Pentagon awards Glaxo $342 million contract for COVID vaccines

WASHINGTON - The Pentagon on Thursday announced a $342 million contract has been awarded to British pharmaceutical giant GlaxoSmithKline to deliver "mass quantities of COVID-19 vaccines" to US troops.

It said GSK was the only company to make a bid for the contract, which will consist of supporting "military locations and personnel throughout the continental US and outside the continental US."

The work will be carried out in North Carolina "with an estimated completion date of Feb. 28, 2021," the Pentagon said.

The US Army will supervise execution of the project.

Agence France-Presse

The world will need more than one COVID-19 vaccine, GSK CEO says

LONDON - The world will need more than one COVID-19 vaccine so drug companies must partner in the race to develop the weapons to fight the novel coronavirus, GlaxoSmithKline Chief Executive Officer Emma Walmsley said on Wednesday.

GlaxoSmithKline Plc and Sanofi SA said on Tuesday they would develop a vaccine to fight the fast-spreading coronavirus.

The drugmakers said they expect to start clinical trials for the vaccine in the second half of this year. If successful, the vaccine would be available in the second half of 2021.


Walmsley said GSK's partnership with Sanofi brings scale to the attempt to get a COVID-19 vaccine but that there was still an enormous amount of work to do.

"The world's going to definitely need more than one vaccine when you think about demand in this hugely challenged global health crisis," she told BBC Radio.

The adjuvanted vaccine will be developed by combining Sanofi's S-protein COVID-19 antigen and GSK's pandemic adjuvant technology.

"It normally takes a decade, sometimes even more, to develop a vaccine but obviously we are in an unprecedented situation, the need is incredibly urgent. We are partnering with regulators to try and go as fast as we safely can." 

As of April 14, at least 1.97 million people have tested positive for COVID-19, according to a Reuters tally. 

-reuters-

Pharma giants Sanofi, GSK working on COVID vaccine for 2021

Pharma giants Sanofi and GlaxoSmithKline will join forces to work on a coronavirus vaccine they hope will enter clinical trials this year, potentially making it available in the second half of 2021, the companies said Tuesday.

The vaccine will combine a Sanofi-developed antigen, which stimulates the production of germ-killing antibodies, with GSK's adjuvant technology, a substance that boosts the immune response triggered by a vaccine, they said in a statement.

"The companies plan to initiate phase I clinical trials in the second half of 2020 and, if successful, subject to regulatory considerations, aim to complete the development required for availability by the second half of 2021," they said.

"As the world faces this unprecedented global health crisis, it is clear that no one company can go it alone," added Sanofi's chief executive Paul Hudson. 

Given the extraordinary humanitarian and financial toll of the pandemic, Sanofi and GSK said global access to COVID-19 vaccines was a priority.

They said they were committed to making any vaccine developed through the collaboration "affordable to the public and through mechanisms that offer fair access for people in all countries."

Sanofi, based in Paris, said it would contribute its S-protein COVID-19 antigen, designed to exactly match proteins found on the surface of the new virus.

Britain's GlaxoSmithKline said it would add its adjuvant, an ingredient for vaccines that can create stronger and longer-lasing immunity.

"The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people," the statement said.

It can also improve the likelihood of delivering an effective vaccine that can be manufactured at scale. 

Sanofi and GSK said their joint effort was supported by funding and a collaboration with the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services. 

"The companies plan to discuss funding support with other governments and global institutions prioritising global access," they added.

BARDA Director Rick Bright said the development of an adjuvanted COVID-19 vaccine promised "to end this pandemic, and help the world become better prepared or even prevent future coronavirus outbreaks."

The coronavirus outbreak has killed more than 120,000 people worldwide since the first cases were reported in China last December.

Agence France-Presse

Britain's GSK joins race to develop China virus vaccine

LONDON - UK pharmaceuticals giant GlaxoSmithKline (GSK) said Monday it was joining a global race to develop a vaccine for a new strain of a coronavirus that has killed more than 360 people.

The UK government also pledged £20 million ($26 million, 24 million euros) in funding for research at the Coalition for Epidemic Preparedness Innovations (CEPI) -- a group formed at the in Davos in 2017 -- and released its sequencing data for the viral genome.

GSK said its work would complement the 4 projects already being funded through CEPI to develop a vaccine for the deadly China strain.

"Our (vaccine) adjuvant technology has previously been used successfully in the pandemic flu setting," GSK Vaccine chief medical officer Thomas Breuer said in a statement.

Adjuvants are agents that boost a body's response to vaccines or other treatments.

The World Health Organization has declared a global virus emergency but refrained from calling the new epidemic a "pandemic". 

That term is reserved for a disease that spreads across multiple continents or worldwide.

