GlaxoSmithKline (GSK)

[DewDiligence]

GSK 4Q17 CC slides:

https://www.gsk.com/media/4628/fy-2017-results-slides.pdf

[Inoviorulez]

https://seekingalpha.com/article/4115400-glaxosmithkline-lands-big-win-shingles-vaccine

[Trend-Setter]

Mymetics to Present New Preclinical Data on Thermostable and Cold-Chain Independent Virosome based Vaccines

The new preclinical data will be presented at three upcoming events.

12 – 14 September, 2017: Modern Vaccines Adjuvants & Delivery Systems, Porto, Portugal.
16 – 18 September, 2017: ILS Liposome Advances & Liposome Research, Athens, Greece.
10 – 12 October, 2017: World Vaccine Congress Europe, Barcelona, Spain.

The preliminary results are showing that spray drying and lyophilization may conserve the virosome structure and antigens during the manufacturing process. Preclinical studies showed that Mymetics HIV-1 vaccine candidate, after being downstream processed into different powder solid dosage forms, could trigger specific antibodies, which were variable depending on the formulation. Antibodies were quantified in serum, nasal washes, vaginal washes and feces by the immuno-PCR Imperacer® assays.

https://www.otcmarkets.com/stock/MYMX/news/Mymetics-to-Present-New-Preclinical-Data-on-Thermostable-and-Cold-Chain-Independent-Virosome-based-Vaccines?id=169649&b=y

[Trend-Setter]

Breakthrough in vaccine delivery will disrupt the vaccine industry worldwide.

http://www.businesswire.com/news/home/20170810005176/en/

doc.video: https://vimeo.com/227783144

[Trend-Setter]

http://www.paneuropeannetworks.com/health/dutch-biotech-leads-vaccine-h2020-project/

[3DYOGI]

Google/GSK started Galvani Biosciences a private company and have ponied up 750 Million in bioelectronics

http://www.reuters.com/article/us-gsk-alphabet-idUSKCN10C1K8

Apple entering Bio electronics Steve Jobs secretly started a Bio electronics program before his death.


http://nypost.com/2017/04/12/apple-has-a-secret-team-developing-diabetes-treatments/


Pulse Biosciences PLSE Robert Duggan CEO Founder owns a huge stake in PLSE

http://www.reuters.com/article/brief-robert-duggan-reports-182-pct-stak-idUSFWN1HJ0D4

ENDV the most under valued and furthest along the bio electronics sector with 21 patents huge insider buying over 40 Million shares 85 million floating President has spent half his salary on buying shares on the open market at .26

$GSK/GOOG Bioelectronic partnership or buyout?
$ENDV

[Trend-Setter]

MACIVIVA = Game Changer

"Vaccines are often produced as liquid biological products containing > 80% of water, which explains in part their instability during the storage in laboratories, hospitals, or manufacturing facilities. Liquid vaccines are inherently prone to physical and/or chemical modification, and degradation might also affect the immunological properties of the vaccine immunogens, with unwanted immune responses or insufficient immune protection. There is growing evidence that solid vaccine forms (e.g. powder) may offer several advantages over the liquid formulations, such as slowing down modifications and degradation.
The vaccine industry has developed freeze-drying lyophilization with low residual moisture content for improving stability and extending vaccine shelf-life. Such vaccines are stored as stable lyophilized dry products in a continuously frozen state at < -18°C, while others can be stored in refrigerators (+2-8°C). Therefore, maintenance of the cold chain is fundamental for preserving the bioactivity of most liquid and lyophilized vaccines currently on the market as well as those under development. However, many regions of developing countries also lack electricity and cooling capability for keeping vaccines below +8oC. The development of cold-chain independent vaccines in solid powder forms may greatly simplify the logistics and represent one of the long-term global solutions for addressing important issues faced by the vaccine field."

"Furthermore, lyophilized vaccines must be reconstituted with a diluent prior to administration, which implies also that lyophilized vaccines must be packed and shipped together with vials/syringes containing the diluents for reconstitution. As most of the standard liquid vaccines, reconstituted lyophilized vaccines are generally administered intramuscularly, subcutaneously or intradermally with syringes. All the above suggests that liquid and freeze-dried vaccines, despite their good immunogenicity and stability, could be further improved by: i) Developing vaccines that are more thermostable, which means able to support high and low temperature excursions outside the recommended cold chain conditions or storage outside the cold chain; ii) Circumvent the powder reconstitution step prior administration; iii) Needle-free vaccination by one of the mucosal routes (sublingual, nasal or oral) with the solid vaccine powder forms."

