France's Sanofi to buy US group Principia Biopharma for $3.68 billion

PARIS - French pharma giant Sanofi said Monday it will buy US group Principia Biopharma for $3.68 billion in a deal that will boost its research and development into autoimmune and allergic diseases.

The deal will see Sanofi "acquire all of the outstanding shares of Principia for $100 per share in cash, which represents an aggregate equity value of approximately $3.68 billion", Sanofi said in a statement.

Sanofi had been cooperating with San Francisco-based Principia since 2017, securing a global exclusive licence to develop and market its drug for treating multiple sclerosis and other central nervous system illnesses known as BTK'168.

"Full ownership... removes complexities for this priority development programme and simplifies future commercialisation," chief executive Paul Hudson said.

Beyond diseases of the nervous system, Principia hopes to develop "a whole portfolio" of similar drugs that could target different organ systems in patients suffering from "immune-mediated" diseases after the Sanofi merger, chief executive Martin Babler said.

The French company said it aims to complete the acquisition between October and December 2020.

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-

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

Sanofi to pay $25 million in US over bribery probe

NEW YORK - French pharmaceutical giant Sanofi will pay more than $25 million to settle US charges over bribery committed in Kazakhstan and the Middle East, US authorities announced Tuesday.

The US Securities and Exchange Commission said Sanofi employed a kickback system in Kazakhstan to win public contracts and increase prescriptions of its products. 

In the Middle East, the company employed "pay-to-prescribe" schemes to induce healthcare providers to increase their prescriptions of Sanofi products, the agency said.

"Bribery in connection with pharmaceutical sales remains as a significant problem despite numerous prior enforcement actions," said Charles Cain an SEC enforcement official who leads the unit on the Foreign Corrupt Practices Act.

"While bribery risk can impact any industry, this matter illustrates that more work needs to be done to address the particular risks posed in the pharmaceutical industry," Cain said.

The probe covered Sanofi and its affiliates in Kazakhstan, Jordan, Lebanon, Bahrein, Kuwait, Qatar, Yemen, Oman and the United Arab Emirates for activities between 2006 and 2015.

Sanofi did not admit or deny any wrongdoing.

source: news.abs-cbn.com

Sanofi may seek U.S. approval for Dengvaxia

PARIS - Sanofi will decide shortly whether to seek regulatory approval for its dengue vaccine Dengvaxia in the United States and remains committed to the medicine despite a health scare in the Philippines, a senior executive said on Wednesday.

David Loew, head of Sanofi Pasteur, the French drugmaker's vaccines division, said his teams had complied with all regulations regarding Dengvaxia and had no regrets about the way the product had been developed.

The Philippines, where more than 800,000 school-age children were vaccinated in 2016, suspended a vast public immunisation programme last year because of safety concerns.

Sanofi warned in November that the use of Dengvaxia was to be limited due to evidence it can worsen the disease in people who have not previously been exposed to the infection.

In February, a Philippine government agency filed a lawsuit against Sanofi, demanding compensation for the parents of a 10-year-old girl who the agency said had died as a result of receiving Dengvaxia.

Sanofi has repeatedly said it knew of no deaths resulting from the vaccine. While some experts have said the company and regulators might have ignored warnings about how the vaccine was developed, executives at Sanofi deny any wrongdoing.

"On the whole path of development, we always worked with the World Health Organisation (WHO) and experts in the dengue community. We were always transparent," Loew told Reuters in an interview, referring to the WHO and other regulators.

"You need to ask yourself: what was done with the information that was available at the time? Looking back, I would say no, we would not have done anything differently."

Mosquito-borne dengue is the world's fastest-growing infectious disease, afflicting up to 100 million people worldwide. It causes half a million life-threatening infections and kills about 20,000 people, mostly children, each year.

Loew said the company would decide within two months whether to make a regulatory filing for Dengvaxia with the U.S. Food and Drug Administration.

He also said Sanofi was holding discussions with external partners and universities to come up with a test which would be applicable before vaccination. Such a test would take at least two years to bring to the market.

"We operate in environments where the temperature is 30-40 degrees Celsius so you want to be sure that the tests resist (...) If you have a vaccination campaign taking place in a school for example, you want to make sure it is 'implementable,'" he said.

Dengvaxia has been approved and registered in 19 countries so far, mostly in the developing world. It is currently under review by the European Medicines Agency.

Sanofi booked an impairment charge of 87 million euros ($108 million) related to Dengvaxia in its fourth-quarter results.

Loew said the prospect of another financial charge this year was "extremely low."

source: news.abs-cbn.com

Brazil approves dengue vaccine

Brazil became the first South American country Monday to authorize the world's first-ever dengue fever vaccine, which its French manufacturer says has the potential to save hundreds of lives here.

The tropical disease, a flu-like illness carried by mosquitoes, killed 839 people this year in Brazil and infected more than 1.5 million.

The sprawling South American country's decision to allow the new vaccine, called Dengvaxia, is a coup for French pharmaceutical giant Sanofi, which has now gotten the green light from regulators in three countries.

Mexico became the first country to allow the vaccine on December 9, and the Philippines followed suit last week.

Sanofi has requested regulatory approval in 20 countries across Asia and Latin America.

The vaccine is a potential "blockbuster" drug for the company, which estimates it could generate more than $1 billion a year in revenue.

The Brazilian government said regulators must still set a price per dose, a process that takes about three months on average.

A separate review would have to be carried out for the vaccine to be incorporated in the national vaccination plan, a health ministry official told AFP.

Scientists have long been stumped by dengue, which has four separate strains.

Clinical tests -- carried out on 40,000 people from 15 countries -- have found Dengvaxia can immunize two-thirds of people aged nine years and older, rising to 93 percent for the more severe form of the disease, dengue hemorrhagic fever.

Dengue infects as many as 400 million people per year, and the deadliest form kills 22,000 per year, says the World Health Organization.

It was once considered a disease of the tropics, endemic in only nine countries.

But globalization, urbanization, climate change and air travel are helping it to move into more temperate zones. It is now endemic in more than 100 countries.

The WHO says cases have risen 30-fold over the last 50 years, with more than half the world's population potentially at risk.

The 20 countries where Sanofi Pasteur hopes for regulatory approval have a total population of two billion people -- 200 million of them in Brazil.

source: www.abs-cbnnews.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