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Wednesday, August 12, 2020

Mexico’s new warning labels on junk food meet supersized opposition from U.S., EU

The United States, European Union, Canada and Switzerland, home to some of the world’s biggest food companies, have pressed Mexico to delay upcoming health warnings on processed food and drinks, a World Trade Organization document showed.
The Mexican standard, scheduled to take effect in October, will require front-of-pack nutrition labeling that clearly describes the health risks posed when those products are high in sugars, calories, salt, and saturated or trans fat.
Mexico, the largest consumer of processed food in Latin America and the fourth-largest in the world, has long struggled with high rates of obesity and diabetes. That health crisis has been exacerbated by the novel coronavirus, which hits people suffering from those illnesses particularly hard.
Obesity reached epidemic proportions in Mexico after it joined the North American Free Trade Agreement with the United States and Canada in the early 1990s, making processed food more easily available, several studies have shown.
Last week, the southern Mexican state of Oaxaca banned the sale, distribution and advertising of junk food and sugary drinks to children, becoming the nation’s first state to do so.
According to WTO minutes of a May 13-14 meeting of the Committee on Technical Barriers to Trade, published on Monday, the U.S. delegation said it supports Mexico’s public health objective of reducing diet-related non-communicable diseases but that it was concerned the planned labeling may be “more trade restrictive than necessary to meet Mexico’s legitimate health objectives.”
“Mexico has chosen more stringent nutrient thresholds than the thresholds set by other countries,” the U.S. delegation said, citing the views of the government and nine trade groups.
The United States, Switzerland, Canada and the EU opposed the Oct. 1 implementation date. Washington and the EU sought a two-year delay while Canada asked for the start to be pushed back 12 months. Switzerland urged postponement without specifying a timeline.
Washington said a delay was needed “in light of the COVID-19 global pandemic, which has placed significant pressure on the food and beverage industry.”
The Mexican government did not immediately respond to a request for comment. But a Mexican government official with knowledge of the matter, who declined to be named, said: “We told them there would be no additional time.”
Pepita Barlow, assistant professor of health policy at the London School of Economics and Political Science, said countries that are home to major multi-national food corporations such as Switzerland, the United States and EU most frequently opposed new food standards, focusing on trade costs and profits.
The Mexican government official said the countries opposing Mexico’s standard were acting in a last-ditch effort to derail the changes and putting their concerns ahead of public health.
The Mexican private sector has also opposed the new rules. Jaime Zabludovsky, president of lobby group ConMexico which represents food and beverage companies, recently said the labels would confuse the public, according to Mexican media outlet Aristegui Noticias.
The government official said Coca-Cola Co (KO.N), PepsiCo Inc (PEP.O), Nestle (NESN.S) and Mexican breadmaker Grupo Bimbo (BIMBOA.MX) were among companies that asked for a delay.
The companies did not immediately respond to requests for comment. Representatives at the U.S., EU, Canadian and Swiss embassies did not respond to requests for comment.

Germany says Russian COVID-19 vaccine has not been sufficiently tested

German Health Minister Jens Spahn on Wednesday said Russia’s COVID-19 vaccine had not been sufficiently tested, adding the aim was to have a safe product rather than just being first to start vaccinating people.
President Vladimir Putin announced on Tuesday that Russia had become the first country to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing.
Moscow’s decision to grant approval before final trials have been completed has raised concerns among some experts.
“It can be dangerous to start vaccinating millions, if not billions, of people too early because it could pretty much kill the acceptance of vaccination if it goes wrong, so I’m very sceptical about what’s going on in Russia,” Spahn told radio broadcaster Deutschlandfunk.
“I would be pleased if we had an initial, good vaccine but based on everything we know – and that’s the fundamental problem, namely that the Russians aren’t telling us much – this has not been sufficiently tested,” he added.
Spahn said it was crucial, even during a pandemic, to carry out proper studies and tests and make the results public to give people confidence in the vaccine.
“It’s not about being first somehow – it’s about having an effective, tested and therefore safe vaccine,” he said when asked about Russia’s vaccine, which will be called “Sputnik V” in homage to the world’s first satellite launched by the Soviet Union.
Only about 10% of clinical trials are successful and some scientists fear Moscow may be putting national prestige before safety.
Putin and other officials have said it is completely safe. Government officials have said it will be administered to medical personnel, and then to teachers, on a voluntary basis at the end of this month or in early September. Mass roll-out in Russia is expected to start in October.