CEPI was originally formed in response to the Ebola epidemic that killed more than 11,300 people of the 29,000 recorded cases in West Africa from 2013 to 2016.

"Our hope is that, with our partners, we can get an investigational vaccine from gene sequencing of the pathogen through to clinical testing in 16 weeks," CEPI chief executive Richard Hatchett said.

CEPI's four other projects aimed at stamping out the new strain include a partnership between the US biotech company Moderna and the US National Institute of Allergy and Infectious Diseases.

GSK said it will initially be joining the work already being performed by the University of Queensland in Australia.

The other two projects involve the German biopharmaceutical company CureVac and the US-based Inovio pharmaceuticals firm.

UK Health Secretary Matt Hancock said Public Health England has been able to sequence the genome from the two cases of new viral strain recorded in Britain.

"Their findings suggest the virus has not evolved in the last month," Hancock told parliament.

China shared its genome sequencing data on January 10.

Hancock said health ministers from Group of Seven (G7) nations spoke by telephone Monday to coordinate their response.

"It is clear that the virus will be with us at least some months to come," the British health minister said.

Agence France-Presse 

GSK recalls popular heartburn drug Zantac globally after cancer scare

GlaxoSmithKline on Tuesday said it was recalling the popular heartburn medicine Zantac in all markets as a "precaution", days after the US Food and Drug Administration found "unacceptable" levels of probable cancer-causing impurity in the drug.

Zantac, also sold generically as ranitidine, is the latest drug in which cancer-causing impurities have been found. Regulators have been recalling some blood pressure and heart failure medicines since last year.

Britain's medicines watchdog said GlaxoSmithKline (GSK) was recalling four prescription-only Zantac medicines: a syrup, an injection and tablets of 150 and 300 milligram (mg) dosages.

Over-the-counter 75 mg dosage Zantac products are produced by a different company and are not affected by the recall, it added.

"GSK informed the MHRA of our decision to suspend the release, distribution and supply of all dose forms of Zantac products," a company spokesman confirmed to Reuters.

"GSK is continuing with investigations into the potential source of the NDMA," he said, adding that the investigations include continued engagement with its suppliers and with external laboratories to conduct tests on finished product batches of Zantac.

The Medicines and Healthcare products Regulatory Agency (MHRA) said healthcare professionals were told on Monday to "stop supplying the products immediately, quarantine all remaining stock and return it to their supplier".

"We are advising that patients should not to stop taking their medication, and do not need to see their doctor until their next routine appointment but should seek their doctor's advice if they have any concerns," the MHRA said.

GLOBAL STOPPAGE

US and European health regulators said last month they were reviewing the safety of ranitidine, after online pharmacy Valisure flagged the impurities.

The FDA said Valisure's higher-temperature testing method generated very high levels of NDMA from the ranitidine drugs.

NDMA had previously been found in some blood pressure medicines from a class of drugs known as angiotensin II receptor blockers, or ARBs.

After checking the over-the-counter drugs using a low-heat method of testing, the FDA said it found much lower levels of NDMA than was discovered with a higher temperature test employed by Valisure.

The US regulator has asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency.

Swiss drugmaker Novartis halted global distribution of its ranitidine drugs last month.

Last week, Walmart Inc joined pharmacy chains CVS Health Corp, Walgreens Boots Alliance Inc and Rite Aid Corp in suspending the sale of over-the-counter heartburn drugs containing ranitidine.

Canada's health authorities have asked makers of the drugs to halt distribution as they gather more information. Last month, regulators in Hong Kong pulled four products, while in Ireland 13 products containing ranitidine were recalled.

The impurity was believed to have been introduced by changes in the manufacturing process.

source: news.abs-cbn.com

GSK sells health drinks arm, buys US cancer treatment firm

LONDON -- British pharmaceutical group GlaxoSmithKline announced 2 multi-billion-dollar deals Monday -- the sale of its Asian health drinks unit to Anglo-Dutch food giant Unilever and the purchase of US cancer specialist Tesaro.

GSK said it is buying Tesaro for $5.1 billion (4.5 billion euros), while Unilever is spending 3.3 billion euros to acquire the drinks unit, whose brands include iconic night-time hot drink Horlicks.

"The acquisition of Tesaro will strengthen our pharmaceuticals business by accelerating the build of our oncology pipeline and commercial footprint, along with providing access to new scientific capabilities," GSK chief executive Emma Walmsley said in a statement.

But GSK's share price tumbled on news of the deal to further its role in finding new cancer drugs, diving almost eight percent by the close to £14.98 on London's benchmark FTSE 100 index, which closed up 1.18 percent overall. Unilever shares ended flat.

