GSK Releases Good Bird Flu Vaccine Data!
Het hele bericht;
LONDON, England (Reuters) -- A bird flu vaccine for humans that uses only a very low dose of active ingredient has proved effective in clinical tests and could be available in 2007, its maker GlaxoSmithKline Plc has said.
The promising result means Europe's biggest pharmaceuticals group is on track to start making the vaccine in commercial quantities by the end of the year.
Glaxo believes its H5N1 vaccine will work more efficiently than rival ones in development because of the proprietary adjuvant used in its manufacture. Adjuvants are additives put into vaccines that boost the immune system and make it respond more efficiently.
A key challenge in the race to produce a vaccine for millions of people around the world -- which governments are keen to stockpile -- is how to make the maximum number of shots from the minimum amount of antigen, or active ingredient.
Glaxo's vaccine contains just 3.8 micrograms of antigen, yet more than 80 percent of healthy adult volunteers who received two doses had a strong immune response.
That level of protection meets or exceeds requirements set by regulatory agencies for approving new flu vaccines, and is twice as good at half the dose as results with an experimental vaccine produced by Sanofi-Aventis.
Glaxo Chief Executive Jean-Pierre Garnier said it was a "significant breakthrough."
"All being well, we expect to make regulatory filings for the vaccine in the coming months," he said.
Sanofi in May reported good responses with a vaccine using a conventional adjuvant given at two doses of 30 micrograms. But when the dose was reduced to 7.5 micrograms, only 40 percent of people were protected.
While Glaxo's vaccine offers protection against the deadly H5N1 avian flu virus now circulating, its impact on any mutated strain of virus is not certain.
However, experts say it could "prime" a person's immune system so they will get stronger effects from a later, better-matched vaccine.
Glaxo said it would now also study the ability of its vaccine to offer cross-protection to variants of the H5N1 virus.
The H5N1 strain of avian influenza has spread rapidly out of Asia and has killed more than 130 people who have come into close contact with infected birds.
Experts fear it could trigger a global epidemic of flu that could kill millions, if it acquires the ability to pass easily from human to human.
Companies are racing to develop pandemic H5N1 vaccines that could save lives and buy time to develop a vaccine against a pandemic strain. It could take from four to six months from the start of a pandemic before a specific vaccine will be ready.
Other firms working on a bird flu vaccine include Novartis AG and Baxter International Inc
Press Release Source: GlaxoSmithKline
New Seasonal and Perennial Rhinitis Intranasal Treatment Submitted for U.S. and European Marketing Approval
Thursday July 27, 8:00 am ET
- Allermist(TM) / Avamys(TM) (fluticasone furoate) Significantly Improved Symptoms of Seasonal and Perennial Allergic Rhinitis in Clinical Studies -
RESEARCH TRIANGLE PARK, N.C., July 27 /PRNewswire-FirstCall/ -- GlaxoSmithKline (GSK) today announced it has submitted applications for both U.S. and European marketing approval for a new medicine to treat the symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). The medicine (fluticasone furoate) is an enhanced affinity intranasal corticosteroid with the proposed name of ALLERMIST in the U.S. and AVAMYS in Europe.
The efficacy and safety of ALLERMIST / AVAMYS have been evaluated in seven clinical trials with 2,555 adult and pediatric patients two years of age and older with symptoms of SAR and PAR. Patients taking the medicine reported significant improvements in a range of nasal symptoms compared to those taking a placebo. In adult patients with SAR, in addition to nasal symptom improvement, ALLERMIST / AVAMYS use was also consistently associated with significant improvement in ocular symptoms such as watery, itchy eyes.
"This is an important milestone in our respiratory research and we hope this medicine will offer help to millions of seasonal and perennial allergy patients," said Kathy Rickard, M.D., Vice President Clinical, Respiratory Medicine Development Center (North America).
Developed after ergonomic testing, ALLERMIST / AVAMYS is dispensed using a novel nasal device, designed with the patient in mind. There is minimal or no aftertaste with ALLERMIST / AVAMYS and the product is unscented and alcohol- free.
About Allergic Rhinitis
Allergic rhinitis is an inflammatory disease characterized by the symptoms of runny nose (rhinorrhea), nasal congestion, watery eyes, sneezing and itching of the nose and ocular symptoms of red, itching/burning and watery eyes. Symptoms occur after exposure to allergens such as mold spores and pollens which cause SAR, or to year-round allergens such as dust mites or animal dander which cause PAR.