"MACIVIVA Consortium has for main objective to develop robust “universal-like” manufacturing processes by heat spray drying or freeze-drying for obtaining new thermostable virosome dry powders for novel vaccine formulations for sublingual, oral and intranasal delivery, each representing a different manufacturing Pilot Line allowing GMP scale-up. If the project is successful, these thermostable virosomal vaccines could be stored outside the cold chain without affecting the vaccine properties, simplifying the logistics and addressing one of the major problems in the vaccine field. In the future, this may also allow the manufacturing of other human safe virosome-based vaccine formulations, as well as other vaccines. These innovative needle-free vaccines could be self-administered directly to the subject through the following non-invasive routes: Intranasal, oral and sublingual, without the need of reconstitution, favoring a broad acceptance in the target population."

"From May 2015 to October 2016 (M1-M18), all six MACIVIVA partners have closely collaborated together to achieve the project milestones and objectives set for this period. During the downstream processing from liquid to solid dosage forms, various analyses on virosomes were performed to make sure that they retain their original physical and biological properties after formulation as sublingual tablet, nasal spray and oral capsule. Mymetics SA had produced 12 different virosome fomulations during the first 18 months of the project, which were distributed among Upperton, Catalent, Chimera and Mymetics SA/BV. Catalent and Upperon have then evaluated various buffers and excipients for identifying the most suitable one for preserving the initial virosome structure, antigens and pH, respective to their own manufacturing process. Several manufacturing process parameters were investigated and optimized."

Full Coverage Report: http://cordis.europa.eu/result/rcn/194900_en.html


MACIVIVA : http://www.maciviva.eu/

Consortium partners:
http://www.mymetics.com/
http://www.catalent.com/index.php
http://www.bachem.com/
http://www.upperton.com/
http://www.chimera-biotec.com/

[pearsby09]

For 2016, it's been all about TAF - sweet, sweet tenofovir alafenamide fumarate. What's so special about TAF, you ask? TAF (you may know it as Vemlidy) is replacing TDF (Viread) in a variety of HIV treatments because it's safer and less costly to produce. How much less? Here's a quote from the Q3'16 conference call:

John F. Milligan

We're particularly excited about the role that TAF will play. With a small daily dose and improved side effect profile, it is ideal for resource-constrained areas of the world and requires only one-tenth of the manufacturing capacity to supply the same number of patients.
TAF's manufacturing efficiency bodes well for the future profit margins in the HIV business. Now how about safety? TAF is both safer for renal health and bone density. This abstract from CROI illustrates the point clearly. 0 out of 866 patients developed clinically significant renal issues on TAF, whereas 12 out of 867 patients developed renal issues on TDF. This is statistically significant, and the efficacy results are similar. All you need to know is TAF is a safer version of TDF, and that safety is paramount in HIV treatment.

In the HCV market, side effects are important. However, they are even more crucial in HIV because the disease is chronic. In other words, treatment durations are decades rather than a few weeks. Drug-drug interactions, side effects, PK and PD data, and various other factors play a huge role in these lifetime treatment fields. TAF solved long-term concerns related to renal and bone damage seen with TDF treatments, leading to fast uptake.

When Gilead released TAF, it was quickly adopted as a preferred treatment in the US Department of Health & Human Services (DHHS) and International Antiviral Society (IAS) guidelines. It has also been adopted in the guidelines of a variety of other countries such as Germany, the UK, Spain, and Italy. In addition, guidelines are starting to label TDF-backed regimens as alternative treatments. A quote from the Wells Fargo broker conference back in September 2016 illustrates the importance of this:

[wshaw14]

Who knows? http://seekingalpha.com/article/4049323-gilead-hcv-problem

[trendmkr]

GlaxoSmithKline Plc (NYSE:GSK) Phase 3 Trials Looks Positive: Will Gilead Endure? http://marketexclusive.com/glaxosmithkline-plc-nysegsk-phase-3-trials-looks-positive-will-gilead-endure/49461/?icd1

[Honeycomb777]

INNV has FlutiCare a comin...lookout Flonase !!