"GSK has previously sat on the sidelines as rivals engaged in deal making, a situation current chief executive Emma Walmsley is keen to change," said Fiona Cincotta, a senior market analyst at City Index traders. 

"However, her enthusiasm is clearly not shared with shareholders" after GSK agreed to pay a 60-percent premium on Tesaro's closing share price Friday.

Earlier Monday, Unilever said its own deal was for GSK's business in India, Bangladesh and 20 other predominantly Asian markets, as it looks to profit from increased popularity of health foods in high-growth emerging markets.

"GSK's health drinks portfolio is the undisputed leader... in India, with iconic brands such as Horlicks and Boost and a product portfolio supported by strong nutritional claims," Unilever said.

Horlicks has a long history in India -- which accounts for almost 90 percent of the GSK arm's turnover in Asia -- having been introduced there in the 1930s.

"Horlicks products have been an everyday staple in South Asian households across generations," Unilever said, adding that GSK's health drinks portfolio has grown by double digits in the last 15 years.

"Despite this, the category still remains under-penetrated in India," it said.

Unilever's acquisition is the first since Paul Polman last week announced his retirement as head of the consumer products giant, after a failed plan to move the firm's headquarters from London to the Netherlands.

Speaking of the oncology deal meanwhile, Tesaro chief executive Lonnie Moulder said the "transaction marks the beginning of a new global partnership that will accelerate our oncology business and allow our mission of delivering transformative products to individuals living with cancer".

Boston-based Tesaro is "an oncology-focused biopharmaceutical company devoted to providing transformative cancer" treatments, according to a joint statement with GSK.

source: news.abs-cbn.com

Dengue fever spreads around the world

PARIS - Dengue fever, the world's fastest growing mosquito-borne disease, has spread its wings from being a tropical disease, endemic in just nine countries, to a worldwide threat.

Globalization, urbanization, climate change and jet travel have enabled it to move into more temperate zones.

Following are some basic facts:

- What is dengue fever ? -Dengue fever is a flu-like infection, caused by the flavivirus in the same family as yellow fever.

Dengue fever has four separate strains -- DEN-1, DEN-2, DEN-3 and DEN-4. Once cured, the patient is protected for life but only against the strain he was stricken by.

- How is the virus transmitted ? -Dengue is transmitted by several species of mosquito within the Aedes aegypti, which originate in Africa but which are now present in all tropical and subtropical areas.

- The symptoms - Dengue can trigger a crippling fever along with headache, nausea, vomiting, muscle and joint pain, and skin rashes similar to measles.

- The most severe form -The most severe form of the disease, dengue haemorrhagic fever, accounts for one percent of cases, killing 22,000 people a year, the World Health Organisation (WHO) says. It results in bleeding and blood plasma leakage. It can be fatal, in particular among children.

- How many cases ? -The number of cases in the world has risen 30-fold over the last 50 years, according to the WHO, making it the world's fastest growing mosquito-borne disease and leaving more than half of the world's population potentially at risk.

The WHO says that half a million people are hospitalised by the illness every year, many of them children of which around 2.5 percent die.

- Treatment and vaccination -There is currently no specific treatment for dengue fever.

The world's first-ever dengue vaccine, Dengvaxia, manufactured by French pharmaceutical giant Sanofi, secured its first regulatory approval in Mexico on December 9.

The Philippines became the first Asian country on Tuesday to approve the sale of the vaccine.

Other pharmaceutical companies are developing dengue vaccines, including US firm Merck, Japan's Takeda and Britain's GlaxoSmithKline.

source: www.abs-cbnnews.com

How PH ranks in dental health

MANILA -- The Philippines has nine million denture wearers in urban areas, making it the country with the highest number of people wearing dentures in Asia, according to a study by an international pharmaceutical company.

The information was revealed in the study "Oral Care U&A: Market Understanding Study Middle East & Asia" conducted by Ipsos Marketing for GlaxoSmithKline (GSK).

Based on the study, majority of the nine million denture wearers are in the 35 to 69 year old age group. Eighty-four percent of denture wearers reside in Metro Manila, with nine percent in Cebu, and six percent in Davao.

Another study, "The Emerging Consumer Denture Journey" by Nick Newall and Rachel Kern also outlined the causes for such spike in denture wearing, among them the limited access to oral hygiene, expensive dentist fees, and lack of awareness of importance of oral hygiene and its effects to self-confidence.

The study also showed that Filipinos' oral and dental health care practices are very limited.

"The Filipinos' oral and dental health care practices are limited to very simple routines like brushing the teeth using regular toothpastes and toothbrushes. Some even use alternative household products such as salt water for cleaning the teeth," cited the study.