One of the most prevalent and chronic diseases in the U.S., allergic rhinitis affects up to 40 million people annually, including 10 to 30% of adults and up to 40% of children. In Europe, more than 1 in 5 adults are estimated to suffer from allergic rhinitis, of which nearly half are undiagnosed.
Allergic rhinitis can limit productivity, resulting in both work absenteeism and reductions in effectiveness among adult patients. In children, allergic rhinitis can significantly reduce energy, negatively affect behavior, and impair learning.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit www.gsk.com.
NEW YORK (AP) -- U.S. shares of GlaxoSmithKline PLC gained some lift Wednesday after an analyst predicted that data to be presented at an upcoming diabetes conference will be the first of a series of positive catalysts for the British drug maker.
American depositary shares GlaxoSmithKline rose 98 cents to $56.78 in afternoon trading on the New York Stock Exchange. Earlier in the session, shares rose as high as $57.10 to flirt with their 52-week high of $58.40.
Merrill Lynch analyst Graham Parry said that positive data from a large clinical trial treating pre-diabetic patients with the diabetes drug Avandia should energize the stock, which the analyst rates as "Buy."
On Sept. 15, GlaxoSmithKline is scheduled to present study data at a meeting of the European Association for the Study Diabetes. The study covers data from nearly 5,300 patients with impaired blood sugar tolerance who were given Avandia, the high blood pressure drug ramipril, a combination of both or placebo for three to five years.
Given the study's modest endpoint -- that Avandia or ramipril will reduce the risk of developing diabetes by 22 percent -- Parry believes the study's data will positively affect the stock price. Avandia is already approved for people who already have diabetes.
If Avandia is approved for pre-diabetic patients, GlaxoSmithKline could add another $1.4 billion in sales of Avandia in 2012, Parry said. The analyst currently estimates $6.3 billion in Avandia sales in 2012. Sales of Avandia and the related drug Avandamet totaled about $2.34 billion in 2005.
Other positive catalysts the analyst sees is the likelihood of raised guidance in the third quarter; growth of asthma medication Advair and Avandia in the U.S.; and potential data on the company's Cervarix cervical cancer vaccine and blood disorder treatment Promacta.
Even gekeken naar deze reus is een heel degelijk bedrijf alleen doet op een goed bericht nooit veel gezien de grootte. (156 B !)
Op forum kwam ik nog wel een verwijzing tegen naar HEB. Laatstgenoemde kan bij goede berichtgeving of enige belangstelling fors stijgen.
Al met al is GSK voor mij meer iets voor later.
Biotech Day in Review: Glaxo Gets Approval for Tykerb
Wednesday March 14, 5:37 am ET
Centient Biotech Investor submits: GlaxoSmithKline (NYSE: GSK - News) won FDA approval of Tykerb for advanced breast cancer. Because the indication is tightly limited, the effect on GSK will not be great until Tykerb becomes used for more types of cancer.
Initially, Tykerb, which will be administered along with Herceptin from Genentech (NYSE: DNA - News), is to be given to patients with HER2 positive breast cancer as a second-line treatment. Tykerb inhibits both the HER2 and EGFR proteins. It is thought to be especially effective in preventing brain metastases. Tykerb remains in trials as a first-line breast cancer drug and for other types of cancer as well.
GlaxoSmithkline 6% dividend en bodem bereikt? beurskrant.com/2018/03/11/glaxosmithk...
GSK flirt met de grens van de 1200 pence. Aandeel noteert zijn laagste koers in 5 jaar, we moeten zelfs terug naar 2011 om deze koersstand terug te vinden.
Ik ben op morningstar de financials even aan het bekijken, dat ziet er allemaal goed uit in de jaren 2015-2019. Dan verwacht je een zéér problematisch 2020, maar cijfermatig zie ik niet direct reden voor de zware afstraffing.(toch 25 a 30%, dat is geen kleine daling meer). Ik moet nog wat dieper graven (want ik ken het bedrijf veel te beperkt, voor de duidelijkheid, ik weet wel dat ze het bedrijf gaan splitsen, dus dat lijkt me dan de primaire reden te zijn?).
Iemand die het bedrijf beter kent en hier alvast een insight wil geven? Want dit ziet er high-level uit als een solid buy.
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