* Easy 12-15% immediate grab of GSK's nasal allergy relief marketshare

[TERIA]

Smithers Rapra have forecast the global market for Pre-Filled Syringes to rise to $6.6 Billion by 2020. Good news for GSK!

Excited to hear more insight from their Device Development Manager - David Blakey, when he presents in Central London at Pre-Filled Syringes Europe.

Details on the event in Jan 2017 are available at http://www.pre-filled-syringes.com/ihub

[itsallgood11]

http://www.stockhouse.com/news/press-releases/2016/10/13/theralase-demonstrates-significant-increase-in-survival-for-brain-cancer

[nyctraydr]

GlaxoSmithKline Partners With VBI Vaccines, SciVac To Eliminate Cold Chain
http://marketexclusive.com/glaxosmithkline-nysegsk-partners-with-vbi-vaccines-nasdaqvbiv-scivac-otcmktssvacf-to-eliminate-cold-chain/3031/

[nyctraydr]

GlaxoSmithKline Charged With Anti-Competitive Practices And Fined A Whopping £37.6 Million
http://marketexclusive.com/glaxosmithkline-nysegsk-charged-with-anti-competitive-practices/2864/

[Pure_Greatness]

GSK NICE NEWS

[TREND1]

5.91% Dividend Yield.

05/13/2015Ex-Dividend Date.

$45.00BofAML 12 Month
Objective.

[TREND1]

GSK 30 D

[TREND1]

about GSK'S TANZEUM
http://www.tanzeum.com/

[TREND1]

Big Pharma Dividend Stocks That Are Dragging Down Your Returns

Dividends are a great way to supplement capital gains, especially for large pharmaceutical companies that have more cash than they know what to do with. But dividends aren't enough in and of themselves to produce substantial gains.


Cheryl Swanson: British drug-maker GlaxoSmithKline now sports a massive yield of 5.2%, which, in this yield-parched world, could appear tempting. But Glaxo is a real return-killer, having largely missed the equity rally of the past six years. In fact, the stock price has dropped 16% in the past 12 months, truly terrible compared to the almost 18% gain of the overall pharmaceutical sector.

While Glaxo's Chinese bribery scandal is becoming old news, as 2015 progresses, the company keeps running into new foul ups. On April 16 Glaxo announced a recall of all remaining doses (1.7 million) of its four-in-one flu vaccine because of effectiveness problems. On April 24, potency issues were also reported with the company's malaria vaccine.

The recent vaccine snafus make the company's decision to send its high-margin oncology assets to Novartis (NYSE: NVS ) -- in exchange for the Swiss pharma's less-profitable vaccine business -- even more questionable. The $20 billion-plus asset swap was supposed to refocus Glaxo in its core area of expertise, as well as take up slack from its respiratory med business, and vaccines are expected to churn out 14% of company sales going forward.

But this past season's flu vaccines posted one of the worst efficacy rates in recent memory, so it's likely considerably fewer people will be lining up for jabs next year. Meanwhile, what about the dividend? Could it be cut? Glaxo paid out about 85% of its profit in dividends last year, the highest ratio among all Big Pharmas. While management has been scrambling to reassure investors the dividend is secure, with key drug Advair sales floundering and wannabee-blockbusters Anoro and Breo falling short of estimates, a dividend cut is not off the table for this stock, no matter what management says. Dividend dogs have their appeal, but this seems destined to remain a real howler. I'd stand well clear.

[TREND1]

Avandia for the treatment of type 2 diabetes

[TREND1]

LONDON-- GlaxoSmithKline PLC (GSK.LN) said Monday it is selling its meningitis vaccines Nimenrix and Mencevax to Pfizer Inc's (PFE) Irish subsidiary for 115 million euros ($130.6 million).

Glaxo said it is selling the vaccines to gain regulatory approval for a deal with Novartis AG (NVS) that includes Glaxo buying Novartis's vaccines business.

Nimenrix and Mencevax, which are sold outside the U.S. and achieved combined global sales in 2014 of 34 million pounds ($54 million), Glaxo said.

Shares at 1115 GMT, up 16 pence, or 1.2%, at 1,374 pence valuing the company at GBP66.8 billion.