Russia says allegations COVID-19 vaccine is unsafe are groundless

Russian Health Minister Mikhail Murashko said on Wednesday allegations that Russia’s COVID-19 vaccine was unsafe were groundless and driven by competition, the Interfax news agency reported.
President Vladimir Putin said on Tuesday that Russia had become the first country to grant regulatory approval to a COVID-19 vaccine, after less than two months of human testing.
Moscow’s decision to grant it approval has raised concerns among some experts. Only about 10% of clinical trials are successful and some scientists fear Moscow may be putting national prestige before safety.

Evotec SE reports 1H results

Evotec SE (OTCPK:EVOTF): 1H net income of €7.3M
Revenue of €231M (+11.5% Y/Y)

Tuesday, August 11, 2020

Sinovac launches Phase 3 trial for Covid vax in Indonesia, reports Phase 2 details

China’s Sinovac Biotech Ltd launched a late-stage human trial on Tuesday that will involve as many as 1,620 patients in Indonesia for a COVID-19 vaccine candidate that it is developing with Indonesian state-owned peer Bio Farma.

Separately, Sinovac released details on Monday from a mid-stage, or Phase 2, study in which it said the vaccine candidate appeared to be safe and induced detectable antibody-based immune responses in subjects.
The candidate, known as CoronaVac, is among a few potential vaccines that have entered late-stage trials for a large-scale study to gather proof of efficacy for regulatory approval.
CoronaVac is already undergoing a late-stage trial in Brazil and Sinovac expects to also test it in Bangladesh.
Sinovac’s Indonesia trial comes as Southeast Asia’s most populous country grapples with spiking infection numbers, with over 127,000 cases recorded as of Tuesday. The trial has so far recruited 1,215 people and will last six months.
“The threat of COVID-19 will not subside until a vaccine is given to all the people,” said Indonesian President Joko Widodo at a ceremony to launch the trial in Bandung, West Java. “Hopefully in January, we can produce and vaccinate everyone in the country.”
In addition to Bio Farma and Sinovac, private Indonesian firm Kalbe Farma and South Korea’s Genexine are cooperating to produce a separate vaccine. It is yet unclear how many doses these partnerships will produce and by when.
In Sinovac’s mid-stage trial involving 600 participants in China, the rate of fever in patients was relatively lower than other COVID-19 candidates including one from AstraZeneca, the study showed ahead of peer review.
Mid-stage trials usually test a candidate’s safety and ability to trigger an immune response in a relatively small number of people before it enters late-stage tests.
The study noted that the process to make the vaccines used in the Phase 2 trial was more optimised than in Phase 1, which produced more immunogens and triggered better immune responses.
Vaccines used in the late-stage trials will be made using the optimised process, a Sinovac spokesman said.
The Phase 2 results only included antibody-based immunity, the researchers said, adding that the candidate was being evaluated for other important components of the immune system.
Sinovac is testing its vaccine abroad because China is no longer a satisfactory site for late-stage trials due to the low number of new infection cases.

Bayer to buy KaNDy Therapeutics

Bayer AG will acquire U.K.-based biotech company KaNDy Therapeutics Ltd. in order to expand its women’s health-care pipeline with a potential new medicine, both companies said Tuesday.
“KaNDy Therapeutics recently completed the Phase IIb with NT-814, a first in class, non-hormonal, once-daily, oral neurokinin-1,3 receptor antagonist, publishing positive data for the treatment of frequent symptoms of the menopause, hot flashes and night sweats,” it said.
The phase 3 clinical trial should start in 2021 and, once the medicine is approved, it could generate peak sales potential of more than 1 billion euros ($1.17 billion) globally, they said.
Under the deal, the German pharmaceutical and chemical conglomerate will pay an upfront consideration of $425 million and a potential additional consideration in the form of milestone payments, the companies said.
The deal includes “potential milestone payments of up to $450 million until launch followed by potential additional triple-digit million sales milestone payments,” they said.
The deal is expected to close by September 2020, once approved by antitrust authorities in particular, they said.

NOVO NORDISK Receives a Buy rating from Goldman Sachs

In a research note published by Jonathan Kownator, Goldman Sachs advises its customers to buy the stock. The target price is lowered from DKK 475 to DKK 484.