2%) sometime during the first week in March.
- The transaction, first announced in April of last year, consists of GSK buying NVS's vaccines business, the creation of a consumer healthcare joint venture between the two firms and the sale of GSK's marketed oncology portfolio to NVS, including related R&D and the rights to two AKT inhibitors in development.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly (April 22, 2014)
Tue, Feb. 24, 8:14 AM
- Merck (NYSE:MRK) extends a royalty-free license to the Medicines Patent Pool (MPP) for its pediatric formulations of raltegravir (marketed as Isentress in the U.S.) for the treatment of HIV-1 infection in infants and children from four weeks to under 12 years of age in developing countries. This is the MPP's first agreement that provides access to an HIV integrase inhibitor for use in combination HIV therapy for patients in this age range.
- Raltegravir is the only integrase inhibitor cleared for use in infants and children as young as four weeks in the U.S. and European Union. Pediatric formulations are available as chewable tablets (25 mg and 100 mg) and granules for oral suspension (single-use 100 mg packets).
- There are ~3.2M children infected with HIV worldwide.
- The MPP, founded in 2010, is a United Nations-backed organization that aims to increase access to HIV medicines and technologies to people in developing countries. It has agreements with AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY), Gilead Sciences (NASDAQ:GILD), Roche (OTCQX:RHHBY), NIH and ViiV Healthcare (NYSE:PFE) (NYSE:GSK).
Mon, Feb. 23, 12:42 PM| Comment!
Fri, Feb. 20, 7:15 AM
- The World Health Organization (WHO) approves the use of a 15-minute point-of-care test developed by Corgenix Medical (OTCQB:CONX) to detect the presence of the Ebola virus. The company developed the assay with funding assistance of the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.
- Procurement and roll-out in Africa will begin in a few weeks pending the completion of administrative procedures with the U.S. FDA.
- Ebola-related tickers: (NYSE:MRK) (NASDAQ:NLNK) (NYSEMKT:IBIO) (NASDAQ:NVAX) (NYSE:GSK) (NYSE:JNJ) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:BCRX) (NASDAQ:SRPT) (NASDAQ:CMRX) (NASDAQ:ABIO) (OTCQB:AEMD) (OTCPK:BVNRY) (NASDAQ:INO) (OTCQX:RHHBY)
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%)
Tue, Feb. 17, 7:50 AM
- GlaxoSmithKline (NYSE:GSK) replaces President, GSK North America Pharmaceuticals Deidre Connelly with Jack Bailey, SVP for Policy, Payers and Vaccines. The move was prompted by a 12% drop in U.S. sales last year, weighed down by the under-performance of its respiratory unit. Bailey's experience in dealing with healthcare payers was a key factor in the decision.
- The respiratory franchise will struggle again this year but should return to growth in 2016 led by the clearance of several new products.
Fri, Feb. 13, 8:30 AM
- UBS does an about-face on Glaxo (NYSE:GSK), upgrading shares to Buy from Sell, and bumping price target to 1700p from 1250p (implied upside 16.2%).
- "GSK has been a difficult investment case for years, with declining earnings since 2010, as sales growth has been anemic and the operating margin trended steadily down despite several rounds of restructuring," firm says. "For the first time in over a decade, we see scope for substantial earnings growth in the coming three-five years, driven by new products in ViiV and Vaccines."
- UBS notes impact of GSK's Triumeq and Tivicay HIV treatments presents a "blockbuster opportunity," and is currently under-appreciated by the market. Assuming 25% patient market share in the U.S. by 2018, sales could reach $4.6B. UBS previously forecast $2.8B.
- Also sees strong potential in shingles vaccine HZ/su, estimating sales of $1.4B by 2020, which is still not reflected in consensus forecasts.
- Shares +3.8% premarket and +4.4% in London.