-Write to Rory Gallivan at [e-mail]; Twitter: @RoryGallivan

[TREND1]

The Best Return on Equity in Healthcare

What's a good way to compare different stocks? One of the best methods of comparison is to look at stocks' returns on equity, or ROE. This financial metric shows the amount of net income as a percentage of shareholders' equity. Shareholders' equity, also known as book value, is calculated by subtracting total liabilities of a company from its total assets.

It's best to use ROE for comparing stocks within the same sector. Different dynamics drive different sectors. But looking at ROE values for stocks in the same sector can help investors more effectively stocks to put on their watchlists. If you're wanting to buy healthcare stocks, for example, examining ROE is a good place to start. These three stocks have the best returns on equity across all of healthcare.

1. Catalent (NYSE:CTLT)
The highest ROE among healthcare stocks with a market cap of at least $250 million belongs to a company you might not have heard of. Catalent's ROE currently stands just under 218% -- twice as high as the second-place healthcare company.

While Catalent's initial public offering was less than a year ago, the company isn't new to the scene. Cardinal Health spent years scooping up oral drug delivery technologies before ultimately spinning off the business in 2007, which ultimately became known as Catalent.

Catalent focuses on three different areas -- oral technologies, medication delivery solutions, and development and clinical services. Oral technologies generate over 60% of total revenue and nearly 90% of total earnings. What's really impressive about this business model is that nearly half of new chemical entities approved by the FDA over the last decade relied on Catalent's technology in some way!

Catalent's ROE is impressive, but some of its other financial metrics aren't. For example, revenue dropped slightly last quarter compared to the same quarter in 2014. Catalent's profit margin is less than 5%. And the company carries $1.88 billion in debt on its balance sheet with a little over $116 million in cash (including cash equivalents).

2. GlaxoSmithKline plc (NYSE:GSK)
Big pharmaceutical company GlaxoSmithKline claims the No. 2 spot on our list with a return on equity of nearly 108%. Glaxo's products include household names like Aquafresh toothpaste and Nicoderm patches and prescription medications from Advair to Zantac.

Glaxo looks attractive on other financial measures also. The stock's trailing price-to-earnings multiple is a low 6.58. Glaxo's profit margin of over 44% isn't bad at all. And Glaxo's dividend yields 5.3% with a low payout ratio of only 41%.

Before you rush to buy this stock, though, you might want to consider some challenges facing GlaxoSmithKline. Blockbuster respiratory drug Advair is experiencing declining sales and could be in for more difficulties when the patent for the Diskus inhaler expires next year. Glaxo also recently made a big bet by selling its oncology business and acquiring the vaccine business of Novartis. There are a lot of things in flux for this drugmaker that could drag that lofty ROE value downward in the near future.

3. Medivation (NASDAQ:MDVN)
Medivation's return on equity of just under 104% ranks it as the top biotech stock and third-highest healthcare stock. The company's success comes from prostate cancer drug Xtandi, which generated over $129 million in revenue for Medivation in the first quarter this year. Xtandi racked up over $1 billion in sales in 2014. Medivation splits this revenue with collaboration partner Astellas Pharma.

Outside of ROE, Medivation's financial metrics are something of a mixed bag. The biotech saw strong revenue growth last quarter, but earnings dropped from the same quarter in the prior year. Medivation's balance sheet looks pretty solid, with debt of a little over $245 million and cash of almost $569 million. However, the stock appears to be pricey with a trailing P/E of 32 and forward multiple just below 30.

Medivation's future success, like its current success, rides on Xtandi. Several clinical studies are currently under way for the drug in other stages of prostate cancer. Xtandi also is being studied as a potential treatment for breast cancer. Good news on those fronts should keep Medivation rolling.

Looking ahead
If we only used ROE as our criterion for selecting a healthcare stock, Catalent would win hands down. However, basing an investing decision on just one factor is never a smart idea.

My view is that Catalent should continue to do well. It has a solid business model and a diverse customer base. On the other hand, don't expect sizzling earnings growth for Catalent.

I'm taking a wait-and-see stance with Glaxo. Maybe the Novartis deal will turn out to be a good one. With generic competition for Advair on the way, though, I'm leery of this Big Pharma stock despite its compelling ROE.