The study also discussed the fact that in the Philippines, dentists are rarely a source of awareness in terms of oral care. It reported that there is a forced relationship between dentists and patients who meet only during emergency cases. Some people, according to the study, even have others pull their teeth off.

However, the most damaging of these is the loss of practice of revisiting the dentist for follow-ups.

"We must create value for our teeth regardless of financial difficulties. In terms of dental relationships, people neglect returning to their dentists for maintenance purposes, doing so only when the damage has been too great to bear," said Dr. Danny Magtanong of the Philippine Prosthodontic Society (PPS).

Magtanong, who specializes in reconstructive dentistry and is an associate professor in prosthodontics at the UP College of Dentistry, also explained that Filipinos have become apathetic toward their teeth.

"Not only is the "bahala na" attitude of Filipinos alarming, but also the lack of value for teeth. For example, people in the past would have attitudes like "okay lang 'yan, masisira din naman ngipin mo," these attitudes have evolved to be damaging towards the total dental health of the individual. So now, many become more and more subject to dental problems not only because of this attitude, but also largely due to Filipinos' inadequacy to acquire proper dental health implements. What Filipinos largely know of is only to brush their teeth; on some occasions, gargle with salt if financial circumstances are not favorable."

PPS, in coordination with GSK, has been undertaking an education and information campaign both in urban and rural areas to promote dental health and proper denture care.

source: www.abs-cbnnews.com

Ebola vaccine promising in first human trials: NIH

WASHINGTON - Researchers say they are one step closer to developing an Ebola vaccine, with a Phase 1 trial showing promising results, but it will be months at the earliest before it can be used in the field.

The news comes amid the worst ever outbreak of the hemorrhagic fever, which has killed 5,500 people so far, mostly in West Africa.

Pharmaceutical companies and health agencies scramble to fast-track experimental drugs and vaccines that could help.

In the first phase of testing, all 20 healthy adults injected with a higher or lower dose of the vaccine developed antibodies needed to fight Ebola, said the National Institutes of Health (NIH), which conducted the study.

Results were published Wednesday in the New England Journal of Medicine.

"The unprecedented scale of the current Ebola outbreak in West Africa has intensified efforts to develop safe and effective vaccines," said Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, which is developing the vaccine alongside GlaxoSmithKline.

The vaccines under development "may play a role in bringing this epidemic to an end and undoubtedly will be critically important in preventing future large outbreaks," he noted.

"Based on these positive results from the first human trial of this candidate vaccine, we are continuing our accelerated plan for larger trials to determine if the vaccine is efficacious in preventing Ebola infection," he added.

But the NIAID/GSK vaccine is still a long way from being ready for use in the field.

The NIAID is "in active discussions with Liberian officials and other partners about next-stage vaccine testing in West Africa" for efficacy and safety, the NIH said, but no announcement on larger-scale trials was expected before early next year.

There is no licensed treatment or vaccine against the Ebola virus, which is transmitted through bodily fluids and has been fatal in an estimated 70 percent of cases in the current outbreak.

Antibodies within four weeks

The volunteers were injected starting in September, and each showed a positive result for Ebola antibodies in blood tests within four weeks.

The 10 volunteers in the higher-dose group developed higher antibody levels, the NIH said.

In addition, two of the lower-dose group and seven of the higher-dose group developed a kind of immune cell called CD8 T cells, which are an important part of the body's response against disease.

"We know from previous studies in non-human primates that CD8 T cells played a crucial role in protecting animals" who got the vaccine and then were exposed to Ebola, said researcher Julie Ledgerwood, the trial’s principal investigator.

None of the volunteers experienced serious side effects within the study period, though two had a brief, mild fever within the 24 hours after the injection.

The vaccine uses a modified chimpanzee cold virus to deliver segments of genetic material from the Ebola virus.

The genetic material cannot spread in the body like the virus does, but can still prompt the antibody response.

The version tested at NIH contains material from two species of Ebola -- the Zaire species, responsible for the outbreak in West Africa, and another called Sudan Ebola.

"This work is encouraging and another significant contribution to efforts to tackle the Ebola crisis," said Dr Jeremy Farrar, Director of the Wellcome Trust.

The White House also congratulated the vaccine researchers.

"We congratulate Drs Francis Collins and Tony Fauci and their teams at the National Institutes of Health on the first published results from Phase 1 clinical trials of a promising Ebola vaccine candidate," a White House statement said, adding that President Barack Obama would visit the NIH next week.

A second version of the vaccine, aimed at blocking just Zaire Ebola, also began human testing in October, at the University of Maryland.

Another experimental vaccine that has shown promising results in primates is the Canadian VSV-EBOV, licensed by US firm NewLink Genetics. It is also in early stages of human testing.

source: www.abs-cbnnews.com