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

UK signs up for Sanofi-GSK coronavirus vaccine

PARIS - Pharma giants Sanofi and GSK have agreed to supply Britain with up to 60 million doses of a potential COVID-19 vaccine, the firms announced Wednesday.

The agreement covers a vaccine candidate developed by France's Sanofi in partnership with the UK's GSK and is subject to a "final contract".

Amid a global race to find a vaccine to halt the pandemic, Sanofi announced "ongoing discussions with the European Commission, with France and Italy on the negotiation team, and other governments to ensure global access to a novel coronavirus vaccine."

Both companies voiced in a statement their commitment "to making their COVID-19 vaccine candidate affordable and available globally."

The vaccine candidate "has the potential to play a significant role in overcoming the COVID-19 pandemic, both in the UK and around the world," said GSK Vaccines President Roger Connor.

Sanofi predicted regulatory approval for the vaccine "could be achieved by the first half of 2021."

UK Business Secretary Alok Sharma, quoted in the statement, hailed the progress but noted "the fact remains that there are no guarantees."

“In the meantime, it is important that we secure early access to a diverse range of promising vaccine candidates, like GSK and Sanofi, to increase our chances of finding one that works so we can protect the public and save lives."

Britain has already secured access to 90 million doses of potential coronavirus vaccines in deals with biotech firms BioNTech, Pfizer and Valneva.

The deals involve 30 million doses of a vaccine being developed by US pharma giant Pfizer and Germany's BioNTech, and 60 million doses of another created by France's Valneva.

The government in London has also said it would purchase 100 million doses of a vaccine currently being trialed by Oxford University in partnership with AstraZeneca.

Britain has been one of the worst affected countries in the world since the outbreak began, with more than 45,750 deaths.

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-

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

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