Out of the three, I'm most bullish about Medivation. Xtandi should continue to perform well. And I wouldn't be surprised to see a bigger player ultimately buy Medivation.

[TREND1]

Just watched TV add for TANZEUM
A once a week injection for type 2 diabetics.

Approved by FDA ON 4/14/20414

[eddy2]

Malaria not Ebola my gosh man.

[oscaraft]

GSK to skyrocket to $100+ with Ebola Vaccine -

There is very little doubt that GSK will skyrocket to $100 + once the Ebola vaccine comes out at the end of this month. This is an incredible opportunity! $100 - $125 would not be unreasonable in the short term. GSK is definitely a strong buy at the moment and possibly the chance of a lifetime.

Fasten your seat belts folks! A huge run is coming with GSK!

[oscaraft]

Ebola Vaccine due out this month! GSK will undoubtedly explode to $100 a share in the short terms. Get ready!

As the owner of the websites and forums at ebolainfo.org and avianflutalk.com, trust me when I tell you that GSK is about to explode, and the poultry industry is about to crash due to the ongoing avian flu outbreaks in the U.S

Good luck!

[TheMotivatedTrader]

12/16/14: Obama Signs $1.1 Trillion Spending Bill Into Law

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=109132797

[TheMotivatedTrader]

12/16/14 VIDEO: Ebola Vaccine Research Panel on C-SPAN

Watch here now if you didn't see it live in its entirety earlier today: http://www.c-span.org/video/?323340-1/discussion-ebola-vaccine-research

[TheMotivatedTrader]

RIGHT NOW: Ebola Research Panel on C-Span NOW!

www.c-span.org or your cable channel. Can also watch live here:

http://csis.org/event/ebola-vaccines-and-antivirals-what-lies-ahead

As of 4:43PM EST on 12/16/14.

[TheMotivatedTrader]

12/15/14: Obama confirms he will sign the spending bill

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=109089281

[Fibanotch]

why not buy in the high 30's?

[TheMotivatedTrader]

We are getting closer:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=109076037

[TheMotivatedTrader]

12/15/14: Obama expected to sign spending bill today. The bill was approved by Congress over the weekend.

It contains $5.4 Billion to help fight Ebola

[MinnieM]

$GSK - Ebola vaccine from Glaxo passes early safety test
http://news.yahoo.com/ebola-vaccine-glaxo-passes-early-safety-test-070012725--finance.html

[Fibanotch]

interesting

[RNsidersbuying]

At the meeting, GlaxoSmithKline (GSK) of Rixensart, Belgium, which has the vaccine furthest in development, spelled out how it might scale up production in parallel with the safety and efficacy trials now under way so that the product could be ready for wider distribution by April if warranted. The company expects to have preliminary data in November from phase I studies that analyze safety and immune response in small numbers of people not at risk of contracting Ebola. If those data are positive, efficacy trials could start as early as January in Guinea, Sierra Leone, and Liberia, the three West African countries hard hit by the epidemic.

GSK estimates (see table below, and here) that it will have 24,000 doses of its vaccine ready by January for the efficacy trials. If it cranks up production to full capacity before the those trials are complete, the company could have 230,000 doses available in April, and then could steadily increase capacity to produce more than 1 million doses a month by December 2015.

http://news.sciencemag.org/health/2014/10/leaked-documents-reveal-behind-scenes-ebola-vaccine-issues

[RNsidersbuying]

Drugmakers to join forces to make millions of Ebola vaccine doses
BY BEN HIRSCHLER
LONDON Wed Oct 22, 2014 2:18pm EDT

(Reuters) - Leading drugmakers plan to work together to speed up the development of an Ebola vaccine and hope to produce millions of doses for use next year.

U.S. firm Johnson & Johnson said on Wednesday that it aims to produce at least 1 million doses of its two-step vaccine next year and has already discussed collaboration with Britain's GlaxoSmithKline, which is working on a rival vaccine.

The economics of an Ebola vaccine are still unclear but drug companies with an eye on their reputations are under pressure to respond to the major international health crisis now ravaging one of the poorest corners of Africa.

J&J's head of research Paul Stoffels said it was important to have several experimental vaccine candidates in development, since it is not clear which ones will work, but resources could in future be focused on one clear winner.