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)
Wed, Feb. 11, 3:38 AM
- President Obama is expected to announce plans today to withdraw most of the U.S. troops assigned to combat the Ebola outbreak in West Africa, where they had been deployed to assist with supply logistics, construction and training.
- The return of the troops comes as the number of new infections drops in the region - from 1,000 new suspected, probable and confirmed Ebola cases a week in October to about 150 a week in recent reports.
- Ebola-related stocks: JNJ, GSK, HEB, BCRX, NLNK, NNVC, INO, TKMR -0.5% AH
Fri, Feb. 6, 10:06 AM
- On March 19, the FDA's Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly discuss the supplemental New Drug Application (sNDA) for the expanded use of Breo Ellipta (fluticasone furoate and vilantrol dry powder for inhalation) for the once-daily treatment of asthma in patients at least 12 years old.
- Breo Ellipta is currently approved for the once-daily treatment of the symptoms of chronic obstructive pulmonary disease (COPD). It is being jointly developed by GlaxoSmithKline (GSK +0.7%) and Theravance (THRX +0.2%).
Fri, Feb. 6, 9:20 AM
- According to some observers, Pfizer's (NYSE:PFE) $17B takeout of Hospira (NYSE:HSP) is only a prelude to a bigger deal(s) considering that it was prepared to spend $120B for AstraZeneca (NYSE:AZN).
- According to Gabelli analyst Kevin Kedra, Actavis Plc (NYSE:ACT) is an attractive target, especially since nabbing Allergan (NYSE:AGN) and its fast-growing drug portfolio. A Pfizer takeover would be big enough to overcome the U.S. Treasury's stricter rules on inversions and lower its tax bill.
- John Boris of SunTrust Banks says GlaxoSmithKline (NYSE:GSK), AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY) and Mylan (NASDAQ:MYL) may be on the radar as well.
- Pfizer had $33B in cash at the end of September which it will use a portion of plus debt to pay for Hospira.
Thu, Feb. 5, 8:12 AM
- GlaxoSmithKline (NYSE:GSK) commences an offering of its entire stake of 4,471,202 shares (7.9%) of Danish biotech GenMab. The company is selling its position because it no longer considers it a core asset since it sold its oncology portfolio to Novartis (NYSE:NVS).
- The outcome of the divestment should be announced today.
Wed, Feb. 4, 8:46 AM
- GlaxoSmithKline (NYSE:GSK) Q4 results (₤M): Total Revenues: 6,186 (-10.4%); Pharmaceuticals: 4,224 (-10.5%); Vaccines: 846 (-12.5%); Consumer Healthcare: 1,116 (-8.4%).
- Pharmaceuticals: Innovative: 2,985; Respiratory: 1,664; Oncology: 335; Cardio, Metabolic, Urology: 260; Immuno-inflammation: 61; Other: 665; Seretide/Advair: 1,119 (-20.0%).
- Vaccines: Infanrix, Pediarix: 212 (+1.9%); Hepatitis: 148 (-2.6%); Synflorix: 130 (-19.3%).
- Consumer Healthcare: Wellness: 420 (-10.4%); Oral Health: 460 (+2.9%).
- COGS: 2,029 (-19.7%); R&D Expense: 979 (-8.5%); SG&A Expense: 2,207 (+0.3%); Net Income: 1,025 (-59.1%); EPS: 0.215 (-62.1%); CF Ops: 2,210 (+1.1%); Quick Assets: 5,494 (-4.6%).
- Gross Profit: 4,157 (-5.1%); COGS: 32.8% (-10.3%); Gross Margin: 67.2% (+6.0%); Operating Earnings: 691 (-71.7%); Operating Earnings Yield: 11.2% (-68.4%); Net Earnings Yield: 16.6% (-54.3%).
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GlaxoSmithKline PLC incorporated in United Kingdom. The Company creates, discoveres, develops, manufactures and markets pharmaceutical products including vaccines, over-the-counter (OTC) medicines and health-related consumer products.
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