GSK's chief executive Andrew Witty told reporters on Wednesday that a meeting of experts in Geneva this week would discuss ways to ensure that all companies, including those with no direct involvement in the Ebola work, pulled together to help remove supply bottlenecks.

http://www.reuters.com/article/2014/10/22/us-health-ebola-johnson-johnson-idUSKCN0IB0N420141022

[RNsidersbuying]

By late 1998, Dr. Sullivan had produced a vaccine candidate that she and colleagues at the Centers for Disease Control and Prevention in Atlanta tested in monkeys. On July 28, 1999, she received word via an email from the CDC that tests of blood serum samples from vaccinated test monkeys showed immune responses that, she says, “went through the roof.” She wrote “Yahoo!” in the margin of her lab notes, realizing they had broken new scientific ground.

The vaccine was tested in infected macaque monkeys in the most intensive protective environment known to man, called BSL-4 or Biosafety Level-4, at the CDC, and later by Army researchers at Ft. Detrick in Maryland. Unvaccinated monkeys became sick and died within about a week. The four vaccinated monkeys had no detectable virus-something science had never before accomplished.

“These findings demonstrate that it is possible to develop a preventive vaccine against Ebola virus infection in primates,” wrote Drs. Sullivan, Nabel and colleagues in a letter to the journal Nature in Nov. 2000.

http://online.wsj.com/articles/ebola-vaccine-push-ramps-up-1413762856

[MinnieM]

$GSK - GlaxoSmithKline's vaccine is currently being tested and if efficacious it could have 10,000 doses ready in a few months.

http://www.economist.com/news/international/21625813-ebola-epidemic-west-africa-poses-catastrophic-threat-region-and-could-yet

In large part because of worries that Ebola might be used as a biological weapon, vaccines that protect lab animals against the virus were already on the shelf when the outbreak began. Two are now being tested for safety in humans, and one of them could, if it is safe, be tested for efficacy quite soon, most likely in health-care workers in west Africa. Its maker, GlaxoSmithKline, could have 10,000 doses ready in a few months.

[Stock Guy777]

GlaxoSmithKline (NYSE: GSK) wants binding bids by next month for older drugs worth $3 billion, according to reports from Reuters. Potential bidders include KKR, India's Lupin and Denmark's Lundbeck, the report said.

[Stock Guy777]

Going to get interesting

[Stock Guy777]

http://mobile.bloomberg.com/news/2014-08-27/glaxo-s-ebola-vaccine-to-be-tested-for-safety-in-humans.html

[Stock Guy777]

http://m.naturalnews.com/news/047086_ebola_vaccine_human_trials_hidden_agenda.html

[MONEYMADE]

ONLY ZMAPP WORKS! GSK??? What's the drugs name....You do realize that this stupid virus has been around since 1976! So If GSK gave a damm it would have been in trials already.

PBS says Ebola is not profitable and I believe them!!

[Pure_Greatness]

Mali holds Ebola vaccine trials


Bamako - Mali's health minister says the west African country has started trials of an Ebola vaccine on scientific researchers.

"It's purely a scientific step. The trials are on volunteer researchers," said Ousmane Kone.

Mali has no Ebola cases but it borders Guinea, where the outbreak began.

The trials in Bamako are being supervised by the vaccine research centre of the medical school of the University of Maryland in the United States and Mali's health ministry, Kone said.

Trials of the vaccine started in September on 10 US volunteers and 60 in Britain.

The vaccine is being developed by the British drug company GlaxoSmithKline and the US National Institute of Health.

The WHO said 4 033 people died from Ebola up to 8 October out of a total of 8 399 registered cases in seven countries.

AFP

http://www.news24.com/Africa/News/Mali-holds-Ebola-vaccine-trials-20141011-2

[MONEYMADE]

*****GSK SUCKS!!!! THEY'VE KNOWN ABOUT EBOLA SINCE 1976!!!!********

[Pure_Greatness]

Awesome $tart today. Go GSK

[MinnieM]

That China fiasco is still hurting it share price. But, if these results can be verified by other doctors it is huge.

[Pure_Greatness]

Nice

$GSK - GlaxoSmithKline Subsidiary HIV Product Appears Successful Against Ebola

http://seekingalpha.com/article/2538625-glaxosmithkline-subsidiary-hiv-product-appears-successful-against-ebola